| 19 Oct 2012 | Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-383-28. | Watson Laboratories Inc | Drug | Class II | 5 |
| 12 Oct 2012 | GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to,… | GE Healthcare, LLC | Device | Class II | 1 |
| 11 Oct 2012 | Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21. | Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals | Drug | Class II | 1 |
| 9 Oct 2012 | Cascadian Farm Organic peanut butter chip Chewy Granola Bars, 6-1.2 oz (35g) bars, Net Wt 7.4 oz (210g). UPC 21908-14631 | General Mills, Inc | Food | Class I | 1 |
| 8 Oct 2012 | Kraft Jalapeno String Cheese, Net Wt 12 Oz (340 g); a natural low-moisture part-skim mozzarella cheese with jalapeno peppers; 12 individually wrapped 1 oz snacks per 12 oz. bag, 12 bags per case; Distributed by Kraft Foods Global, Inc., Northfield, IL 60093-2753 USA; UPC 0 21000 02977 8 Event 63391 | Kraft Foods, Inc. | Food | Class II | 1 |
| 5 Oct 2012 | Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.78 L), Distributed by: Earthborn Products, San Diego, CA 92103. Event 63406 | Earthborn Products, Inc. | Drug | Class II | 1 |
| 5 Oct 2012 | Kilwins Sugar Free S/F PEANUT BUTTER FUDGE, Nt. Wt. 7-oz (198 g) | Kilwin's Quality Confections, Inc. | Food | Class I | 1 |
| 4 Oct 2012 | BUITONI brand Spinach & Portobello Mushroom All Natural Ravioli, packaged in an 18 oz. bag, frozen UPC code 24842-99186 Event 63370 | Nestle Prepared Foods Company | Food | Class I | 1 |
| 3 Oct 2012 | Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. The Repeater Pump is a device that provides a peristaltic pump driven fluid… | Baxa Corporation | Device | Class II | 1 |
| 3 Oct 2012 | Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 , | Paddock Laboratories, LLC | Drug | Class II | 1 |
| 2 Oct 2012 | Starbuck Protein Bistro Box, 6.80 oz. package, UPC 762111881502. The Starbuck Protein Bistro Box contains the 0.5 oz. single-serve Honey Peanut Butter Blend squeeze pack with the UPC 894455000391. Event 63340 | Name withheld | Food | Class I | 1 |
| 2 Oct 2012 | Whole Foods Roasted Garlic Eggplant Soup , 24oz plastic container UPC: 3640630269 | Whole Foods Market Group Inc. | Food | Class I | 1 |
| 28 Sep 2012 | 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system. | ICU Medical, Inc. | Device | Class II | 1 |
| 28 Sep 2012 | 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair. | Encore Medical, Lp | Device | Class II | 1 |
| 28 Sep 2012 | Late July Organic Mini Peanut Butter Sandwich Crackers packaged in : 5oz box UPC 890444000700 8ct carton/1.125oz (single serve caddy) & 1.125oz pack (single serve pack UPC: 890444000724 & 890444000717 Event 63342 | Late July Snacks, LLC | Food | Class I | 1 |
| 28 Sep 2012 | Peanut Butter Fudge 3 oz bag, manufactured from 6-28-12 thru 9-20-12 Event 63318 | C.G. Higgins Confections, LLC | Food | Class I | 1 |
| 28 Sep 2012 | Fairytale Brownies Brand Peanut Butter Brownies, 3.2 oz, 3" x 3" in clear wrap, UPC Code 606961100072. Labeling reads in part:"Fairytal Brownies***PEANUT BUTTER***Fairytale Brownies Phoenix, AZ 85040***". | Fairytale Brownies, Inc | Food | Class I | 3 |
| 27 Sep 2012 | Newman's Own Organics brand Newman-O's Peanut Butter Creme Filled Chocolate Cookies 8oz/6 pack, Unit UPC#7 57645 02170 8, Case UPC#7 57645 02171 5; 13oz/6 pack, Unit UPC# 7 57645 02150 0, Case UPC#7 57645 02151 7; 9oz/6 pack, Unit UPC#7 57645 02288 0, Case UPC # 7 57645 02388 7; 16oz/ 12 pack, Unit UPC# 7 57645 02239… Event 63320 | Newman's Own Organics | Food | Class I | 1 |
| 27 Sep 2012 | Peanut Butter Bars Original: 3.0 oz, Two-Bar Box, UPC Code 837305005023, Manufactured by Sweet's Candy Company, Salt Lake City, UT; 2) 1.5 oz, One-Bar Box, UPC Code 837305006235; 3) .45 oz, Change Makers, UPC Code 837305005832; 4) 4 oz., Gable Box, UPC Code 837305005795 | Name withheld | Food | Class I | 5 |
| 27 Sep 2012 | Label reads in part "*** ORGANIC Alden's ICE CREAM PEANUT BUTTER 'n CHIP 1.5 QTS ***" upc 0 72609 74191 2. | Oregon Ice Cream, LLC | Food | Class I | 2 |
| 26 Sep 2012 | ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in… | MOOG Medical Devices Group | Device | Class II | 1 |
| 26 Sep 2012 | Evolution Fresh brand Cinnamon and Apple Almond Butter Sandwiches in plastic wrap, NET WT 5.75 oz., UPC 726111926371. Label reads in part, perishable. keep refrigerated. CINNAMON APPLE & ALMOND BUTTER SANDWICH; MANUFACTURED FOR EVOLUTION FRESH, INC. | Name withheld | Food | Class I | 2 |
| 26 Sep 2012 | Individual wrapper: Nature Valley Sweet & Salty Nut, granola bars, Peanut, net WT 1.2 oz (35 g) UPC 0 1600044282 5, Distributed by General Mills Sales, INC., Minneapolis, MN 55440. Ingredients: Roasted Peanuts, High Maltose Corn Syrup......, Mixed Tocopherols Added to Retain Freshness CONTAINS PEANUT,WHEAT, MILK,SOY… | General Mills, Inc | Food | Class II | 1 |
| 26 Sep 2012 | Natural Honey Peanut Butter; 16 oz jars, UPC 855188003035; Natural Honey Peanut Butter Squeeze Packs 0.5 oz, UPC 894455000391, Natural Honey Peanut Butter Squeeze Packs 1.15 oz, UPC 855188003042. | Name withheld | Food | Class I | 8 |
| 25 Sep 2012 | Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 25 Sep 2012 | Belmont Rapid Infuser, a Fluid Management System, Model FMS2000. Event 62703 | Belmont Instrument Corporation | Device | Class II | 1 |
