| 9 Jul 2012 | Probitotic Dietary Supplement. : iFlora¿ Kids Multi-Probiotic¿ (52052) | Nutri-Health Supplements Llc. | Food | Class I | 1 |
| 6 Jul 2012 | HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4. | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 6 Jul 2012 | HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7. | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 3 Jul 2012 | Romaine Lettuce tied with a rubber band (62502) | Pacific International Marketing | Food | Class I | 1 |
| 3 Jul 2012 | Fruiti Pops Coconut Ice Bars, 4 oz. Product labeling reads in part:" Fresh fruit bar Fruiti Pops Classic Coconut 4 FL OZ (118mL)***FRUITI POPS 15418 CORNET SANTA FE SPRINGS, CA 90670 PLANT NO. 06-4562***". (62491) | Fruiti Pops Inc. | Food | Class I | 1 |
| 2 Jul 2012 | Drager PT 4000 Phototherapy System | Draeger Medical Systems, Inc. | Device | Class II | 1 |
| 2 Jul 2012 | Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 2 Jul 2012 | Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC 3 0186-5040-85 0. (62439) | ASTRA ZENECA Lp | Drug | Class III | 1 |
| 29 Jun 2012 | Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for… | Arjo, Inc. dba ArjoHuntleigh | Device | Class II | 3 |
| 29 Jun 2012 | Dole brand Hearts of Romaine; Net Wt. 10 oz. UPC 71430 00956; Dole | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 28 Jun 2012 | Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA. (62442) | Health Plus Incorporated | Drug | Class III | 1 |
| 27 Jun 2012 | Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: The Micro-switch is used on the HOTLINE¿ 3 Blood and Fluid Warmer. This product, for use in conjunction with HOTLINE¿ 3 L-370 Fluid Warming Set are intended for the delivery of warmed blood and intravenous fluids at normothermic… | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 27 Jun 2012 | SP Standard Process, Cataplex ACP (Product #0700 and 0750) , Dietary supplement, 90 & 360 Tablets, Proprietary Blend: Dried buckwheat ( leaf) juice, buckwheat (seed), carrot (root), calcium lactate, nutritional yeast, bovine adrenal, bovine kidney, alfalfa flour, dried alfalfa, (whole plant) juice, magnesium citrate,… | Standard Process, Inc. | Food | Class I | 3 |
| 26 Jun 2012 | Cedar's Bakery Pita Bread, 10 loaves, White; ingredients flour water,yeast, sugar, salt. Nt. Wt. 22 oz.(1 lb. 6 oz. - 624 GMs) (62424) | Cedars Bakery | Food | Class II | 1 |
| 26 Jun 2012 | Banner Mountain Sprouts;Alfalfa Sprouts; California Certified Organic Sprouts. 100% certified organic seeds used. Sacramento, Ca 95820. Net Wt. 4 oz; 1 lb and 2 lb packages. Rinse and Eat; Perishable, Keep refrigerated. UPC 4 oz size: 0- 9691172842 3; UPC 1 lb size: 0 96911 72850 8 | Banner Mountain Sprouts Inc | Food | Class I | 5 |
| 25 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 |
| 25 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 | Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used… | Terumo Cardiovascular Systems Corporation | Device | Class II | 3 |
| 22 Jun 2012 | Central Control Module for System 1: 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… | Terumo Cardiovascular Systems Corporation | Device | 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 in 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 | Carrot juice. Labeling reads in part:"***LIQUID GOLD 24K CARROT JUICE***JUICE CONNECTION LOS ANGELES CALIFORNIA 90058*** 7 62313 00130 0***INGREDIENTS: PASTEURIZED CARROT JUICE***". (62388) | Healthy Choice/Island Blends, Inc. (dba Juice Connection) | Food | Class II | 1 |
| 21 Jun 2012 | Terumo Advanced Perfusion System 1 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… | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 21 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 |
| 21 Jun 2012 | Monaco Product Usage: Planning of radiation therapy | Elekta, Inc. | Device | Class II | 1 |
| 21 Jun 2012 | Focal SIM Planning of radiation therapy | Elekta, Inc. | Device | Class II | 1 |
