| 16 Aug 2012 | Southern Home Cranberry Nut Antioxidant Blend, Trail Mix, Net Wt. 16oz. (1 LB) 454g, Distributed by Southern Home, P.O. Box 99, Mauldin, SC 29662. (62901) | Winn Dixie Stores, Inc. | Food | Class II | 1 |
| 10 Aug 2012 | Cilantro, 2.5 dozens, 30 bunches/case (62806) | Fresco Green Farms, Inc. | Food | Class I | 1 |
| 9 Aug 2012 | AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device | AGFA Corp. | Device | Class II | 1 |
| 9 Aug 2012 | Pine Nuts, 5lbs, Item 40476-214, UPC 8 12986 01288. (62802) | Essential Living Foods, Inc | Food | Class I | 1 |
| 9 Aug 2012 | Spartan/Fresh Selections Wedge Sandwich W/Sandwich Spread 4oz (62951) | Spartan Central Kitchen | Food | Class II | 1 |
| 8 Aug 2012 | Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 16 PET/CT, GEMINI GXL 16 PET/CT, GEMINI TF Big Bore PET/CT, Philips Medical Systems, Cleveland, OH. The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 7 Aug 2012 | Two Moms in the Raw, Gluten-Free Pesto Sea Cracker enclosed in brown semi-synthetic packaging with a transparent section displaying the contents. Labeling on the product is green, white, and blue with blue, green, and red print writing. (62777) | 2 Moms in the Raw, LLC | Food | Class I | 1 |
| 7 Aug 2012 | Frozen fermented seasoned oysters, bulk packaged 22 lbs per case. (62616) | Individual firm, name withheld | Food | Class II | 1 |
| 6 Aug 2012 | Menno Beachy, Cresco, IA Certified Organic Grape Tomato packaged in 1-pint square-shaped clear plastic clamshell containers, UPC 044419310176, 12/1-pint. containers per case. (62793) | Individual firm, name withheld | Food | Class I | 1 |
| 3 Aug 2012 | The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 3 Aug 2012 | Medstream 81" (206 cm) 20 Drop Standard bore Universal Administration Set with Y-Site, Sterile Manufactured for MSD (Medical Specialties Distributors LLC, Stoughton, MA. Product of China Product Number: MS721 Disposable Infusion set (62747) | Medical Specialties Distributors, Inc. | Device | Class II | 1 |
| 3 Aug 2012 | Organic Pinenut, 25 kg, Product of China | Specialty Commodities, Inc. | Food | Class I | 1 |
| 2 Aug 2012 | Crispy Punjabi Cookies, By TWI Foods, Net Wt. 800g/1.76 lb, Manufactured by TWI Foods, Inc. 1-866-9-CRISPY, www.crispyjustbaked.com, UPC 627265001520, Product of Canada. | Deep Foods Inc | Food | Class I | 1 |
| 31 Jul 2012 | DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of the product Product Usage: Description: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 30 Jul 2012 | Trader Joe's Roasted Butternut Squash, Red Quinoa and Wheatberry Salad, 9.5 oz. Product packaged in plastic tray with plastic lid. 18 units/basket. (62686) | Huxtable's Kitchen Inc | Food | Class I | 1 |
| 30 Jul 2012 | 4/5 SYS SLICED YELLOW ONIONS, 720621 SUPC 1232222, Distributed by: SYSCO | St Clair Foods, Inc. | Food | Class I | 2 |
| 30 Jul 2012 | Crispy Just Baked Punjabi Cookies 800g, 14 cartons/case. (62781) | Shah Distributors, Inc | Food | Class I | 1 |
| 27 Jul 2012 | Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component. | Biomet U.K., Ltd. | Device | Class II | 1 |
| 27 Jul 2012 | IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF) | AGFA Corp. | Device | Class II | 1 |
| 27 Jul 2012 | Kaiser Rolls, Seeded Rolls, Brat Buns, French Bread, Pretzel Rolls, Pretzels, Pizza Dough, Hoagie Rolls and French Baguettes each packaged in identical semi-transparent plastic bags identified as fresh from the OVEN SOUR DOUGH 12 KAISER ROLLS, NET WT 20 OZ, WIMBERGER'S OLD WORLD BAKERY 2321 Bott St., Colorado… (62671) | Wimberger's Old World Bakery, Inc. | Food | Class I | 1 |
| 27 Jul 2012 | Conch Salad w/onions. Product is labeled in part: "***KEYS FISHERIES CONCH SALAD***Ingredients Ground Conch, Fresh tomatoes, Fresh Cucmber, Mojo (grapefruit juice, lime juice, orange juice, extra virgin olive oil, garlic, onion, sugar, spices, cumin) Tomatoe juice, Line juice, Parsley, Black pepper, Salt, Spices,… (62753) | Keys Fisheries, Inc. | Food | Class I | 1 |
| 27 Jul 2012 | Diced Yellow Onion. 1) Product is labeled in part: "***Onion Yellow Diced***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" "***FC Onion Yellow Diced***ORB***Orthodox Rabbinical Board of Broward and Palm Beach Counties***Refrigerate at 34 F***" Item # 159280 Onion Yellow… | FreshPoint South Florida | Food | Class I | 10 |
| 26 Jul 2012 | Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data Perfusion oftware and the system. The data… | Terumo Cardiovascular Systems Corporation | Device | Class II | 4 |
| 26 Jul 2012 | System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 26 Jul 2012 | Yellow onions Diced 3/8", packaged in 25-lb. plastic bags, 1 per case (item 19551); Diced 1/4", packaged in 5-lb. bags, 2 per case (item #19516), 4 per case (item 19510), and 1 per case (item 19515). Diced yellow onion packaged in 5-oz. plastic containers, 4 per case, UPC 815970010153, and 10-oz. plastic containers,… | Cool Creations, LLC | Food | Class I | 19 |
| 26 Jul 2012 | Crispy Just Baked Punjabi Cookies, packaged in clear clam shell container and sealed in clear plastic wrap. Net weight is 800 gram (1.76 lb). The UPC is 6 27265 00152 0. The product is labeled in parts: "***CRISPY PUNJABI COOKIES Just Baked!***By TWI Foods***Ingredients: Wheat Flour, soybean oil, margarine, sugar,… (62694) | Reshmi's Group Inc. | Food | Class I | 1 |