| 25 Sep 2012 | Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Teleflex Medical, Research Triangle Park, NC 27709. Teleflex Medical’s Hem-o-lok polymer ligating clips are single use, sterile, non-absorbable medial devices that have been designed to ligate vessels and tissue structures during various types of… | Teleflex Medical | 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 | ***Publix***Hearts of Romaine***Chopped Hearts of Romaine***Triple Washed***& Ready to Eat***No Preservatives***NET WT 10 OZ (284g)*** Event 63289 | Publix Super Markets | Food | Class I | 1 |
| 25 Sep 2012 | SunRidge Candy - Energy Nuggets; the flavor bursting and hearty unity of energy packed nuts, seeds, Peanut Butter, Carob. sweetened with honey! a SunRidge Farms tradition! conveniently chewable bite-sized squares baked and cut fresh in-house. Packed in 10 pound case. UPC code: 086700221600 Manufactured by Falcon… | Falcon Trading Co., Inc. | Food | Class I | 7 |
| 25 Sep 2012 | Moon Pie(R) Crunch Peanut Butter, CRUNCHY chocolate cookie sandwich, NET WT 2.4 oz and 9.6 oz , Baked by Chattanooga Bakery, Inc., Chattanooga, TN 37401 Event 63271 | Chattanooga Bakery Inc | Food | Class I | 1 |
| 24 Sep 2012 | Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. | Terumo Cardiovascular Systems Corporation | Device | Class II | 3 |
| 24 Sep 2012 | Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features… | Greatbatch Medical | Device | Class II | 1 |
| 24 Sep 2012 | MJM Tropical Treats, Tropical Shaped Grahams, Orange, Net Wt. 1 oz., MJM Marketing, Super Wholesome Grahams, P.O. Box 1477, Kailua Kona, HI 96745-1477. Event 63315 | Richmond Baking of Georgia Inc | Food | Class II | 1 |
| 24 Sep 2012 | Hot Pepper Jelly, 4 and 8 ounce jars, labeled in part ***Jill's Jams & Jellies, Hampstead, MD 21074*** | Hanover Pike Enterprises, Inc. | Food | Class I | 4 |
| 24 Sep 2012 | Archer Farms Creamy Almond Butter, 16 oz, packed in plastic jars with a plastic screw on lid, UPC 8523902334; stick on labeling is red, green, yellow, and maroon with yellow, red, and black print writing. Distributed by Target Corporation, Minneapolis, MN 55403. | Sunland, Incorporated | Food | Class I | 187 |
| 22 Sep 2012 | Fresh Express Leafy Green Romaine; Crunchy Romaine Lettuce & Tender Green Leaf Lettuce 9 oz. bag, Keep refrigerated, no preservatives. UPC 71279-26112. Fresh Express Incorporated Salinas, CA. | Fresh Express Incorporated | Food | Class I | 1 |
| 21 Sep 2012 | 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA | Baxter Healthcare Corp. | Drug | Class II | 5 |
| 21 Sep 2012 | Seasoned Clams, 240 grams Event 63150 | M & K Trading Inc | Food | Class II | 1 |
| 20 Sep 2012 | Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 20 Sep 2012 | Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33 | Sandoz Incorporated | Drug | Class III | 1 |
| 20 Sep 2012 | Alden's Cookies and Cream is an ice cream product. It is packaged in a 1.5 quart (48 oz) cup. The LID of the recalled product is labeled in parts:"***ORGANIC***Alden's ICE CREAM***COOKIES 'n CREAM***1.5 QTS (1.42L)***". The CUP of the recalled product is labeled in parts: "***ORGANIC***Alden's ICE CREAM***CHOLOCATE… Event 63245 | Oregon Ice Cream, LLC | Food | Class II | 1 |
| 19 Sep 2012 | Helion and Xenion surgical lights, 501/01 series KLM lights. The surgical lights are intended to locally illuminate an operating or examination area of the patient’s body with a high intensity light. | Trumpf Medical Systems, Inc. | Device | Class II | 1 |
| 19 Sep 2012 | Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches). There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10… Event 63241 | Cure Medical LLC | Device | Class II | 1 |
| 19 Sep 2012 | Coast Tropical Brand Whole Mangoes, Kent & Keitt's varieties, 10 lb box. The recalled mangos were sold between July 7, and August 30, 2012 and can be identified by the brand sticker along with one of the following numbers: 3114, 4051, 4311, 4584, and 4959 and the words PRODUCT OF MEXICO. Packed in carboard open… Event 63259 | Name withheld | Food | Class I | 1 |
| 18 Sep 2012 | FRESH SELECTIONS by Kroger" Tender Spinach NET WT 10 OZ (283g) BEST IF USED BY 09/16/12 Product of USA 10:09 HarvestMark.com, 1104 A244 0105 KN01 INGREDIENTS: SPINACH DISTRIBUTED BY THE KROGER COM. CINCINNATI OHIO 45202 | Kroger Co | Food | Class I | 1 |
| 18 Sep 2012 | GFS Individually Wrapped Blueberry Muffins, 1.8 Ounce, in 80 count case, Net Weight 9 lb./4.1 kg; Manufactured for Gordon Food Service, Grand Rapids, MI 40546; UPC 0 009390-157700 9 Please note: there is no labeling on the individual muffin wrappers other than the code date. The product is sold for institutional/food… Event 63218 | Ralcorp Frozen Bakery Products | Food | Class II | 1 |
| 18 Sep 2012 | Fresh Fruit Burst fruit cup, packaged in 1 and 1.5 lb containers. Labeled in part: "***Fruit Burst***Ingredients: Watermelon, Cantaloupe, Pineapple, Honeydew, Grapes, Mango, Blueberries. Packed in its own juice***" | World Food LLC. | Food | Class I | 3 |
| 17 Sep 2012 | LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15), (3.5/25), (5.0/15), (5.0/25), and (4.0/25). Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or… | Boston Scientific Corporation | Device | Class II | 3 |
| 17 Sep 2012 | BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient positioning capabilities and built-in… | KCI USA, Inc. | Device | Class II | 1 |
