| 8 Nov 2012 | EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with… | MOOG Medical Devices Group | Device | Class II | 1 |
| 6 Nov 2012 | Beagle Bay Organics Brand Raw Sauerkraut, Kimchi Net. Wt. 16 oz (416g). Product is stored/distributed under refrigeration and is intended to be eaten raw as a condiment. Beagle Bay Organics, 4501 Manatee Ave W # 105, Bradenton, FL 34209 Event 63664 | Cracker Industries, LLC | Food | Class II | 1 |
| 5 Nov 2012 | SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are… | Sentec AG | Device | Class II | 2 |
| 2 Nov 2012 | KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD Patient Size: 10-20kg Product Usage: Laryngeal airway | King Systems Corp. | Device | Class II | 10 |
| 2 Nov 2012 | Grape Tomatoes, 199 cartons x 12 packages x 1 pint. Event 63611 | E.D. Produce | Food | Class I | 1 |
| 31 Oct 2012 | All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com | Ameridose LLC | Drug | Class II | 2 |
| 26 Oct 2012 | Tub labeled as Kay's Classic Vanilla Bean ice Cream. UPC 87848-13021, 1.5 Quarts (1.42L). Lid labeled as Kay's Classic Toasted Butter Pecan ice cream Event 63588 | Schoep's Ice Cream Co, Inc | Food | Class II | 1 |
| 26 Oct 2012 | Peanut Butter Pave, UPC code 693868102117 & 69386905312, in the following sizes: 1) 5 Piece Peanut Butter Pave, 63 Grams per pack, 12 Packs per case. 2) 2 Piece Peanut Butter Pave, 26 Grams per pack, 10 Packs per case. 3) Bulk Peanut Butter Pave, 415 Grams per pack. Event 63582 | B.T. McElrath Chocolatier, Inc | Food | Class I | 1 |
| 25 Oct 2012 | BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting… | Kerr Corporation | Device | Class II | 1 |
| 25 Oct 2012 | INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments | Carl Zeiss Meditec, Inc. | Device | Class II | 3 |
| 24 Oct 2012 | Superstat Modified Collagen Hemostatic Sponge.115mmx115mm Pledget, 1.5%, Part#9500-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types… | Superstat Corp | Device | Class II | 13 |
| 23 Oct 2012 | Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC 0 87614 24092 3. | Swanson Health Products, Inc | Food | Class III | 1 |
| 20 Oct 2012 | Rudi's Organic Bakery, Colorado Cracked Wheat, 22 oz, UPC 031493-54373-6, packed in flexible plastic bags. Labeling is tan, yellow, white, maroon, and orange with white, black, green, maroon, and orange print writing. | Charter Baking Company | Food | Class II | 3 |
| 19 Oct 2012 | IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro II-SE and Neuro III-SV Magnetic Resonance Imaging Systems. Event 63500 | Innovative Magnetic Resonance Imaging Systems Inc. | Device | Class II | 1 |
| 19 Oct 2012 | qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or… | Spacelabs Healthcare, Llc | Device | Class II | 1 |
| 19 Oct 2012 | TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular… | Trivascular, Inc | Device | Class II | 1 |
| 19 Oct 2012 | AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI). | American Medical Systems, Inc. | Device | Class II | 1 |
| 18 Oct 2012 | 4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name:… | OrthoPediatrics Corp | Device | Class II | 1 |
| 18 Oct 2012 | Gilster-Mary Lee Corporation, Better Valu Fruit Whirls, Naturally Flavored packaged in a 28 oz (1 LB 12 OZ) (794g) plastic bag. (manufactured by Gilster Mary Lee, Joplin, MO) | Gilster-Mary Lee Corp. | Food | Class I | 1 |
| 18 Oct 2012 | The Nut Shop (brand) Roasted Peanuts, 3.0 oz MIN Wt. Event 63587 | Williams and Company Inc dba The Nut Shop | Food | Class I | 1 |
| 17 Oct 2012 | PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube | Gyrus Acmi, Incorporated | Device | Class II | 1 |
| 17 Oct 2012 | 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system is designed to… | Biomerieux Inc | Device | Class II | 1 |
