| 8 Jan 2013 | Woodstock All Natural Tamari Almonds, 7.5 OZ in a gusseted re-sealable poly bag. (64046) | Woodstock Farms | Food | Class I | 1 |
| 7 Jan 2013 | Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are indicated for use in perfusion… | Terumo Cardiovascular Systems Corporation | Device | Class II | 6 |
| 7 Jan 2013 | Somersault brand Cinnamon Crunch. Crunchy nuggets baked with sunflower seeds and toasted grains. Sunflower seed snack. .5 oz, 1 oz., 2 oz., 6 oz., and 16 oz. | Somersault Snack Co., LLC | Food | Class I | 1 |
| 4 Jan 2013 | Andy Capp's Cheddar Cheese Fries packaged in Andy Capp's Hot Fries, 0.85-oz foil bags, snack size, Case UPC: 20-0-26200-47169-7 and Unit UPC: 00-0-26200-47168-6. | Conagra Inc | Food | Class II | 1 |
| 2 Jan 2013 | Coca-Cola, 12 fluid ounce aluminum cans in 20-packs and 32-packs, The Coca Cola Company. | Coca-Cola Company (The) | Food | Class III | 1 |
| 28 Dec 2012 | Kinnikinnick Pie Crust Gluten Free (frozen) weight 290 g/ 10 oz Qty/Pkg: 2, UPC 620133006229, Kinnikinnick Foods 10940 120 Street, Edmonton, AB Canada. (63998) | United National Foods (Unfi) | Food | Class I | 1 |
| 27 Dec 2012 | ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tips, REF/Catalog No. 7-100-8CS, Sterile, Rx ONLY -- CONMED CORPORATION Electrosurgical, Cutting and Coagulation and Accessories. | ConMed Corporation | Device | Class II | 20 |
| 22 Dec 2012 | Cold Smoke Salmon in vacuum plastic bags, labeled in part: ***BLACK BEAR***of the BLACK FOREST*** Naturally Smoked***Smoked Salmon***Extra Fancy***1 lb.*** | Marine Harvest USA, LLC | Food | Class I | 11 |
| 21 Dec 2012 | Candy Canes, Peppermint Flavor, 5 oz boxes, packed 12 individually candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA*** | Dollar Tree Distribution, Inc. | Food | Class II | 2 |
| 21 Dec 2012 | Tzatziki; Greek yogurt with cucumber and dill. sold in 8 oz retail and 5 lb bulk food service containers. Undeclared milk. Manufactured by Haigs Delicacies, Hayward, CA. | Individual firm, name withheld | Food | Class I | 4 |
| 20 Dec 2012 | Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion. | Medisystems a NX Stage Company | Device | Class II | 2 |
| 20 Dec 2012 | FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the… | Concentric Medical Inc | Device | Class II | 1 |
| 20 Dec 2012 | Diet Wild Cherry Pepsi two liter plastic bottles UPC 1234107 | Pepsi Cola North America | Food | Class II | 2 |
| 19 Dec 2012 | Marketside, Chunky Bleu Cheese Dressing, Net Wt. 14 fl. oz (414)mL, Manufactured For Marketside, a division of Wal-Mart Stores, Inc., Bentonville, AR 72716. (63943) | Naturally Fresh Inc. | Food | Class II | 1 |
| 19 Dec 2012 | Udi's gluten free au naturel granola in 12 ounce clear plastic bag, UPC 6-98997-80615-8, best by 041913 12265 1. (63928) | Udi's Healthy Foods,Granola & Gluten Free | Food | Class I | 1 |
| 18 Dec 2012 | Medical Surgical Bed, Model 3002SEX Medical Surgical Bed The S3" MedSurg Bed, is intended to support and transport patients within the Med/Surg and Critical Care hospital environments. The bed is typically used in pre-op, post-op and recovery areas of hospital facilities. The intended user for this product is both… | Stryker Medical Division of Stryker Corporation | Device | Class II | 2 |
| 18 Dec 2012 | Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone) Fast Acting Antacid, 200 mg/200 mg/20 mg, 12 fl oz (355 mL) bottles, Distributed by: Belmora LLC, PO Box 3063, Arlington, VA 22203, UPC 8 53030 00209 0, NDC 27854.101.01. (64109) | Belmora LLC | Drug | Class III | 1 |