| 17 Sep 2012 | Carol's Cuts, mangos cubed, item # 71035, packaged in 5-lb, black plastic tray, heat sealed with a film lid, single-use package. The responsible firm name on the label is Carol's Cuts, Kansas City, KS Event 63213 | Liberty Fruit Co Inc - Carols Cuts Div | Food | Class I | 1 |
| 15 Sep 2012 | Fruit Medley - 1) Zupan's brand Island Medley 12 oz UPC 92504723497 2) Mary's Select brand Island Fruit Medley - 12 oz UPC 9250473497 3) Mary's Select brand Fruit Mix Ensalada - 12 oz UPC 9250473216 4) Trader Joe's Plant Code: P-002 brand - Tropical Fruit Medley - 1 lb UPC 0094-9361 | United Salad Company | Food | Class I | 3 |
| 15 Sep 2012 | Nice, Fruit Mango, Product of Mexico, single, 6 ct; UPC 0.4902252988.5 | Caito Foods Service, Inc. | Food | Class I | 12 |
| 14 Sep 2012 | Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and podiatry use, critical and emergency… | Hologic, Inc. | Device | Class II | 2 |
| 14 Sep 2012 | Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in extracorporeal blood or fluid circuits. The connectors… | Sorin Group USA, Inc. | Device | Class II | 2 |
| 14 Sep 2012 | AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of… | Advandx Inc | Device | Class II | 1 |
| 14 Sep 2012 | AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and… | Advandx Inc | Device | Class II | 1 |
| 13 Sep 2012 | 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only. | 3M Company - Health Care Business | Device | Class II | 1 |
| 13 Sep 2012 | CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty. | Zimmer, Inc. | Device | Class II | 3 |
| 13 Sep 2012 | Macadamia Nuts Style 2, RAW, SHELLED. DESCRIPTION OF CARTON FROM GUATEMALA: LOT 2 70 JUNE 25/12 423, 43 1 NORMAL/BIG . | Specialty Commodities, Inc. | Food | Class I | 1 |
| 13 Sep 2012 | CANTALOUPE, HONEY DEW, PINEAPPLE AND GRAPES (CHPG) UNDER THE FOLLOWING BRANDS: Indianhead Foods 13105 FRUIT MIX CHPG 5# Manufactured by Cut Fruit Express Mpls, MN 55076 Following products Distributed by H. Brooks & Co. Mpls, MN 55112: H.Brooks & Company 31165 MIXED FRUIT CHPG 4/16OZ 16oz 4 per case UPC# 0 3823231165… | Cut Fruit Express, Inc. | Food | Class I | 9 |
| 13 Sep 2012 | Cut Cantaloupe: G.O Fresh: 0379729 4/5# CANTALOUPE CHUNKS (PACKER) 130250 BEST BY 9/16/12. SYSCO Imperial: 2229268 4/5# MELON CANTALOUPE 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12 UPC# 1007 4865593455. SYSCO Imperial: 6520878 1/5# PAIL CANTALOUPE CHUNK 3/4" 130249 & 130250 BEST BY 9/15/12 & 9/16/12 UPC# 1007… | G.O. Fresh | Food | Class I | 9 |
| 12 Sep 2012 | Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System | Philips Healthcare Inc. | Device | Class II | 1 |
| 12 Sep 2012 | Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 12 Sep 2012 | Cantaloupes are packed in 6ct, 9ct, 12ct, 15ct, 18ct, cardboard cartons with the DFI Brand. "826 California Westside" is also stamped on outside of the carton. Each cantaloupe also has a DFI brand sticker on it. Event 63176 | Dfi Marketing Inc | Food | Class I | 1 |
| 12 Sep 2012 | E-3 Seasoning/Spice, Part #1690. Product is packaged in a white bucket. Net weight 35 lbs. The product is labeled in parts: "***E-3 SEASONING***NET WT 35 LB***Distributed by Boyd Coffee Company, Portland, OR 97230*** Event 63177 | Boyd Coffee Co | Food | Class II | 1 |
| 11 Sep 2012 | Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment. | Philips Healthcare Inc. | Device | Class II | 1 |
| 11 Sep 2012 | Frescolina and Mitica brand Ricotta Salata cheeses were cut into wedges, packaged in clear plastic wrap and sold with a Whole Foods Market scale label using PLU 293427 and PLU 294413, respectively. All "sell by" dates through Oct. 2 are affected. | Whole Foods Market | Food | Class I | 1 |
| 11 Sep 2012 | Marathon brand- 4 kilo boxes, label on the mango says "MARATHON...PRODUCE OF MEXICO", 952 ctns. of number 6 mangos, 714 ctns. of number 7's, 1186 ctns. of number 8's, 952 ctns. of number 9's, 714 ctns. of number 10's, 476 ctns. of number 12's. Event 63202 | GM Distributing Co, Inc | Food | Class I | 1 |
| 10 Sep 2012 | Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the… | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 10 Sep 2012 | Marte brand Frescolina Ricotta Salata. Matured and packed by: Fattorie Chiarappa SRL VIA Dell'ulvio, 5 Conversano (BA) - Italy. --- Product is vacuum packaged and is labeled with a round label. Product may also be cut into smaller wedges, but will still have the same Frescolina Ricotta Salata label. Event 63151 | Forever Cheese Inc | Food | Class I | 1 |
| 10 Sep 2012 | Fresh Cuts, Pineapple Dices, 2 oz, Best By: SEP/15/12, Lot Number: 243 and 245. Event 63163 | Henderson's Best Fresh-Cuts, LLC | Food | Class II | 1 |
| 10 Sep 2012 | Pound Cake 12 ounces | Spartan Central Kitchen | Food | Class II | 139 |
| 10 Sep 2012 | Ricotta Salata Frescolina Brand Soft Cheese. Product is packaged in a retail package, wedge shaped, size ranges from 6-7 oz. The product is labeled in parts: "***Frescolina Ricotta Salata MARTE***IMPORTED BY FOREVER CHEESE,NY 11106***PRODUCT OF ITALY***" Event 63217 | Floyd Peterson Company Inc. | Food | Class I | 1 |
| 7 Sep 2012 | 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder. Event 63136 | C.R. Bard, Inc., Urological Division | Device | Class II | 1 |
