| 11 Apr 2013 | Fresh & Easy Organic 100% Apple Juice from concentrate, 64 oz, 8 units/case. UPC/Barcode: 50513790021007 ORIN: 100012615 SPORIN: 100012623 Event 64911 | Fresh And Easy | Food | Class II | 1 |
| 9 Apr 2013 | Trader Joe's Hummus Dip Size: 16 oz., 12 units/case, SKU 20411. Size: 7 oz, 24 units/case, SKU 15735. | Two Chefs On A Roll, Inc | Food | Class II | 9 |
| 4 Apr 2013 | Little Mermaid Brand Smoked Herring. | Little Mermaid Smokehouse | Food | Class I | 2 |
| 2 Apr 2013 | Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as… | Synvasive Technology Inc | Device | Class II | 1 |
| 29 Mar 2013 | Humboldt Fog (brand) Cypress Grove Chevre, Aged Goat Milk Cheese. Packaged in 7oz (random weight) and 5 oz (random weight). Cypress Grove Chevre # 213146 7oz (random weight) Cypress Grove Chevre # 35363 5oz (random weight) Products are random (various) weight. The 7 oz is packed 6 packs per case. The 5 oz is packed 8… Event 64793 | DPI Specialty Foods West, Inc. | Food | Class III | 1 |
| 28 Mar 2013 | EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. | Advanced Sterilization Products | Device | Class II | 1 |
| 28 Mar 2013 | HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including… | Transonic Systems Inc | Device | Class II | 1 |
| 28 Mar 2013 | Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that contains version 4 of the MPI board 10434200; The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal,… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 28 Mar 2013 | Levoxyl (levothyroxine sodium) tablets, USP 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles ( NDC 60793-850-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620. | Pfizer Inc. | Drug | Class II | 11 |
| 27 Mar 2013 | Fructus Lycii (400g). Dried Medlar (Net Wt: 14.11 oz (400G). Ingredients: Dried Medlar. Distributed Exclusively By: Tristar Food Wholesale Company Inc. 115 Amity Street, Jersey City NJ 07304, USA. Product of P.R.C. UPC: 6931653102466 | Tristar Food Wholesale Co Inc | Food | Class II | 1 |
| 27 Mar 2013 | Product does not have a label. The consignees are provided with an ingredient statement for all the products they purchase. The product is packaged in a reusable plastic tote, with white sticker applied to one side of tote. This sticker has the Prepared Date: which is hand written as the month-day. | New Seasons Market | Food | Class II | 1 |
| 27 Mar 2013 | Large Cheese Crisp & Burrito Size, one dozen, net wt. 30 oz | Red Eagle Enterprises | Food | Class II | 3 |
| 27 Mar 2013 | NatureBox brand Umami Almonds packed in branded stand-up pouches (whole tamari flavored almonds), Net wt. 4.3 oz. No UPC Codes on the product, Product is processed and packaged by NatureBox, San Carlos, CA; NOTE: Product label DOES declare that it is "Packed in a facility that also processes tree nuts, peanuts, milk,… | NatureBox, Inc. | Food | Class II | 1 |
| 26 Mar 2013 | Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use. | Edwards Lifesciences, LLC | Device | Class II | 2 |
| 26 Mar 2013 | Publix Deli Tri Fruit and Grain Salad with red rice, red wheat, quinoa, apricots, cranberry and raisins 12oz. In a clear plastic container. | Publix Super Markets, Inc. | Food | Class I | 1 |
| 25 Mar 2013 | Taco Seasoning, Net Wt. 1.25 lb and 5.75 lb. Distributed by Decoty Coffee Company, San Angelo, TX 76903, 800-588-8001. The products come in 1.25lb and 5.75lb sizes and are distributed in plastic spice containers with resealable lids. Event 64721 | Decoty Coffee Company, Inc | Food | Class II | 1 |
| 22 Mar 2013 | EVOTECH Endoscope Cleaner & Reprocessor System, P/N 50004 Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes. | Advanced Sterilization Products | Device | Class II | 1 |
| 22 Mar 2013 | STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments. | Advanced Sterilization Products | Device | Class II | 2 |
| 22 Mar 2013 | Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. Product Usage: Paradigm insulin infusion pumps are intended for use to deliver basal and bolus… Event 64754 | Name withheld | Device | Class II | 1 |
| 22 Mar 2013 | LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit. | Lighthouse For The Blind | Device | Class III | 8 |
| 22 Mar 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. | Actavis South Atlantic LLC | Drug | Class III | 1 |
| 21 Mar 2013 | The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered… | Hospira Inc. | Device | Class II | 2 |