| 17 Oct 2012 | Iskream brand Peanut Butter and Jelly No Sugar Added, reduced fat, packaged in Pint (retail) an 2.5 gallon bulk cartons Event 63477 | Name withheld | Food | Class I | 1 |
| 17 Oct 2012 | Dole American Blend; Iceberg, Romaine, Red Cabbage, Carrots and Radishes. Net Wt. 12 oz. (340g) UPC 0 71430 00933 8 Distributed by Dole Fresh Vegetables, Monterey, CA 93940 | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 17 Oct 2012 | Earthbound Farms Organic Baby Spinach Grab & Go Salad; with sesame, soy vinaigrette and peanuts. USDA Organic 3.5 oz. Clamshell package. UPC 0 32601 08875 0 Natural Selection Foods San Juan Bautista, CA. Event 63484 | Natural Selection Foods LLC dba Earthbound Farm | Food | Class I | 1 |
| 17 Oct 2012 | Peanuts in Shell, R&S, 8oz, Item#304, 12pk/case, UPC 070334003046. Peanuts in Shell, R&S, 8oz, Item#304P, 12pk/case, UPC 170334003046. Peanuts in Shell, R&S, 8oz, Item#307, 36pk/case, UPC 070334003046. Peanuts in Shell, R&S, 16oz, Item#317, 24pk/case, UPC 070334003176. Peanuts in Shell, R&S Clip Strips, Item#327,… | Energy Club Inc | Food | Class I | 2 |
| 17 Oct 2012 | Fiesta Mix 25 pound bags, with UPC 032491208597. The product is labeled in part: "***Fiesta Mix A Blend of the Sweet Crunchy and Salty Ingredient: Peanuts, honey, chili bits, corn, goldfish, nacho flavoring, vegetable oil, salt. *** 25 pounds (11.34 kg) net weight *** The Nut Factory 19425 East Broadway Avenue… Event 63501 | The Nut Factory Inc. | Food | Class I | 1 |
| 16 Oct 2012 | Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. | Vital Signs Devices, a GE Healthcare Company | Device | Class II | 1 |
| 16 Oct 2012 | bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources… | Biomerieux Inc | Device | Class II | 31 |
| 16 Oct 2012 | HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit. | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 16 Oct 2012 | Salted in-shell Peanuts under the following. Salted in Shell PeanutsGless Ranch Label, Item Number 450-175, Pack Size 24/12 oz bags, UPC Code 72488980310. Salted in Shell PeanutsSun Harvest Label, Item Number 450-248, Pack Size 24/16 oz bags, UPC Code 646670306785. Salted in-shell Peanuts, Item Number 450-195, 50 lb… | Torn & Glasser Inc. | Food | Class I | 2 |
| 16 Oct 2012 | Frozen Publix Brand Premium Tempura Shrimp, 11 oz box packed 10 boxes per case. Event 63493 | Publix Corporate Office | Food | Class I | 1 |
| 16 Oct 2012 | Green & Black's Organic Peanut & Sea Salt Milk Chocolate Bar NET WT. 3.5 oz (100g). UPC 708656 100562. | Mondelez Global Llc | Food | Class I | 1 |
| 16 Oct 2012 | PureFit Peanut Butter Bars, size 2 oz (56.7g) and box of 15 bars in 1 box/carton. UPC 812787001008, 812787002005 Event 63438 | PureFit Inc | Food | Class I | 1 |
| 15 Oct 2012 | AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-count 2 fl oz (59 mL) Repair Lotion (benzoyl peroxide 3.7% w/v) AFCS-0301-00 per carton, Dist. by: University Medical… | Valeant Pharmaceuticals | Drug | Class III | 8 |
| 15 Oct 2012 | Peanut brittle, 2 lbs packaged in plastic bags (bulk product) | Southern Belle, Inc. | Food | Class I | 2 |
| 15 Oct 2012 | Turkey Hill Mint Chocolate Chip All Natural Ice Cream, 48 oz, UPC 0-20735-11203-8 Event 63470 | Turkey Hill Dairy, Inc. | Food | Class II | 1 |
| 12 Oct 2012 | Mega Raw Oriental Produce Wholesaler- Valencia Peanuts, No UPC, Item numbers M10101. | Sunland, Incorporated | Food | Class I | 32 |
| 12 Oct 2012 | Nutrition bar. Crunch thinkThin Brand, Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts***Ventura, CA 93003***". 10 bars/carton, 12 cartons/case. 120 bars per case | Think Thin, LLC | Food | Class I | 7 |
| 12 Oct 2012 | Ridgebar Peanut Butter Crunch, 40 grams Event 63453 | Creative Energy Foods, Inc. LLC | Food | Class I | 1 |