| 26 Jul 2012 | Tartar Sauce sold under the following brand names: 1) Golden Corral Tartar Sauce, 1 gallon,refrigerated Product Code: GD2517; 2) Fatz Tartar Sauce, 1 gallon cases, refrigerated, Product Code FD0666; 3) Ken's Tartar Sauce, 1 gallon cases refrigerated, Product Code: KE0666, 1.5 oz. cups, Product Code: KE066A5 | Ken's Foods, Inc. | Food | Class I | 3 |
| 26 Jul 2012 | Cut N Clean Greens Comfort Greens Kit, Ready-to-Cook Kit, 24 oz. Packaged in 24 oz plastic clamshell at 6 per case. This product is sold as a 24oz clamshell (plastic container with lid) cooking greens kit. Product is identifiable by the UPC Number 028764000616 this is located on the back label of the product. Product… (62718) | San Miguel Produce, Inc. | Food | Class I | 1 |
| 26 Jul 2012 | CRISPY Just Baked Punjabi Cookies by TWI Foods, Net Wt 800 gr, (1.76 lbs, 28.2 oz). Product of Canada Manufactured by TWI Foods, Mississauga, Ontario, Canada. (62727) | Nuts and Spice Co., Inc. | Food | Class I | 1 |
| 26 Jul 2012 | Crispy By TWI Foods Punjabi Cookies Just Baked Product of Canada 2600 Drew Road, Mississauga, ON Canada L4T 3M5 Net Wt. 800g/1.76 lb Ingredients: Wheat Flour, soybean oil, margarine, sugar, semolina, baking powder, ammonium carbonate. (62693) | Fahman Enterprises, Inc | Food | Class I | 1 |
| 26 Jul 2012 | NO LABEL. Sub sandwiches are prepared fresh - made to order - wrapped in paper and then a generic label applied. The scale label would only state 1/2 sub or whole sub and the price from the Publix Deli. Publix does not have a mechanism to track sub sandwiches prepared with fresh onions. | Publix Super Markets, Inc. | Food | Class I | 1 |
| 26 Jul 2012 | Asian Stir Fry, packaged under the following labels and sizes: Delish, 8.5 oz. Albertson's Generic Label, 10 oz, Chef Essentials - 10 oz. Raley's, 10 oz. Manufactured by GH Foods CA LLC, Rancho Cordova, CA. | GH Foods CA LLC | Food | Class I | 33 |
| 25 Jul 2012 | Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic… | Philips Healthcare Inc. | Device | Class II | 1 |
| 25 Jul 2012 | Topiramate Tablets, 50 mg, 30-count (3 x 10) unit-dose blisters per carton, Rx only, Mfd by: Cadila Healthcare Ltd., Ahmedabad, India; Dist By: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, Pkg by: American Health Packaging, Col. OH 43217, NDC 68084-343-21, blister barcode 6808434311 | American Health Packaging | Drug | Class III | 1 |
| 25 Jul 2012 | Onions Diced. Products are labeled in part: "***Onions Yellow Diced***Ready To Eat Product***4/5 LB***Slot Location***". "***FP CENTRAL FL. FRESHCUTS ONIONS, FC YELLOW DICED***4/5#***RT # FC***" Item # 599104 ONIONS, FC YEL DICED 1/4" CORONADO 4/5# bags; Item # 599645 ONIONS, FC YELLOW DICED 1/2" 4/5# bags; Item #… | FreshPoint Central Florida | Food | Class I | 15 |
| 25 Jul 2012 | Processed Yellow Onions - Yellow Sliced 1/8", 1/4" and 3/16" | Freshpoint Atlanta, Inc. | Food | Class I | 13 |
| 25 Jul 2012 | Brand name is Yatta. OYSTERS 1/2 SHELL 144CT, PRODUCT OF KOREA | Icrest International LLC | Food | Class II | 4 |
| 24 Jul 2012 | Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 24 Jul 2012 | OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7. (62643) | Cadence Pharmaceuticals | Drug | Class II | 1 |
| 24 Jul 2012 | Crispy Just Baked Punjabi Cookies sold in 800 gr clamshell packages. Manufactured by : TWI Foods, Inc., Mississauga, ON, Canada. (62666) | CHETAK SAN FRANCISCO LLC. | Food | Class I | 1 |
| 24 Jul 2012 | CRISPY Just Baked Punjabi Cookies 800 g/1.76 lb (28.2 oz): Product of Canada Manufactured by: TWIK Foods Inc. Mississauga, ON, Canada. (62672) | Shah Distributors | Food | Class I | 1 |
| 23 Jul 2012 | Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #: CMS-1667-R2(94-2478), Manufactured for KM Medical, Inc., 124 Jewett Street, Georgetown, MA 01833, the tray also contains other components not listed in this product description. | Custom Medical Specialties, Inc. | Drug | Class II | 3 |
| 23 Jul 2012 | Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90. | Stat Rx USA | Drug | Class III | 1 |
| 23 Jul 2012 | Crispy Just Baked Punjabi Cookies, packaged in clear clam shell container and sealed in clear plastic wrap. Net weight is 800 gram (1.76 lb). The UPC is 6 27265 00152 0. The product is labeled in parts: "***CRISPY PUNJABI COOKIES Just Baked!***By TWI Foods***Net Wt. 800 g/1.76 lbs***Ingredients: Wheat Flour, soybean… (62701) | Mother India foods LLC | Food | Class I | 1 |
| 23 Jul 2012 | Sunrise Indian Corn Candy which is packaged in 16 oz clear plastic tubs/12 tubs per case | Mount Franklin Foods LLC | Food | Class I | 2 |
| 20 Jul 2012 | Visual-ICE¿ Cryoablation System, Model FPRCH 6000 Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is… (62871) | Galil Medical, Inc. | Device | Class II | 1 |
| 20 Jul 2012 | TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. | Teleflex Medical | Device | Class III | 1 |
| 20 Jul 2012 | Spillson's Texas BBQ Beef Sandwich, 4 oz. | Spillson's, Ltd. | Food | Class I | 17 |
| 18 Jul 2012 | The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 18 Jul 2012 | Trabecular Metal Reverse Shoulder Liner 40mm, part 00-4309-028-00 - Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly… | Zimmer, Inc. | Device | Class II | 4 |
