| 18 Jun 2012 | Frozen Korean Oyster Meat I.Q.F.: , 1) 40x8oz., UPC 19964 30091; 2) 1x25lbs, .; 3) 5x4lbs.UPC 19964 30092 Event 62339 | Red Chamber Company | Food | Class II | 1 |
| 13 Jun 2012 | seprafilm Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the… | Genzyme Corporation | Device | Class II | 2 |
| 13 Jun 2012 | Oyster Frozen Half Shell; 144 Pc/CS Processed by: Dai One Food Co., LTD #150 Jun-RI, Sanyang-UP Tongyeong-City Kyungsangnam-DO. to: Khee Trading, Vernon, CA 90058. | True World Foods San Francisco LLC. | Food | Class II | 3 |
| 8 Jun 2012 | Frozen Oysters: 1) CHORIPDONG) FROZEN OYSTER, IQF 8OZ*40; 2) CJ FOOD, INC.)FROZEN OYSTER 8oz*40; Not for Retail Sale, Must be fully cooked before serving. Distributed by CJ Foods, Inc., Commerce, CA; 3) JAYONE FOODS, INC.) FROZEN OYSTER 8 oz*40, IQF, Distributed by Jayone Foods, Inc.., Paramount, CA 92723 Product of… | Woosung America Corp. | Food | Class II | 4 |
| 7 Jun 2012 | Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to… | Arrow International Inc | Device | Class II | 1 |
| 6 Jun 2012 | Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD 21046; A subsidiary of King Pharmaceuticals, Inc.; NSN 6505-01-274-0951, NDC 11704-600-01. Event 62015 | Meridian Medical Technologies a Pfizer Company | Drug | Class II | 1 |
| 6 Jun 2012 | Fresh Baby Clam Meat Labels on outer styrofoam container; 200 g packages, 30 or 40 packages/case, refrigerated. Refrigerate after opening. Product arrived via Korean Air Cargo directly to consignees. Event 62060 | J&I TRADING GROUP, INC. | Food | Class II | 1 |
| 5 Jun 2012 | Campbell's Oyster Stew, Net Wt 10.5 oz (298g), Campbell Soup Company, Camden, NJ 08103-1701 | Campbell Soup Supply Co., LLC | Food | Class III | 1 |
| 2 Jun 2012 | Tiny IQF Oysters, 40pk/cs, 8oz. | Ocean Group Inc. | Food | Class II | 3 |
| 1 Jun 2012 | T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 2 |
| 1 Jun 2012 | Granadaisa whole Oysters, Net WT. 8 oz (225 grams); Packed For King Seafoods Inc. PO BOX 107, Mount Holly, NJ USA 08060 Product of Korea Farm Raised, UPC 719882002049. Event 62312 | King Seafoods Inc. | Food | Class III | 1 |
| 1 Jun 2012 | KERRY, 4 CHEESE SEAS 30506103, CONTAINS MILK, Net Wt 50 Lb (22.68 Kg), Item Number 30506103.465 | Kerry Foods | Food | Class II | 62 |
| 1 Jun 2012 | Orchids brand Whole Oysters, Net Wt. 8 oz (226 g) Ingredients: oysters, salt, water. Packed for CTC Food Int'l Inc. South San Francisco, CA 94080 Product of Korea | CTC Food International Inc | Food | Class II | 2 |
| 30 May 2012 | Oskri, Peach Granola, Gluten Free, Nut Free, Dairy Free, Vegan, Halal, Kosher, Ingredients: Buck Wheat , Peaches 20% Sunflower Seeds , Apricots, Date Syrup, Chicory Root extract, Rice protein., NET WT 3.5oz (100) G., UPC 66616111743, Oskri, Lake Mills, Wisconsin 53551. Event 61970 | Oskri Organics Corp. | Food | Class I | 1 |
| 30 May 2012 | 1) Mrs.Friday's brand, Gourmet Breaded Oysters, Medium 18-25 CT, Ready to Fry, Net Wt 2.5 lbs (1.13 kg). 2) Mrs.Friday's brand, (Canada) Gourmet Breaded Oysters, Medium, Ready to Fry, Net Wt 2.5 lbs (1.13 kg), Distributed by King & Prince Corp., Brunswick, GA 31521. Product is packed in unlabeled, clear plastic bags. | King & Prince Seafood | Food | Class III | 3 |
| 30 May 2012 | Polar Whole Boiled Oysters, 8 oz. net weight, 12 cans/carton. | Milky Way Intl Trading Corp | Food | Class III | 1 |
| 30 May 2012 | Napoleon canned, Smoked Oysters, Medium. Item no. 48-312. Net WT. per can is 3.66 oz (106 g). The UPC is 0 41253 00312 7. The product is labeled in parts: "***NAPOLEON***Medium***SMOKED OYSTERS***NET WT. 3.66 OZ (106 g)***INGREDIENTS: SMOKED OYSTERS, SOYA OIL, SALT***PRODUCT OF KOREA***FARM RAISED***". | Napoleon Company, The | Food | Class III | 2 |
