| 11 Mar 2013 | PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework. | Keystone Dental Inc | Device | Class II | 1 |
| 7 Mar 2013 | Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054. | Novartis Consumer Health | Drug | Class III | 5 |
| 1 Mar 2013 | Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias. | Boston Scientific CRM Corp | Device | Class II | 1 |
| 1 Mar 2013 | 55613210946 Western Family, Easy Sides, Herb & Butter Pene, Net WT 5.5 oz (156 g), UPC "0 15400 12655 7", Proudly Distributed by Western Family Foods, Inc., P.O. Box 4057, Portland OR, 97208 | Bay Valley Foods LLC/ TreeHouse Foods, Inc | Food | Class II | 4 |
| 1 Mar 2013 | Ezekiel 4:9 Sprouted Grain Cereal- Original, 16 oz. Packaging label reads in part:"***Food FOR Life*** Ezekiel 4:9 SPROUTED WHOLE GRAIN CEREAL ORIGINAL NET WT. 16 OZ (454g)***MANUFACTURED BY: FOOD FOR LIFE BAKING COMPANY, INC. P.O. BOX 1434 CORONA, CA 92878-1434***". | Food For Life Baking Company Inc. | Food | Class II | 3 |
| 28 Feb 2013 | Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures. | Allen Medical Systems, Inc. | Device | Class II | 1 |
| 28 Feb 2013 | See's Candies, Divinity with Walnuts; Net Wt. 1.7 oz, (48 gr). See's Candies, South San Francisco, CA. | See's Candies Inc. | Food | Class I | 1 |
| 27 Feb 2013 | Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a… Event 64479 | Natus Neurology Incorporated | Device | Class II | 1 |
| 27 Feb 2013 | Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis… | Vascular Solutions, Inc. | Device | Class I | 1 |
| 27 Feb 2013 | Mochiko Blue Star Sweet Rice Flour, Net Wt 50 lb. or packaged in 1 lb bags. Koda Farms Milling, Inc. South Dos Palos, CA. 93665 Event 64483 | Koda Farms Inc | Food | Class II | 1 |
| 26 Feb 2013 | INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment. Event 64435 | Intio Inc | Device | Class II | 1 |
| 26 Feb 2013 | TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency… | Hill-Rom, Inc. | Device | Class II | 1 |
| 25 Feb 2013 | ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 25 Feb 2013 | GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump… Event 64423 | Symbios Medical Products, LLC | Device | Class I | 1 |
| 22 Feb 2013 | King Arthur Unbleached All-Purpose Flour, 5-lb. bag UPC 0-71012-01050-9 | The King Arthur Flour Company, Inc. | Food | Class II | 2 |
| 21 Feb 2013 | Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate… | Bard Access Systems | Device | Class II | 2 |
| 21 Feb 2013 | Food Club(R) MEXICAN STYLE ENCHILADA SAUCE, RED, NET WT 10 OZ (284g), DISTRIBUTED BY TOPCO ASSOCIATES LLC, 7711 GROSS POINT RD., SKOKIE, IL 60077 UPC: 036800292208 Event 64442 | Bruce Foods Corp | Food | Class I | 1 |
| 21 Feb 2013 | NuGo Free Trail Mix Bars, UPC 6 91535 45301 2 | NuGo Nutrition HQ | Food | Class I | 1 |
| 21 Feb 2013 | Case UPC: 144000031944 Carton: Nabisco belVita Chocolate Variety Net Wt. 8.8 oz UPC 0 44000 03194 7 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA Inner Pouch: Nabisco belVita Chocolate Variety Net Wt. 1.76 oz UPC 0 44000 03192 3 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753… | Mondelez Global Llc | Food | Class II | 2 |
| 20 Feb 2013 | 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine. Event 64421 | Genesys Orthopedic Systems, LLC | Device | Class II | 1 |
| 20 Feb 2013 | HERBALIFE Formula 1 Instant Healthy Meal, Nutritional Shake Mix ( Vanilla Dream) Packets; net WT 1.83 oz/52 g; packaged as 12 packets in a cardboard carton; just add water; single serve powder in a packet; Event 64419 | Herbalife International Of America Inc | Food | Class I | 1 |
| 20 Feb 2013 | Sunchips 6 Grain Medley Creamy Roasted Garlic, Net WT. 9 oz. (255.1 g), UPC 2840000690 | Frito-Lay, Inc | Food | Class II | 2 |
| 19 Feb 2013 | Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331. | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 19 Feb 2013 | Brownberry Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g) | Bimbo Bakeries Usa | Food | Class II | 13 |
| 19 Feb 2013 | Heartland, AMERICA'S ORIGINAL, Harvest Spice Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090394 | Blue Planet Foods, Inc. | Food | Class II | 7 |