| 7 Sep 2012 | Cemented Tibial Drill Product Usage: The cemented tibial drill is used to prepare the tibial bone prior to the impaction of the applicable stemmed tibial broach. The cemented tibial drill has engraved lines that are size specific to guide the user as to the depth to insert the drill into the tibial bone. | Zimmer, Inc. | Device | Class II | 1 |
| 7 Sep 2012 | Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. | Baxter Healthcare Corp. | Device | Class I | 4 |
| 7 Sep 2012 | Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is… | Optovue Inc. | Device | Class II | 1 |
| 7 Sep 2012 | Sam's Club Chunky Cinnamon Streusel, Net Wt 25 lb, in white plastic pails, Manufactured for Sam's Club, Bentonville, AR 72716, Best if stored in a cool, dry location between 65 - 75 degrees Farenheit. Event 63153 | Dawn Food Products, Incorporated | Food | Class I | 1 |
| 7 Sep 2012 | Color Cheddar Cheese Curds: Springside Cheese, Color Curd, 55-0172, V1, August 27, 2012, | Springside Cheese Corp | Food | Class II | 24 |
| 7 Sep 2012 | Maryland Crab Cake Bulk (fresh), #81868, 4oz @2x8ct, Net Wt. 4 lbs, Packed by 3fish, Inc. | 3fish Inc. | Food | Class I | 12 |
| 6 Sep 2012 | Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transvenous introduction of diagnostic /… | Greatbatch Medical | Device | Class II | 1 |
| 6 Sep 2012 | Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the… Event 63253 | Gynex Corporation | Device | Class III | 1 |
| 6 Sep 2012 | Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics. | Philips Healthcare Inc. | Device | Class II | 1 |
| 6 Sep 2012 | SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 16 |
| 6 Sep 2012 | Licorice Sticks sold under the following brand names: 1) Orange Patch Country Store Licorice Sticks, New Wt, 12 oz. Packaged in plastic bag; 2) Desert Delite Licorice Sticks, New Wt, 12 oz. Packaged in plastic bag; 3) 17th Street Market Licorice Sticks, New Wt, 12 oz. Packaged in plastic bag; 4) Flagstaff Farmers… Event 63206 | Lehi Valley Trading Co. | Food | Class II | 1 |
| 6 Sep 2012 | florAlign Prebiotic Formula, sizes: 90g, 180g, 270g Event 63106 | Eco Health, Inc. | Food | Class I | 1 |
| 6 Sep 2012 | 3/16" Slivered Red Onions, 1/5 lb; 1/4" Slivered Red Onions, 2/5lb, 4/5lb; | Gills Onions, LLC | Food | Class I | 4 |
| 4 Sep 2012 | The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant… | Advanced Neuromodulation Systems Inc. | Device | Class II | 1 |
| 4 Sep 2012 | Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, KS 06106, UPC 0-70038-63439-3 | Raritan Pharmaceuticals, Inc. | Drug | Class II | 12 |
| 3 Sep 2012 | UniCel DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be… | Beckman Coulter Inc. | Device | Class II | 1 |
| 31 Aug 2012 | Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material… Event 63064 | Accuro Medical Product LLC | Device | Class II | 1 |
| 31 Aug 2012 | SooNyeoWon Soybean Sprouts (5 lbs., 10 lbs., and 16-ounce packages - all packaged in plastic bags). 16-oz bag UPC 0 28346 07121 8; Manna Organics Inc. 170 Avenue 'L', Newark, NJ 07105; MSB West, LLC 622 South Anderson Street, Los Angeles, CA 90023 | Manna Organics Inc | Food | Class I | 8 |
| 31 Aug 2012 | VA Kit New Gourmet Fruit Salad 7.75#. Item # 70006, UPC is 0 20728 70006 8. Label reads in part "***VA KIT NEW GOURMET FRUIT SALAD 7.75# *** Ingredients: INGREDIENTS: Watermelon, Honeydew, Cantaloupe, Mangos, Kiwi, Blue Berries. *** Pacific Coast Fruit Portland, OR 97232 ***". | Pacific Coast Fruit Company | Food | Class I | 2 |
| 31 Aug 2012 | Fruit Mixes: 1) Dining In Super Fruit Medley,10.5oz, UPC 1122508396, Use by date 9/6/2012; 2) Ready Pac Super Fruit Blend, 6oz, UPC 7774523076, Use by Dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012; 3) Ready Pac Super Fruit Medley, 10.5oz, UPC 7774523746, Use by dates 9/8/2012 or earlier, 9/6/2012 & 9/7/2012.… | Ready Pac Foods Inc | Food | Class I | 12 |
| 31 Aug 2012 | Kerry Organic Pure 900, Organic Soy Protein Isolate, Item #722234.454, packaged in 20-kg. bags. The firm name on the label is Kerry China, Shanghai, China. | Kerry Foods | Food | Class I | 1 |
| 30 Aug 2012 | ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the… | Medtronic Sofamor Danek USA Inc | Device | Class II | 3 |
| 30 Aug 2012 | Wawa Mango Net Wt. 8 oz (227 g) Distributed by Wawa, Inc. Wawa, PA 19063 UPC 726191069267 | Taylor Farms, Inc. | Food | Class I | 8 |
| 30 Aug 2012 | Pistachios, Shelled Raw, 4 /2.5 Packed by Tropical Food Nut & Fruit- Orlando, FL 32811 Event 63058 | Gordon Food Service | Food | Class I | 1 |
| 30 Aug 2012 | Cushman's Fruit and Flower Basket | Harry and David Operations, Inc. | Food | Class I | 4 |
| 29 Aug 2012 | Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are… | Remington Medical Inc. | Device | Class II | 1 |
| 29 Aug 2012 | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and… | Hospira Inc. | Device | Class I | 2 |
| 29 Aug 2012 | Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc.,… | Hospira Inc. | Drug | Class II | 1 |
| 29 Aug 2012 | BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA Made in USA NDC 0015-3012-18 NDC 0015-3012-60 | Bristol-myers Squibb Company | Drug | Class I | 1 |
| 29 Aug 2012 | Mango Peeled Halved and Cored, wrapped in plastic and refrigerated. Distributed by FreshPoint Central California, Turlock, CA | FreshPoint Central California, Inc. | Food | Class I | 2 |