| 21 Jun 2012 | Frozen Half Shell Oysters, 144 pcs (62400) | Khee Trading | Food | Class II | 1 |
| 21 Jun 2012 | Kroger Fresh Selections Greener Supreme; Iceberg lettuce, Romaine lettuce, Carrots and Red Cabbage; 12 oz plastic bag. Best if used by date: June 19, 2012: UPC 0 11110 91039 4 Distributed by the Kroger Co., Cincinnati, OH 45202 | Dole Fresh Vegetables Inc | Food | Class I | 2 |
| 20 Jun 2012 | Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and… | Philips Healthcare Inc. | Device | Class II | 1 |
| 20 Jun 2012 | Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life… | Philips Healthcare Inc. | Device | Class II | 1 |
| 20 Jun 2012 | Product is labeled in part: "***LEASA Living Alfalfa Sprouts***CHOLESTEROL FREE***PRESERVATIVE FREE***KEEP REFRIGERATED***NET WT. 6 OZ. (168 g)***" Product is packaged in 6 oz clear plastic containers with UPC 75465-55912. UPC Code and expiration date are located on the side of the container. (62377) | LEASA Industries Co., Inc. | Food | Class I | 1 |
| 19 Jun 2012 | CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered… (62349) | CareFusion 203, Inc. | Device | Class I | 1 |
| 19 Jun 2012 | Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray… (62346) | Individual firm, name withheld | Device | Class II | 1 |
| 19 Jun 2012 | Giusto's Wheat Germ, Raw, Net Wt. 25 lb, (11.34 Kg) paper bag; Item number: 154205 Giusto's 344 Littlefield Ave. South Francisco, CA 94080 (62409) | Giusto's Specialty Foods LLC | Food | Class II | 1 |
| 18 Jun 2012 | Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases.… | Varian Medical Systems, Inc. Oncology Systems | Device | Class II | 1 |
| 18 Jun 2012 | superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an… (62381) | superDimension, Inc | Device | Class II | 1 |
| 18 Jun 2012 | Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital. | Hill-Rom, Inc. | Device | Class II | 1 |
| 18 Jun 2012 | CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. The Stealth 360-degree Orbital PAD system is a percutaneous orbital… | Cardiovascular Systems, Inc. | Device | Class II | 1 |
| 18 Jun 2012 | Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I 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… | Terumo Cardiovascular Systems Corporation | Device | Class II | 11 |
| 18 Jun 2012 | Rosati Cry Baby Sour Watermelon water ice, 6 fl oz (62417) | Individual firm, name withheld | Food | Class II | 1 |
| 18 Jun 2012 | Cinnamon Xylishield xylitol gum, net wt 84 g, Ultradent Products, South jordan, UT 84095 60 pieces of gum per pack. Packaging is red, white, and black with black, red and white print writing. The product is advertised for use in fighting against tooth decay. Part number 8419. | Ultradent Products, Inc. | Food | Class II | 3 |
| 16 Jun 2012 | Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits | DeRoyal Industries Inc | Device | Class II | 1 |
| 15 Jun 2012 | AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar… (61529) | Encision, Inc. | Device | Class II | 1 |
| 15 Jun 2012 | Hannaford brand Mini Frosted Cookies, 10 oz UPC # 4126872374 (62340) | Individual firm, name withheld | Food | Class I | 1 |
| 15 Jun 2012 | Coca Cola Cherry Zero, 20 fl. oz. (1.25 pt), The Coca Cola Company. | Coca-Cola Refreshments USA, Inc. | Food | Class II | 1 |
| 15 Jun 2012 | Truitt Brothers, Pacific Northwest Premium Navy Beans, net weight 15 oz. per metal can. The UPC is 0 82225 24145 1. The product is labeled in parts: "***TRUITT BROTHERS***Pacific Northwest PREMIUM NAVY BEANS***NET WT 15 OZ***INGREDIENTS: NAVY BEANS, WATER, SEA SALT, NATURAL CALCIUM CHLORIDE***TRUITT BROS.,… (62335) | Truitt Bros., Inc. | Food | Class II | 1 |
| 15 Jun 2012 | CJ Het Oyster (CJ Frozen Oyster), 40x8oz.. Material#912329, Frozen Oyster (KR 12 SP 050110), Material#912330, Frozen Oyster (KR 12 SP 050210), Material#912331, Frozen Oyster (KR 12 SP 050310). (62380) | CJ Foods, Inc., A Division of CJ America | Food | Class II | 1 |
| 15 Jun 2012 | Surasang Chanbada Frozen Oyster I.Q.F (8oz), 40pack/case (51108) | Individual firm, name withheld | Food | Class II | 1 |