| 30 May 2012 | Canned oysters. Crown Prince Whole Boiled Oysters, 8 oz. Each case is 8oz/12. | Crown Prince Inc | Food | Class III | 4 |
| 29 May 2012 | Reese Colossal Smoked Oysters. Distributed by: World Finer Foods, Inc. Bloomfield, NJ 07003 USA. Product of Korea. UPC 70670-00576 | World Finer Foods, Inc. | Food | Class III | 3 |
| 29 May 2012 | Smoked Oysters In cottonseed oil sold under the following brand names: 1) Fredmeyer Smoked Oysters In cottonseed oil Net Wt 3.75 oz (106 g) Distributed by Inter-American Products, Cincinnati, Ohio 45202, Product of Korea; 2) Ralph's Smoked Oysters In Cottonseed Oil Distributed by Inter-American Products Cincinnati,… | Camerican International | Food | Class III | 3 |
| 29 May 2012 | Daufuski Brand boiled Oysters, 8 oz; Distributed by Liberty Gold Fruit, Inc. Event 61975 | Liberty Gold Fruit Company, Inc. | Food | Class III | 1 |
| 26 May 2012 | 1) Chicken of the Sea Whole Oysters, 12 units per case, 8oz., UPC 4800000267; 2) Ace of Diamonds Whole Oysters 24 units per case, UPC 7760015508 | Tri-Union Seafoods, L.L.C dba Chicken of the Sea. | Food | Class III | 3 |
| 25 May 2012 | Bumble Bee Fancy Whole Oysters 12/8 oz can. Event 62000 | Bumble Bee International | Food | Class III | 1 |
| 24 May 2012 | Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product… | Ultradent Products, Inc. | Device | Class II | 1 |
| 22 May 2012 | Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary Fluoroscopic system | Philips Healthcare Inc. | Device | Class II | 1 |
| 22 May 2012 | Shiitake-Ya brand Dried Shiitake mushroom slices, 6 oz plastic jars, UPC 7 1452 22183 9. Product labeling reads in part: " Shiitake-Ya gourmet Shiitake SLICES***Antioxidants Amino Acids Omega 3+6***Immune-Boosting*** NET WEIGHT. 6 oz (170 g)***Natural Enzymes Fiber (80% Chitin) Iron Kojic Acid Event 61937 | LA Link Corporation | Food | Class III | 1 |
| 22 May 2012 | Tempeh Starter Yeast, Rhizopus Oligosporus cultures, soybean rice flour, Original, packaged in clear plastic packages in 30gm, 50gm, 250 gm, and 1000 gm sizes and labeled in part ***Indonesianfoodmart.com*** | Indonesian Food Mart | Food | Class I | 2 |
| 22 May 2012 | Private Selections Organic Baby Spinach, 5 oz plastic clamshell, UPC 0-11110-91128-5; Marketside Baby Spinach Organic, 10 oz plastic clamshell, UPC: 6-8113132900-2 | Taylor Farms Retail, Inc. | Food | Class I | 1 |
| 22 May 2012 | Florentine Lasagna Rolls; Perishable, keep frozen; Net weight 15 pounds, 60 x 4 oz. For HRI Use Only. Cook Thoroughly per state food code standards. West Best Foods, inc. 3425 Wynn Road, Las Vegas, NV 89102 | Best West Foods | Food | Class II | 2 |
| 21 May 2012 | Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic… | Natus Medical Incorporated | Device | Class II | 1 |
| 21 May 2012 | Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more… | Philips Healthcare Inc. | Device | Class II | 1 |
| 21 May 2012 | Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446 Event 61960 | Kutol Products Co Inc | Drug | Class II | 1 |
| 19 May 2012 | Diced Red Onions, 7oz clear plastic clamshell labeled Gills Onions with the May 17, 2012 use by date, United States UPC 6 43550 00041 2. Fresh Diced Red Onions, Oignons rouges frais, en des, 198 grams, Canadian UPC 6 43550 00045 0. | Gills Onions, LLC | Food | Class I | 3 |
| 18 May 2012 | Santos Brand, Bulgar Wheat, flour packed in clear plastic bags, 2 lbs. | Santos Inc. | Food | Class I | 14 |
| 18 May 2012 | AlsoSalt Sodium Free Butter flavored Salt Substitute, 2.5 oz. bottle Event 61924 | Diversified Natural Products, Inc. | Food | Class II | 1 |
| 17 May 2012 | Bourbon Seasoning 30458458, item number 30458458.01. Distributed by Kerry Ingredients & Flavours 3330 Millington Road, Beloit, WI 53511 Ingredients: brown sugar, maltodextrin, molasses, yeast extract, spices, dried tomato, worcestershire sauce (distilled vinegar, molasses, corn syrup, salt, caramel color, garlic… | Kerry Ingredients & Flavours Research & Developement Center | Food | Class II | 8 |