| 18 Dec 2012 | Nautifish Frozen Cooked Lobster Meat. CKL 12 X 11.3 oz. Metal Cans. 12 items/case. Keep Frozen. | Cap Sur Mer, Inc. | Food | Class I | 6 |
| 18 Dec 2012 | Product labeled in part: ***PARAMOUNT RESERVE***PRODUCT OF CHILE FARM RAISED ATLANTIC SALMON PACKED BY: ALIMENTOS MULTIEXPORT S.A. *** DISTRIBUTED BY MULTIEXPORT FOODS INC. 703 WATERFORD WAY (NW 62ND AVE) SUITE 510, MIAMI, FL 33126*** (63980) | Multiexport Foods, Inc. | Food | Class I | 1 |
| 17 Dec 2012 | Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040. | L. Perrigo Co. | Drug | Class II | 1 |
| 17 Dec 2012 | Sam's Club Artisan Fresh Miniature Candy Cookie Carton 504 Count , 28.35 lb (12.89 kg) (63932) | Dawn Food Products, Inc. | Food | Class II | 1 |
| 13 Dec 2012 | Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the… | Becton Dickinson & Co. | Device | Class II | 1 |
| 13 Dec 2012 | Cold-smoked salmon in vacuum plastic bags that are partially clear and partially colored black, white, gold and pink. Nathan's, 3oz Nova Salmon, has the UPC 0 73030 80368 2. The front panel is labeled in part: "***NATHAN'S TRADITIONAL DELICATESSEN NOVA SALMON CLASSIC SMOKED***NET WT 3 OZ (85g)***" back panel:… | Ocean Beauty Seafoods, LLC | Food | Class I | 2 |
| 13 Dec 2012 | Taylor Farms Hearts of Romaine Lettuce, All Natural, Fresh Hand Selected, Triple Washed and Ready to Enjoy. 10 oz. bags. Taylor Farms, Salinas, CA. UPC 0 30223 04032 3 | Taylor Farms Retail, Inc. | Food | Class I | 1 |
| 13 Dec 2012 | Nature's Plus GLUTEN Free SPIRU-TEIN HIGH PROTEIN ENERGY MEAL, S'mores (Flavor), 1.2 OZ. (34g) Packet, Display Box Product No. 95903, Individual Packet Product No. 45905, UPC Code 097467459052. There are 8 foil packets per corrugated display box. --- Serving Size - 1 packet (1.2 oz.). (63828) | Natural Organics | Food | Class II | 1 |
| 12 Dec 2012 | Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests), 03L52-35 (ROW) and 03L52-37 (U.S.) (5 x 100 tests); in vitro diagnostic. | Abbott Laboratories | Device | Class II | 1 |
| 12 Dec 2012 | Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25. | Boehringer Ingelheim Roxane Inc | Drug | Class III | 1 |
| 11 Dec 2012 | GreenLight HPS (High Performance System) GreenLight XPS (Xcelerated Performance System) Manufactured by AMS, Solutions for Life Innovation Center. GreenLight HPS and XPS Surgical Lasers Systems and accessories are intended for use in endoscopic 532 nm laser resection of the prostate for the treatment of benign… (63972) | AMS Innovative Center - San Jose | Device | Class II | 1 |
| 11 Dec 2012 | Yangsheng Eggs Preserved Duck Eggs Content 6 pcs Net Wt: approx 12.69 oz (360g) S& M (USA) Enterprise Corp Rm3 8/F., Yuexiu Bldg., 160-174 Lockhart Road, Wan Chai, HK Distributed by : S & M Int'l Inc 100 Pulaski ST., Bayonne NJ 07002 Product of China UPC… | S & M International Inc | Food | Class II | 1 |
| 11 Dec 2012 | Yangsheng Duck Eggs Cooked Salted Duck Eggs Content:6 pieces Net Wt. 12.69 oz (360g) S&M (USA0 ENTERPRISE CORP. RED. B/T YUOXIU Bldg. 160-174 Lockhart Road, Man Chai, HK Distributed by: S&M INT'L. INC 100 Pulaski Street, Bayonne NJ 07002 UPC 6949682803568 | S & M International Inc | Food | Class II | 1 |
| 11 Dec 2012 | Markets of Meijer 16oz Redskin Peanuts | Meijer Distribution, Inc | Food | Class III | 1 |
| 10 Dec 2012 | Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis. | Arjo, Inc. dba ArjoHuntleigh | Device | Class II | 1 |
| 10 Dec 2012 | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 10 Dec 2012 | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11. | Upsher Smith Laboratories, Inc. | Drug | Class III | 1 |