| 14 Jun 2012 | Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine simplifies the… | Philips Healthcare Inc. | Device | Class II | 1 |
| 14 Jun 2012 | Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076 | Kimberly-Clark Corporation | Drug | Class II | 2 |
| 14 Jun 2012 | IQF Oysters 3lbs, Assi Brand, Item# 20083K,10x3 lb; Oyster Block, Assi Brand, item# 20085K, 30x1 lb; Oysters 8 oz - Tiny, Assi Brand, item# 20086, 40x8 oz; IQF Oysters 20 oz - Tiny, Assi Brand, item#20093, 20x20 oz. (51667) | KOREAN FARM, INC. | Food | Class II | 1 |
| 13 Jun 2012 | Ocean Manna Korean IQF Oysters, sizes: Tiny, Medium, Large. Packed: 40x8oz, 10x2lbs, 2lbs, 6x4lbs, 10x4lbs, 30x1lb, 6x5lbs. Item Code: FO/HMART-2LB, FO/HMART-1LB, FO/HMART-8OZ, FO/HMART-5LB, FO/HS-OHS144, FO/LP-OL6X4, FO/HS-0L4, FO/KO-OM4, FO/HS-OM4, FO/LP-OS8, FO/HS-OT8, HS-0B2. (62314) | Pacific Giant, Inc | Food | Class II | 1 |
| 12 Jun 2012 | Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient. | Teleflex Medical | Device | Class II | 1 |
| 12 Jun 2012 | Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or… | Spacelabs Healthcare, Llc | Device | Class II | 1 |
| 12 Jun 2012 | GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004. | GE Healthcare, LLC | Device | Class II | 1 |
| 12 Jun 2012 | Cho-Rip-Dong Frozen Oysters in plastic bags: 1) Item no. BG1501, net wt. 1 lb.; 2) Item no. BG1521, net wt. 8 oz.; 3) Item no. BG1551, net wt. 3 lb.; 4) Item no. BG1601, net wt. 10 lb.; 5) Item no. BG1631, net wt. 1 lb. | Seoul Trading Inc. | Food | Class II | 3 |
| 12 Jun 2012 | Maryland Style Crab Soup 2340 Net Weight 4-4LBS. Winter Garden Quality Foods, Inc. 304 Commerce St. New Oxford, PA 17350 | Winter Gardens Quality Foods Inc | Food | Class II | 4 |
| 11 Jun 2012 | iForce Nutrition Xtreme Series, PROTEAN, Lean Protein, Strawberry Creamsicle, Dietary Supplement, 4 lbs. Mfg. for Dist by, Tribravus Enterprises, LLC, Vista, CA 92081 (62292) | PGP International, Inc. | Food | Class II | 1 |
| 11 Jun 2012 | Product Name: Eroxil bottles of 30 tablets taken orally Nokomis Research Inc #6 | H & L Jerch Sales, Inc. | Food | Class III | 4 |
| 8 Jun 2012 | MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086 (62302) | Impac Medical Systems Inc | Device | Class II | 1 |
| 8 Jun 2012 | SunOpta, Canadian Harvest Oat Fiber, Oat Fiber 300-33, Manufactured by SunOpta Ingredients, Chelmsford, MA 01824 (62323) | SunOpta Ingredients Group (Corporate HQ) | Food | Class II | 1 |
| 8 Jun 2012 | T.G.I. Friday's Mozzarella Sticks 2.25oz, 3.5oz, and 4.8 oz. Item#30187, 30588, 30588B, 30707, 30819, 30834. | Inventure Foods | Food | Class II | 3 |
| 7 Jun 2012 | Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644.… | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Device | Class III | 1 |
| 7 Jun 2012 | Sienna Bakery¿ White Chocolate Macadamia Nut Gourmet Cookies, UPC 093901201706, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, CHOCOLATE FLAKES (SUGAR, COCOA, BUTTER, WHOLE MILK POWDER, SKIM MILK POWDER, MILK FAT, SOY LECITHIN ADDED AS EMULSIFIER, VANILLA… | Minnesota Best Maid Cookie Co, Inc. | Food | Class II | 2 |
| 7 Jun 2012 | F-Tara Saikyozuke (Cod Fish with miso), 3.1lb., 20pc.x ab.2.5oz. | Mutual Trading Company Inc | Food | Class I | 1 |
| 6 Jun 2012 | AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer¿ is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit… (62283) | Thayer Medical Corporation | Device | Class II | 1 |
| 6 Jun 2012 | Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement. | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 6 Jun 2012 | Pasta Roni Parmesan Cheese Flavor angel hair pasta in a Parmesan sauce with other natural flavors; Net Wt. 5.1 oz. box/12 boxes/case; Distributed by Golden Grain Co., P.O. Box 049003, Chicago, IL 60604-9903; UPC 0 15300 44049 | Quaker Foods and Snacks North America | Food | Class II | 1 |
| 6 Jun 2012 | Reggano, Linguine and Parmesan Pasta Entree, NET WT 4.8 OZ(136g), UPC 4149813345, Distributed by ALDI Inc., Batavia, IL 60510. | TreeHouse Foods, Inc / Bay Valley Foods | Food | Class II | 9 |
