| 12 Aug 2013 | Penguinos - four cream filled chocolate cupcakes: gluten, wheat & dairy free & vegan; 4 x 2.2oz cupcakes, net wt 8.8 oz. Ingredients: organic unrefined cane sugar, filtered water, expeller pressed canola oil, rice flour, cocoa powder, tapioca starch, potato starch, Ener-G egg Replacer, gluten free rice milk, organic… (65971) | Mariposa Baking Co. | Food | Class II | 1 |
| 7 Aug 2013 | Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36 | Sandoz Incorporated | Drug | Class III | 1 |
| 6 Aug 2013 | Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44872 5. | Novartis Consumer Health | Drug | Class III | 9 |
| 6 Aug 2013 | REEVA (triclosan) Antibacterial Hand Soap and Dishwashing Liquid, Green Apple, 0.10%, 24 fl oz. bottle, Distributed by Aldi Inc,. Batavia, IL 60510; UPC 0 4198 1525 8. (65951) | Showline Automotive Products, Inc. dba US Soaps Mfg. Company | Drug | Class II | 1 |
| 5 Aug 2013 | Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye. (65908) | Medicel Ag | Device | Class II | 1 |
| 2 Aug 2013 | Getinge Assure Accufast Biological Indicators, Catalog Number 61301606636 (50 Pack) and 61301606637 (100 Pack), STEAM --- Manufactured for: Getinge USA, Inc. 1777 E. Henrietta Rd., Rochester, NY 14623. Getinge Assure AccuFast Biological Indicators (BIs) are designed for biological testing of 121¿C, 132¿C, 134¿C and… (65866) | Getinge USA Inc | Device | Class II | 1 |
| 2 Aug 2013 | Ranitidine Hydrochloride Tablets, USP, 150 mg, OTC, a) Equate brand Maximum Strength Acid Reducer, 65 count bottle Dist. By: Wal-Mart Stores, Inc., Bentonville, AR 72710, NDC 49035-404-61 b)Equaline brand maximum strength heartburn relief, , DISTRIBUTED BY SUPERVALU INC., EDEN PRAIRIE, MN 55344, NDC 41163-404-61,… (65885) | Individual firm, name withheld | Drug | Class II | 1 |
| 1 Aug 2013 | Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA | AbbVie Inc. | Drug | Class III | 1 |
| 1 Aug 2013 | Raw Pistachio Halves, 1 pound bag. Item Number 11910, UPC Code: 172043119107; Raw Pistachio Halves, 4 pound bag. Item Number 11911, UPC Code: 172043119114; Raw Pistachio Halves, 10 pound bag in box. Item Number 11912, UPC Code: 172043119121; Raw Pistachio Halves, 25 pound case, bag in box. Item Number 11913, UPC… (65860) | Superior Nut Co. Inc. | Food | Class I | 1 |
| 31 Jul 2013 | Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients. | Arrow International Inc | Device | Class II | 1 |
| 31 Jul 2013 | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6. | Actavis Inc | Drug | Class III | 1 |
| 30 Jul 2013 | Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting and/ or perfusing blood or cardioplegic solution distal to the anastomosis site during the… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 30 Jul 2013 | Lisinopril Tablets, USP, 2.5 mg, Rx only, packaged in a) 100-count bottles (NDC 0143-1265-01) and b) 1000-count bottles (NDC 0143-1265-10), Manufactured by: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724; and c) 1000-count bottles (NDC 24658-240-10), Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134;… | West-Ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 30 Jul 2013 | Belladonna Alkaloids with Phenobarbital Tablets, 1000 count (NDC 0143-1140-10) and 5000 count (NDC 0143-1140-51) PET bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724. | West-Ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 26 Jul 2013 | CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds. | ASO, LLC | Device | Class II | 9 |
| 26 Jul 2013 | Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 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… | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 26 Jul 2013 | 100/120V AC, Advanced Perfusion System 1 Product Usage: 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… | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 26 Jul 2013 | Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: 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… | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 26 Jul 2013 | WHOLEY Shrimp, Farm Raised, Cooked, Peeled Deveined, Tail on, Ingredients: Shrimp, Salt and Sodium Tripolyphosphate..., ,Net Wt 1 LB (16 oz) , 399103 UPC Number: 094776074556; Product of Indonesia | Lipari Foods, Inc. | Food | Class I | 1 |