| 12 Oct 2012 | Su-Nun Crushed Roasted Thai Red Pepper, 10.58 oz. 12 jars/case. Packaged in clear plastic jars, red plastic screw on lid, with a red and yellow label. The principal display label has a red background with a yellow oval that reads in part:"SU-NUN***BRAND***HOT***CRUSHED ROASTED THAI RED PEPPER". Label on the back… Event 63444 | S & P Company Limited | Food | Class I | 1 |
| 11 Oct 2012 | Peanut Butter Cup Ice Cream: 1) Velvet Supreme Peanut Butter Cup 1/2 gallon MFD BY VELVET ICE CREAM CO., INC UTICA, OHIO 43080 1-800-589-5000; UPC #70682-10119; 2) Velvet Peanut Butter Cup, 3 gal, UPC #70682-10539 | Velvet Ice Cream Company | Food | Class I | 2 |
| 11 Oct 2012 | Mazzio's Marinara Sauce, 6.65-lb pouch, 6 pouches per case Pouches are packed in cardboard box for shipment Event 63508 | Paradise Tomato Kitchens Inc | Food | Class II | 1 |
| 11 Oct 2012 | Organic Toffee Peanuts;Bulk packaging - 20 pound cases; Ingredients: Organic Peanuts, Organic Sugar, Salt. Event 63452 | Sconza Candy Company, Inc. | Food | Class I | 1 |
| 11 Oct 2012 | Pierre Peanut Butter & Grape Jelly on White Bread, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246. | Name withheld | Food | Class I | 19 |
| 11 Oct 2012 | Hannaford Red Velvet Cake Truffle, 6 count UPC #20335800000 | Name withheld | Food | Class I | 2 |
| 11 Oct 2012 | Fresh Express, Hearts of Romaine, 18 oz, Fresh Express Incorporated, packed in clear flexible plastic package. | Fresh Express Incorporated | Food | Class I | 1 |
| 10 Oct 2012 | Albertsons Brand Peanut Butter Chocolate Ice Cream, 1.5 Quarts (1.42L), commonly called a 48 fl oz container. Peanut Butter Chocolate Ice Cream (Chocolate ice cream with a peanut butter swirl); 1.5 QTS (1.42L), (UPC Code: 0 41163 45903 8 for Albertsons Peanut Butter Chocolate) Packaged in paper cardboard round oblong… | Dean Foods of California Inc | Food | Class I | 2 |
| 10 Oct 2012 | Ice Cream - label reads in part "*** Lovin' SCOOPFUL CHURNED LIGHT ICE CREAM *** SUPER DUPER PEANUT BUTTER CUP*** Event 63443 | Super Store Industries | Food | Class I | 1 |
| 10 Oct 2012 | Albertsons Peanut Butter Cup Ice Cream, 1.5 QTS (1.42 L)(vanilla ice cream with peanut butter cup pieces, fudge and peanut butter swirls) | Dean Foods Company | Food | Class I | 3 |
| 9 Oct 2012 | Chocolate Peanut Butter Non-Dairy Frozen Dessert is sold under brand Luna & Larry's Organic Coconut Bliss. It is packaged in One Pint (473ml) StanPac paperboard container, 8 cups per case. The UPC code 8 96767 00121 9. The product is labeled in parts: "***CHOCOLATE PEANUT BUTTER NON-DAIRY FROZEN DESSERT***Luna &… Event 63413 | Name withheld | Food | Class I | 1 |
| 9 Oct 2012 | Prime Time brand Buckeye Bites Ice Cream in a paper carton 48 oz containers and 3 gallon tubs Event 63489 | Toft Dairy Inc | Food | Class I | 1 |
| 9 Oct 2012 | Whole Foods Meal Shrimp Stir Fry, 16 oz plastic container, Refrigerated, Product Code 3640630222 | Whole Foods Market Group Inc. | Food | Class II | 1 |
| 9 Oct 2012 | Clemmy's Brand Peanut Butter Chocolate Chip Ice Cream, Pint Size, 16 OZ (437mL), UPC 8 94509 00231 9. Labeling reads in part: "CLEMMY'S RICH AND CREAMY PEANUT BUTTER CHOCOLATE CHIP*** 100% SUGAR FREE LACTOSE FREE GLUTEN FREE, 16 OZ (473mL)***DIST BY: Clemmy's Ice Cream P.O.Box 1746, Rancho Mirage, CA 92270**". 8pints… Event 63408 | Clemmy's LLC | Food | Class I | 1 |
| 9 Oct 2012 | Belfonte Home Run Sundae Ice Cream, A Baseball Nut Blend of Chocolate Peanuts, Chocolate Coated Pretzels, and a Thick Fudge Swirl in Peanut Butter/Chocolate Ice Cream, 56 oz. (1.66L) Belonite Ice Cream Company, Kansas City, MO | Belfonte Ice Cream & Dairy Foods Co | Food | Class I | 2 |
| 6 Oct 2012 | All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com | New England Compounding Center | Drug | Class II | 2 |