| 5 Jun 2012 | PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves, under the fascia. The rod is secured to… | Zimmer, Inc. | Device | Class II | 1 |
| 5 Jun 2012 | Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Electrosurgical./Extendable Pencils, 510(k) #K936304, Model Number: 75820. The device is packaged in a sterile Tyvek peel pouch within a cardboard box which contains 24 pouches per box. Pens/Pencils and Handles -- Olsen Medical Pens/Pencils and… | PSC Industries Inc | Device | Class II | 2 |
| 5 Jun 2012 | Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during minimally invasive surgery to fuse the spine. Per… | Zimmer, Inc. | Device | Class II | 2 |
| 5 Jun 2012 | Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02 (62013) | JHP Pharmaceuticals, LLC | Drug | Class III | 1 |
| 5 Jun 2012 | Wheat Germ, brand name PFM, package in bulk tote, approximately 1650 lbs. per tote. Product SKU is 1344. (62126) | Pendleton Flour Mills, Llc | Food | Class II | 1 |
| 4 Jun 2012 | Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18 (62392) | GlaxoSmithKline Inc | Drug | Class II | 1 |
| 4 Jun 2012 | Queso Pringles, 40 g , and Cont. Neto Net Weight: 139 g( 4.9 oz) Queso /Cheese; Busting with more Flavor "Ahora con Man Sabor" | Kellogg Company | Food | Class III | 1 |
| 1 Jun 2012 | Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical… | PSC Industries Inc | Device | Class II | 6 |
| 1 Jun 2012 | Coca Cola Zero, 20 fl. oz., The Coca Cola Company. | Coca-Cola Refreshments, USA Inc. | Food | Class II | 1 |
| 1 Jun 2012 | Clams, Frozen Boiled Baby, in shell, 10 oz packages, 24 pkgs/carton, item #20699K. UPC 081652 206996. (62492) | Rhee Brothers Incorporated | Food | Class II | 1 |
| 31 May 2012 | Broaster Fish Coating, 96627, Ingredients: Corn Meal, Wheat Flour, Corn Crumbs, Salt, Spices, Paprika, Citric Acid, Onion, Sugar, Garlic, Celery Seed, Modified Con Starch, Lemon Oil, Natural and Artifical Flavors, Silicon Dioxide (Anti-Caking Agent) and FD&C yellow #5., Net Weight 20 pounds, Manufactured By The… (61980) | The Broaster Company, LLC | Food | Class II | 1 |
| 30 May 2012 | ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum… | Abbott Laboratories | Device | Class II | 1 |
| 30 May 2012 | Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia. | SALTER LABS | Device | Class II | 1 |
| 30 May 2012 | Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16. | VistaPharm, Inc. | Drug | Class II | 1 |
| 29 May 2012 | Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Control Slides, SLO3-10, ATCC Licensed Derivative, MediMart Europe, 11 rue Emile, Zola B.P. 2332, 38933 Grenoble Cedex 2 France. They are microscope slide preparations contains specific organisms populations of known and predictable… | Microbiologics Inc | Device | Class II | 1 |
| 29 May 2012 | AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient. | Carefusion 2200 Inc | Device | Class I | 3 |
| 29 May 2012 | MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma. | Sekisui Diagnostics Llc | Device | Class II | 1 |
| 29 May 2012 | Northern Catch Harvest of the Sea Fancy Whole Oysters and SeaNet Fancy Whole Oysters; Net Wt. 8 oz (227g) cans, 12 cans per carton; Distributed by Aldi Inc., Batavia, IL 60510-1477; Product of Korea; UPC 0 41498 11984 3 | Aldi Inc | Food | Class III | 1 |
| 24 May 2012 | EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the MicroSonic Device (MSD). It is intended for the… | EKOS Corporation | Device | Class II | 1 |
| 24 May 2012 | GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed Tomography (CT) and functional images from… | GE Healthcare, LLC | Device | Class II | 1 |
| 23 May 2012 | Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 23 May 2012 | Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical procedures powered by a high frequency generator. (62024) | Stingray Surgical Products, LLC | Device | Class II | 1 |