| 21 Mar 2013 | Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080. | Precision Dose Inc. | Drug | Class II | 1 |
| 21 Mar 2013 | Sweet P's Bake Shop branded Caramel Apple Danish Coffee Cake, 14 oz, in a plastic clamshell package, UPC Code: 011225113833 | Gold Standard Baking, Inc. | Food | Class I | 1 |
| 20 Mar 2013 | HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes. | Horiba Instruments, Inc dba Horiba Medical | Device | Class II | 1 |
| 20 Mar 2013 | REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants. | Biomet U.K., Ltd. | Device | Class II | 1 |
| 20 Mar 2013 | Meijer, Spiced Jelly Beans, 32 oz, Product of Mexico, UPC 8-86926-50931-1. | Meijer Distribution, Inc | Food | Class II | 1 |
| 19 Mar 2013 | Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment. | Accuray Incorporated | Device | Class II | 1 |
| 19 Mar 2013 | Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15. Event 64733 | Name withheld | Drug | Class III | 1 |
| 19 Mar 2013 | GERBER Pure Water (1 Plastic Gallon) Event 64735 | Nestle Puerto Rico Inc | Food | Class III | 1 |
| 19 Mar 2013 | Miravalle brand "Pan Rallado Sazonado", 8 oz. Seasoned bread crumbs. Also packaged in 12 pack. Product labeling reads in part:"Miravalle PAN RALLADO SAZONADO SEASONED BREAD CRUMBS Net Wt. 8 Oz.***Packed and Distributed by: Miravalle El Monte, CA 91733***". Event 52857 | Miravalle Food, Inc | Food | Class II | 1 |
| 18 Mar 2013 | Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures. Event 64665 | Integra Burlington MA, Inc. | Device | Class II | 1 |
| 18 Mar 2013 | LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures. | LeMaitre Vascular, Inc. | Device | Class II | 2 |
| 18 Mar 2013 | Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01. | West-ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 18 Mar 2013 | Ferrous Sulfate Tablets 325 mg, 100 count bottles, Nutritional Supplement. Label reads in part "OPTIMUM *** FERROUS SULFATE 325 * mg 5 Grain *** Gluten Free Dietary Supplement *** Manufactured & Distributed by: Magno-Humphries Labs Tigard, OR 97223 U.S.A. *** *325 mg calculated as Ferrous Sulfate Heptahydrate. ***"… Event 64672 | Magno Humphries Inc | Food | Class III | 1 |
| 15 Mar 2013 | Vitrea CT Multi-Chamber Cardiac Functional Analysis application on Vitrea version 5.2 (Vitrea Enterprise Suite 1.3 and Vitrea fX 3.1) and subsequent versions of VitreaWorkstation, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite, through version 6.4. Vitrea CT Multi-Chamber Cardiac Functional Analysis provides… | Vital Images, Inc. | Device | Class II | 1 |
| 15 Mar 2013 | IS2000 USER MANUAL for Intuitive Surgical da Vinci S Surgical System, Model IS2000. Arm drapes protect equipment from contamination. | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 15 Mar 2013 | ACIST Medical Systems Inc. The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. | Acist Medical Systems | Device | Class II | 1 |
| 15 Mar 2013 | IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbound Reporting. Facilitates digital reports for catheterization, echocardiography, and congenital heart disease. | AGFA Corp. | Device | Class II | 1 |
| 15 Mar 2013 | IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component facilitates the quick , effective creation of digital structured reports for adult catheterization and echocardiography, pediatric echocardiography, congenital heart disease, nuclear cardiology and non-invasive vascular disease management. | AGFA Corp. | Device | Class II | 1 |
| 14 Mar 2013 | Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 14 Mar 2013 | The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic… | Synvasive Technology Inc | Device | Class II | 1 |
| 14 Mar 2013 | Precise Treatment Table. To be used as part of radiation therapy treatment process. | Elekta, Inc. | Device | Class II | 1 |
| 14 Mar 2013 | Happy Kids Creamy Peanut Butter, packed in 8 oz, 12 oz, 28 oz, 40 oz jars; packed 12 jars/box and 6 jars/box (40 oz), and labeled in part ******Manufactured by Producers Peanut Co., Inc. 337 Moore Ave., Suffolk, VA 23434*** | Producers Peanut Company Inc | Food | Class II | 4 |
| 14 Mar 2013 | MUSCLEPHARM brand COMBAT POWDER (R), COOKIES 'N' CREAM, NATURAL AND ARTIFICAL FLAVORS, HYBRID SERIES DIETARY SUPPLEMENT, NET WEIGHT 2 LBS (907 GRAMS), EXCLUSIVELY DEVELOPED AND MANUFACTURED FOR: MUSCLEPHARM(TM) CORP., 4721 Ironton St., Denver, CO, 80239, UPC 736211050670 | F.H.G Corporation dba Integrity Nutraceuticals | Food | Class II | 2 |