| 18 Jul 2012 | Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.… | Nellcor Puritan Bennett Inc. (dba Covidien LP) | Device | Class I | 1 |
| 18 Jul 2012 | WE-24541 Vit/Min Premix Toddler (1-4 yr old) w/o DHA*ARA, NET WEIGHT 22.68 KG (62608) | The Wright Group dba Wright Enrichment, Inc. | Food | Class I | 1 |
| 18 Jul 2012 | Wellements Baby Move Prune Concentrate with Prebiotics, 4oz., 12 units per case, SKU# 141161, UPC 729609019878. (62615) | Wellements, LLC | Food | Class I | 1 |
| 17 Jul 2012 | Siemens ADVIA Centaur¿ Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usage: The ADVIA Centaur Syphilis (SYPH) assay is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA, lithium or sodium heparinized,… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 17 Jul 2012 | RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spinal, and neurosurgical applications. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 2 |
| 17 Jul 2012 | Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose… | Conformis Inc | Device | Class II | 1 |
| 17 Jul 2012 | Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimension(R) clinical chemistry analyzers are floor model, fully automated, microprocessor-controlled, integrated instrument systems that use prepackaged Flex(R) reagent test cartridges to measure a variety of analytes in… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 17 Jul 2012 | 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR… | Nico Corp. | Device | Class II | 2 |
| 17 Jul 2012 | Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system. | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 17 Jul 2012 | Libby's Gourmet Desserts brand pecan pie. Pies placed in metal pie tins which are then put in a cardboard sleeve with plastic wrapping (62688) | Individual firm, name withheld | Food | Class II | 1 |
| 17 Jul 2012 | Diced Yellow Onions, 7oz, UPC 643550000405, Gills Onions Label; Diced Yellow onions, 5lb bag, UPC 898634001018, True Leaf label; Diced Yellow onions, 8oz, UPC 643550000498, clear plastic containers sold in Wegmans stores; Diced Yellow Onions, Oignons jaunes frais, en des, 198 grams, UPC 643550000443, Gills Onions… | Gills Onions, LLC | Food | Class I | 11 |
| 16 Jul 2012 | djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair | Encore Medical, Lp | Device | Class II | 1 |
| 16 Jul 2012 | Apple Pies Case Label (side 1) 24 COUNT FRAGILE FLYWHEEL'S PIES, PRESCOTT, AR Ingredients: Cocoa, Coconut, Sugar, Butter, Vanilla, Cornstarch, Eggs Case Label (side 2) 24 COUNT FRAGILE FLYWHEEL'S PIES PRESCOTT, AR Ingredients: Fruit, Sugar, Butter, Almond, Salt. Pie Label: Apple | Individual firm, name withheld | Food | Class II | 14 |
| 16 Jul 2012 | Meiko Foods Co. Inc. Cooked Shrimp Balls, 8 oz. Product labeling reads in part:" TOM VIEN COOKED SHRIMP BALLS***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box. | Meiko Food Company Inc | Food | Class II | 4 |
| 14 Jul 2012 | The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crated for shipping. | Steris Corporation | Device | Class II | 1 |
| 14 Jul 2012 | Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The Dyonics Electroblade Resector is effective in soft and osseous… | Smith & Nephew, Inc. Endoscopy Division | Device | Class II | 2 |
| 13 Jul 2012 | syngo Dynamics Version 9.5 | Siemens Medical Solutions, USA, Inc | Device | Class II | 1 |
| 13 Jul 2012 | INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems. | Intuitive Surgical, Inc. | Device | Class II | 6 |
| 13 Jul 2012 | Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets per case; Made in Costa Rica, Hospira,… | Hospira Inc. | Device | Class II | 1 |
| 13 Jul 2012 | The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage. | Zimmer, Inc. | Device | Class II | 1 |
| 13 Jul 2012 | AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Product Usage: The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing. | Baxter Healthcare Corp. | Device | Class I | 4 |
| 13 Jul 2012 | Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids. (62520) | Westone Laboratories, Inc. | Device | Class II | 1 |
| 13 Jul 2012 | Strawberry Filled Cake, 21.9 oz (1lb 6oz) (620g), UPC 3 760147 195867 | Individual firm, name withheld | Food | Class II | 2 |
| 13 Jul 2012 | Nature's Grain Garlic French Bread, 10 oz (284 g) packages, (62552) | Southern Bakeries, LLC | Food | Class II | 1 |
| 12 Jul 2012 | Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 12 Jul 2012 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3. | Noven Pharmaceuticals, Inc. | Drug | Class II | 3 |
| 12 Jul 2012 | Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30, | Axcentria Pharmaceuticals LLC | Drug | Class III | 1 |
| 11 Jul 2012 | Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R. | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 11 Jul 2012 | Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use. | Philips Healthcare Inc. | Device | Class II | 1 |
| 11 Jul 2012 | Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System | Philips Healthcare Inc. | Device | Class II | 1 |
| 11 Jul 2012 | Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment… | Straumann USA, LLC | Device | Class II | 1 |
| 11 Jul 2012 | Cheese Pizza. Label is not provided. Product is packaged and delivered in bulk. | KT Specialty Foods Inc. | Food | Class II | 3 |