| 6 Oct 2012 | Starbucks Protein Bistro Box, Net Wt 6.8 OZ (193g), Contains Cage-free egg, white Cheddar Cheese, multigrain muesli bread with honey peanut butter spread and fruit. Event 63440 | Flying Food Group, Inc. | Food | Class I | 1 |
| 5 Oct 2012 | Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3… | Philips Medical Systems (Cleveland), Inc. | Device | Class II | 1 |
| 5 Oct 2012 | The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor… | Spacelabs Healthcare, Llc | Device | Class II | 1 |
| 5 Oct 2012 | Dannon Activia LIGHT Nonfat Yogurt Peach Flavor, Each unit 4-pack of 4-oz cups/6, 4-count pack to a case (24 cups/case) UPC 3663202633 | The Dannon Company Inc | Food | Class II | 1 |
| 5 Oct 2012 | Peanut Butter Ice Cream (1.75 Qt & Half Gallon) Peanut butter ice cream with a peanut butter ribbon and a delightful crunch candy Artificial flavor added MFD. BY SMITH DAIRY PRODUCTS COMPANY, ORRVILLE, OHIO 44667 1-800-778-7078. Sold under the following names: SMITH'S Peanut Butter Crunch Ice Cream, Acme Peanut… | Smith Dairy Products Co | Food | Class I | 2 |
| 5 Oct 2012 | Starbucks brand Protein Bistro Box. cage free egg, white cheddar cheese, multigrain muesli bread, apple slices, red grapes and peanut butter packet. Net weight: 6.8 oz. Starbucks Bistro box UPC 762111881502; Justin's honey Peanut Butter blend UPC 894455000391. Honolulu Baking Co. Honolulu, HI 96813 Event 63519 | Honolulu Baking Company, Ltd. | Food | Class I | 1 |
| 5 Oct 2012 | Organic NuttZo Omega-3 SEVEN Nut & Seed Butter, Net Wt. 16 oz (1lb) 454 g, UPC 894697002030. Event 63437 | Name withheld | Food | Class I | 1 |
| 4 Oct 2012 | Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip… | Biomet, Inc. | Device | Class II | 1 |
| 4 Oct 2012 | Ma Baensch Marinated Herring in Wine Sauce, Net Wt. 24 oz.. (680g), UPC 714449-10220 in glass jars with gold metal lids. Event 63409 | Wild Foods, Inc | Food | Class I | 1 |
| 3 Oct 2012 | West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies… | Focus Diagnostics Inc | Device | Class III | 1 |
| 2 Oct 2012 | American Vines band Natural Vines Black Soft Licorice Twists; All Natural Ingredients, 8 oz (226g), No Preservatives, Product is processed and packaged by American Licorice Company, Union City, CA; Displays and Pallets info: ----6 ct. Case, Item: #8483, Case UPC: 00-41364 08483-8; ----12 ct. Case, Item: #8481, Case… Event 63357 | American Licorice Co | Food | Class II | 1 |
| 2 Oct 2012 | Kentucky Rose, blue cheese Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel Packaging could be vacuum packed bags, paper wrap, or plastic wrap | Name withheld | Food | Class I | 4 |
| 2 Oct 2012 | Kellogg's Frosted Mini Wheats , Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 96 ct case single serve,each Nt. Wt. 1 oz (28g); 18 oz carton; 24 oz carton; 30 oz., 70 ct case single serve, 70 oz carton Canadian product: Kellogg's Mini-Wheats Original Frosted Cereal 440 G, 510 G,850 G, 1300 G, 1600 G carton | Kellogg Company | Food | Class II | 4 |
| 1 Oct 2012 | Mini BigMouth: Chocolate, confections. 1) Bulk Milk Mini BigMouth, item number 093. 15 pieces per case; 2) 4-Piece Mini BigMouth, item number 284, 48 pieces per case: 3) 6-Piece Mini BigMouth, item number 002, 72 pieces per case | Xan Confections | Food | Class I | 11 |
| 28 Sep 2012 | Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a… | Biomet 3i, LLC | Device | Class II | 2 |
| 28 Sep 2012 | Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma;… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 28 Sep 2012 | Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P.… Event 63428 | Name withheld | Drug | Class III | 1 |
| 27 Sep 2012 | Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05 Event 63524 | Name withheld | Drug | Class II | 1 |