| 13 Mar 2013 | ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative determination of Vit D. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 4 |
| 13 Mar 2013 | Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta. | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 13 Mar 2013 | Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures… | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 13 Mar 2013 | NewChapter Probiotic Elderberry, 90 vegetarian capsules bottle. Dietary Supplement UPC: 7-27783-00123-8 Event 64614 | New Chapter, Inc. | Food | Class I | 1 |
| 13 Mar 2013 | Sunchang Ssamjang Sesame and Garlic Seasoned Bean Paste 500 g - Net Wt. 17.64 oz., UPC Code 880152435671 Distributed by: Daesang America, Inc. Hackensack, NJ 07601 TEL: (201) 488-4010 Product of Korea Event 64681 | Daesang America Inc | Food | Class I | 1 |
| 12 Mar 2013 | Portia (levonorgestrel and ethinyl estradiol) Tablets, USP, 0.15 mg/0.03 mg, 28-count tablets (containing 21 pink tablets followed by 7 white tablets) per blister card packaged in 6 blister cards per carton, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-9020-58. | Teva Pharmaceuticals USA, Inc. | Drug | Class III | 2 |
| 11 Mar 2013 | All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch Verio”IQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood… Event 64624 | Lifescan Inc | Device | Class I | 1 |
| 11 Mar 2013 | Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT). | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 11 Mar 2013 | Aniracetam & Choline capsules, 430mg Aniracetam 88mg Choline, a) 30 count bottle b) 60 count bottle, c) 90 count, d) 180 count , OTC, BoostYourGrade, LLC Orlando, FL 32826 | Palmer Natural Products | Drug | Class II | 7 |
| 11 Mar 2013 | LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA Event 64695 | Gsms | Drug | Class II | 1 |
| 11 Mar 2013 | Proti Diet High Protein Chocolate Dream Bar, is sold in 210 g packages (7 bars per package) UPC 6 21498 42238 1 Event 64615 | Nashua Nutrition | Food | Class I | 1 |
| 9 Mar 2013 | Metal cans; labeled as containing 29 oz of pinto beans packed in water and salt Event 64572 | La Preferida Inc | Food | Class II | 1 |
| 8 Mar 2013 | Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Angiographic x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 8 Mar 2013 | Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment | Ormco/Sybronendo | Device | Class II | 1 |
| 8 Mar 2013 | ProtiDiet High Protein Chocolate Dream Bar Event 64606 | Name withheld | Food | Class I | 1 |
| 8 Mar 2013 | Opalescence Treswhite Supreme Peach Patient Kit | Ultradent Products, Inc. | Food | Class III | 1 |
| 8 Mar 2013 | Kameda Brand Rice Cracker Kotsubukko, 12/4.37 oz, Item #63018. Event 64636 | Nishimoto Trading Co Ltd | Food | Class I | 1 |
| 8 Mar 2013 | Mikesell's Honey Barbecue TOMATO AND SPICES WITH A HINT OF SWEET FLAVORED POTATO CHIPS Gluten Free 1 oz., 2 oz., 6 oz., 10 oz., 16 oz. MIKESELL'S SNACK FOOD CO. P.O. BOX 115 DAYTON, OH 45404. Event 64649 | Mike-Sells Potato Chip Co | Food | Class II | 1 |
| 7 Mar 2013 | MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring… | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 7 Mar 2013 | Torrent" irrigation tubing. Product Usage: The Torrent” irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an… | US Endoscopy Group Inc | Device | Class II | 1 |
| 7 Mar 2013 | Glory Foods Mixed Greens, Verduras Mixtas 16 oz Event 64555 | Riggio Dist Co | Food | Class II | 1 |
| 7 Mar 2013 | CHU MINH TOFU Fresh Soybean Cake (Tofu), net weight 16 oz. The UPC is 8 18140 00002 2. The product is labeled in parts: "***CHUMINH TOFU***Fresh Soybean Cake (Tofu)***Ingredients: Soybean, Water, Calcium Sulfate***NET WT. 16 OZ***Perishable***Keep Refrigerated***CHUMINH TOFU INCORPORATION***6754 Martin Luther King… | Chu Minh Corp | Food | Class II | 2 |
| 6 Mar 2013 | Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. | Carefusion Corporation | Device | Class I | 1 |
| 6 Mar 2013 | Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System | Carefusion Corporation | Device | Class II | 1 |
| 6 Mar 2013 | Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST). | Alere San Diego, Inc. | Device | Class II | 1 |
| 6 Mar 2013 | TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery | Smith & Nephew Inc | Device | Class II | 1 |