| 17 Feb 2013 | Great Value All Natural Mild Chunky Salsa, 24 oz (1-lb 8-oz) 680 g.; UPC 007874208639; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR | Conagra Inc | Food | Class II | 4 |
| 15 Feb 2013 | Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 15 Feb 2013 | METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24) | Hospira Inc. | Drug | Class II | 1 |
| 15 Feb 2013 | Kellogg's Special K Red Berries, Crunchy Rice & Wheat Flakes with Strawberries 11.2oz; 37 oz; 22.4 ounce Twin Pack | Kellogg Company | Food | Class II | 1 |
| 15 Feb 2013 | Mochiko Blue Star Sweet Rice Flour; Net Wt. 50 lbs. (22.68 k) Koda Farms Milling, Inc. South Dos Palos, CA 93665 Event 64384 | Koda Farms Inc | Food | Class II | 1 |
| 15 Feb 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 64369 | Decoty Coffee Company, Inc | Food | Class I | 1 |
| 14 Feb 2013 | Sold as In-House brand iced tea: Garbanzo Mediterranean Grill Organic Lemongrass Ginger Green Tea, 3 oz. packages Event 64359 | Teatulia | Food | Class I | 1 |
| 14 Feb 2013 | 10021 Roman Meal Premium Oat Bran Mix ( Oat Flour, Oats, Oat Bran, white Wheat Bran, Red Wheat Bran, Stabilizi...., Wheat Germ), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS. | Dakota Specialty Milling, Inc | Food | Class II | 52 |
| 13 Feb 2013 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, 15 mg, Rx Only, C II, 100 capsules per bottle, MFG. By Actavis Elizabeth LLC. 200 Elmora Ave, Elizabeth, NJ, 07207, USA, NDC 0228-3063-11. | Actavis Elizabeth LLC | Drug | Class III | 1 |
| 13 Feb 2013 | Montelukast Sodium Tablets, 10 mg (base), packaged in a) 30-count tablets per bottle (NDC 68462-392-30) and b) 90-count tablets per bottle (NDC 68462-392-90), Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430. | Glenmark Generics Inc., USA | Drug | Class III | 1 |
| 13 Feb 2013 | ZARAH Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28 | Watson Laboratories Inc | Drug | Class II | 1 |
| 13 Feb 2013 | GFS Lemon Pulling, Net Wt. 113 oz (7 lb 1 oz) 3.20 kg UPC 93901-10676. Distributed by Gordon Food Service, Grand Rapids, MI 49548. Event 64365 | Associated Milk Producers, Inc | Food | Class I | 1 |
| 13 Feb 2013 | ALL NATURAL ANCIENT GRAIN BREAD, NET WT. 13.8 OZ. (393 g), PRODUCT OF CANADA, UPC 0 49800 08712 5 (appears on bag), Product Code 08712 --- RICH PRODUCTS CORP., BUFFALO, NY 14213 --- The product is a frozen bread dough packaged in a plastic bag with 24 plastic bags per case. The frozen dough is sold to in-store… | Rich Products Corp | Food | Class II | 1 |
| 13 Feb 2013 | Potato Dumplings, Net Weight 2 lb. (32 oz.), KEEP FROZEN, UPC 6 54368 10038 6, EST # A613069 --- JS Pelmeni OK - 667 Coney Island Ave., Brooklyn, NY 11218 - (718) 469-1490 | Js Pelmeni Ok, Inc. | Food | Class I | 2 |
| 13 Feb 2013 | Sara Lee Thin Style Buns, 100% Multi-Grain, 1.5 oz., Goglanian Bakeries Product Code 77474, UPC 072945611788 --- The product is packaged in a plastic bag with a green bag clip. There are 8 buns per retail package (plastic bag) and there are 18 bags per tray. | Rich Products Corp | Food | Class II | 2 |
| 12 Feb 2013 | Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including… Event 64316 | Oculus Innovative Sciences Inc | Device | Class II | 1 |
| 12 Feb 2013 | Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting. | Integra LifeSciences Corp. | Device | Class II | 1 |
| 12 Feb 2013 | AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. | Steris Corporation | Device | Class II | 1 |
| 12 Feb 2013 | 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08 | Hospira Inc. | Drug | Class II | 1 |
| 12 Feb 2013 | The Muffin Mam, Inc 24oz Strawberry Crème Cake, UPC 7-60366-00986-3 Event 64366 | Muffin Mam Inc (The) | Food | Class I | 1 |
| 11 Feb 2013 | ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease. Event 64348 | Innominata Dba Genbio | Device | Class II | 1 |
| 11 Feb 2013 | LYFE Kitchen, Sweet Corn Chowder with Cashew Cream, Yukon Gold Potatoes and Bell Peppers; 28 oz. 680 gr, Keep Refrigerated. UPC 855764003527 Del Monaco Specialty Products, Morgan Hill, CA Event 64341 | LYFE Kitchen Retail, Inc. | Food | Class II | 1 |