| 10 Jul 2012 | IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non-invasive vascular disease management.… | AGFA Corp. | Device | Class II | 1 |
| 10 Jul 2012 | Chromovision High Definition (HD) Wireless Camera, Pt # CC-9715900. Visual recording of surgical procedures. | Berchtold Corp. | Device | Class III | 1 |
| 9 Jul 2012 | SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2). | Sentec AG | Device | Class II | 1 |
| 9 Jul 2012 | IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only. | Iris Diagnostics | Device | Class III | 1 |
| 9 Jul 2012 | Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern | Beekley Corporation | Device | Class II | 4 |
| 9 Jul 2012 | Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange. (62563) | Apheresis Technologies, Inc. | Device | Class II | 1 |
| 9 Jul 2012 | Dinner Rolls, 12 oz. net weight,, manufactured by Italian Peoples Bakery, 61-63 Butler Street, Trenton, NJ 08611; | Peoples Bakery Inc | Food | Class I | 3 |
| 9 Jul 2012 | Hannaford Meatball Panini - cold, UPC # 941260723096 Hannaford Meatball Panini - hot, UPC # 94126072102 Packaged in 10 oz plastic clamshell (62548) | Individual firm, name withheld | Food | Class I | 1 |
| 6 Jul 2012 | Finapres Medical Systems Portapres with NiMh battery pack Product Usage: Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used. (62556) | FMS, Finapres Medical Systems BV | Device | Class II | 1 |
| 6 Jul 2012 | Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated… (62528) | Baxter Healthcare Renal Div | Device | Class II | 1 |
| 6 Jul 2012 | PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch. | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 1 |
| 6 Jul 2012 | Peppermint Bon Bon Light Ice Cream under the following three brands: Hornbachers, Peppermint Bon Bon Light Ice Cream, Half Gallon (1.89 L), UPC 41130-21663, Distributed by Supervalu Inc, Eden Prairie, MN 55344. SunnyBrook, Peppermint Bon Bon Light Ice Cream, Half Gallon (1.89 L), UPC 70422-24919, Distributed by Mason… (62513) | Cass Clay Creamery AMPI Fargo Division | Food | Class I | 1 |
| 6 Jul 2012 | Chocolate, 1pt., UPC 8 52244 00300 8 | Arctic Zero, Inc. | Food | Class I | 10 |
| 5 Jul 2012 | Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces. | Synthes USA HQ, Inc. | Device | Class I | 1 |
| 5 Jul 2012 | The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and… | Radiometer America Inc | Device | Class II | 3 |
| 5 Jul 2012 | Flavored coffee. Cafe Moto Almond Truffle Flavored Coffee, 16 oz. (51441) | Cafe Moto | Food | Class II | 1 |
| 5 Jul 2012 | Great American Seafood Imports Co. Cooked Shrimp Meat. Size: 300/500 count per pound in 2-lb (item #06834) and 5-lb (Item #07756) packages. | Southwind Foods LLC dba Great American Seafood Imports Co. | Food | Class II | 1 |
| 3 Jul 2012 | Smith & Nephew 5.5 mm TWINFIX Ultra Ti Suture Anchor with two #2 ULTRABRAID sutures (blue, blue-COBRAID) with Needles Product Usage: intended for use for the reattachment of soft tissue to bone Part Number: 72202618 | Smith & Nephew, Inc. Endoscopy Division | Device | Class II | 4 |
| 3 Jul 2012 | Multiple lots of cheese produced by Andante Dairy, Petaluma, CA; Sold in 5 oz to 8 oz sizes with no code date or variety information on packaged. Varieties include: Largo, a triple-creme cow's milk, and Picolo, a triple-creme cow's milk. Also made with cow's milk: Pianoforte, Nocturne. Goat's milk cheese varieties:… (62497) | Andante Dairy | Food | Class II | 1 |
| 2 Jul 2012 | Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate. | Beekley Corporation | Device | Class II | 1 |
| 2 Jul 2012 | Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management… | Varian Medical Systems, Inc. Oncology Systems | Device | Class II | 1 |
| 2 Jul 2012 | SPIDER Surgical Instrument: Flexible Clip Applier The SPIDER¿ Surgical Instruments are intended for use in minimally invasive surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during a laparoscopic… (62583) | Transenterix, Inc | Device | Class II | 1 |
| 2 Jul 2012 | 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes. | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 2 Jul 2012 | Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia | Hospira Inc. | Drug | Class III | 1 |
| 29 Jun 2012 | Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV),… | CareFusion 303, Inc. | Device | Class I | 1 |
| 29 Jun 2012 | Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. (62772) | Prometheus Laboratories Inc. | Drug | Class II | 1 |
| 29 Jun 2012 | Aloha Maid Natural brand Coconut Water with Pineapple in 11.5 fl oz (340mL) Can; UPC Code: 8-35146-00818-3; 24 cans per case (4 packs X 6 cans each) Product is processed and packaged by ITO EN (USA) INC., Honolulu, Hi (62472) | Itoen (USA) Inc | Food | Class III | 1 |
| 29 Jun 2012 | 21st Century Foods Soy Tempeh, packaged in 12 lb plastic bags and 8 oz containers (62473) | 21st Century Foods, Inc. | Food | Class II | 1 |
| 29 Jun 2012 | Designer Whey Chocolate, 2lbs, item#10200131, 4 units/case. UPC 8-44334-00131-5. | Designer Protein LLC | Food | Class II | 3 |
| 28 Jun 2012 | STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System… | Advanced Sterilization Products | Device | Class II | 1 |