| 6 Mar 2013 | ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar). | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 6 Mar 2013 | KIMGUARD Container Filters, 7.5in (19cm), Round and 9in. X 9in. (23cm x 23cm), Square. Intended to be used to enclose another medical device that is to be sterilized by a health care provider. | Kimberly-Clark Corporation | Device | Class II | 1 |
| 6 Mar 2013 | ShanTea Enlightened Mind Mate/Kukicha (UPC 794504284102) USDA Organic. | ShanTea LLC | Food | Class II | 2 |
| 5 Mar 2013 | SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR” and PRIMUS” family of… | Siemens Medical Solutions USA, Inc | Device | Class II | 9 |
| 5 Mar 2013 | 20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System. | Biosense Webster, Inc. | Device | Class II | 1 |
| 5 Mar 2013 | Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-021-01. | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 4 Mar 2013 | Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be sued to… | Arrow International Inc | Device | Class II | 1 |
| 4 Mar 2013 | Sepp, Compound Benzoin Tincture Packaged and Tincture 3,000 Bulk. Product Usage: Preoperative skin product | CareFusion 213, LLC | Device | Class III | 1 |
| 4 Mar 2013 | SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211. | CareFusion 213, LLC | Drug | Class II | 6 |
| 4 Mar 2013 | Chicken of the Sea Brand 5-ounce chunk white albacore tuna in water. UPC: 4800003355, Case UPC 4800003355: 24 cans per case, Shipper display UPC 4800016335: 80 cans per case, Pallet display UPC 4800023355: 1008 cans per pallet Product labeling reads in part:"***Chicken of the Sea CHUNK WHITE ALBACORE TUNA IN… | Tri-Union Seafoods, L.L.C dba Chicken of the Sea. | Food | Class II | 2 |
| 2 Mar 2013 | Sonoma Mock Chix Salad Ingredients: Dist. by Whole Foods Market 525 N. Lamar Blvd, Austin, TX 78703. Product is made in store and sold under the name of Sonma Mock Chix Salad. It comes in 6oz, 8oz, 16oz, and 24oz clear plastic hinged containers. | Whole Foods Market | Food | Class I | 1 |
| 1 Mar 2013 | Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 1 Mar 2013 | Propolis Powder -100% Standardized Bee-Propolis Lot #: 021113-55/60, EXP: 10/14 11# Bag & Lot#: 10081155/60-120612-100, EXP: 12/15, 1# BAG. | Beehive Botanicals, Inc. | Food | Class II | 2 |
| 1 Mar 2013 | Brunswick and Bumble Bee Brand 5oz Chunk Light Tuna in Water. | Bumble Bee International | Food | Class II | 3 |
| 27 Feb 2013 | Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3. Event 64497 | Name withheld | Device | Class II | 1 |
| 27 Feb 2013 | Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids. | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 3 |
| 26 Feb 2013 | IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the diagnosis of infectious Mononucleosis. | Alere San Diego, Inc. | Device | Class III | 1 |
| 26 Feb 2013 | LEEP REDIKIT Product No. 6060 In a Loop Electrosurgical Excision Procedure, a thin, low-voltage electrified wire loop is used to cut out abnormal cervical tissue. The cartridges of Polocaine and Xylocaine with Epinephrine contained in the LEEP RediKit are local anaesthetic which the physician may choose from during… | Cooper Surgical, Inc. | Device | Class II | 1 |
| 26 Feb 2013 | Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception. | Cooper Surgical, Inc. | Device | Class II | 1 |
| 26 Feb 2013 | Cooper Surgical Incontinence Ring Flexible Pessary #4, 2 3/4", 70mm. Milex Part Number: MXPCON04 A pessary is a medical device that is inserted into the vagina to function as a supportive structure of the uterus and/or bladder and rectum. | Cooper Surgical, Inc. | Device | Class III | 9 |
| 26 Feb 2013 | Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960. | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 26 Feb 2013 | Kroger Value Wheat Bread, PAN DE TRIGO, net wt/peso neto 22.5 oz (1 lb 6.5 oz) 637g UNBLEACHED ENRICHED FLOUR***CONTAINS: WHEAT AND SOY.*** DISTRIBUTED BY/DISTRIBUIDO OR THE KROGER CO., CINCINNATI, OHIO 45202. | Kroger Co | Food | Class II | 4 |
| 26 Feb 2013 | Giant Eagle Lotsa Chocolate Chip Cookies Event 60546 | Name withheld | Food | Class II | 1 |
| 25 Feb 2013 | LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603. Testing of Blood Glucose Levels. | Lifescan Inc | Device | Class II | 2 |