| 23 May 2012 | IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 23 May 2012 | Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other… | Integra Limited | Device | Class II | 1 |
| 23 May 2012 | LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment (62337) | LMA North America Inc | Device | Class II | 1 |
| 23 May 2012 | Pear juice concentrate 70 Brix in 55 gallon steel drums with plastic liner that are filled to 52 gallons. Labeled in part: "CLAREX PEAR JUICE CONCENTRATE "cRc-KOSHER"***52 GALLONS" and "TREE TOP***PEAR CONCENTRATE TYPE III***RESOURCE #: 4200815003***Selah, Wa. 98942***MADE IN USA***". (62003) | Tree Top Inc - Selah Plant | Food | Class II | 1 |
| 23 May 2012 | Whole Oysters: 1) Empress Whole Oysters, NET WT 8 OZ. Distributed By Mitsui Foods Inc. Norwood NJ 07648 Product of Korea, UPC 7360000719. 2) Premium Quality Private Selection Whole Oysters, NET WT 8 OZ. Distributed By Inter-American Products, Inc. Cincinnati, OH 45202. Product of Korea, UPC 111081484. | Mitsui Foods Inc | Food | Class III | 2 |
| 22 May 2012 | Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 22 May 2012 | Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens. | Alere San Diego, Inc. | Device | Class I | 5 |
| 22 May 2012 | Frozen Half Shell Oysters(S) and Frozen Half Shell Oysters(M) (62366) | Rong Chang Trading LLC dba: Always Best | Food | Class II | 1 |
| 21 May 2012 | Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and… (61955) | Individual firm, name withheld | Device | Class II | 1 |
| 21 May 2012 | MUFFIN CHOCOCHIPS IMPORTED BY ELCAMPEON LEAMINGTON 519-324-2616 4oz | Mexicantown Wholesale | Food | Class I | 18 |
| 18 May 2012 | Oysters Breaded/Kaki Fry, 12x2lbs, item #88250, SK Breaded Oyster 10x2lb, item#91750, and Oyster Breaded Big KOR SK F, item#91306. (62343) | Nishimoto Trading Co Ltd | Food | Class II | 1 |
| 18 May 2012 | Frozen Seasoned and Cooked Clam Meat with Hot Pepper (Item #33229120) (5kg X 2). | Grand Supercenter Inc. | Food | Class II | 3 |
| 17 May 2012 | GoBed+ . Model FL20E Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also… | Stryker Medical Division of Stryker Corporation | Device | Class II | 5 |
| 17 May 2012 | Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA (61872) | Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc. | Drug | Class III | 1 |
| 17 May 2012 | Dannon Fruit on the Bottom, Raspberry flavor. 6oz form fill seal cup yogurt with predominantly blue labelling. | The Dannon Company Inc | Food | Class III | 2 |
| 17 May 2012 | Turkey Dripping Type Marinade X1, 50 lb. bags, Manufactured by Newly Weds Foods, Chicago, IL 60639, product G00988 | Newly Weds Foods Inc | Food | Class II | 2 |
| 16 May 2012 | ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink… | DePuy Orthopaedics, Inc. | Device | Class II | 19 |
| 16 May 2012 | Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 15 May 2012 | PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately… | Polymer Technology Systems, Inc. | Device | Class II | 1 |
| 14 May 2012 | Hartmann Econolux Ref 416 105 Sterile Gauze sponge 4"x4" 12-ply 24 boxes/case 1200 total sponges For use in wound cleansing, debriding of wounds, wound packing, covering and swabbing | Hartmann USA, Inc | Device | Class II | 2 |
| 14 May 2012 | Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes,… | Alere San Diego, Inc. | Device | Class II | 1 |
| 12 May 2012 | Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder. | Zimmer, Inc. | Device | Class II | 1 |
| 11 May 2012 | Organic Paprika packaged under the following labels: (1) Archer Farms organic Paprika, packaged in 1.0-oz rectangle glass bottles, packed in cases-9 glass bottles/case, Distributed by: Target Corporation, Minneapolis, MN 55483; and (2) O Organic organic Paprika, packaged in 1.6-oz glass bottles, packed in cases- 48… (61844) | Brinkhoff & Monoson Inc | Food | Class II | 1 |