| 25 Jul 2013 | Stryker Visum 300 Ceiling-mounted Exam Light. (65888) | Individual firm, name withheld | Device | Class II | 1 |
| 25 Jul 2013 | Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons. | Hi-Tech Pharmacal Co., Inc. | Drug | Class III | 1 |
| 25 Jul 2013 | RYBACKA WIES brand HERRING FILLETS IN OIL (MATJES SLEDZ W OLEJU), Net Wt. 17.6 oz. (500g), UPC 0 21143 24122 8, Distributed By Gold Star, Inc., Brooklyn, NY 11231 --- The product is vacuum packed in a sealed plastic package. (65808) | Gold Star Smoked Fish Corp. | Food | Class I | 1 |
| 24 Jul 2013 | GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping,… | Gyrus Medical, Inc | Device | Class II | 1 |
| 24 Jul 2013 | Nestle Nutrition, Compat, Enteral Feeding Tube, sterile, 8 French (REF 08310400), 10 French (REF 08310600), and 12 French (REF 08310500). Product Usage: The Compat Nasogastric Feeding Tube is indicated for the administration of nutrition, fluids and medications into the stomach r small bowel by the naso-enteric,… (65781) | Nestle HealthCare Nutrition | Device | Class II | 1 |
| 24 Jul 2013 | 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw. | OrthoPediatrics Corp | Device | Class II | 1 |
| 24 Jul 2013 | DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07 | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 24 Jul 2013 | Giant Eagle Candy Place Chocolate Covered Peanuts NET WT. 5 OZ, UPC code 3003404313 This product was packaged in a facility that also processes peanuts, nuts, milk products, soy, wheat, sesame seeds, whey and eggs. Distributed By: Giant Eagle, Inc. Pittsburgh, PA 15328-2809 (65801) | Individual firm, name withheld | Food | Class II | 1 |
| 24 Jul 2013 | Evviva Fresh Peach Spumante, UPC 84279-99137 | Johnson Brothers Liquor Company, Inc | Food | Class II | 2 |
| 24 Jul 2013 | Tortillas Lupita White Corn Tortillas, Manufactured by Tortilleria Lupita, 235 SW 25th St, Oklahoma City, OK 73109 (65804) | Tortilleria Lupita, Inc. | Food | Class II | 1 |
| 23 Jul 2013 | Terazosin Hydrochloride Capsules,10 mg, 100-count bottle, Rx only, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-4339-01 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 22 Jul 2013 | Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30 | Torrent Pharma Inc | Drug | Class II | 1 |
| 20 Jul 2013 | Maple flavored lipid-based inclusions. Maple NT-RF and Maple NT-MF, NET WT: 50 lbs, Ingredients: Sugar, vegetable oil (palm, palm kernel), wheat flour, cocoa powder, glucose, extractives of foenugreek, maple sugar, caramel color, soy lecithin. SensoryEffects¿¿ , 136 Fox Run Dr., Defiance, OH 43512 (65845) | SensoryEffects Powder Systems | Food | Class II | 1 |
| 19 Jul 2013 | Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting. | Blue Belt Technologies MN | Device | Class II | 1 |
| 19 Jul 2013 | C-QUR Mesh (All Sizes, shapes). Intended for use in soft tissue deficiencies. | Atrium Medical Corporation | Device | Class II | 4 |
| 19 Jul 2013 | Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53 | Bracco Diagnostics Inc | Drug | Class III | 1 |
| 19 Jul 2013 | 10-inch Supreme Chocolate Layered Cake; 12 units per shipping case (65766) | CSM Bakery Products North America | Food | Class II | 1 |
| 19 Jul 2013 | Plum Organics Mighty 4 Essential nutrition blend; Kale, Strawberry, Amaranth, Greek yogurt in 4 oz pouch. Six pouches per box. USDA Organic. Selling case USPC: 846675003409; Case USPC: 00846675003522 Distributed by Plum Inc., Emery ville, CA. | Plum Inc | Food | Class II | 5 |
| 19 Jul 2013 | FOSFOREL brand Herring Fillet in Oil 400 gram (14 oz.) in plastic packaging containers; refrigerated | Zip International Group LLC. | Food | Class I | 1 |
| 18 Jul 2013 | Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5… | Aspen Surgical Products, Inc. | Device | Class II | 1 |
| 18 Jul 2013 | Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring. | Vital Signs Devices, a GE Healthcare Company | Device | Class II | 1 |
| 18 Jul 2013 | TUMS, Antacid/Calcium Supplement, ULTRA Strength 1000, Assorted Berries, 72 Chewable Tablets, GlaxoSmithKline, Moon Twp, PA 15108, NDC 0135-0181-02 | GlaxoSmithKline, LLC. | Drug | Class III | 1 |