| 25 Feb 2013 | Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81 The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management… Event 64499 | Nipro Diagnostics, Inc. | Device | Class II | 1 |
| 25 Feb 2013 | Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA. | Hospira Inc. | Drug | Class II | 1 |
| 25 Feb 2013 | GREEN DAY brand White Melon Seeds, Net Wt. 9.8 oz (280g) , UPC 6 868978 724120, Produce of P.R.C. --- Firms on Label: Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. Add: Donggua Hill, Beltou Village, Qibao, Xinhui District, Jiangmen City, Guangdong -- Packed For: Domega NY International Co., ltd. 1915 West 13th… | Domega NY International Co Ltd | Food | Class I | 1 |
| 23 Feb 2013 | Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France The Baseplate Impactor Extractor is… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 22 Feb 2013 | Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) method used on the Dimension(R) clinical chemistry system is an in vitro diagnostic test intended for the quantitative measurement of phosphorus in human serum, plasma, and urine. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 22 Feb 2013 | Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations. | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | Device | Class II | 1 |
| 22 Feb 2013 | LiveSmart Bruschetta Pizza #661, Contains 2 - 6.30 OZ PIZZAS, net WT 12.60 oz (357 G), UPC 631488, Distributed by Schwan's Home Service, Marshall, MN 56258, Event 64622 | Schwan's Corporate One Building HS/FS | Food | Class II | 1 |
| 21 Feb 2013 | OsteoSelect DBM Putty Product Usage: Orthopedic bone filler | Bacterin International, Inc. | Device | Class II | 1 |
| 21 Feb 2013 | Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnostic product. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 21 Feb 2013 | Ruthies Cranberry Orange Breakfast Cookie, individually wrapped in plastic, net wt. 4.9 oz. The product is labeled in parts: "***Ruthies Cranberry Orange Breakfast COOKIE***INGREDIENTS***Butter (pasteurized cream, salt)***Contains the following allergens: Wheat, Eggs***NET WT. 4.9 Oz***Manufactured for Ruthie's,… | Wholesale Baking, Inc. | Food | Class II | 2 |
| 21 Feb 2013 | Nutrex Research Lipo 6 Black Ultra concentrate Fat Destroyer Event 64595 | Nutrex Research, Inc. | Food | Class I | 1 |
| 18 Feb 2013 | VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat.… | Biomerieux Inc | Device | Class II | 3 |
| 18 Feb 2013 | 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045 | Hospira Inc. | Drug | Class II | 1 |
| 18 Feb 2013 | PE Daytime Cold/Flu LiqGel, Multi Symptom Relief, Acetaminophen/Dextromethorphan HBr/Phenylephrine HCL 325/10/5 mg gel caps 20 count blister pack, Distributed By: Wal-Mat Stores Inc., Bentonville, AR, 72716 | L. Perrigo Co. | Drug | Class III | 1 |
| 15 Feb 2013 | ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection… | Horiba Instruments, Inc dba Horiba Medical | Device | Class III | 1 |
| 15 Feb 2013 | Amoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 08807 Event 64405 | Name withheld | Drug | Class II | 1 |
| 15 Feb 2013 | Item #1815, Kettle brand Natural Chocolate Lovers Trail Mix UPC 8411401910 Label reads in part "8411401910 Honey Roast Harvest Mix Net Weight 24 Lbs. ***" | Kettle Foods, Inc. | Food | Class III | 3 |
| 14 Feb 2013 | BD Vacutainer C&S Transfer Straw Kit C&S Preservative Plus Urine Tube. 4.0 ml, 13 X 75 mm STERILE REF 364953. Becton Dickinson & Company, Franklin Lakes, NJ USA, The kit consists of a transfer straw and urinalysis tube intended for UA chemistry urine testing. | Becton Dickinson & Company | Device | Class III | 1 |
| 14 Feb 2013 | Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique. Event 64538 | Elana, Inc. | Device | Class II | 1 |
| 12 Feb 2013 | Intellispace Portal (ISP) Philips Medical Systems (Cleveland), Inc., IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 12 Feb 2013 | Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces. | Polymedco, Inc | Device | Class II | 2 |
| 12 Feb 2013 | Access Immunoassay System; P/N 107405S Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. | Beckman Coulter Inc. | Device | Class II | 4 |
| 11 Feb 2013 | Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis. | Covidien LP | Device | Class II | 1 |
| 11 Feb 2013 | Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides). Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents. | Microbiologics Inc | Device | Class II | 1 |