| 8 Feb 2013 | Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets. | Ultradent Products, Inc. | Device | Class III | 1 |
| 8 Feb 2013 | Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01 | Watson Laboratories Inc | Drug | Class II | 2 |
| 8 Feb 2013 | Jamba Multigrain Fruit Chips( Blueberry) 5ozx12 and 1.5ozx55 | Inventure Foods, Inc. | Food | Class II | 2 |
| 8 Feb 2013 | Egyptian Parsley Flakes, Weight: 10kg Net. | Specialty Commodities, Inc. | Food | Class I | 1 |
| 8 Feb 2013 | Organic Lemon Grass Tea Bag Cut (TBC), Item#410. Packing Size: 25 kgs net double craft paper bags and double polyethylene bags each inner liner and repacked product packed in corrugated cartons with polyethylene inner liner. Organic Lemon Grass Tea Bag Cut (TBC) bulk sold in original, repacked cases, and as component… Event 64345 | Name withheld | Food | Class I | 1 |
| 7 Feb 2013 | Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical. Event 64434 | Myco Medical Supplies Inc | Device | Class II | 1 |
| 7 Feb 2013 | CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette… | AGFA Corp. | Device | Class II | 1 |
| 7 Feb 2013 | INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation. | Smith & Nephew Inc | Device | Class II | 2 |
| 7 Feb 2013 | Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device. | Ebi, Llc | Device | Class II | 1 |
| 7 Feb 2013 | Bream Dry Salted Fish Net Wt.: about 14.2 oz Imported by Zip International Group LLC Product of Russia Event 64337 | Zip International Group | Food | Class I | 1 |
| 6 Feb 2013 | Rye bread with the following brands: Village Hearth , Rye Cottage Bread, NET WT 24 OZ ( 1 LB 8OZ) (680g) , East Coast Caraway Rye, NET WT 20 OZ (1 LB 4 OZ (567g) , PAN-O-GOLD VILLAGE HEARTH BAKER ST, ST. CLOUD, MN 56302. Cub Foods, Deli Rye, NET WT 16 OZ (1 LB) 454 g, Distributed by SUPERVALU INC., Eden prairie, MN… Event 64617 | Pan -O- Gold Baking Co | Food | Class II | 1 |
| 5 Feb 2013 | REF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument | Biomet, Inc. | Device | Class II | 1 |
| 5 Feb 2013 | Specialist 2 IM Rod, Non-Sterile and associated Surgical Techniques: Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining &… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 5 Feb 2013 | Salted Print Butter, Rose Valley brand. Product is packaged in 1 lb. unit package, 36 units per case. The UPC is 0 32395 09322 0. The product is labeled in parts: "***ROSE VALLEY***SWEET CREAM BUTTER***NET WT. 16OZ***MFD. BY FARMERS CO-OPERATIVE CREAMERY***McMINNVILLE***ORE***97128***AA GRADE***KEEP… Event 64295 | Farmers Cooperative Creamery | Food | Class III | 1 |
| 4 Feb 2013 | SourceCF(R) Pediatric Drops, Multivitamins with A, B, D, E and K Plus Zinc, 2 FL OZ. (60ML), NDC 66212-300-60, UPC 668212300600 Event 64245 | Aptalis Pharma Us Inc | Food | Class II | 1 |
| 1 Feb 2013 | Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, or end-to-end and eliminate the need of rebuilding the entire system with a longer rod in order to include the new… | Orthofix, Inc | Device | Class II | 1 |
| 1 Feb 2013 | Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508. | Exactech, Inc. | Device | Class II | 1 |
| 1 Feb 2013 | CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10 Event 64266 | Fresenius Kabi USA LLC (FK USA) | Drug | Class III | 1 |
| 1 Feb 2013 | GoldCoast Salads Blue Crab Spread (8oz and 16oz in flexible plastic cup with flexible plastic lids - keep refrigerate at 38 or below) | Name withheld | Food | Class I | 4 |
| 31 Jan 2013 | Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures. Event 64383 | Name withheld | Device | Class II | 1 |
| 31 Jan 2013 | Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 30 Jan 2013 | Z Pro 25 High Protein Supplement Net. Wt. 1.3 oz. - Vanilla Flavor Formulated and Distributed by: R-Kane Products, Inc. 8351 National Highway, Pennsauken, NJ 08110 | R-Kane Products Inc. | Food | Class II | 2 |
| 29 Jan 2013 | Cold-smoked salmon in a vacuum packed, clear plastic bag. Product labeled: Csea brand Cold Smoked Smoked Sockeye Trim, 2 lb., Ingredients: Sockeye Salmon, Salt, and Natural Hardwood Smoked Produced by Ocean Beauty Seafoods, LLC KEEP REFRIGERATED AT 38 DEG OR BELOW" | Ocean Beauty Seafoods, LLC | Food | Class I | 1 |