| 11 May 2012 | Salted/marinated Pollock roe packaged in white plastic trays with either a clear or opaque plastic lid. Product is packaged in 1.0 lb., 2.2 lb., and 5 lb. sizes and is labeled in part: "Marinated Pollock Roe***Weight: 5.0lb***Production Date: March 2012 Packed by: Young Ocean Inc. 20233 80th Ave. S., Kent, WA 98032".… (61894) | Young Ocean, Inc | Food | Class II | 1 |
| 10 May 2012 | Persimmon Hill Farm, Shiitake Mushroom Sauce, packaged in 8 oz/glass jars. The firm name on the label is Persimmon Hill Farm, 367 Persimmon Hill Lane, Lame, MO 65681. (61840) | Persimmon Hill Farm Gourmet Foods | Food | Class II | 1 |
| 9 May 2012 | Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GAUGE BLUE NEEDLE RECTANGULAR FLANGE, 6" (15 CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent… | Terumo Cardiovascular Systems Corporation | Device | Class II | 20 |
| 9 May 2012 | Oysters, IQF Standard, packed in 5 lb polyethlene bags, further packaged as 2 bags/box and 6 bags/box, and labeled in part ***Wanchese Fish Company 2000 Northgate Commerce Parkway, Suffolk, VA 23435*** Product of S Korea*** | Wanchese Fish Company | Food | Class II | 3 |
| 8 May 2012 | Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 8 May 2012 | Frozen Oysters, Net Wt 1 LBS (454g). Distributed by: Seoul Shik Poom, Engleside, NJ. Origin: Republic of Korea. | Seoul Shik Poom, Inc. | Food | Class II | 2 |
| 8 May 2012 | POLVORONES AMARILLO QTY: 100 MEXICANTOWN BAKERY 313-894-2000 | Mexicantown Wholesale | Food | Class II | 11 |
| 7 May 2012 | CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the label is CIVCO, Kalona, IA. The kit… | Civco Medical Instruments Inc | Device | Class II | 5 |
| 4 May 2012 | Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 4 |
| 4 May 2012 | Hitachi Scenaria CT System Software Product Usage: The Scenaria system is indicated to acquire axial volumes of the whole body including the head. The images can be acquired in either axial, helical, gated or dynamic modes. The volume datasets acquired by the Scenaria can be post processed by the Scenaria to provide… | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 4 May 2012 | Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from the patient without the system being… | Argon Medical Devices, Inc | Device | Class II | 1 |
| 4 May 2012 | Old Fashioned Foods, Jalapeno Bean Dip, Ingredients: water, pinto beans, partially hydrogenated soybean oil, red bell pepper, jalapeno peppers, salt, dehydrated onions, green bell peppers, sorbic acid (as a preservative), vinegar, citric acid, paprika, ,pepper flavor, gallic powder,Net WT, 3 oz (86g), MFG by Old… | Old Fashioned Foods, Inc. | Food | Class II | 2 |
| 4 May 2012 | Tom's Bacon Cheddar Fries, Flavored Corn and Potato Snacks, Net Wt., 2.75 oz (78.0g), | Snyder's - Lance Inc. | Food | Class II | 1 |
| 3 May 2012 | Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation. | Arrow International Inc | Device | Class I | 1 |
| 2 May 2012 | Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 1 May 2012 | Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants. (61807) | Atom Medical Corporation | Device | Class II | 1 |
| 1 May 2012 | Organic 100% Pomegranate Juice packed in glass bottles Smart Juice Organic Pomegranate 100% Juice 33.8 FL. Oz. 100% Juice Distributed by: Smart Juices LLC, Bethlehem, PA 18018 BBE: 09.09.2014 ORGANIC N49 (61856) | Smart Juice LLC | Food | Class II | 1 |
| 26 Apr 2012 | Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. blister, OTC, Distributed by Bayer Health Care, Morristown, NJ 07962 NDC 0280-8015-24 | Bayer Healthcare, LLC | Drug | Class III | 2 |
| 24 Apr 2012 | Epinephrine Injection, USP, 1:1000 (1 mg/mL), 25 x 1 mL Ampules, For SC and IM Use, For IV and IC Use after Dilution, Rx Only, American Regent, Inc., Shirely, NY 11967 --NDC 0517-1071-25 (61714) | Luitpold Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 24 Apr 2012 | Sprouts, Soybean, packed in clear plastic 1.0 lb and 1.5 lb. bags, labeled in part *** Henry's Farm Inc. 5500 Fair Oak Lane, Woodward, VA 22580*** and also bulk packaged in unlabeled 10 lb black plastic bags. | Henrys Farm Inc. | Food | Class I | 2 |