| 8 Feb 2013 | Zimmer NexPosure, retractor portals of the NexPosure MIS Access System, Part Numbers or REF numbers: N1830R80-100, N1830R80-090¿, N1830R80-080¿, N1830R80-070¿, N1830R80-060, N1830R50-100, N1830R50-090, N1830R50-080, N1830R50-070, N1830R50-060, N1830L80-100, N1830L80-090, N1830L80-080, N1830L80-070, N1830L80-060,… | Zimmer, Inc. | Device | Class II | 1 |
| 8 Feb 2013 | GE Healthcare LOGIQ S8 (with software revisions R1.1.1 and R1.5.1) and LOGIQ S7 (with software revisions R1.0.1, R1.0.2 and R1.0.3) diagnostic ultrasound system with the S4-10-D Ultrasound Probe. The device is intended for use in ultrasound evaluation. | GE Healthcare, LLC | Device | Class II | 1 |
| 8 Feb 2013 | The LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators. Product part's numbers: 3200731-xxx, 3202177-xxx, U3200731-xxx, and U3202177-006. Automated external defibrillators. | Physio Control, Inc. | Device | Class II | 1 |
| 8 Feb 2013 | Canned Peach Slices in Light Syrup or canned Peach Slices in Heavy Syrup or canned Peach halves in Heavy Syrup. The PDP reads "HOOD-CREST ELBERTA PEACHES YELLOW FREESTONE SLICES IN LIGHT SYRUP NET WT. 28 OZ. (1LB. 12 OZ.) 793G" The back panel reads in part "***INGREDIENTS: PEACHES, WATER, SUGAR. MUIRHEAD CANNING CO.… | Sage Creek Inc | Food | Class II | 3 |
| 7 Feb 2013 | VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes. | Ortho-Clinical Diagnostics | Device | Class II | 3 |
| 7 Feb 2013 | CLONAZEPAM ORALLY DISINTERGRATING Tablets, USP, 0.5 mg, 60 tablets (10 blister cards of 6 tablets each), TEVA PHARMACEUTICALS USA, Sellersville PA 18960, NDC #0555-0096-96 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 7 Feb 2013 | Ideal Protein, Sea Salt & Vinegar Ridges, 7 packets Net WT 1.4 oz (40 g) each. Total net weight 9.9 oz (280 g). Distributed by Laboratories C.O.P Inc., 60 Jean-Proulx St Gatieau QC Canada J8Z 1W1 | Zumbro River Brand, Inc | Food | Class II | 2 |
| 6 Feb 2013 | Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI Remote Alarm Cable is designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) system to transfer alarm… | Smiths Medical ASD, Inc. | Device | Class I | 1 |
| 6 Feb 2013 | Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the… Event 64848 | Heritage Labs International LLC | Device | Class II | 1 |
| 6 Feb 2013 | bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card, REF 410 028. For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents. | Biomerieux Inc | Device | Class II | 1 |
| 6 Feb 2013 | Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01 | West-ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 6 Feb 2013 | Norwegian Smoked Salmon Sides (2-3 lbs.) | Mkg Provisions Inc | Food | Class I | 12 |
| 5 Feb 2013 | Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except 6.1.6, 6.2.3 and 6.3 The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multidimensional digital images acquired from a… | Vital Images, Inc. | Device | Class II | 1 |
| 4 Feb 2013 | EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis Event 64395 | Endogastric Solutions Inc | Device | Class II | 1 |
| 4 Feb 2013 | Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). Event 64501 | Genetic Testing Institute,inc | Device | Class II | 1 |
| 4 Feb 2013 | GREEN DAY DRIED COCONUT, Net Wt: 3oz (85g), UPC bar code 6 950296 800744 -- Manufacturer: Jiangmen Xinhui Parksun Food Co., Ltd. -- Add: Donggua Hill, Beitou Village, Qibao, Xinhui District, Jiangmen City, Guangdong, Produce of P.R.C. -- Packed For: Domega NY International Co., Ltd., 1916 West 13th Street Brooklyn,… | Domega NY International Co Ltd | Food | Class I | 1 |
| 1 Feb 2013 | TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960 Manufactured in Israel. | Ferring Pharmaceuticals Inc | Drug | Class III | 1 |
| 31 Jan 2013 | Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03. | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 31 Jan 2013 | Canned mushrooms, #10 cans (Brites, not labeled) Event 64446 | L. K. Bowman, Incorporated | Food | Class II | 1 |
| 30 Jan 2013 | Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood samples. | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 25 Jan 2013 | Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09. | Hospira Inc. | Drug | Class I | 1 |
| 24 Jan 2013 | Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip. | Stelkast Co | Device | Class II | 1 |