| 18 Jul 2013 | Mild Chunky Salsa, a Home Style Select brand, in 16oz glass jars, UPC: 3927759137; Product is distributed by Dollar Tree; Product is processed and packaged by Olam Tomato Processors, Inc. Lemoore, CA; The label on the salsa indicates distributed by Greenbrier International, Inc., Chesapeake, VA | Olam Tomato Processors, Inc. | Food | Class II | 2 |
| 18 Jul 2013 | Chocolate malted milk balls packaged in 6 lbs. bags and each case contains 3 x 6 lbs. bags; BEST BY 04/17/14; BRCH CHOC (65790) | Ferrara Candy Company | Food | Class I | 1 |
| 17 Jul 2013 | Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples. | Beckman Coulter Inc. | Device | Class II | 1 |
| 16 Jul 2013 | PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters. | Atrium Medical Corporation | Device | Class II | 1 |
| 16 Jul 2013 | Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement. | Zimmer, Inc. | Device | Class II | 1 |
| 16 Jul 2013 | Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 16 Jul 2013 | Pimento Cheese, packaged in 7 oz. plastic containers, and labeled in part ***Made by Whole Foods Market, Landover, MD 20785***UPC: 000000234801 (65737) | Whole Foods Market Mid-Atlantic Kitchen | Food | Class I | 1 |
| 16 Jul 2013 | Square Mile Original Hard Apple Cider is hard cider is in liquid form and is an alcoholic beverage. It is packaged in 22 fl oz glass bottles shipped in a corrugated master carton that contains 12 bottles. Individual bottle is sold at retail stores. UPC codes case: 7-02770-04812-0; UPC Bottle: 7-02770-24810-0; PDCN… | Craft Brewers Alliance Inc. | Food | Class III | 2 |
| 15 Jul 2013 | Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator. | Boston Scientific CRM Corp | Device | Class II | 1 |
| 15 Jul 2013 | Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of… | Nova Biomedical Corporation | Device | Class I | 10 |
| 15 Jul 2013 | StealthStation S7 Framelink Software version 5.4. Aid for locating anatomical structures and planning surgical trajectories in open and percutaneous procedures. | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 15 Jul 2013 | Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02 (65676) | Braintree Laboratories Inc. | Drug | Class III | 1 |
| 15 Jul 2013 | Hummus is packed in 1.5 oz plastic portion cups with foil peel lids, 100 cups in a case. The product labeled in parts: "***HUMMUS***1.5 oz*** KEEP REFRIGERATED*** (65768) | Northwest Gourmet Food Products, Inc. | Food | Class I | 1 |
| 13 Jul 2013 | Penny's Garlic Hummus 12 oz has UPC 7 49404 83061 4; Harbor Greens Garlic Hummus 8 oz has UPC 7 49404 802123; Tacoma Boys Garlic Hummus 8 oz has UPC 7 49404 902120; The 1 Gallon hummus does not have any brand name and does not have any UPC. | Hagee Foods Inc. | Food | Class I | 9 |
| 12 Jul 2013 | IsoGel AIR 84, Support Surface. Intended to assist in improving human patient outcomes. | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 12 Jul 2013 | Asian Taste Sun Flower Seeds, 40pk/carton, Net Wt: 8-oz. (227g), Item #1641819, UPC 6 919037 022708. | Walong Marketing, Inc. | Food | Class III | 1 |
| 11 Jul 2013 | LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur. | DePuy Orthopaedics, Inc. | Device | Class I | 1 |
| 11 Jul 2013 | The master case Bar Code is 20731149654062 and the Retail UPC is 7 31149 65406 8. The Retail Label reads in part "*** Aqua Star Raw Shrimp Easy-Peel Shell-On*** Ready to Cook *** Net Wt 1 lb (454g) ***" (65730) | Aqua Star (USA) Corp. | Food | Class II | 1 |
| 10 Jul 2013 | Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in… (65724) | Precision Dynamics Corporation | Device | Class II | 1 |
| 10 Jul 2013 | Earth's Pride Organics: Organic Oregano, 2.2 oz. Packaged at 12 units per case. Packaged in a glass jar with cork closure. Product labeling reads in part:"earth's pride organics PANTRY COLLECTION***ORGANIC OREGANO***NET WT. 2.2 OZ (62.4g)***DISTRIBUTED BY BJWC 25 RESEARCH DRIVE WESTBOROUGH, MA 01581 1-800-934-1204***". | Olde Thompson, Inc. | Food | Class I | 1 |
| 10 Jul 2013 | Okami Fully Cooked Wild-Caught Lobster Roll with Avocado, in a 7oz plastic tray with lid, to be stored less than or equal to 40 degrees F. (65820) | Individual firm, name withheld | Food | Class III | 1 |