| 29 Aug 2012 | Pico De Gallo in a plastic container labeled: "Pineapple/Mango Pico De Gallo Roma Tomato, Pineapple, Mango, Red Onion, Green Bell Pepper, Anaheim Pepper, Cilantro Lime Juice, jalapeno Pepper, Salt 88694 83987 Keep Refrigerated Best used by: 09/10/12 Packed by Spokane Produce, Inc 1905 S Geiger Blvd Spokane, WA 16 oz… | Spokane Produce, Inc. | Food | Class I | 1 |
| 28 Aug 2012 | TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a… Event 63111 | Kardium | Device | Class II | 1 |
| 28 Aug 2012 | PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples. | Biomerieux Inc | Device | Class II | 1 |
| 28 Aug 2012 | Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI product #8A0947 Event 63095 | Dispensing Solutions, Inc | Drug | Class II | 1 |
| 28 Aug 2012 | Sadie's Salads Egg Salad, 5 lb, 10 lb plastic tubs | Name withheld | Food | Class I | 10 |
| 28 Aug 2012 | Product Name: Walnuts 160z. Brand Name: Markets of Meijer Meijer Distribution, Inc. Grand Rapids, MI49544 UPC 8-8692619782-2 | Meijer Distribution, Inc | Food | Class II | 1 |
| 27 Aug 2012 | Frozen IQF PND Shrimp (Farm Raised), size 61/70 and size 71/90, 30 lbs (6bgsx5lbs) Event 63182 | Chang Jiang Seafood Ca Inc | Food | Class III | 1 |
| 25 Aug 2012 | Neera's Tikka Curry Rich and Creamy All Natural Simmering Sauce, 16 fluid ounces/ 473 ml. Packaged in jar. Packaged at 12/16oz units/case. Product labeling reads in part:" NEERA'S TIKKA CURRY Rich and Creamy All Natural Simmering Sauce***Just add meat, fish or vegetables!***16 Fluid Ounces / 473 mL***Manufactured by… Event 62990 | Cinnabar Specialty Foods Inc | Food | Class II | 1 |
| 25 Aug 2012 | Daniella Mangoes May be identified by Daniella sticker with a PLU code of 3114, 4051, 4311, 4584 or 4959. Event 63032 | Splendid Products | Food | Class I | 1 |
| 24 Aug 2012 | Whey Protein Concentrate, Net Weight: 1lb (454g) | MyoSci Technologies Inc. | Food | Class I | 5 |
| 23 Aug 2012 | Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended… | Biomet, Inc. | Device | Class II | 2 |
| 23 Aug 2012 | Dole brand Sliced Mushrooms, Net Wt. 8 OZ. (227G), UPC: 0 33383 67600 5, in a plastic container over-wrapped with plastic film. Labeled in part: Dole Sliced Mushrooms, Distributed by Oakshire Mushroom Sales, LLC under license Kennett Square, PA 19348 1-866-355-2077, Product of Canada Event 62997 | Oakshire Mushroom Sales, Llc | Food | Class I | 1 |
| 23 Aug 2012 | Champ's Sliced White Mushrooms, 227 g/8 oz, in a styrofoam container with shrink wrap, UPC 0 33383 67600 5. Labeled in part: "CHAMP'S MUSHROOMS Sliced White Mushrooms, Product of Canada, 227g/8 oz, 0 33383 67600 5 KEEP REFRIGERATED | Spokane Produce, Inc. | Food | Class I | 1 |
| 23 Aug 2012 | Sliced White Mushroom, Champ's Mushroom, net wt. 8 oz. The UPC is 0 33383 67600 5. | Triple B Corporation | Food | Class I | 1 |
| 23 Aug 2012 | Cucina Fresca Smoked Tomato Sauce. Product is packaged in a glass jar, net weight 24 oz. The UPC is 8-84337 00522-4 Event 63010 | Cucina Fresca, Inc. | Food | Class I | 1 |
| 21 Aug 2012 | Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 21 Aug 2012 | Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation… | Covidien LP | Device | Class II | 8 |
| 21 Aug 2012 | Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer. | Elekta, Inc. | Device | Class II | 1 |
| 21 Aug 2012 | Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of… | Caraco Pharmaceutical Laboratories Ltd. | Drug | Class II | 1 |
| 21 Aug 2012 | Furikake (a Japanese rice seasoning of seaweed flakes with toppings/seasonings). JFC Brand Furikake-Seto Fumi, 1.7 oz. Packaged in a clear glass jar with plastic twist lid. | J F C International Inc | Food | Class I | 1 |
| 21 Aug 2012 | Organic Pine Nuts (Raw, No Shell) 1 lb.Nuts.com NutsOnline, 125 Moen Street, Cranford, NJ 07016 800-558-8881 Event 63164 | Newark Nut Stores, Inc. | Food | Class I | 1 |
| 21 Aug 2012 | Gourmet Firm Tofu is packaged in a retail vacuum plastic package and each has net wt. 7.5 oz.. The product is sold under the Dae Han Tofu Soya Select brand. The UPC is 0 34199 718903; | Pacific Northwest Tofu, LLC | Food | Class II | 4 |
| 20 Aug 2012 | Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature. Event 63092 | Name withheld | Device | Class II | 1 |
| 17 Aug 2012 | Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients… | Varian Medical Systems, Inc. Oncology Systems | Device | Class II | 1 |
| 16 Aug 2012 | Luigi's Real Italian Ice Birthday Cake 6 FL OZ cups Net Wt 36 FL OZ (1.06 L) upc 73321-04418 J & J Snack Foods Corp. Pennsauken, NJ 08109 USA at Plant #42-2479 www.luigis.com Event 63149 | J & J Snack Foods Corporation | Food | Class I | 1 |
| 15 Aug 2012 | HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit). | Hospira Inc. | Drug | Class I | 1 |
| 14 Aug 2012 | Prometh VC Plain, Each 5mL contains: Promethazine Hydrochloride 6.25mg & Phenylephrine Hydrochloride 5mg, One Pint Bottles (473mL), Rx Only, Manufactured by: Actavis Mid Atlantic, LLC., 1877 Kawaii Road, Lincolnton, NC, 28092, USA, NDC 0472-1628-16. | Actavis Mid Atlantic LLC | Drug | Class III | 2 |
| 14 Aug 2012 | diet Orange Crush, no calorie orange soda, 2 L (2.1 QT), UPC 078000013979 Event 63205 | Pepsi Bottling Group Nashville | Food | Class II | 1 |
| 13 Aug 2012 | Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during… Event 63156 | Neomend Inc | Device | Class II | 1 |