| 27 Sep 2012 | Harry & David Crunchy Almond and Peanut Butter, 12 oz. jar., labeled in part: "HARRY & DAVID CRUNCHY ALMOND AND PEANUT BUTTER***NET WT. 12 OZ. (340g)***INGREDIENTS: ROASTED ALMONDS, ROASTED PEANUTS, SEA SALT.***MADE FOR HARRY AND DAVID MEDFORD, OR 97501***7 80994 73873 7***" The 12 oz. jars are sold individually and… | Harry and David Operations, Inc. | Food | Class I | 4 |
| 27 Sep 2012 | ***Fresh Point***Fresh Cuts***Service Salsa Mango***2 x 5lb Tray***Net Wt. 50 lb.*** | FreshPoint South Florida | Food | Class I | 5 |
| 25 Sep 2012 | ILLlCO MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal… | Alphatec Spine, Inc. | Device | Class II | 1 |
| 25 Sep 2012 | Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional… | Terumo Cardiovascular Systems Corporation | Device | Class II | 6 |
| 25 Sep 2012 | Fruit Mango Peeled & Halved, Ready-To-Eat Product, 2, 2.5-lb trays per case | FreshPoint Central Florida | Food | Class I | 8 |
| 24 Sep 2012 | ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application. | Varian Medical Systems, Inc. Oncology Systems | Device | Class II | 1 |
| 24 Sep 2012 | Jamba Juice brand Peanut Butter Moo'd Smoothie; All sizes (small, medium, large); A Blend Of: Nonfat Vanilla Yogurt (Contains Milk), Chocolate Moo'd Base (Contains Milk), Soymilk (Contains Soy), Ice, Bananas, Peanut Butter (Contains Peanuts); The product is processed and packaged by Jamba Juice Co. | Name withheld | Food | Class I | 2 |
| 21 Sep 2012 | Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05. | Watson Laboratories Inc | Drug | Class I | 1 |
| 21 Sep 2012 | Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA Event 63550 | American Enterprises LLC dba Sterling Gelatin | Drug | Class II | 1 |
| 20 Sep 2012 | The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint… | Zimmer, Inc. | Device | Class II | 1 |
| 20 Sep 2012 | GE Healthcare Optima XR 200amx with digital upgrade Mobile general purpose radiographic imaging of the human head and body. | GE Healthcare, LLC | Device | Class II | 4 |
| 20 Sep 2012 | SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical… | Sorin Group USA, Inc. | Device | Class II | 2 |
| 20 Sep 2012 | CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II Spinal System is a posterior, non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following… Event 63633 | Captiva Spine, Inc | Device | Class II | 1 |
| 19 Sep 2012 | S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. | Sorin Group USA, Inc. | Device | Class II | 5 |
| 18 Sep 2012 | MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive… | Elekta, Inc. | Device | Class II | 1 |
| 18 Sep 2012 | Popcorn Indiana Aged White Cheddar Popcorn 0.8 oz - UPC 843571004233 3.5 oz- UPC 843571000532 8 oz- UPC 843571000785 8.3 oz - UPC 843571002956 9 oz - UPC843571000785 Popcorn, Indiana LLC 1 Cedar Lane, Englewood, NJ 07631 Made in the USA | Dale & Thomas Popcorn, LLC | Food | Class II | 14 |
| 17 Sep 2012 | UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403 | DermaCare, Inc. | Drug | Class II | 2 |
| 14 Sep 2012 | Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. Minotrol 16 is an in… | Horiba Instruments, Inc dba Horiba Medical | Device | Class III | 1 |
| 14 Sep 2012 | ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline… | Horiba Instruments, Inc dba Horiba Medical | Device | Class III | 1 |
| 13 Sep 2012 | HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without… Event 63139 | Heartsine Technologies, Limited | Device | Class I | 1 |
| 13 Sep 2012 | Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone… | OrthoPediatrics Corp | Device | Class II | 1 |