| 9 Jul 2013 | Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments utilized in various ear, nose and throat (ENT) and head and neck surgical procedures. | Medtronic Xomed, Inc. | Device | Class II | 1 |
| 8 Jul 2013 | Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs. | Sorin Group USA, Inc. | Device | Class II | 1 |
| 8 Jul 2013 | GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic | Smith & Nephew Inc | Device | Class II | 1 |
| 8 Jul 2013 | Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart. | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 8 Jul 2013 | "***Gasco Golden Egg Yellow Shade Liquid***" 32 oz plastic bottles & 15 gallon drums | Gasco Industrial | Food | Class II | 1 |
| 4 Jul 2013 | Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771 | VistaPharm, Inc. | Drug | Class II | 1 |
| 4 Jul 2013 | Crave Brothers Les Freres cheese sold with labeling as: Les Freres, Crave Brothers Les Freres, Les Freres Wash Rind Product of USA, Crave Bros Les Freres, Crave Brothers Les Freres Cheese by Pound, Les Freres Crave Brothers, and Les Freres Crave Brothers PO-RK. Cheese was cut and wrapped. | Whole Foods Market | Food | Class I | 1 |
| 3 Jul 2013 | Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for barrel length and as a result, maximum insulin… (65644) | Individual firm, name withheld | Device | Class II | 1 |
| 3 Jul 2013 | DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HCl 5 mg) liquicaps and NyQuil Sinex NightTime Sinus Relief (acetaminophen 325 mg, doxylamine succinate 6.25 mg, and phenylephrine HCl 5 mg) liquicaps Combopack, each 48-count liquicaps per carton contains 32 DayQuil Sinex DayTime Liquicaps… | Procter & Gamble Co | Drug | Class II | 1 |
| 3 Jul 2013 | Lehman's Hot Veggie Mix, packaged in 12/16-oz jars per case, distributed by Lehman's, Kidron, OH 44636 (65665) | Ozark Bottling, LLC | Food | Class III | 1 |
| 3 Jul 2013 | Crave Brothers Farmstead Classics Les Freres Semi-Soft French Style Cheese, LF225. 2.5 lb wheel packaged in cheese paper. Two 2.5 lbs wheels in a case. | Crave Brothers Farmstead Cheese, LLC | Food | Class I | 3 |
| 1 Jul 2013 | MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patients with intra-venous or intra-arterial… | Iradimed Corporation | Device | Class I | 1 |
| 1 Jul 2013 | Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of Tacrolimus are used as an aid in the… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 28 Jun 2013 | REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm Diameter Nonsterile, Qty -1 Instrumentation used in shoulder replacement surgery. The glenosphere helmet is used to insert the glenosphere onto the base plate prior to impaction with the glenospere impactor. | Zimmer, Inc. | Device | Class II | 2 |
| 28 Jun 2013 | ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6 pack - REF). For calibrating the following assays using the ADVIA Centaur or ACS:180 systems: FT3, T3, T4, Tup, FT4, THEO2. | Siemens Healthcare Diagnostics, Inc | Device | Class III | 1 |
| 28 Jun 2013 | Duet DHA Balanced, 1) 30 count tablet blister cards and 5 count softgels blister cards combination pack (NDC 44118-775-30 and NDC 44118-800-30) 2) physician samples (carton contain 7 envelopes each with one 5 count tablet blister card and 5 softgels (NDC 44118-800-05) Rx only, Manufactured for Eckson Labs,… | Stayma Consulting Service, LLC. | Drug | Class III | 7 |
| 26 Jun 2013 | Fisher's Homestyle Salads LLC***New England Clam Chowder*** packaged in 5 lb and 10 lb plastic containers. | Individual firm, name withheld | Food | Class I | 5 |
| 25 Jun 2013 | ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication. | Convatec Inc. | Device | Class III | 2 |
| 25 Jun 2013 | Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4. | Apotex Inc | Drug | Class II | 1 |
| 25 Jun 2013 | Spartan Fresh Dark Chocolate Covered Dried Cherries 8oz | Shoreline Fruit Inc | Food | Class II | 3 |
| 24 Jun 2013 | Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable, including neurosurgery, gastrointestinal and affiliated organ surgery,… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 3 |
| 24 Jun 2013 | Acidified Tea in a glass bottle with a multi-colored, stick-on label that reads in part: " HARMONY Chai concentrated Fresh brewed on Orcas Island, WA Black Spiced Chai 22oz. (650 ml)***Ingredients: water, Organic Raw Sugar, Black Tea, cloves, cinnamon, Ginger, secret spices, citric Acid***7 05105 01311 4***" There is… | Harmony Chai | Food | Class II | 2 |