| 10 Aug 2012 | IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps… | Immunodiagnostics Systems Ltd | Device | Class II | 7 |
| 9 Aug 2012 | Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM, SYNTEL RT-EMB; A4408, 7F-80CM, SYNTEL RT-EMB;… | Applied Medical Resources Corp | Device | Class II | 3 |
| 7 Aug 2012 | Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA *** | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 7 Aug 2012 | "Sofrito a Mi Gusto***100% Natural (Natural Seasoning)***Keep Refrigerated***Elaborado y Envasado por Ernesto Tropical Foods, Inc. Guadalupe#62 Ponce, Puerto Rico 00731***" | Ernesto Tropical Food, Inc | Food | Class II | 2 |
| 6 Aug 2012 | Invacare I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub. | Invacare Corporation | Device | Class II | 1 |
| 3 Aug 2012 | Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculo mucosal tissue. The… | Ethicon Endo-Surgery Inc | Device | Class I | 1 |
| 3 Aug 2012 | Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate… | Biomet 3i, LLC | Device | Class II | 1 |
| 30 Jul 2012 | DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System Event 62830 | Imaging Sciences International, LLC | Device | Class II | 1 |
| 30 Jul 2012 | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Product Usage: Enzyme n Immunoassay, Phenobarbital | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 30 Jul 2012 | Thallous Chloride Tl 201 Injection, Diagnostic Sterile, Non-Pyrogenic Solution, a) 2.8 mL (NDC 0019N12028) b) 6.3ml (NDC 0019N12063) For Intravenous Administration, each milliliter contains 37 MBq (1 mCi) Thallous Chloride Tl 201 (no carrier added) at date and time of calibration, 9 mg sodium chloride and 0.9% (v/v)… | Mallinckrodt Inc | Drug | Class III | 1 |
| 27 Jul 2012 | The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled… | Integra Limited | Device | Class II | 2 |
| 27 Jul 2012 | AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. | Nipro Medical Corporation | Device | Class II | 5 |
| 27 Jul 2012 | Levetiracetam Tablets, USP 500 mg, 500 count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-5615-05 | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 24 Jul 2012 | Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of… | Beckman Coulter Inc. | Device | Class II | 2 |
| 19 Jul 2012 | Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL 60064, NDC: 0074-4552-90. | Abbott Laboratories | Drug | Class II | 3 |
| 16 Jul 2012 | IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. | Animas Corporation | Device | Class II | 1 |
| 12 Jul 2012 | Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes,… | Alere San Diego, Inc. | Device | Class II | 1 |
| 12 Jul 2012 | Wildwood Emerald Valley Kitchen Organic Medium Salsa, 30 oz. Pack size 6/30 oz per case, 14 oz Pack size 6/14oz per case, Packaged in plastic cup, sealed with film and capped with plastic cap. Product labeling reads in part:" WILDWOOD Emerald Valley KITCHEN ORGANIC MEDIUM SALSA***MANUFACTURED BY PULMUONE FOODS USA,… | Pulmuone Wildwood Inc | Food | Class II | 7 |
| 11 Jul 2012 | Fentanyl Transdermal System, 100 mcg/h, each transdermal system contains: 10 mg fentanyl and 0.4 mL alcohol USP, Rx only, supplied in single pouches (NDC 0591-3214-54 (pouch)), 5 pouches per carton (NDC 0591-3214-72 (Carton)), Manufactured by Watson laboratories Inc., Corona, CA, Distributed by: Watson, Pharma Inc. | Actavis | Drug | Class II | 1 |
| 10 Jul 2012 | Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made… | Winco Mfg., LLC | Device | Class II | 2 |
| 6 Jul 2012 | Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853. Product Usage: The UniCel DxC Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in-vitro… | Beckman Coulter Inc. | Device | Class II | 1 |
| 6 Jul 2012 | NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah, NJ 07430; NDC 68462-190-01. | Glenmark Generics Inc., USA | Drug | Class II | 1 |
| 3 Jul 2012 | BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the… | OPTI Medical Systems, Inc | Device | Class II | 1 |
| 2 Jul 2012 | KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant Event 62948 | Mc-NEIL-PPC, Inc. | Device | Class II | 1 |
| 2 Jul 2012 | EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or… | Ethicon, Inc. | Device | Class II | 1 |
| 29 Jun 2012 | Earth's Best Organic Wheat Teething Biscuits, 6 pack, UPC # 23923-90015, HCG#C90615 Event 63192 | Lovin Oven, LLC | Food | Class II | 1 |
| 28 Jun 2012 | Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01 | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 26 Jun 2012 | "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 6 |
| 26 Jun 2012 | Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10. | Ben Venue Laboratories Inc | Drug | Class I | 1 |
| 19 Jun 2012 | EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination. Event 62621 | Eos Imaging Inc | Device | Class II | 1 |
| 18 Jun 2012 | MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 12 Jun 2012 | "Derby City Vending "Infielder's Breakfast" Biscuit and Gravy, Daybreak Selections, Ingredients: PILLSBURY buttermilk biscuit, PIONEER biscuit gravy mix, PURNELLS sausage***Fresh Thru***Derby City Vending Louisville, KY 40206" | Derby City Vending Inc | Food | Class I | 3 |