| 13 Sep 2012 | Zatarain's New Orleans Style Beef Flavor Rice Mix, packaged in 6.8 oz boxes, 12 boxes per carton, Box UPC: 7142901001 | McCormick & Company, Inc. | Food | Class II | 3 |
| 13 Sep 2012 | Penn State Creamery/Berkey Creamery Ice Cream -- Black Raspberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic) | Pennsylvania State University Berkey Creamery | Food | Class II | 12 |
| 12 Sep 2012 | The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in… | Mako Surgical Corporation | Device | Class II | 1 |
| 12 Sep 2012 | "Tacos de Jueyes" (Crab Tacos) - Food Service | Fabrica Confecciones Soto, Inc. | Food | Class II | 2 |
| 11 Sep 2012 | Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro diagnostic test… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 10 Sep 2012 | HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21 | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals | Drug | Class I | 1 |
| 10 Sep 2012 | Aunt Marie's Bakery Gourmet Cookie Dough, Chocolate Chunk, packaged in 3-lb. plastic tubs. Distributed by Racine Danish Kringles, Racine, WI. Event 63317 | RDK Corp | Food | Class II | 1 |
| 6 Sep 2012 | Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7. | Church & Dwight Inc | Drug | Class II | 1 |
| 5 Sep 2012 | Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS,… | Wright Medical Technology Inc | Device | Class II | 3 |
| 5 Sep 2012 | ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. | Zimmer, Inc. | Device | Class II | 1 |
| 4 Sep 2012 | Alloclassic SL Shaft | Zimmer, Inc. | Device | Class II | 40 |
| 31 Aug 2012 | Multipolar Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a “popping” sound as conformation that the… | Zimmer, Inc. | Device | Class II | 1 |
| 28 Aug 2012 | Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant. | SpineFrontier, Inc. | Device | Class II | 1 |
| 27 Aug 2012 | Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty. | Zimmer, Inc. | Device | Class II | 1 |
| 27 Aug 2012 | Mango Medley, 16 oz (contains cantaloupe, honeydew, mango, grapes), distributed by Fresh Food Mfg, 2500 Love Road, Freedom, PA 15042, UPC 3003430338 (4 -16 oz clear plastic containers per case) Event 63082 | Name withheld | Food | Class I | 1 |
| 23 Aug 2012 | Venlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30 | Stat Rx USA | Drug | Class III | 1 |
| 22 Aug 2012 | S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to… | SpineFrontier, Inc. | Device | Class II | 1 |
| 21 Aug 2012 | ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous… | Ethicon, Inc. | Device | Class I | 2 |
| 21 Aug 2012 | Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257 USA; by: Ranbaxy Laboratories Ltd., New Delhi -110 019, India; NDC 63304-827-90 | Ranbaxy Inc. | Drug | Class II | 1 |
| 20 Aug 2012 | Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO; Liquid Assayed Integrated Immunoassay Control. Intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Assay values are provided for the specific systems listed. The user can compare observations with… | Microgenics Corporation | Device | Class III | 1 |
| 20 Aug 2012 | "***Productos El Gauchito Empanadillas Argentinas Caprese (Caprese Turnovers)***keep frozen or refrigerated***consumer contact: productoselgauchito@hotmail.com Av. Minillas NM-16 Bayamon PR 00956***" | Name withheld | Food | Class II | 4 |
| 17 Aug 2012 | Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperature | Vital Signs Colorado Inc. | Device | Class II | 1 |
| 17 Aug 2012 | Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from… | Stryker Howmedica Osteonics Corp. | Device | Class II | 2 |
| 15 Aug 2012 | "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery | Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc. | Device | Class II | 4 |
| 13 Aug 2012 | Mindray A3 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation. | Mindray DS USA, Inc. d.b.a. Mindray North America | Device | Class I | 2 |