| 21 Jun 2013 | MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); Common Name: Medical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation… | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK | Device | Class II | 1 |
| 21 Jun 2013 | Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an array of 108 holes that store 3 types of… | SpineFrontier, Inc. | Device | Class II | 1 |
| 21 Jun 2013 | Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes. (65666) | Picis Inc. | Device | Class II | 1 |
| 21 Jun 2013 | MERREM I.V. (meropenem for injection), 1 g meropenem equivalent, 30 mL vial, Rx only, Mfd for: AstraZeneca Pharmaceuticals LP, Wilmington, DE by ACS Dobfar SpA Viale Addetta, Tribiano, Milano Italy NDC 0310 0321 30 | AstraZeneca Pharmaceuticals LP | Drug | Class II | 1 |
| 21 Jun 2013 | Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-EM Canada Inc. Anjou Quebec H1J2Z4, Canada, NDC 0270-0445-40 | Bracco Diagnostics Inc | Drug | Class II | 1 |
| 18 Jun 2013 | CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery. | Invacare Corporation | Device | Class II | 1 |
| 18 Jun 2013 | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 3 |
| 17 Jun 2013 | Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare… | CareFusion 303, Inc. | Device | Class I | 1 |
| 17 Jun 2013 | Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146. | Physicians Total Care, Inc. | Drug | Class II | 1 |
| 14 Jun 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial… | Biomerieux Inc | Device | Class II | 15 |
| 14 Jun 2013 | Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide. Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile EO. The Affinity Pediatric Arterial Filters are single-use, sterile, nonpyrogenic devices designed to filter microemboli… | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 14 Jun 2013 | Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20 | Boehringer Ingelheim Roxane Inc | Drug | Class III | 1 |
| 14 Jun 2013 | OSKRI, Coconut Bar Dark Chocolate, Net Wt. 1.9 oz ( 53g), UPC 6 66016 30070 3. Ingredients: Coconuts 55%, Rice Syrup, Dark Chocolate 20% ( Sugar, Cocoa Butter, Chocolate, Soy Lecithin, Natural Vanilla). | Oskri Corp. | Food | Class I | 4 |
| 13 Jun 2013 | BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA… | Becton Dickinson & Co. | Device | Class II | 1 |
| 13 Jun 2013 | El Campestre Brand Ceviche Mixto, 2/5 lbs bulk containers into 1/10lbs carton. Packaged in 2/5lbs white plastic buckets with lid and handle, into 1/10lbs carton. Labeling reads in part:"CEVICHE MIXTO***NET WT..10 LBS***DIST.BY EL CAMPESTRE DIST TEL (562) 505-7247***". | Individual firm, name withheld | Food | Class I | 6 |
| 12 Jun 2013 | Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes. (65498) | Accelerated Care Plus Corporation | Device | Class II | 1 |
| 12 Jun 2013 | Arm & Hammer Baking Soda a) Net Wt. 1 LB. (454 g) UPC 3320001130 b) Net Wt. 8 oz. (277 g) UPC 3320001110 Church & Dwight, Co. Inc. 469 N. Harrison Street Princeton, NJ 08543-5297 USA | Church & Dwight Inc | Food | Class II | 1 |
| 11 Jun 2013 | Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of… | Philips Healthcare Inc. | Device | Class II | 1 |
| 11 Jun 2013 | Synthes Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 11 Jun 2013 | Grove Grow Notes Dried Mushroom, Net Wt. 200g/7 oz. packaged in plastic tray in plastic bag. UPC 6949682800734 Product of China Product label is in Chinese | S & M International Inc | Food | Class III | 1 |
| 10 Jun 2013 | syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, display, storage, archive, and manipulation of digital medical images, including quantification and reportgeneration. syngo¿ Dynamics is not intended to be used for reading mammography… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 10 Jun 2013 | Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles.… | Steritec Products Mfc. Co., Inc. | Device | Class II | 8 |
| 7 Jun 2013 | 00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. Used in total knee arthroplasty and indicated for patients with severe pain. | Zimmer, Inc. | Device | Class II | 47 |