| 7 Jun 2012 | SunFresh Natural Pitted Prunes Net wt. 6 oz. Distributed by: Sunfresh Natural LLC, Passaic, NJ 07055 Please visit us at: www.sunfreshnatural.com Event 63203 | SUNFRESH NATURAL LLC. | Food | Class II | 1 |
| 6 Jun 2012 | Siemens syngo.plaza radiological image processing system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 5 Jun 2012 | Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA, Marketed By: Bristol-Myers Squibb Company, Princeton NJ 08543, USA and AstraZeneca… | Bristol-myers Squibb Company | Drug | Class II | 2 |
| 4 Jun 2012 | "Tacos de Langosta" (Lobster-filled turnovers)***Keep Refrigerated***Manufacturado por Sun Boricua Pa'l Mundo Inc, Carr. 486 km 0.1 Bo. Quebrada, Camuy PR 00627 | Sun Boricua Pa'l Mundo Inc. | Food | Class II | 4 |
| 1 Jun 2012 | CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01 | Bracco Diagnostics Inc | Drug | Class II | 1 |
| 29 May 2012 | This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Constellation 23G Total PLUS Pak,… | Alcon Research, LTD. | Device | Class II | 1 |
| 29 May 2012 | Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera. | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | Device | Class III | 1 |
| 24 May 2012 | GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. | GE Healthcare, LLC | Device | Class II | 1 |
| 24 May 2012 | GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When… | GE Healthcare, LLC | Device | Class II | 1 |
| 22 May 2012 | CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry.… | Beckman Coulter Inc. | Device | Class II | 3 |
| 22 May 2012 | Da Vinci Pesto Genovese with basil and pine nuts Net Wt. 10 oz. (283 g) Distributed by World Finer Foods, Inc. Bloomfield, NJ 07003 Product is packaged in a glass jar with lid. www.worldfiner.com Product of Italy UPC: 0 70670-00822 4 | World Finer Foods, Inc. | Food | Class II | 1 |
| 22 May 2012 | Luna & Larry's Coconut Bliss Mocha Maca Crunch; UPC 8 96767 00143 1 Event 62554 | Name withheld | Food | Class II | 1 |
| 18 May 2012 | Boulart Multigrain Ciabatta Baquette, 18/11.5 ounce loaves, UPC 82684622102. Event 62942 | Wakefern Food Corp. | Food | Class II | 1 |
| 12 May 2012 | BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source. Event 62966 | Invuity, Inc. | Device | Class II | 1 |
| 9 May 2012 | Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) | Aesculap, Inc. | Device | Class II | 1 |
| 4 May 2012 | Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair. | Stanley Security Solutions, Inc. | Device | Class II | 5 |
| 29 Apr 2012 | Flow Meter, CM Assembly, Model #27025, Serial # 13686, 13690, 13712, 13793. Flowmeter, CM Assembly, Model#31970, Serial#13692. Product Usage: Conscious Sedation Unit Analgesia Gas Machine. | Accutron Inc | Device | Class I | 4 |
| 24 Apr 2012 | The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment. | Ormco/Sybronendo | Device | Class III | 1 |
| 23 Apr 2012 | ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01. | Carefusion 213, Llc | Drug | Class II | 1 |
| 20 Apr 2012 | Grafton DBM Putty Multiple Sizes Grafton is a human bone allograft product containing demineralized human bone tissue combined with inert additive to yield a demineralized bone matrix (DBM) allograft. It is intended for use as a bone graft extender, bone graft substitute and bone void filler in bony voids or gaps of… | Osteotech Inc | Device | Class II | 12 |
| 17 Apr 2012 | Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 25 lb; Bulk Foods, Inc. Yellow Corn Meal, Light Roast, 50 lb | Name withheld | Food | Class II | 3 |
| 11 Apr 2012 | AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The AutoMate 1200/2500 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system automates the sample sorting, decapping, and archiving processes. Handling and sorting of samples includes automatic… | Beckman Coulter Inc. | Device | Class II | 1 |
| 3 Apr 2012 | Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte… | Beckman Coulter Inc. | Device | Class II | 1 |
| 2 Apr 2012 | Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing the fit of the proposed Implants. The cone body… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 29 Mar 2012 | buPROPion Hydrochloride Extended-Release Tablets (XL), 150 mg, UD 100 Tablets (10 x 10) per carton, Rx only, Mfg By: CMIC-VPS Corporation, Cranbury, New Jersey 08512; blister barcode N (01)003 63739 449 10 7, Dist By: McKesson Packaging, Concord, NC 28027; NDC 63739-449-10, carton barcode 6373944910. | McKesson Packaging Services | Drug | Class III | 2 |
| 29 Mar 2012 | Frozen Red Cod Fillet (Red Snapper) Individually Quick Frozen was labeled and identified as Snapper FILL IQF (ROCKFISH). 1/10 lb, code #14343. | Southwind Foods LLC dba Great American Seafood Imports Co. | Food | Class III | 1 |
| 12 Mar 2012 | DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring… | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 1 |
| 24 Feb 2012 | Fenugreek Leaves, 30 bunches (2.5 dozens/carton). Event 63345 | Samra Produce & Farm Inc | Food | Class II | 1 |
| 23 Feb 2012 | Hard Ten Days Capsule, 4500 mg, boxes of 6 packets, OTC, Developed by: American Federal International Living Creature Group and Tibet Gold Source Living Creature Engineering Limited Company, Unit 18, 55 Beijing Road Central, Lhasa, Tibet | Name withheld | Drug | Class I | 3 |