| 10 Dec 2012 | Hemp Plus Granola. The product is packaged in a 25 lb. container. The UPC is 0 58449 88001 1. The product is labeled in parts: "***HempPlus Granola***INGREDIENTS: Organic rolled oats, organic evaporated cane juice, organic soybean oil, organic brown rice flour, organic flax seeds, organic hemp seed, organic oat syrup… | Nature'S Path Foods Inc | Food | Class II | 1 |
| 8 Dec 2012 | Red Apple Slices 2.4 oz, Item #71746, 20 oz, Item # 71729 14 oz, Item # 71735. Item #71729 is sold under the brand name Sonic UPC 95829 20000. The other two packages are in clear plastic bags. | Fresh Unlimited Inc | Food | Class I | 12 |
| 7 Dec 2012 | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product… | Hospira Inc. | Device | Class II | 3 |
| 7 Dec 2012 | Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu… | West-ward Pharmaceutical Corp. | Drug | Class II | 2 |
| 7 Dec 2012 | Pastillage (gum paste) Flowers | Individual firm, name withheld | Food | Class I | 8 |
| 6 Dec 2012 | Liko Standard Slingbar 450. The Standard Slingbar 450 is a versatile sling bar which can be used for most lifting situations. It can be used with different Liko ceiling and mobile lifts. | Hill-Rom, Inc. | Device | Class II | 1 |
| 6 Dec 2012 | Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum. | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 6 Dec 2012 | JOEY'S GOURMET LEMON CAKE; NET WT 3 oz. (85 g); UPC 026104613403; Joey's Fine Foods, Inc., Newark, NJ 07104; 973-482-1400 (64006) | Local Baking, Co, Inc. T/A Joey's Fine Foods | Food | Class II | 1 |
| 5 Dec 2012 | Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with an upgrade option to 72 hours. The… | Spacelabs Healthcare, Llc | Device | Class II | 1 |
| 5 Dec 2012 | Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible… | SynCardia Systems Inc. | Device | Class II | 1 |
| 5 Dec 2012 | PredniSONE Tablets, USP, 20 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1477-01), b) 500-count tablets per bottle (NDC 0143-1477-05), and c) 1000-count tablets per bottle (NDC 0143-1477-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724. | West-ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 5 Dec 2012 | Protandim is packaged in a 90cc cylindrical blue bottle with a silver cap and contains thirty caplets per bottle. Label has a blue background with multi-colored print and pictorial stating in part: Lifevantage PROTANDIM *the Nrf2 Synergizer Dietary Supplement I 30 Caplets&. (63826) | Lifevantage Corp | Food | Class II | 1 |
| 4 Dec 2012 | Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL… (63746) | Individual firm, name withheld | Device | Class II | 1 |
| 4 Dec 2012 | Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT LABORATORIES NORTH CHICAGO, IL 60064 U.S.A. | Abbott Laboratories | Drug | Class II | 1 |
| 3 Dec 2012 | Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 30 Nov 2012 | Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. | West-ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 28 Nov 2012 | Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (thyrotropin, TSH) in serum. It is intended strictly for in vitro diagnostic. Used as an aid in the assessment of thyroid status. | Siemens Healthcare Diagnostics | Device | Class III | 3 |
| 26 Nov 2012 | NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the… | Perkinelmer | Device | Class II | 5 |
| 26 Nov 2012 | Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment. | Fresenius Medical Care Holdings, Inc. | Device | Class III | 9 |
| 21 Nov 2012 | Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose,… | Siemens Healthcare Diagnostics Inc | Device | Class II | 7 |