| 29 Jan 2013 | Cold-smoked salmon in plastic containers. An example of the labeling follows, however, the "SELL BY:" and "PACK DATE" changes. "0297629 015885 SOCKEYE SALMON LOX TRIM WHOLE FOODS MARKET SALMON, SALT, SUGAR AND NATURAL HARDWOOD SMOKE. CONTAINS: FISH***SELL BY: 02.06.13***PACK DATE: 01.30.13***" There is a light blue… | Whole Foods Market Pacific NW Distribution Center (PDC) | Food | Class I | 3 |
| 28 Jan 2013 | Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnires sur Seine (France) Coagulation Assay | Diagnostica Stago, Inc. | Device | Class II | 1 |
| 28 Jan 2013 | Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage. | Bacterin International, Inc. | Device | Class II | 1 |
| 28 Jan 2013 | Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias | Sorin Group USA, Inc. | Device | Class II | 1 |
| 28 Jan 2013 | Clover sprouts, product is packaged in a 4 oz or 5 oz. clamshell containers, and 1 lb. bag or 2 lb. tray. Product is sold under brand Sprouters Northwest. Clover Sprouts, 4oz container, has a UPC 8 15098 00201 6; Clover Sprouts, 5oz container, has a UPC 0 33383 70235 3; Clover Sprouts, 1 lb bag, has a UPC 0 79566… | Giant Greens, Inc. | Food | Class I | 10 |
| 25 Jan 2013 | KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc. | Mc-NEIL-PPC, Inc. | Device | Class II | 3 |
| 25 Jan 2013 | Whole Foods Market Whole Catch Wild Alaskan Sockeye Smoked Salmon, Cold Smoked Sliced, Net Wt. 4 oz, Distributed by Whole Foods Market, Austin, TX 78703 | Whole Foods Market | Food | Class I | 1 |
| 25 Jan 2013 | Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc… Event 35761 | Mandalay Trading Corporation | Food | Class III | 1 |
| 24 Jan 2013 | D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone | Linvatec Corp. dba ConMed Linvatec | Device | Class III | 2 |
| 24 Jan 2013 | Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 23 Jan 2013 | Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 22 Jan 2013 | Medi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831. Event 64541 | RX South LLC DBA RX3 Pharmacy | Drug | Class II | 1 |
| 21 Jan 2013 | Ingenuity TF PET/CT. Diagnostic imaging system | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 21 Jan 2013 | GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension Cardiovascular X-ray imaging systems. Model numbers 2236709, 2353620 ,2223039-2, and 2270677-2. | GE Healthcare, LLC | Device | Class II | 1 |
| 21 Jan 2013 | Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports. | Churchill Medical Systems, Inc. | Device | Class II | 1 |
| 18 Jan 2013 | Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation. | Aesculap, Inc. | Device | Class II | 1 |
| 18 Jan 2013 | ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 18 Jan 2013 | Elekta, Apex add-on Micro MLC, collimator for radiation therapy. | Elekta, Inc. | Device | Class II | 1 |
| 18 Jan 2013 | Well at Walgreens Wal-Tussin CF Max, MAXIMUM STRENGTH ADULT NON-DROWSY, Multi-Symptom Cold, (dextromethorphan HBr 10 mg, guaifenesin 200 mg, phenylephrine HCI 5 mg), 8 FL OZ (237 mL) bottles, Distributed by: Walgreen Co, Deerfield, IL 60015 ---- NDC 0363-0229-08 | Aaron Industries Inc | Drug | Class III | 4 |
| 18 Jan 2013 | Tausi Brand Salted Black Beans. Net Weight 180g (6.34 oz). Distributed by: V8 Commercial Co., Inc. San Juan, Metro Manila. Product of the Philippines. | Phil-Am Trading, Inc. | Food | Class III | 1 |
| 18 Jan 2013 | Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc… Event 34821 | Golden Dharma International Corp | Food | Class III | 1 |
| 18 Jan 2013 | MET-Rx EXTREME NOS PUMPED WATERMELON Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 27603 8, Label Revision 02C, Item Number 27603 (Bottle) Item Number 27604 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487 | NBTY Inc. | Food | Class III | 3 |
| 17 Jan 2013 | SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 17 Jan 2013 | Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic, Sold under the following brands: a) Good Neighbor… | Humco Holding Group, Inc | Drug | Class II | 1 |