| 6 Jun 2013 | EndoGastric Solutions EsophyX2 Device with Serosa Fastener and Accessories. Models R2001 and R2002. Indicated for the treatment of symptomatic chronic gastroesophageal reflux disease. (65855) | Endogastric Solutions Inc | Device | Class II | 1 |
| 6 Jun 2013 | Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry System Refurbished, 3) VITROS 4600 Chemistry… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 6 Jun 2013 | Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2030 02 Foreign packaging: c) Parsel Forte and d) Cibalenaa (250 mg Acetaminophen, 250 mg Aspirin,… | Novartis Consumer Health | Drug | Class II | 4 |
| 5 Jun 2013 | 5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit Rod 310mm 5.0mm Unit Rod 330mm 5.0mm Unit Rod 350mm 5.0mm Unit Rod 370mm 5.0mm Unit Rod 390mm 5.0mm Unit Rod 410mm 5.0mm Unit Rod 430mm 5.0mm Unit Rod 450mm pedicle screw spinal system; Intended to provide immobilization and stabilization of spinal segments in… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 5 Jun 2013 | Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient. (65822) | Fisher Scientific Co | Device | Class II | 1 |
| 5 Jun 2013 | Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 4 Jun 2013 | Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in determining the efficacy of steam sterilization processes. | Mesa Laboratories, Inc., Bozeman Manufacturing Facility | Device | Class II | 2 |
| 4 Jun 2013 | VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown, NJ 07724 NDC 61748-014-06, | West-Ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 3 Jun 2013 | AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions), Model Numbers AU5811, AU5821, AU5831 and AU5841. This system is for in vitro diagnostic use only. | Beckman Coulter Inc. | Device | Class II | 1 |
| 3 Jun 2013 | Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. | Carestream Health Inc. | Device | Class II | 1 |
| 30 May 2013 | Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput. (65777) | Individual firm, name withheld | Device | Class I | 1 |
| 30 May 2013 | Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. | Exactech, Inc. | Device | Class II | 1 |
| 29 May 2013 | R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic. | Smith & Nephew Inc | Device | Class II | 2 |
| 27 May 2013 | Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR (65606) | Earthlabs, Inc. DBA Wise Woman Herbals | Drug | Class II | 1 |
| 25 May 2013 | Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50 mL, 50 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-33 | Hospira Inc. | Drug | Class II | 1 |
| 23 May 2013 | ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. | Sotera Wireless, Inc. | Device | Class II | 2 |
| 21 May 2013 | GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 21 May 2013 | Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, India, NDC 68084-225-01 | American Health Packaging | Drug | Class II | 1 |
| 21 May 2013 | IMAGIC Vegetarian Burger Mix, VB 100, textured vegetable protein, contains soy and wheat, packaged in 25-lb/bulk cartons. CHS Inc., Hutchinson, KS. | C H S Inc | Food | Class II | 1 |
| 20 May 2013 | Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045. | Hospira, Inc. | Drug | Class II | 1 |
| 20 May 2013 | Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01. | Sandoz Incorporated | Drug | Class I | 1 |
| 20 May 2013 | Sunny Sea Sardines in Tomato Sauce, 24 cans/case, 15 oz. (65723) | Golden Beach Inc | Food | Class III | 1 |
| 18 May 2013 | Texas Wild UPC 51/60 BSO Shrimp Headless Shell-on IQF, Wild Caught, Product of the USA 20 # Net Weight, Galveston Shrimp Co., Galveston, TX 77550 | Galveston Shrimp Company, Inc. | Food | Class II | 9 |
| 17 May 2013 | Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07 (65461) | Warner Chilcott US LLC | Drug | Class II | 1 |
| 17 May 2013 | Marmalade Fonariky Net 105.8 oz (3 kg) Product of Russia upc 460161417406 | Zip International Group LLC. | Food | Class II | 1 |
| 16 May 2013 | Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) | HeartWare Inc | Device | Class II | 1 |
| 15 May 2013 | AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays. | Tosoh Smd Inc | Device | Class II | 1 |