| 19 Nov 2012 | Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1,… | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 19 Nov 2012 | Roche COBAS INTEGRA 400 and 400 plus Analyzer, an in vitro diagnostic analyzer. | Roche Diagnostics Operations, Inc. | Device | Class III | 1 |
| 19 Nov 2012 | Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient. | Fisher & Paykel Healthcare, Ltd. | Device | Class I | 1 |
| 19 Nov 2012 | Cherry tomatoes packaged in 1 pint clear, plastic clamshells. The clamshells are packaged either 9/1-pint clamshells or 12/1-pint clamshells per case. (63750) | Capital City Fruit Co. | Food | Class I | 1 |
| 17 Nov 2012 | Cocoa~Latte Hot Drink Maker; an electric hot drink mixer and dispenser with a 32 fl.oz. heating and mixing jar, twist and lock lid, "perfect temperature" feature, mixing paddle, and dripless faucet; Focus Electrics, LLC, West Bend, WI 53095 (63700) | Focus Products Group Llc | Food | Class II | 1 |
| 16 Nov 2012 | Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder. (63729) | Praxair Inc. | Device | Class I | 1 |
| 16 Nov 2012 | Sanh Yuan Preserved Plum Candy (Sweet and Sour Prune), 5 oz (142g) (63802) | Cho Fuku Group (usa) Inc | Food | Class II | 1 |
| 15 Nov 2012 | Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 60051L, 60081L) ophthalmic viscosurgical device. The 27G disposable cannula is attached to the syringe standard luer… (63698) | Bausch and Lomb, Incorporated | Device | Class I | 1 |
| 13 Nov 2012 | Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4 | Cardinal Health | Food | Class II | 1 |
| 12 Nov 2012 | Zimmer Spine Ardis Inserter, Rx, non-sterile | Zimmer, Inc. | Device | Class I | 1 |
| 12 Nov 2012 | Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features… | Greatbatch Medical | Device | Class II | 1 |
| 12 Nov 2012 | Publix 7 Yellow Special Blend Layers, Net Wt. 14.25 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores. | Maplehurst Deli-Bake South Inc | Food | Class I | 2 |
| 9 Nov 2012 | AVAIRA (enfilcon A) Soft (Hydrophilic) Daily Wear Toric Contact Lenses | Cooper Vision Caribbean Corp. | Device | Class II | 1 |
| 9 Nov 2012 | Grandma's Peanut Butter Sandwich Creme Cookies, Net WT. 3.025 oz, Frito-Lay, Inc. Plano, TX 75024 | Frito Lay, Inc | Food | Class I | 2 |
| 8 Nov 2012 | Spence & Co New York-Style Nova Lox 4oz , refrigerated Spence & Co Smoked Salmon Trimmings, 2lb bulk (bag) (63658) | Spence & Co., Ltd. | Food | Class I | 1 |
| 7 Nov 2012 | Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through… | HemoCue AB | Device | Class III | 1 |
| 7 Nov 2012 | 25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be used in conjunction with other clinical… (63840) | IDS (Immunodiagnostic Systems Ltd.) | Device | Class II | 1 |
| 7 Nov 2012 | Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and ablation of soft tissue; Tattoo removal;… | Quanta System, S.p.A. | Device | Class II | 3 |
| 7 Nov 2012 | DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component. | DePuy Spine, Inc. | Device | Class II | 9 |
| 7 Nov 2012 | Fresh Express brand, Fresh Spinach, 9 oz. | Fresh Express Incorporated | Food | Class I | 1 |
| 5 Nov 2012 | Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0. | Ansell Healthcare Products LLC | Device | Class II | 1 |
| 5 Nov 2012 | Laparoscope, general; plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments. | Applied Medical Resources Corp | Device | Class II | 1 |