| 28 Jun 2012 | VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN)… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 28 Jun 2012 | Frozen Fermented Salted and Seasoned Oyster, 39.7 lbs, 2 packs/container. (62784) | SJBW Corp | Food | Class II | 1 |
| 28 Jun 2012 | Oyster Meat Med IQF Farm, OYS101, 10/4lbs., Oyster Meat Large IQF Farm, OYS102, 10/4lbs., Oyster Meat Tiny 8oz IQF Farm, OYS105, 40/8oz., | Pacific American Fish Co Inc | Food | Class II | 3 |
| 27 Jun 2012 | Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of… | Perkinelmer | Device | Class II | 1 |
| 27 Jun 2012 | Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In… | Stryker Medical Division of Stryker Corporation | Device | Class II | 4 |
| 27 Jun 2012 | Nestle Nesquik Chocolate Flavor, chocolate beverage powder, New Wt 48.7 OZ. Product labeling reads in part:"***Nestle Nesquick Chocolate FLAVOR*** NET WT***48.7OZ***DISTRIBUTED BY***NESTLE USA, INC., GLENDALE, CA 91203 USA***". | Nestle USA | Food | Class III | 1 |
| 27 Jun 2012 | Winn-Dixie Cheeseburger Macaroni Skillet Dinner WD Code 202410, Size 5.8 oz (62560) | Winn Dixie Stores, Inc. | Food | Class II | 1 |
| 27 Jun 2012 | Southern Home Pasta Salad Ranch with Bacon, 7.5 oz., UPC 0788002891, 12 packages per case | Southern Home | Food | Class II | 2 |
| 26 Jun 2012 | Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions. | Sunrise Medical (US) LLC | Device | Class II | 1 |
| 26 Jun 2012 | BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic… (62450) | Bridgepoint Medical | Device | Class II | 1 |
| 26 Jun 2012 | Whiskey Pecan Cookies, packaged in cellophane sleeve wrap, 9.6 oz each. Sold in individual sleeves or in a case of 6 packages (cello sleeves). | Breadfarm | Food | Class II | 3 |
| 26 Jun 2012 | Frozen Oyster, IQF, Surasang Brand, 1) 8 oz, packed in plastic bags, 40 bags/case, Item No.: 03777; 2) 2.5 lb, packed in plastic bags, 10 bags/case, Item No.: 06413. | Hanmi Incorporated | Food | Class II | 2 |
| 26 Jun 2012 | Maya Kaimal All Natural Coconut Curry Indian Simmer Sauce, Net Wt 15 oz, Medium, Coconut Milk & Ginger (refrigerated product in flexible plastic tub) | Two Chefs On A Roll, Inc | Food | Class II | 1 |
| 25 Jun 2012 | ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 25 Jun 2012 | New England Clam Chowda, pouch 8 lbs., refrigerated. For Institutional Use Only. Mfd. by Plenus Group, Inc., Lowell, MA 01852 Product Number 1023 UPC #: 7 3051691023 3 | Plenus Group Inc. | Food | Class II | 2 |
| 22 Jun 2012 | System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this… | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 22 Jun 2012 | Frozen Yellow Fin Tuna Loins (AAA)Co Treated Skinless Frozen. 44 lbs./carton (3-4 Loins/Case) Imported from Vietnam (62399) | East Bay Seafood Co., Inc. | Food | Class II | 1 |
| 22 Jun 2012 | Hidden Valley Salad Crispins Original Ranch; crisp mini-croutons, crunchy carrot bits and a blend of buttermilk and spices; Net Wt. 2.5 Oz. canister, 12 canisters per case; UPC 10071100 008347 (62288) | Clorox Co (The) | Food | Class II | 1 |
| 21 Jun 2012 | OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK (62698) | Oklahoma Respiratory Care Inc | Drug | Class II | 1 |
| 21 Jun 2012 | Oyster IQF L size Frozen Wild, 10/4lbs. | J F C International Inc | Food | Class II | 6 |
| 20 Jun 2012 | System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the… | Terumo Cardiovascular Systems Corporation | Device | Class III | 1 |
| 18 Jun 2012 | Frozen Oysters (IQF), Net Weight: 30 lbs (6/5lbs). (62941) | J&S Group | Food | Class II | 1 |
| 15 Jun 2012 | Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of… | CareFusion 303, Inc. | Device | Class I | 1 |
| 15 Jun 2012 | Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices. Product Usage: The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with physiological and clinical information that can be useful in diagnosis determination. | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 15 Jun 2012 | Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty | Exactech, Inc. | Device | Class II | 6 |
| 15 Jun 2012 | AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis. (62341) | Angiodynamics Worldwide Headquarters | Device | Class II | 1 |
| 15 Jun 2012 | Itoen Green Tea 11.5 fl oz (340 mL) can. Natural Source of Antioxidants; 0 calories, no sugar: ITO-EN USA Inc. 125 Puuhale Road Honolulu, HI 96819 (62348) | Itoen (USA) Inc | Food | Class II | 1 |
| 14 Jun 2012 | OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures. | OrthoPediatrics Corp | Device | Class II | 1 |
| 14 Jun 2012 | Sonoran Rice, 14 lbs (224 oz). Chonita Foods 847 E. 18th St. Tucson, AZ 85719. (51821) | Namias dba Chonita Foods | Food | Class II | 1 |
| 12 Jun 2012 | Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream Health, Inc., 150 Verona St, Rochester, NY 14608. --- The battery may be sold with the DRX-1 imaging device or as a stand-alone accessory. | Carestream Health, Inc. | Device | Class II | 1 |
| 8 Jun 2012 | NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO.,… | Philips And Neusoft Medical Systems Co., Ltd. | Device | Class II | 1 |
| 8 Jun 2012 | Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700 | Stryker Instruments Div. of Stryker Corporation | Device | Class I | 4 |