| 23 Apr 2012 | SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters. (61691) | Sigma | Device | Class III | 1 |
| 17 Apr 2012 | Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01. | Watson Laboratories Inc | Drug | Class III | 5 |
| 17 Apr 2012 | Morphine Sulfate Injection, USP, 4mg/mL, 1 mL fill in 2.5 mL Carpuject Cartridge Unit with Luer Lock, packaged 10 Carpujects/carton, CII, Rx only, Hospira, Inc., Lake Forest, IL ---- NDC 0409-1258-30 | Hospira Inc. | Drug | Class I | 1 |
| 17 Apr 2012 | Crispy by TWI Foods Almond Cake Rusk, Biscotte Croustillante Almande, Net Wt 750 g, Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3. | Indian Foods & Spices, LLC | Food | Class I | 4 |
| 12 Apr 2012 | BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. | Becton Dickinson & Co. | Device | Class II | 2 |
| 9 Apr 2012 | GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light. (62408) | Gulf Fiberoptics, Inc. | Device | Class II | 1 |
| 6 Apr 2012 | Etac¿ Ono Walker, Etac¿ Avant Walker, and Etac¿ Salsa Walker. These products are four-wheeled walkers intended as a walking aid for indoor and outdoor use for persons weighing up to 125 KG. | Etac Supply Center Ab | Device | Class II | 1 |
| 6 Apr 2012 | TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, TDXSI-2, TDXSI-2-S, TDXSI-CG, TDXSI-HD, TDXSI-HD-S, TDXSIV, TDXSIV-2, TDXSIV-2-S, TDXSIV-HD, TDXSIV-HD-S, TDXSP, TDXSPBASE, TDXSP-CG, TDXSPEURO, TDXSP-MCG, TDXSP-MCG-GT, TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-MCG, FDX,… | Invacare Corporation | Device | Class II | 1 |
| 4 Apr 2012 | GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR ) | GE Healthcare, LLC | Device | Class II | 1 |
| 4 Apr 2012 | Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain. | Integra LifeSciences Corp | Device | Class II | 1 |
| 3 Apr 2012 | Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA Manufactured by Ferrosan Medical Devices Ferrosan Medical Devices A/S Sydmarken 5, DK-2860 Soeberg, Denmark Mixed with sterile saline or thrombin solution is indicated for surgical… | Ethicon, Inc. | Device | Class II | 1 |
| 3 Apr 2012 | Crispy by TWI Foods Almond Cake Rusk, Biscuit, Net Wt 26.4 oz. Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court , Mississauga, Ont, Canada . L5S 1S3 | Deep Foods Inc | Food | Class I | 4 |
| 2 Apr 2012 | Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine venipuncture procedures. They are for single-use only and should only be used by adequately trained healthcare personnel… | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 2 Apr 2012 | MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit. | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 2 Apr 2012 | Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 29 Mar 2012 | Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5,… | Fresenius Medical Care Holdings, Inc. | Device | Class I | 2 |
| 29 Mar 2012 | Crispy by TWI Foods Almond Cake Rusk, Biscotte Croustillante Almande, Net Wt 750 g, Product of Canada Manufactured by TWI Foods Inc. 1869 Gage Court, Mississauga, Ont, Canada L5S 1S3. | Singh And Singh Distributors Inc. | Food | Class I | 4 |
| 27 Mar 2012 | Jugos Naturales del Pepino, Jugo de China Natural (Natural Orange Juice), 1 Gal (128 oz), Este producto no est¿ pasteurizado (This product is not pasteurized), Carr 466 Km 4.7 Bo. Robles, San SEbastian, PR 00685 (61530) | Jugos Naturales del Pepino, Inc. | Food | Class II | 1 |
| 23 Mar 2012 | Infusomat(R) Space Pump (US Version) with software version 686G030103 (commonly termed 'G03'), 686E030003, 686F030005, 686F030007, 686G030002, and 686G030102. Intended for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated… | B. Braun Medical, Inc. | Device | Class I | 1 |
| 23 Mar 2012 | Colgate Adult Motion Battery Toothbrush UPC 035000686213 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing. | Colgate Palmolive Company | Device | Class II | 5 |