| 15 May 2013 | Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA | Actavis South Atlantic LLC | Drug | Class II | 1 |
| 13 May 2013 | Siemens AXIOM Artis zeego x-ray, angiographic system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 13 May 2013 | Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10 | Zydus Pharmaceuticals USA Inc | Drug | Class I | 1 |
| 10 May 2013 | Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse… | SpineFrontier, Inc. | Device | Class II | 1 |
| 10 May 2013 | ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). | Siemens Healthcare Diagnostics, Inc | Device | Class II | 6 |
| 10 May 2013 | Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L) | Biomet 3i, LLC | Device | Class II | 2 |
| 10 May 2013 | Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0 | Apotex Corp. | Drug | Class I | 1 |
| 7 May 2013 | Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 6 May 2013 | Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2). | Chang Kwung Products | Drug | Class I | 2 |
| 2 May 2013 | Mobiletta Mira Mobile X-ray System | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 2 May 2013 | GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations. | GE Healthcare, LLC | Device | Class II | 1 |
| 1 May 2013 | BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes. | Becton Dickinson & Company | Device | Class II | 1 |
| 1 May 2013 | CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product… (65559) | Medicis Pharmaceutical Corp | Drug | Class II | 1 |
| 30 Apr 2013 | uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run on an automated… (65084) | Wako Life Sciences, Inc. | Device | Class II | 1 |
| 25 Apr 2013 | S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for… | SpineFrontier, Inc. | Device | Class II | 1 |
| 22 Apr 2013 | Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are… | SpineFrontier, Inc. | Device | Class II | 1 |
| 22 Apr 2013 | 1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir… | Carefusion 2200 Inc | Device | Class II | 1 |
| 17 Apr 2013 | Roasted Red Bell Pepper Plus Powder 50 lb carton | Pacific Pure Aid | Food | Class II | 3 |
| 10 Apr 2013 | The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging… | GE Healthcare, LLC | Device | Class II | 1 |
| 9 Apr 2013 | 3M Tekk Brand Industrial/Construction First Aid Kit, Total Resources Int'l Walnut, CA 91789 | Total Resources Intl | Drug | Class II | 3 |
| 9 Apr 2013 | PERFECT 3000 CHOCOLATE POWDER, FORMULA # 3098. The product is loose powder packaged in bulk drum. | Kabco Pharmaceuticals, Inc. | Food | Class II | 2 |
| 1 Apr 2013 | List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospira Blood sets are designed for Blood Product Administration | Hospira Inc. | Device | Class I | 9 |
| 29 Mar 2013 | Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel Dilator)***Cordis***a Johnson and Johnson Company***ENDOVASCULAR*** Label No. SB… | Cordis Corporation | Device | Class I | 1 |
| 29 Mar 2013 | 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09. | Hospira Inc. | Drug | Class I | 1 |
| 28 Mar 2013 | Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the… (65068) | Custom Spine, Inc. | Device | Class II | 1 |
| 28 Mar 2013 | NuGo Free Dark Chocolate Trail Mix Bar, 1.59 oz (45g) Non-Dairy | NuGo Nutrition HQ | Food | Class I | 10 |
| 25 Mar 2013 | Acetylcysteine Ophthalmic Solution, compounded by Pallimed Solutions Pharmacy, Woburn, MA | Pallimed Solutions | Drug | Class II | 25 |
| 22 Mar 2013 | Bulk tablet label: Keytabs W.O. Glandulars (pink) | Ancient Formulas Inc | Food | Class II | 2 |
| 20 Mar 2013 | individual 2 oz chocolate macaroons packaged in plastic wrapper labeled as " Jennies DUTCH CHOCOLATE MACAROON, 2 oz. Red Mill Farms, Inc., Brooklyn, NY". (65754) | Red Mill Farms | Food | Class II | 1 |
| 14 Mar 2013 | Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the inserter before insertion of the screw. They… | SpineFrontier, Inc. | Device | Class II | 1 |
| 13 Mar 2013 | epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit. (65126) | Epocal | Device | Class II | 1 |
| 11 Mar 2013 | Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA (64571) | Green Planet Inc | Drug | Class I | 1 |
| 7 Mar 2013 | Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30 (65701) | Individual firm, name withheld | Drug | Class II | 1 |