| 7 Jun 2012 | EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 7 Jun 2012 | Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 7 Jun 2012 | Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0. | Fougera Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 7 Jun 2012 | Kettle Brand Potato Chips, Sour Cream and Onion, 12/8.5oz, item # 0711387001, UPC 0 84114 11393 1 | Kettle Foods, Inc. | Food | Class II | 4 |
| 6 Jun 2012 | "***Tres Monjitas***Tropical Splash***Guanabana***15 oz***" | Altura Food, Inc. | Food | Class I | 2 |
| 5 Jun 2012 | Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA… | Watson Laboratories Inc | Drug | Class III | 1 |
| 4 Jun 2012 | Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and… | Leica Microsystems, Inc. | Device | Class II | 1 |
| 4 Jun 2012 | Korean Molluscan Shellfish (Seasoned Oysters) 250kg, 1000kg (62294) | Hamchorom Inc. | Food | Class II | 1 |
| 1 Jun 2012 | Frozen Oysters are packaged in 8 oz. 40 oz, and 3 lbs. The item numbers are 06413, 03777, FO/HS-OT8; 136300-20110430. The brand names are Z.Shell Sanggul and Z.Shell HS. (62018) | B & F, Inc., dba Hanmi, Inc | Food | Class II | 1 |
| 1 Jun 2012 | "California Girl" Whole Boiled Oysters, 24/8 oz cans. (51090) | Atlapac Trading Company Inc | Food | Class III | 1 |
| 31 May 2012 | Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small… | Synthes (USA) Products LLC | Device | Class II | 1 |
| 29 May 2012 | Horizon Medical Imaging system. Product Usage: Horizon Medical Imaging is a medical image and information management application that is intended to receive, transmit store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical… (62567) | Mckesson Medical Imaging Group | Device | Class II | 1 |
| 29 May 2012 | Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 info.cp@maquet.com www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures (62471) | Maquet Inc. | Device | Class II | 1 |
| 29 May 2012 | EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 25 May 2012 | Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only. | CareFusion 303, Inc. | Device | Class I | 1 |
| 25 May 2012 | Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model numbers Getinge 9120, 9122, 9125, and… (61974) | Getinge USA Inc | Device | Class II | 1 |
| 25 May 2012 | Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1. | Mallinckrodt Inc. | Drug | Class II | 2 |
| 25 May 2012 | V Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone: 601-866-6746 (61957) | The Menz Club, LLC | Drug | Class I | 1 |
| 25 May 2012 | ACETAZOLAMIDE, LYOPHILIZED 500MG INJECTABLE10 VIAL, 4 VIAL, 5 VIAL, 6 VIAL, 8 VIAL (5 DIFFERENT PRODUCTS) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Drug | Class II | 100 |
| 24 May 2012 | GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3) provided with Advanced Vessel Analysis… | GE Healthcare, LLC | Device | Class II | 1 |
| 23 May 2012 | Eden Quality Product Pasteurized Apple Juice from concentrate vitamin C added in a 46 fluid ounce can. Service Size 8 fl oz. Dist. by S. Bertram Inc., Linden, NJ 07036. Concentrate from China. (62109) | S Bertram Inc. | Food | Class II | 1 |
| 22 May 2012 | 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus… | Synthes USA HQ, Inc. | Device | Class II | 2 |
| 21 May 2012 | VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. | Ortho-Clinical Diagnostics | Device | Class II | 3 |
| 21 May 2012 | INSULIN, LO-DOSE (FROM HUMALOG) 10 UNITS/ML INJECTABLE 10 ML (1 PRODUCT) | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | Drug | Class II | 98 |
| 18 May 2012 | Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 18 May 2012 | Fishery Products International (FPI) Brand : Frozen Breaded Raw Oysters, Net Wt. 10 lbs (4.54 kg) Manufactured by: High Liner Foods, Portsmouth, NH 03801 SKU#: 89695 | High Liner Foods Inc. | Food | Class II | 1 |
| 18 May 2012 | River Ranch brand Three-Color Cole Slaw Mix, 16 oz bag, UPC: 45388-10046; Product is a salad item; bagged in clear polyethylene film (foodservice) and polypropylene/polyethylene (retail). Refrigerate and consume within Best By date. Product is processed and packaged by River Ranch Fresh Foods, LLC, Salinas, CA | River Ranch Fresh Foods LLC | Food | Class I | 87 |
| 15 May 2012 | Oysters, Frozen IQF, packaged in 5 lb bags, 6x5 lb/cartons, labeled in part ***Product of Korea*** (62623) | LD Amory & Company | Food | Class II | 1 |
| 12 May 2012 | HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit). | Hospira Inc. | Drug | Class I | 1 |
| 11 May 2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring. | Edwards Lifesciences, LLC | Device | Class II | 11 |
| 9 May 2012 | Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY (61838) | Grandpa Brands Co | Drug | Class II | 1 |
| 8 May 2012 | Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg fiber drums, Rx only, Art. No. 165811, Bayer Pharma AG, D-13342 Berlin. | Bayer HealthCare Pharmaceuticals Inc. | Drug | Class II | 1 |
| 8 May 2012 | Morton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743. (61818) | Morton Salt Co. | Drug | Class III | 1 |
| 8 May 2012 | Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04 | Hill Dermaceuticals, Inc. | Drug | Class III | 2 |
| 7 May 2012 | BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human use. | JK Products & Services, Inc | Device | Class II | 1 |