| 13 Aug 2012 | Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2. The software is a… | Vital Images, Inc. | Device | Class II | 1 |
| 9 Aug 2012 | Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to… | Name withheld | Device | Class II | 3 |
| 9 Aug 2012 | Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO method is an in vitro diagnostic test for the quantitative measurement of Theophylline in human serum and plasma on the Dimension Vista(R) system. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 3 Aug 2012 | Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of… | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 31 Jul 2012 | cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as… | Roche Molecular Systems, Inc. | Device | Class III | 1 |
| 26 Jul 2012 | Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat. Sterile, single use device designed to prepare plasma from the patient's blood using a tabletop centrifuge. Event 62834 | Stryker Orthobiologics, Inc. | Device | Class II | 1 |
| 25 Jul 2012 | Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator. | Oscor, Inc. | Device | Class II | 1 |
| 20 Jul 2012 | Kalamata Tapenade packaged in 7 oz clear plastic and 5 lb white plastic capacity containers, manufactured by Sartori Inspirations, LLC, Lafayette, CO 80026. | Sartori Inspirations, LLC | Food | Class I | 10 |
| 19 Jul 2012 | Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) Usage:… | Abbott Point Of Care Inc. | Device | Class III | 1 |
| 16 Jul 2012 | Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients who require reconstruction of large acetabular… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 16 Jul 2012 | X-ROCK 3 Day Pill For Men, supplied in 1 and 2 capsule blister packs and 6, 12 and 24 count bottles, UPC 0 00309 50792 7, Distributed by: MATE Enterprises, Miami, Florida 33139, Some labeled as: Manufactured by CRM Laboratories, Distributed by XRock Industries, Ft. Lauderdale, FL, Also, labeled as X-Rock 3 Day Pill… | Coral Rock Man, Inc. | Drug | Class I | 2 |
| 11 Jul 2012 | Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with… | Ventlab Corporation | Device | Class I | 12 |
| 5 Jul 2012 | Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits are reusable instruments, sterilized prior to… Event 63272 | Name withheld | Device | Class II | 1 |
| 5 Jul 2012 | ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. | Kimberly-Clark Corporation | Device | Class II | 2 |
| 5 Jul 2012 | Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus) | Ben Venue Laboratories Inc | Drug | Class II | 1 |
| 3 Jul 2012 | Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 27 Jun 2012 | RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction | KCI USA, Inc. | Device | Class II | 1 |
| 20 Jun 2012 | Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination. Event 63603 | Gulf South Medical Supply Inc | Device | Class II | 1 |
| 18 Jun 2012 | Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05, | Stat Rx USA | Drug | Class III | 1 |
| 15 Jun 2012 | STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. | Diagnostica Stago, Inc. | Device | Class II | 1 |
| 12 Jun 2012 | QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 4 Jun 2012 | Product is a liquid dietary supplement packaged in white plastic bottles with a shrink wrap sleeve label. The product comes in 3 sizes, 2 oz, 16oz. and 33.8oz. The product label reads in part: "Fast Absorbing Liquid 1-OZ A DAY***WELLESSE***Digestive 3-in-1 Health Soluble Fiber Prebiotics Aloe Vera Promotes Gentle… Event 62058 | Botanical Laboratories Inc | Food | Class I | 1 |
| 1 Jun 2012 | Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations… | Sysmex America, Inc. | Device | Class II | 3 |