| 17 Jan 2013 | Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc… | Walong Marketing, Inc. | Food | Class III | 1 |
| 16 Jan 2013 | Tausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc… Event 34820 | G.L. Food Wholesale Inc | Food | Class III | 1 |
| 15 Jan 2013 | Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not… | Del Mar Reynolds Medical, Ltd. | Device | Class I | 1 |
| 15 Jan 2013 | DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. | DePuy Spine, Inc. | Device | Class II | 4 |
| 14 Jan 2013 | Atricure Inc., Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias… | Atricure Inc | Device | Class II | 1 |
| 11 Jan 2013 | Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 11 Jan 2013 | Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 11 Jan 2013 | Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 11 Jan 2013 | Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 11 Jan 2013 | Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening. | Synthes USA HQ, Inc. | Device | Class II | 3 |
| 11 Jan 2013 | PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04 | AstraZeneca LP | Drug | Class III | 2 |
| 11 Jan 2013 | Homestead Creamery Artisan Cheese, Flory's Favorite, whole raw jersey milk, packaged in 1-lb or 1/2-lb block/plastic packs. Event 64092 | Homestead Creamery | Food | Class I | 1 |
| 10 Jan 2013 | Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge. | Extremity Medical LLC | Device | Class II | 1 |
| 10 Jan 2013 | Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04 | Hospira, Inc. | Drug | Class II | 1 |
| 10 Jan 2013 | Tausi Salted Black Beans, 180 gram (6.34 oz.) can. Ingredient: Black Beans, Water, Iodized salt, sugar and caramel. Distributed by V8 Commercial Co., Inc., San Juan, Metro Manila. Product of the Philippines. UPC 97399 00109 Event 64156 | JMT Trading Company, Inc. | Food | Class III | 1 |
| 8 Jan 2013 | 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23, | Hospira Inc. | Drug | Class II | 1 |
| 7 Jan 2013 | Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 7 Jan 2013 | Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward… | West-ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 4 Jan 2013 | buPROPion Hydrochloride Extended - Release Tablets (XL) 300 mg, 30 tablet bottles, Rx Only, NDC 67767-142-30 Actavis Distributed by: Actavis South Atlantic LLC Sunrise, FL 33325 Packaged by by: America Health Packaging Columbus, OH 43217 Event 64317 | Actavis Pharmaceuticals | Drug | Class III | 1 |
| 2 Jan 2013 | Pascalite Capsules 100 count white plastic bottle with a screw on top, Pascalite Inc, PO Box 104 Worland, WY 82401 307-347-3872, Dietary Supplement for adults and children over 12 years two capsules daily, each vegi cap (size 00) contains approx. 1/4 tsp pascalite powder. | Pascalite, Incorporated | Food | Class II | 2 |
| 28 Dec 2012 | Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers. | Beckman Coulter Inc. | Device | Class II | 1 |
| 27 Dec 2012 | Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument. Event 64313 | Name withheld | Device | Class II | 1 |
| 27 Dec 2012 | Deep Best Quality Dry Garlic Chutney (Thechaa); Net Wt. 4 OZ.; UPC 011433111201; Deep Foods, Inc. Union, NJ 07083 | Deep Foods Inc | Food | Class II | 1 |
| 27 Dec 2012 | APPLE DRINK MIX. Yoruk Prens Elma Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of green apple on label. | Ethnic International Holding Inc | Food | Class II | 5 |
| 20 Dec 2012 | Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 20 Dec 2012 | AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction. | Abbott Medical Optics Inc (AMO) | Device | Class II | 1 |
| 20 Dec 2012 | Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100 | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 20 Dec 2012 | Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum. | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 19 Dec 2012 | Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 19 Dec 2012 | Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process. | Elekta, Inc. | Device | Class II | 1 |