| 4 May 2012 | FunFresh Foods World Berry Organic Cacao Nibs 6 oz, packaged in blue, brown, red, white, black and green packaging with red, black, yellow, white, and green print writing. The packaging is resealable. (61795) | FunFresh Foods Inc | Food | Class III | 1 |
| 30 Apr 2012 | Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components. | Zimmer Inc. | Device | Class II | 2 |
| 30 Apr 2012 | ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that… | Stryker Howmedica Osteonics Corp. | Device | Class II | 2 |
| 30 Apr 2012 | Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9 | Apotex Inc. | Drug | Class II | 1 |
| 27 Apr 2012 | Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.). The devices are… (62393) | Respironics, Inc. | Device | Class I | 1 |
| 27 Apr 2012 | Kimberly Clark Patient Warming System - Model 1000 Control Unit. Kimberly Clark Patient Warming System - Model 1000 Control Unit and Energy Transfer Pads is a thermal regulating system, indicated for monitoring and controlling patient temperature. | Kimberly-Clark Corporation | Device | Class II | 1 |
| 25 Apr 2012 | The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW Manufactured by: STRYKER Spine SAS, Z.I.… (62663) | Individual firm, name withheld | Device | Class II | 1 |
| 23 Apr 2012 | LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spine SAS; Z.I MARTICOT-33610-CESTAS-FRANCE; Distributed in the USA by: Stryker Spine. 2 Pearl Ct. Allendale, NJ 07401. Provides access to the thoracic and lumbar spine from a posterior approach via a small incision. (62648) | Individual firm, name withheld | Device | Class II | 1 |
| 18 Apr 2012 | Dried Brewers Yeast TG_YFS004 Naturex 375 Huyler Street, South Hackensack, NJ 07606 USA Phone: 1 201 440 5000 Net Wt 25 kg (62653) | Naturex Inc. | Food | Class III | 1 |
| 17 Apr 2012 | High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV. | ICU Medical, Inc. | Device | Class II | 4 |
| 17 Apr 2012 | Pediatric electrolyte, Fruit Punch flavor---oral electrolyte solution---helps replace fluids & electrolytes---8 FL OZ (236 mL)---UPC Code: 31191129235 Distributed by Duane Reade/(866)375-6925---440 Ninth Ave., NY, NY 10001---Item #51070-8-4- (61726) | Duane Reade Inc | Food | Class II | 1 |
| 13 Apr 2012 | Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately before, during and after the surgical phase.… | Maquet Medical Systems, Usa | Device | Class II | 1 |
| 13 Apr 2012 | Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC… | West-ward Pharmaceutical Corp. | Drug | Class II | 2 |
| 9 Apr 2012 | Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 500 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325 INDIA, NDC 55111-340-05 | Individual firm, name withheld | Drug | Class II | 2 |
| 5 Apr 2012 | Meloxicam Tablets, USP, 15 mg, Rx Only, 100 Tablets per Bottle, Manufactured by: Strides Acrolab Ltd., Bangalore-560 076, India, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-3579-1. | Apotex Corp. | Drug | Class II | 1 |
| 2 Apr 2012 | Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market. They are not intended… | Hill-Rom, Inc. | Device | Class II | 1 |
| 29 Mar 2012 | Chiclets Chewing Gum Fruit Flavors; Made in Lebanon; Manufactured by Cadbury Adams Middle East S.A.L. | Baroody Imports Inc. | Food | Class II | 1 |
| 26 Mar 2012 | TANGO3 Water Storage Tank with Ozone Disinfection System, Tango3, LLC, 132 Citizens Blvd., Simpsonville, KY 40067. Models are WOZ-250-PE, WOZ-240-SS, WOZ-180-SS. The TANGO3 Water Storage Tank with Ozone Disinfection System is intended to be used for disinfection of the water distribution system of a dialysis facility. (62514) | Tango3 LLC | Device | Class II | 1 |
| 23 Mar 2012 | ***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. Intended for surgical placement in the upper or lower jaw to provide a… | Biomet 3i, LLC | Device | Class II | 1 |
| 22 Mar 2012 | Defense Nutrition Warrior Whey Natural Powder, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case. | Defense Nutrition | Food | Class III | 3 |
| 19 Mar 2012 | Model 731 EMV+ Uni-Vent, Impact Instrumentation Inc., 27 Fairfield Place, West Caldwell NJ 07006. Indicated for use in the management of acute or chronic respiratory failure or during resuscitation by providing continuous positive -pressure ventilation. (62535) | Impact Instrumentation, Inc. | Device | Class III | 1 |
| 14 Mar 2012 | Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets per Bottle, Manufactured by: Cadila Healthcare LTD. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-030-10. | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 7 Mar 2012 | i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk… | Abbott Point Of Care Inc. | Device | Class II | 1 |
| 1 Mar 2012 | I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin. | Abbott Point Of Care Inc. | Device | Class II | 1 |
| 24 Feb 2012 | Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human… | Roche Molecular Systems, Inc. | Device | Class III | 1 |
| 24 Feb 2012 | Siemens syngo.plaza. Radiological image processing system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 14 Feb 2012 | Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. | Smiths Medical ASD, Inc. | Device | Class I | 1 |
| 9 Feb 2012 | Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 8 Feb 2012 | The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable products used to cover a fingertip bandage when… (62645) | Afassco Inc | Device | Class II | 1 |