| 17 Feb 2012 | Sunny Boy Peanut Butter. Product is labeled in part: 6/5 lb tubs- "SunnyBoy Creamy PEANUT BUTTER***Net Wt. 5lb. (2.27KG)***INGREDIENTS: Peanuts, Dextrose, Contains less than 2% of the following: Salt, Partially Hydrogenated Oil (Rapeseed Cottonseed And/Or Mono-Diglycerides)***Allergen Statement: CONTAINS… | Sunshine Peanut Company | Food | Class II | 6 |
| 13 Feb 2012 | Fenugreek, 3 dozen per case. Event 63341 | Daaks International | Food | Class II | 1 |
| 5 Feb 2012 | Diet Crush Orange Soda, 12 oz cans Event 63250 | Bottling LLC dba Pepsi Beverages Company | Food | Class II | 1 |
| 4 Feb 2012 | "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto… Event 63081 | Orthosensor | Device | Class II | 1 |
| 27 Jan 2012 | IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate… | Beckman Coulter Inc. | Device | Class II | 1 |
| 20 Jan 2012 | COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. | Beckman Coulter Inc. | Device | Class II | 1 |
| 20 Jan 2012 | Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use. | Beckman Coulter Inc. | Device | Class II | 1 |
| 9 Jan 2012 | "***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium. | The Anspach Effort, Inc. | Device | Class II | 3 |
| 20 Dec 2011 | GE Healthcare innova 3100, Mobile X-ray system. The innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally , rotational angiography procedures. They are also indicated for generating fluoroscopic images… | GE Healthcare, LLC | Device | Class II | 3 |
| 15 Dec 2011 | Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus,… | Beckman Coulter Inc. | Device | Class III | 1 |
| 15 Nov 2011 | Sunquest Laboratory : intended for use by professionals working in a clinical laboratory. | Sunquest Information Systems, Inc. | Device | Class III | 1 |
| 15 Nov 2011 | McClure's Pies & Salads, Inc. Walnut Cinnamon Streusel Cake | McClures, Inc. | Food | Class I | 33 |
| 14 Nov 2011 | Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract. | US Endoscopy Group Inc | Device | Class II | 1 |
| 11 Oct 2011 | Mother's Milk Bank at Austin, Batch # 9429-1, 3 oz. (100 mL), Pasteurized, Exp: 3/25/2012, KCal/Oz: 20, Protein: .9 g/dl | Mothers' Milk Bank at Austin | Food | Class III | 1 |
| 10 Oct 2011 | SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 23 Sep 2011 | UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials… | Micro Therapeutics Inc, Dba Ev3 Neurovascular | Device | Class II | 2 |
| 1 Jul 2011 | Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures. | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 1 |
| 28 Jun 2011 | ***Dulce De Leche "Del Campo"***Ice Cream "Base" (Flavor)***FB 23546***Mfg. Date***Keep Refrigerated at 40*f***Lot#***Net Wt 55 LBS***Indalco Food Corp., Miami, FLA (305) 620 1444*** Caramel milk spread is packed in white plastic pails of 55 lbs. under the firm's brand name "Del Campo". Event 63061 | Indalco Foods Corp. | Food | Class I | 1 |
| 1 Jun 2011 | Label reads in part "***OCHO RIOS***Jamaican***Curry***Seasoning***Net Wt. 4 & 8 oz (227 g)***Gold Series***Low Sodium***Extra delicious!***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredients: Turmeric,***Fenugreek, Coriander, Cumin***Salt, Anise, Pimento, Garlic***"" | Ocho Rios-Miami, Inc. | Food | Class II | 4 |
| 20 May 2011 | ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 2 |
| 2 May 2011 | Mother's Milk Bank at Austin, Batch # 8638-1, 3 oz.(100 mL), Pasteurized, Exp: 02/19/2012, Kcal/Oz: 24, Protein: 0.9 g/dl. | Mothers' Milk Bank at Austin | Food | Class II | 2 |
| 28 Apr 2011 | Approximately 5 lb bag of Pre-cooked Conch Fritters labeled in part: "***NEPTUNE'S CONCH FRITTERS PRECOOKED***Ingredients: Conch, Flour, Onions, Milk, Bell Peppers, Eggs, Garlic, Salt, Black Pepper, Lime Juice & Hot Pepper Sauce.***Packed by Triton Seafood Co. Miami, FL 33166***Pack: 125 Units Net Wt. 5# (approx.)*** | Triton Seafood Co. | Food | Class II | 2 |
| 1 Apr 2011 | 00789502202 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 trial range… | Zimmer, Inc. | Device | Class II | 12 |
| 10 Feb 2011 | Earth Force, Ltd., Power Towels, QS Plus Hand Sanitizing Wipes (antiseptic), 50 pre-moistened Wipes, Manufactured by: ABC Compounding Co., Inc., P.O. Box 16247, Atlanta, GA 30321. Event 63395 | Abc Compounding Company Inc | Drug | Class III | 1 |
| 31 Jan 2011 | Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No. 50027149***Use by… | Cordis Corporation | Device | Class II | 2 |
| 18 Jan 2011 | Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. | Westmed Inc | Device | Class II | 14 |
| 29 Jan 2010 | OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle. | Orthohelix Surgical Designs Inc | Device | Class II | 2 |
| 2 Oct 2009 | Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally, there are three port supports the user incorporates to position the lines that enter and exit the venous bag. The… | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 28 May 2009 | Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct… | Alere San Diego, Inc. | Device | Class II | 1 |
| 13 May 2008 | TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended to produce cross sectional volume sets of… | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 14 Sep 2007 | HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a stimulator (HiRes90K ICS)… Event 63353 | Advanced Bionics Corporation | Device | Class II | 1 |