| 18 Dec 2012 | Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording, monitoring and stimulation equipment, for the recording, monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of… | Ad-Tech Medical Instrument Corporation | Device | Class I | 1 |
| 18 Dec 2012 | UpRiver brand Cold Smoke Atlantic Salmon Pre-sliced Vacuum Packed, 4 oz.. | Mkg Provisions Inc | Food | Class I | 4 |
| 17 Dec 2012 | Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter. | Vygon Corporation | Device | Class II | 1 |
| 17 Dec 2012 | EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA | Pacira Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 17 Dec 2012 | "***Productos 2001**Plantillas para Pastelillos-Empanadillas-Tacos-Cheese Dog y Otros (dough rounds for tacos and turnovers)***18 units***Keep refrigerated***NET WT. 28 oz***" Event 63894 | Productos 2001 Inc. | Food | Class II | 1 |
| 16 Dec 2012 | QuietCare-Networked product, Facility Server/model: QC101601; The QuietCare system is intended to detect and analyze residents' movements. | Intel-GE Care Innovations LLC | Device | Class II | 1 |
| 13 Dec 2012 | REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 13 Dec 2012 | Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system. | Draeger Medical, Inc. | Device | Class II | 1 |
| 7 Dec 2012 | Bronkaid Dual Action Formula, Ephedrine Sulfate 25 mg/Bronchodilator, Guaifenesin 400 mg/Expectorant, a) 24 coated caplets per blister pack, UPC 300240537879, b) 60 coated caplets per blister pack, UPC 300240537855, Bayer HealthCare LLC, Consumer Care, P.O. Box 1910, Morristown, NJ, 07962. | Bayer Healthcare, LLC | Drug | Class III | 1 |
| 4 Dec 2012 | Isoniazid Tablets 300 mg tablets USP, Rx Only, a) 30 tablets - NDC 61748-013-30, b) 100 tablets - NDC 61748-013-01, Mfd for: VersaPharm Incorporated Marietta, GA 30065-1505, Mfd by: West - Ward Pharmaceutical Corp.., Eatontown, NJ 07724 | West-ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 4 Dec 2012 | Dextroamphetamine Sulfate Extended Release Capsules, 5 mg, 90 capsules, Rx only, Manufactured by Catalent Pharma Solutions for CorePharma, LLC Middlesex, NJ 08846 NDC 64720-327-09 | Amedra Pharmaceuticals LLC | Drug | Class II | 3 |
| 30 Nov 2012 | Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01. | West-ward Pharmaceutical Corp. | Drug | Class III | 1 |
| 30 Nov 2012 | VERSAPHARM Ethambutol Tablets, USP,400 mg, Rx Only a)60 tablets, NDC 61748-014-06, b)90 tablets, NDC 61748-014-09, c)100 tablets, NDC 61748-014-01, d)1000 tablets, NDC 61748-014-10, e) blister pack (10s) 61748-014-11 Manufactured for: VersaPharm Incorporated Marietta, GA 30062-2260, Manufactured by: West-ward… | West-ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 28 Nov 2012 | Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose, Magnesium, and Potassium. | Beckman Coulter Inc. | Device | Class II | 1 |
| 27 Nov 2012 | Siemens Somatom CTs equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 27 Nov 2012 | Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 20 Nov 2012 | 365 Organic Orzo, 16oz, 20 carton/case | Whole Foods Market | Food | Class II | 1 |
| 15 Nov 2012 | Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK --- NDC 54868-4507-00 | Physicians Total Care, Inc. | Drug | Class II | 1 |
| 15 Nov 2012 | Raspberry Flavor | Bakery Cash & Carry Inc. | Food | Class II | 4 |
| 15 Nov 2012 | Publix 7 inch Chocolate Cookies n Cream Cake Scale ID Number * 002-13584-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499. | Publix Super Markets, Inc. | Food | Class I | 44 |
| 8 Nov 2012 | Whole Foods Market Panettone Chocolate - 26.4 oz, 12 per case. | Whole Foods Market | Food | Class III | 1 |
| 2 Nov 2012 | ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35 Event 63706 | Bristol Myers Squibb Manufacturing Company | Drug | Class II | 1 |
| 30 Oct 2012 | Philips Digital Diagnost Stationary radiographic system | Philips Healthcare Inc. | Device | Class II | 1 |
| 25 Oct 2012 | Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system | Philips Healthcare Inc. | Device | Class II | 1 |