| 4 Mar 2013 | Siemens syngo.plaza SW version VA20 with Mammography license. image processing, radiological system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 26 Feb 2013 | Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887 (65954) | Sanofi-Synthelabo | Drug | Class II | 1 |
| 19 Feb 2013 | Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing… | Remel Inc | Device | Class III | 1 |
| 4 Feb 2013 | The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. | Hospira Inc. | Device | Class II | 1 |
| 4 Feb 2013 | buPROPion Hydrochloride Extended Release Tablets, USP 100 mg, 100 count carton, 10 blister cards of 10 individually blistered and labeled tablets, Rx only, Actavis South Atlantic LLC, Packaged and Distributed by: American Health Packaging, Columbus, OH --- NDC 68084-470-01 | American Health Packaging | Drug | Class III | 1 |
| 22 Jan 2013 | IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7. (64102) | Fresenius Kabi USA LLC (FK USA) | Drug | Class II | 1 |
| 11 Jan 2013 | Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree. | Acclarent, Inc. | Device | Class II | 7 |
| 4 Jan 2013 | Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico. (64182) | Reumofan Plus USA | Drug | Class I | 1 |
| 28 Dec 2012 | CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the… | Veridex, LLC | Device | Class II | 2 |
| 27 Nov 2012 | TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate. | Radiometer America Inc | Device | Class II | 1 |
| 16 Nov 2012 | Enterprise 8000 Bed; an AC-powered adjustable hospital bed; ArjoHuntleigh AB, Eslov, Sweden; Models 8000, 8001, 8002, 8003, 8500, 8600, 8700 and 8800 General medicine, general and specialist surgery, care of the elderly, HDU, ITU, coronary care and oncology. The bed is appropriate for high dependency patients who… | Arjo, Inc. dba ArjoHuntleigh | Device | Class II | 2 |
| 13 Nov 2012 | Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 9 Nov 2012 | GE Healthcare, LOGIQ e Ultrasound System. The LOGIQ i/e and Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN &… | GE Healthcare, LLC | Device | Class II | 1 |
| 9 Nov 2012 | Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition the drill guide is used as a reference to… | SpineFrontier, Inc. | Device | Class II | 1 |
| 26 Oct 2012 | Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories. | Beckman Coulter Inc. | Device | Class II | 1 |
| 12 Oct 2012 | Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 12 Oct 2012 | Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook and screw (3.2 mm cortex) components of the… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 5 Oct 2012 | Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients | SpineFrontier, Inc. | Device | Class II | 1 |
| 28 Sep 2012 | VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with specific inununohistochemistry or in situ… | Ventana Medical Systems Inc | Device | Class II | 2 |
| 29 Aug 2012 | T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone handled instruments that have a quick release end. The silicone T-handle has an impactor cap on the proximal end of the handle which is designed to be struck with a mallet. T-handles are used primarily to attach to, and operate… | SpineFrontier, Inc. | Device | Class II | 1 |
| 13 Aug 2012 | GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and… | GE Healthcare, LLC | Device | Class II | 1 |
| 7 Aug 2012 | GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen,… | GE Healthcare, LLC | Device | Class II | 1 |
| 26 Jul 2012 | Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain. | St. Jude Medical | Device | Class II | 1 |
| 13 Jul 2012 | GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ… | GE Healthcare, LLC | Device | Class II | 1 |
| 9 May 2012 | Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral. | SpineFrontier, Inc. | Device | Class II | 1 |
| 21 Nov 2011 | SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and… | GE Healthcare, LLC | Device | Class II | 1 |
| 5 Apr 2011 | GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, Spectral, and Gated… | GE Healthcare, LLC | Device | Class II | 1 |
| 22 Sep 2010 | ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON… | Beckman Coulter Inc. | Device | Class II | 1 |