| 22 Mar 2012 | Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12. | Noven Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 16 Mar 2012 | Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08 | Ranbaxy Inc. | Drug | Class III | 1 |
| 9 Mar 2012 | Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10. (51880) | Pack Pharmaceuticals | Drug | Class III | 1 |
| 8 Mar 2012 | Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01 | Shionogi Inc. | Drug | Class II | 1 |
| 7 Mar 2012 | S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments assist in the removal of an occipital cervical screw during revision surgery. | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 28 Feb 2012 | Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in… (62281) | Critical Diagnostics | Device | Class III | 1 |
| 24 Feb 2012 | Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, Iowa 51601 | Lloyd Inc | Drug | Class II | 2 |
| 20 Feb 2012 | FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. | Maquet Cardiovascular Us Sales, Llc | Device | Class I | 1 |
| 20 Feb 2012 | enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by… | Vital Signs Devices, a GE Healthcare Company | Device | Class II | 1 |
| 6 Feb 2012 | Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10 | sanofi-aventis US, Inc. | Drug | Class II | 2 |
| 3 Feb 2012 | Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | Lloyd Inc | Drug | Class II | 2 |
| 31 Jan 2012 | Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held… (62329) | Individual firm, name withheld | Device | Class II | 1 |
| 26 Jan 2012 | Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 13 Jan 2012 | Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610. Intended Use: The trials are designed and… (61723) | Individual firm, name withheld | Device | Class II | 1 |
| 29 Dec 2011 | Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 19 Dec 2011 | Eon Mini Neurostimulation (IPG) System (Model 3788); The product 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. | Advanced Neuromodulation Systems Inc. | Device | Class II | 1 |
| 17 Oct 2011 | Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical LLC Marietta, GA 30062, NDC 68220-086-30 (61683) | Meda Pharmaceuticals Inc. | Drug | Class II | 1 |
| 8 Sep 2011 | iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood Model… | Abbott Point Of Care Inc. | Device | Class II | 6 |
| 7 Jul 2011 | Jimmy Peppers Hot Cherry Sliced Peppers, 1 gallon plastic jars (62347) | Cosmo's Food Products, Inc. | Food | Class II | 1 |
| 28 Jun 2011 | epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system (61147) | Epocal Inc | Device | Class II | 1 |
| 18 Mar 2011 | Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03 | Physicians Total Care, Inc. | Drug | Class II | 1 |
| 1 Dec 2010 | BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 26 Nov 2010 | Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat. | Pride Mobility Products Corp | Device | Class II | 1 |
| 19 Jul 2010 | Pasteurized liquid whole eggs (56317) | Ballas Egg Prod Corp | Food | Class I | 1 |
| 17 Sep 2009 | MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare worker from the transfer of microorganisms,… | Kimberly-Clark Corporation | Device | Class II | 2 |
| 28 Jan 2009 | Medium Chopped Peanut Granules, Product Code #410016, packaged in 30 lb. vacuum packed plastic bags within cardboard shipping boxes. The total packaging size is 2100 lbs = 70 x 30 lb boxes. | Pro Nutech Inc. | Food | Class I | 2 |
| 19 Nov 2007 | OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical… | GE OEC Medical Systems, Inc | Device | Class II | 3 |
| 20 Nov 2006 | OEC Uroview 2800, Model number A349855. Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 8 Nov 2006 | The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a tracking device to bone is required. | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 15 Sep 2006 | InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: 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… | GE OEC Medical Systems, Inc | Device | Class I | 1 |