| 25 Oct 2012 | 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. | Volk Optical Inc | Device | Class III | 1 |
| 24 Oct 2012 | Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore, Model #728243; and Brilliance Computed Tomography (CT) X-Ray Scanners, Big Bore Oncology, Model #728244. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 4 |
| 23 Oct 2012 | Dannon Activia LIGHT Nonfat Yogurt Peach Flavor 4x4oz cups INGREDIENTS: CULTURED GRADE A NONFAT MILK, WATER, PEACHES ***DISTRIBUTED BY: THE DANNON COMPANY, INC. WHITE PLAINS, NY 10603 UPC 36632 02633 Expiration code of DEC 04 2012 MZ | The Dannon Company, Inc - Discovery & Innovation Center | Food | Class II | 3 |
| 22 Oct 2012 | HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54 | Hospira Inc. | Drug | Class II | 1 |
| 15 Oct 2012 | The HINES package is a cello/poly laminated bag, predominately blue, with a yellow label stating "SALTED JUMBO VIRGINIA PEANUTS" packed as 8 oz, 10 oz, 12 oz, 16 oz and 24 oz; Hines also packages three "theme" cello/poly laminated bags that are 5.5oz each. The themes for these bags are: 1) Independence Day - red,… | Hines Nut Co | Food | Class I | 1 |
| 5 Oct 2012 | Chocolate Peanut Butter Cup Gelato. The product was distributed to retail stores throughout the United States between September 2011 and September 2012 and is packaged in clear, plastic One Pint (473ml) containers with UPC code 1 86852 00094 5 printed on the back of the container and "Best By" date range of 3/21/13… Event 63420 | Talenti I, LLC | Food | Class I | 1 |
| 4 Oct 2012 | BMC RF Cannula Curved Sharp RadiOpaque, Non-Pyrogenic, Active Tip: 10mm, Gauge 16 Ga, Length: 100mm. The BMC RF Cannula is sealed in a Tyvek pouch (primary packaging) and then placed into a white shelf-box (secondary packaging) with the instructions for use. A predetermined number of white shelf-boxes are then placed… Event 64250 | Baylis Medical Company Inc. | Device | Class II | 1 |
| 4 Oct 2012 | PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routine skin closure in a wide variety of surgical procedures. | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 28 Sep 2012 | Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomography X-Ray System. 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 x-ray transmission data taken at… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 27 Sep 2012 | VACUETTE Cellestis 1 ml QuantiFERON - TB ANTIGEN; Shake 10x; REF 454074; HE0105; 13X75 50 pcs.,1200 pcs. in total; Product Usage: QuantiFERON-TB Gold (QFT) is an in vitro diagnostic test using a peptide cocktail simulation ESAT-6, CFP-10 and TB7.7 (p4) proteins to stimulate cells in heparinized whole blood. | Cellestis Inc | Device | Class II | 2 |
| 26 Sep 2012 | GE Healthcare Definium 5000 / 5220493 X-Ray System | GE Healthcare, LLC | Device | Class II | 2 |
| 26 Sep 2012 | Peanut Butter Power Chews sold as a bulk item through Whole Foods Market self serve bins, PLU 9663 | Whole Foods Market | Food | Class I | 2 |
| 18 Sep 2012 | Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips Medical Systems, Highland Heights, OH 44143 The Brilliance Scanner are computed Tomography X-ray systems with multi-slice capability of up to 16 slices,which are intended to produce cross-sectional images of the body by computer… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 18 Sep 2012 | Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures. | Instratek, Incorporated | Device | Class II | 1 |
| 24 Aug 2012 | Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation. Event 62993 | Spine Smith Partners LP | Device | Class II | 1 |
| 6 Aug 2012 | Orthofix ISKD Limb Lengthener. ISKD - Intramedullary Skeletal Kinetic Distractor. The ISKD is intended for limb lengthening of the tibia and femur. | Orthofix, Inc | Device | Class II | 1 |
| 3 Aug 2012 | GE Healthcare Brivo XR385 DR-F/ X-Ray System X-Ray System | GE Healthcare, LLC | Device | Class II | 1 |
| 1 Aug 2012 | Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupalli, India 502 325, NDC 55111-342-30 | Name withheld | Drug | Class II | 3 |