| 15 Jan 2013 | Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. Angiographic x-ray system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 11 Jan 2013 | Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 11 Jan 2013 | Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 8 Jan 2013 | Giraffe OmniBed and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer. | GE Healthcare, LLC | Device | Class I | 1 |
| 3 Jan 2013 | Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. | Animas Corporation | Device | Class I | 1 |
| 20 Dec 2012 | Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 20 Dec 2012 | ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of the SIEMENS branded ARTISTE” and ONCOR” family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 18 Dec 2012 | ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum… | Abbott Laboratories, Inc | Device | Class II | 1 |
| 18 Dec 2012 | Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA) Product Usage: Disposal system for counting of… | Cardinal Health | Device | Class II | 9 |
| 13 Dec 2012 | SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected between the patient hoist mechanism and patient… Event 64698 | Name withheld | Device | Class II | 1 |
| 11 Dec 2012 | Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 11 Dec 2012 | BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures.… | Becton Dickinson & Co. | Device | Class II | 1 |
| 10 Dec 2012 | Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and non-stereotactic (frameless stereotactic), collimated beam, computer planned, linear accelerator (Linac) based treatment. | Integra LifeSciences Corp. | Device | Class II | 1 |
| 5 Dec 2012 | Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 4 Dec 2012 | Siya Green Mukwhas Net Wt. 200 gm (7 oz) Distributed by: Miami Growers, Inc. 80 Broadway, Jersey City, NJ 07306 Phone: 201-985-9322, Fax: 201-985-9569 Email: miamigrowers@yahoo.com Visit us: www.miamigrowersinc.com A Product of India Event 64048 | Miami Growers Inc. | Food | Class II | 1 |
| 29 Nov 2012 | CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain… Event 64418 | Thermo Fisher Scientific (Asheville) LLC | Device | Class II | 1 |
| 28 Nov 2012 | BS-200 Chemistry Analyzer Designed for clinical laboratory use. | Mindray DS USA, Inc. d.b.a. Mindray North America | Device | Class II | 1 |
| 27 Nov 2012 | Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy. | Arrow International Inc | Device | Class II | 2 |
| 26 Nov 2012 | Siemens Axiom Artis zeego systems with software version VC14, VC20 and VC21 in conjunction with specific technical configuration Angiographic x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 26 Nov 2012 | TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packaged in a carton containing 1 vial TORISEL injection and 1 vial DILUENT for TORISEL, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA --- NDC 0008-1179-01 | Pfizer Inc. | Drug | Class III | 1 |
| 21 Nov 2012 | Derma-Smoothe/FS (fluocinolone acetonide), 0.01% Topical Oil (Body Oil), Rx only, Hill Dermaceuticals, Inc., Sanford, Florida 32773 --- NDC 28105-150-04 | Hill Dermaceuticals, Inc. | Drug | Class III | 2 |
| 16 Nov 2012 | Clinical Chemistry Phenobarbital, list number 1E08 | Abbott Laboratories, Inc | Device | Class II | 1 |
| 14 Nov 2012 | Toshiba TSX-30IC AQUlLlON ONE System, Computed Tomography X-Ray. This system supports Whole body scanning. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 8 Nov 2012 | ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting. | Stryker Howmedica Osteonics Corp. | Device | Class I | 1 |
| 8 Nov 2012 | Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 31 Oct 2012 | Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others. Event 63622 | J T Posey Company | Device | Class II | 1 |
| 30 Oct 2012 | Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures. | Orthohelix Surgical Designs Inc | Device | Class II | 1 |
| 15 Oct 2012 | MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan 3T MRI System Product Usage: MRI System. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 10 Oct 2012 | Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System. | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 5 Oct 2012 | Siemens syngo WorkFlow SLR, Radiological Information System, Version VA31A SP1/SP2/SP3 The information system syngo(R) Workflow SLR is a digital radiology information system (RIS) with integrated modules for patient administration, examination, reporting, statistics and system administration, as well as multiple… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 5 Oct 2012 | Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09. | Hospira Inc. | Drug | Class I | 1 |