| 21 May 2012 | Salmon Wrap. Two wraps per package. Net Wt 8 oz Event 63419 | Taco Loco Products Inc | Food | Class II | 1 |
| 21 Apr 2012 | X-ROCK For Men, Dietary Supplement, Manufactured by CRM Laboratories, Distributed by XRock Industries, PO Box 120863, Ft. Lauderdale, FL 33312, 0 00309 50792 7. UPC on labeling is: 0 00309 50792 7. UPC in Press Release is: 0030950792. Event 61669 | XRock Industries, LLC | Drug | Class I | 1 |
| 10 Apr 2012 | "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction. | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 2 |
| 10 Apr 2012 | The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific… | Kerr Corporation | Device | Class II | 1 |
| 9 Apr 2012 | "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone. | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 1 |
| 2 Apr 2012 | "Titan Gelatinas***Postres de gelatina (Gelatin Dessert)***Sabor a China (Orange flavored)***Sabor a Fresa (Strawberry flavored)" | Postres de Aqui, Inc. | Food | Class II | 2 |
| 9 Mar 2012 | Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India | Aurobindo Pharma LTD | Drug | Class II | 1 |
| 21 Feb 2012 | The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is… | Kerr Corporation | Device | Class II | 1 |
| 12 Dec 2011 | Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. | Ormco/Sybronendo | Device | Class II | 1 |
| 9 Dec 2011 | Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in… | Progressive Medical Inc | Device | Class II | 1 |
| 17 Nov 2011 | Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is… | Kerr Corporation | Device | Class II | 1 |
| 3 Nov 2011 | Sunquest Laboratory, version 7.0 not available | Sunquest Information Systems, Inc. | Device | Class II | 1 |
| 28 Oct 2011 | Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical… | Progressive Medical Inc | Device | Class II | 1 |
| 28 Oct 2011 | R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography. | Shimadzu Medical Systems | Device | Class II | 6 |
| 1 Aug 2011 | UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of… | Beckman Coulter Inc. | Device | Class II | 3 |
| 13 Apr 2011 | IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of… | Extremity Medical LLC | Device | Class II | 1 |
| 24 Mar 2011 | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | Clinical Diagnostic Solutions | Device | Class III | 3 |
| 2 Feb 2011 | AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed. | Primus Medical LLC | Device | Class II | 1 |
| 9 Dec 2010 | TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral… | Alphatec Spine, Inc. | Device | Class II | 1 |
| 10 Oct 2010 | Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final femoral implant geometry and are used to… | Zimmer, Inc. | Device | Class II | 12 |
| 4 Aug 2010 | Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | Clinical Diagnostic Solutions | Device | Class III | 2 |
| 6 Jan 2010 | ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and… Event 63368 | Sendx Medical Inc | Device | Class II | 1 |
| 19 Nov 2009 | Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. | Sunquest Information Systems, Inc. | Device | Class II | 1 |
| 5 Jan 2009 | Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI | NuVasive Inc | Device | Class II | 31 |
| 13 Oct 2008 | Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem. | Medacta Usa Inc | Device | Class II | 1 |
| 28 Aug 2008 | Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures. | Sechrist Industries Inc | Device | Class II | 2 |
| 1 May 2008 | PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures. | Dako North America Inc. | Device | Class II | 1 |
| 24 Feb 2006 | Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile. | Merit Medical Systems, Inc | Drug | Class I | 1 |