| 2 Nov 2012 | Maquet Yuno Extension Table Device Maquet GmbH & Co. KG Kehler Strabe 31 Baden-Wuerttemberg 76437 Rastatt,Germany Used to support the lower extremities immediately before during and after surgery. The extension device is mounted to the YUNO operating table. The product may only be operated by medically trained staff… (63878) | Maquet Inc. | Device | Class II | 1 |
| 2 Nov 2012 | Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use. (63497) | Brookstone Company, Inc. | Device | Class II | 1 |
| 2 Nov 2012 | Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field. | California Medical Laboratories Inc | Device | Class II | 2 |
| 1 Nov 2012 | Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid… (64043) | Abbott Point of Care Canada Limited | Device | Class II | 1 |
| 1 Nov 2012 | Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access 81600; Access 2 81600N, 386220, A69186, A25656, A12900; Access 2 (LXi) A15642; Access 2 Section, DxC 600i A25640. The Access Immunoassay System is an… | Beckman Coulter Inc. | Device | Class II | 1 |
| 1 Nov 2012 | Wegmans Organic Spinach & Spring Mix --- Product is packaged in clam shell in two sizes: 5oz and 11oz. | Wegmans Food Markets | Food | Class I | 1 |
| 29 Oct 2012 | Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR (63608) | Alara Pharmaceutical Co | Drug | Class II | 1 |
| 27 Oct 2012 | Alaskan Wild Smoked Sockeye Salmon in vacuum packed plastic package, labeled in part: "MICHAEL'S WILD SOCKEYE SMOKED SALMON***INGREDIENTS: WILD ALASKAN SOCKEYE SALMON, SALT, SUGAR, NATURAL HARDWOOD SMOKE.***KEEP FROZEN UNTIL USE/THAWED UNDER REFRIGERATION IMMEDIATELY BEFORE USE.***DISTRIBUTED BY:… (63747) | Michael's Seafood Inc. DBA Michael's Gourmet & Delicacies | Food | Class I | 1 |
| 25 Oct 2012 | Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 25 Oct 2012 | Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01 | Hospira Inc. | Drug | Class II | 1 |
| 23 Oct 2012 | Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 23 Oct 2012 | Asian Boy (EBQ) Tapioca Stick 3.5 oz (100g) New B.C.N. Trading Inc. 701 Hadky South Plainfield, NJ 07080 MINH NGUYET TRADING CO., LTD. BIN CHANH -HOCHIMINH CITY VIETNAM UPC 627404021822 (63965) | New B.C.N. Trading Inc | Food | Class III | 1 |
| 21 Oct 2012 | CMC Pumpkin Coffee Cake 16 oz UPC: 041735225726 Price Chopper/Box (63697) | Golub Corp | Food | Class I | 1 |
| 11 Oct 2012 | COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 10 Oct 2012 | ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry. | Horiba Instruments, Inc dba Horiba Medical | Device | Class II | 2 |
| 5 Oct 2012 | Kentucky Bleu cheese was sold in the Louisville, KY, Whole Foods Market store, and was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading 'Kenny's Farmhouse Cheese KY BL". | Whole Foods Market Brand 365, Llc | Food | Class I | 2 |
| 28 Sep 2012 | Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 26 Sep 2012 | Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA | New England Compounding Center | Drug | Class I | 17 |
| 25 Sep 2012 | (l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Light, and (3)Stryker Flat Panel and… (63355) | Stryker Communications, Inc. | Device | Class II | 1 |
| 21 Sep 2012 | Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes. (63803) | sanofi-aventis US, Inc. | Device | Class II | 1 |
| 20 Sep 2012 | The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping… | Zimmer, Inc. | Device | Class II | 1 |
| 20 Sep 2012 | ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2 | Horiba Instruments, Inc dba Horiba Medical | Device | Class II | 1 |
| 20 Sep 2012 | STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD NX Cassettes are only… | Advanced Sterilization Products | Device | Class II | 1 |