| 1 Feb 2012 | COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample. | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 1 Feb 2012 | i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in… | Abbott Point Of Care Inc. | Device | Class II | 3 |
| 22 Dec 2011 | Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal. | Church & Dwight Inc | Device | Class II | 10 |
| 22 Dec 2011 | Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/-0709/-1113 and 3761-0305/-0709/-1113) and… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 13 Dec 2011 | UniCel DxH Slidemaker Stainer Instrument System, PN 775222. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that… | Beckman Coulter Inc. | Device | Class II | 2 |
| 8 Dec 2011 | PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by… | Tripath Imaging, Inc. | Device | Class II | 4 |
| 2 Dec 2011 | Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion Only, a) Single Use Vial (NDC 42367-203-07), b) 10 Single Use Vials(NDC 42367-203-84), Rx Only, Manufactured by: Cipla LTD, India, Manufactured for: Eagle Pharmaceuticals, Inc. Woodcliff Lake, NJ 07677 USA, Marketed by: The Medicines Company,… (61108) | Eagle Pharmaceuticals Inc. | Drug | Class I | 1 |
| 10 Nov 2011 | Hipoglos Ointment (zinc oxide and lanolin), Helps prevent and treat diaper rash, skin irritation, Manufactured by Laboratorios Andromaco S.A. Av. Quilin 5273, Penalolen, Santiago. www.hipoglos.cl, www.laboratoriosandromaco.cl, Made in Chile, Net wt. per Tube: a) 0.18 oz (5 g), NDC: 50145-111-05; b) 2.2 oz (60 g),… (62541) | Victus, Inc. | Drug | Class II | 1 |
| 17 Oct 2011 | OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee… | Exactech, Inc. | Device | Class II | 1 |
| 17 Oct 2011 | SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing… (62023) | Individual firm, name withheld | Device | Class II | 1 |
| 13 Oct 2011 | UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte… | Beckman Coulter Inc. | Device | Class II | 3 |
| 11 Oct 2011 | Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL. | Beckman Coulter Inc. | Device | Class III | 1 |
| 30 Sep 2011 | Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50 | VistaPharm, Inc. | Drug | Class II | 1 |
| 23 Sep 2011 | Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for… | Exactech, Inc. | Device | Class II | 2 |
| 19 Sep 2011 | .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 12 Aug 2011 | Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use | Sunquest Information Systems, Inc. | Device | Class III | 1 |
| 12 Aug 2011 | CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone. | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 1 |
| 22 Jun 2011 | Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60. | Nephron Pharmaceuticals Corp. | Drug | Class II | 1 |
| 28 Apr 2011 | Sunquest Laboratory SMART & Sunquest Laboratory SMART Select | Sunquest Information Systems, Inc. | Device | Class III | 1 |
| 6 Apr 2011 | Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50 | VistaPharm, Inc. | Drug | Class II | 1 |
| 21 Mar 2011 | Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use. It allows the surgeon to distract the disc space in the lumbar region of the spine using an anterior or anterolateral approach while also allowing them to insert the implant into final… (62415) | Individual firm, name withheld | Device | Class II | 1 |
| 1 Jan 2011 | I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood. | Abbott Point Of Care Inc. | Device | Class II | 1 |
| 26 Apr 2010 | GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5.… | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 1 Feb 2010 | The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a sterile vial to an injection syringe. | Mallinckrodt Inc | Device | Class II | 1 |
| 6 Nov 2009 | 892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and interventional cardiac imaging procedures,… | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 13 Apr 2009 | Sunquest Encompass The reporting site is using the Encompass software in an acute patient care setting. | Sunquest Information Systems, Inc. | Device | Class III | 1 |
| 10 Oct 2008 | GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01. | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 22 Feb 2008 | OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features… | GE OEC Medical Systems, Inc | Device | Class I | 1 |
| 19 Oct 2007 | GEHC OEC 8800 Mobile Fluoroscopic X-ray System, GE Healthcare, Surgery, Salt Lake City, UT. Mobile fluoroscopic examination of human anatomy. | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 2 Apr 2007 | Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such… | GE OEC Medical Systems, Inc | Device | Class I | 1 |
| 27 Mar 2007 | OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical… | GE OEC Medical Systems, Inc | Device | Class II | 3 |
| 20 Nov 2006 | OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic,… | GE OEC Medical Systems, Inc | Device | Class I | 1 |
| 20 Nov 2006 | OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for… | GE OEC Medical Systems, Inc | Device | Class I | 1 |
| 11 Oct 2006 | OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid… | GE OEC Medical Systems, Inc | Device | Class II | 1 |