| 26 Sep 2012 | DeGotzen XRay unit XGenus Dental X-ray unit. Event 64734 | DeGotzen | Device | Class II | 1 |
| 7 Sep 2012 | Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide… | Instrumentation Industries Inc | Device | Class II | 1 |
| 30 Aug 2012 | EphBurn 25, 90 count bottle with red capsules Event 63060 | Brand New Energy, LLC | Food | Class I | 1 |
| 22 Aug 2012 | Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking. Event 64075 | Viscot Medical LLC | Device | Class III | 1 |
| 18 Jul 2012 | Fougera Ketoconazole Cream 2%, 15g tube, Rx only, Labeled with E. Fougera & Co., a division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0099-15 | Fougera Pharmaceuticals Inc. | Drug | Class III | 1 |
| 28 Jun 2012 | GE Healthcare, AW Server. Product Usage: . AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. Both the client and server software are… | GE Healthcare, LLC | Device | Class II | 1 |
| 21 Jun 2012 | Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09 | Hospira, Inc. | Drug | Class III | 1 |
| 23 Apr 2012 | GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body,… | GE Healthcare, LLC | Device | Class II | 1 |
| 13 Mar 2012 | STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer. | Advanced Sterilization Products | Device | Class II | 1 |
| 10 Mar 2012 | Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS Event 63684 | The Menz Club, LLC | Drug | Class I | 1 |
| 6 Mar 2012 | GE Healthcare Quasar Nuclear Medicine System, Hawkeye Option and Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera. Nuclear Medicine imaging systems. Recall includes all Infinia systems, all configurations. | GE Healthcare, LLC | Device | Class II | 1 |
| 20 Feb 2012 | PHYSICIANS TOTAL CARE, TETRACYCLINE, 250 mg, 30 CAPSULES, bottle MFG. BY: TEVA PHARMACEUTICALS USA, SELLERSVILLE PA 18960 NDC 54868-0024-08 | Physicians Total Care, Inc. | Drug | Class II | 2 |
| 23 Jan 2012 | VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care,… | GE Healthcare, LLC | Device | Class II | 1 |
| 4 Jan 2012 | GE Healthcare Muse v7 cardiology information system. Model number 2026443-001: MUSE 7.0 app cd, Model Number 2026443-015: MUSE 7.0.2 app cd, Model number 2026443-017: MUSE 7.1 app cd, Model number 2026443-029:MUSE 7.1.1 A app cd, and Model Number 2026443-031: MUSE 7.1.1 app cd. Intended to store, access and manage… | GE Healthcare, LLC | Device | Class II | 1 |
| 19 Dec 2011 | Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA Event 62836 | Body Basics Inc | Drug | Class I | 1 |
| 30 Nov 2011 | TSX-IOI: AQUILION 32/64; System, X-Ray, Tomography, Computed. Designed to produce cross-sectional images of a human body. | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 21 Oct 2011 | GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventional Imaging System. | GE Healthcare, LLC | Device | Class II | 1 |
| 12 Sep 2011 | Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. . Event 64751 | Engineered Medical Systems,Inc | Device | Class I | 1 |
| 13 Jun 2011 | Z-800 Volumetric Infusion System. For intravenous infusion of parenteral fluids, blood and blood products to a human patient. | Zyno Medical LLC | Device | Class II | 1 |
| 14 Apr 2011 | Mrs. Bridges Scottish Raspberry Preserve ("Jam"); Net Wt. 42g /1.5oz; service size 15g; servings per package: 2.8; ID 3779300377 Manufactured for: Kimm & Miller (UK) Ltd. mille Road, Bedford, MK429TW. United Kingdom; Manufacturer: Mackays Ltd., James Chalmers Road, Kirkton Ind Estate, Arbroath, Scotland UK DD113LR. | The TJX Companies, Inc. | Food | Class III | 1 |
| 18 Aug 2010 | G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood. | Tosoh Bioscience Inc | Device | Class III | 1 |
| 14 May 2010 | Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 5 Apr 2010 | Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at different angles can be reconstructed into… | Philips Healthcare Inc. | Device | Class II | 1 |
| 20 Nov 2009 | Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room. | CareFusion Corporation | Device | Class II | 1 |
| 9 Jun 2008 | Banana Nut Bread packed in carton, placed in polypropelin Bag 1 lb each Event 49017 | Servatii Inc | Food | Class II | 1 |