| 19 Jun 2012 | Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing. | Molded Products Inc | Device | Class II | 1 |
| 25 May 2012 | GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1) Advantage Windows Volume Rendering Option is intended to provide fast, easy, volume visualization of three dimensional… | GE Healthcare, LLC | Device | Class II | 1 |
| 17 May 2012 | Grilled Chicken Marinade, IFF Code 3559317, Net Weight 50 Lb, Batch 0004700696, 004705802, and 004722458, Production Date 04/20/2012 and 05/01/2012, For Manufacturing Use Only. | International Flavors & Fragrances, Inc | Food | Class I | 7 |
| 3 May 2012 | Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Lemonade 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234 UPC 705016895649 | Dymatize Enterprises, LLC | Food | Class I | 3 |
| 28 Mar 2012 | Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator. | Advanced Neuromodulation Systems Inc. | Device | Class II | 1 |
| 5 Mar 2012 | BD Vacutainer PST Gel and Lithium Heparin (LH); 83 Units; Plus Blood Collection Tubes; Sterile; IVD; REF 367962; 4.5 mL, 13 X 100 mm; BD, Franklin Lakes, NJ USA; Made in USA. Used in hospitals, outpatient clinics and physicians' offices to collect blood from patients for specialized chemistry testing. | Becton Dickinson & Company | Device | Class III | 1 |
| 19 Oct 2011 | Yellow Corn Tortillas in 5 lb clear flexible plastic bags with green and yellow printing. Tortilleria Provincia 1200 B Clay Street Bowling Green, KY 42101 Event 60188 | Name withheld | Food | Class II | 1 |
| 6 Jul 2011 | ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone… | Alphatec Spine, Inc. | Device | Class II | 1 |
| 5 Jul 2011 | Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. | Keystone Dental Inc | Device | Class II | 2 |
| 31 May 2011 | Vegi-Fiber Plus; O Trans Fat; only 15.4 Calories; Dietary Supplement; 60 Packets; Scientific formula for Natural Vitality; 15 Vegetable and Fruit Extracts; Newest Japanese Carbohydrate Blocker: Fibersol -2; Each Packet Contains 3.5g of Water-Soluble Dietary Fiber. Manufactured for Wynlife Healthcare, Inc., San Diego,… | Wynlife Healthcare, Inc. | Food | Class II | 2 |
| 27 May 2011 | PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090 | A B Nutrition, Inc. | Drug | Class II | 3 |
| 10 May 2011 | Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner. | GE Healthcare, LLC | Device | Class II | 1 |
| 11 Feb 2011 | The pizza dough shells come in 5 lb. brown cardboard boxes, containing 25 shells per box. Event 57997 | Ron's Pizza Warehouse | Food | Class II | 1 |
| 4 Feb 2011 | GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy. | GE Healthcare, LLC | Device | Class II | 1 |
| 1 Mar 2010 | Eye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072. | K C Pharmaceuticals Inc | Drug | Class II | 1 |
| 15 Jan 2010 | Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.0134 (48mm), 01.26.10.0135 (50mm), 01.26.10.0136 (52mm), 01.26.10.0137 (54mm), 01.26.10.0138 (56mm), 01.26.10.0139 (58mm), 01.26.10.0140 (60mm), 01.26.10.0141 (62mm), 01.26.10.0142 (64mm). Designed for cementless use in total hip arthroplasty. | Medacta Usa Inc | Device | Class II | 1 |
| 6 Feb 2009 | Milk Chocolate Catalog # 111, Dark Chocolate Peanut Clusters Catalog # 112 & Peanut Butter Pieces Catalog # 107 individually wrapped. Date Codes 121401-130831 Event 51893 | Giannios Candy Co Inc | Food | Class I | 1 |
| 3 Feb 2009 | Chocolate bridge mix in 10 oz, 3 oz, and 3.5 oz bags | Gorant Candies Inc A Division of Carlton Cards Retail Inc | Food | Class I | 4 |
| 3 Feb 2009 | B. A. Sweetie Double Dip Peanuts in plastic bags 2 lb, UPC 0 17598 90687 4, 5 lb, UPC 0 17598 00687 1; & Dave's Market Chocolate Double Dip Peanuts in plastic bags, 4 oz, UPC 017598 70687 0 | BA Sweetie Candy Co | Food | Class I | 4 |
| 30 Jan 2009 | Granulated Peanuts in 1 lb plastic bags. Event 50900 | Tropical Nut & Fruit Inc | Food | Class I | 1 |
| 22 Feb 2008 | Wildcat Creek Farms Country Style Butter Flavored Popcorn Salt, 4.5oz glass shaker, UPC 7 28123 91010 4 & 40 oz pete container, UPC 7 28123 91009 8. 4633 Rd. 94, Payne, OH 45880 Event 47202 | WILDCAT CREEK POPCORN | Food | Class I | 1 |