| 18 Sep 2012 | Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument. | Becton Dickinson & Co. | Device | Class II | 1 |
| 14 Sep 2012 | Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 11 Sep 2012 | Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 5 Sep 2012 | Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom (63656) | F. Hoffmann-LaRoche Ltd. | Drug | Class II | 1 |
| 28 Aug 2012 | I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031 (62237) | James G. Cole, Inc. | Drug | Class II | 1 |
| 27 Aug 2012 | La Madeleine Potato Soup, 5 lb clear Cryovac pouches, 4 pouches per case. (63816) | Gourmet Cuisine, Inc. | Food | Class I | 1 |
| 21 Aug 2012 | Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded… (63319) | Vycor Medical, Inc. | Device | Class I | 1 |
| 17 Aug 2012 | Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03 | Axcentria Pharmaceuticals LLC | Drug | Class III | 1 |
| 16 Aug 2012 | &TRIGAL***Empanadillas de Pizza (Pizza turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR& | Pastry Food Products Inc. | Food | Class I | 2 |
| 8 Aug 2012 | AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse. | Zoll Circulation, Inc. | Device | Class II | 1 |
| 6 Aug 2012 | Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 30 Jul 2012 | Trastuzumab Kit containing 1 vial Trastuzumab (nominal content: 440 mg); 1 20 mL multiple dose vial Bacteriostatic Water for Injection, USP (1.1% benzyl alcohol), Manufactured by Hospira, Inc., for Genentech, Inc., South San Francisco, CA 94080-4990, NDC 50242-903-69; and 1 Reconstitution Instructions per kit;… | Genentech Inc | Drug | Class I | 1 |
| 26 Jul 2012 | Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes… | Philips Medical Systems North America Co. Phillips | Device | Class II | 2 |
| 25 Jul 2012 | Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. | Lloyd Inc. of Iowa | Drug | Class II | 4 |
| 24 Jul 2012 | DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct. | DePuy Spine, Inc. | Device | Class II | 1 |
| 26 Jun 2012 | GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713… | GE Healthcare, LLC | Device | Class I | 1 |
| 24 Apr 2012 | CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88 | Teva Pharmaceuticals USA, Inc. | Drug | Class III | 1 |
| 28 Mar 2012 | Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. | St Jude Medical Inc | Device | Class III | 1 |
| 27 Mar 2012 | CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation. | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 23 Mar 2012 | Space Pump Pole Clamps for the Infusomat Space Pump, model number 8713130. The Pole Clamp is an accessory to Space Pumps designed to support 1 to 3 pumps on a pole. | B. Braun Medical, Inc. | Device | Class II | 1 |
| 14 Mar 2012 | Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler | Surgical Tissue Network, Inc. | Device | Class II | 3 |
| 27 Jul 2011 | Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for… | Beckman Coulter Inc. | Device | Class II | 1 |
| 12 May 2011 | DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables… | Mindray DS USA, Inc. d.b.a. Mindray North America | Device | Class II | 1 |
| 12 Dec 2006 | PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Biomet, Inc. | Device | Class II | 1 |
| 6 Jun 2006 | Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers. | Radiometer America Inc | Device | Class III | 1 |
| 7 Dec 212 | Knorr Pasta Sides Cheesy Bacon Macaroni Net Wt. 3.8 oz, (107 g) Unilever Englewood Cliffs, NJ 07632 USA Made in Canada from domestic and imported ingredients Case SCC 10041000082488 UPC 4100008248 | Unilever United States, Inc. | Food | Class II | 1 |