| 16 May 2012 | Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an… | Boston Scientific Corporation | Device | Class II | 3 |
| 16 May 2012 | GB Select Roast Meat Type Flavor Net Wt. 55 lbs.(25 kg) Product of the Netherlands further processed in China and the US Event 61936 | Dsm Nutritional Products, Llc | Food | Class II | 1 |
| 15 May 2012 | Casa de Mesquite brand Mesquite Bean Flour, packaged in 10 kg bag in carton, and 13 kg bag in carton for food manufacturing, and 10, 24 and 44 oz retail bags; Product is processed and packaged by Casa de Mesquite, LLC, Hollister, CA Event 61867 | Casa De Mesquite Llc | Food | Class II | 1 |
| 14 May 2012 | Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05 | Abbott Laboratories | Drug | Class II | 1 |
| 11 May 2012 | The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used to assist physicians in diagnosis and… | Spacelabs Healthcare, Llc | Device | Class II | 1 |
| 11 May 2012 | Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system | Philips Healthcare Inc. | Device | Class II | 1 |
| 11 May 2012 | Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens | Vygon Corporation | Device | Class II | 12 |
| 9 May 2012 | Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis | Covidien LP | Device | Class II | 5 |
| 9 May 2012 | SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7.5" (19 CM) LONG. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. | Terumo Cardiovascular Systems Corporation | Device | Class II | 11 |
| 8 May 2012 | Panera HONEY WALNUT CREAM CHEESE SPREAD, Reduced Fat, 8 0z Refrigerated | Panera Bread LLC | Food | Class II | 2 |
| 7 May 2012 | US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At… | Non-Invasive Monitoring Systems, Inc. | Device | Class II | 2 |
| 7 May 2012 | The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports,… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 7 May 2012 | Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70. | Endo Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 4 May 2012 | LifeGas OXYGEN COMPRESSED UN1072 USP, Distributed by: Linde Event 61917 | Linde Gas LLC | Drug | Class II | 1 |
| 1 May 2012 | NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator. | Nidek Medical Products Inc | Device | Class I | 9 |
| 1 May 2012 | Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8. | Ben Venue Laboratories Inc | Drug | Class II | 2 |
| 27 Apr 2012 | PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery system that is designed for cutting and coagulation in open surgery and laparoscopic surgery. Event 61951 | Plasma Surgical Inc. | Device | Class II | 1 |
| 26 Apr 2012 | Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich Drive, Charlottesville, VA 22911, USA*** Product Usage: A fat collection canister intended for use during liposuction procedures. | MicroAire Surgical Instruments, LLC | Device | Class II | 1 |
| 26 Apr 2012 | Stahl's Famous Original Bakery CUTOUT COOKIES 14oz. INGREDIENTS: Pastry Flour, Sugar, Shortening...Contains Wheat, Eggs, Milk and Soy. | JDS Bakery LLC | Food | Class II | 4 |
| 23 Apr 2012 | Jolessa (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, each Dispenser contains 91 tablets, 91 Day Regimen, Rx Only, Shaping Women's Health, Manufactured by: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-9123-66. | Teva Pharmaceuticals USA, Inc. | Drug | Class III | 1 |
| 11 Apr 2012 | Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA. | Hospira, Inc. | Drug | Class II | 1 |
| 10 Apr 2012 | GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. | GE Healthcare, LLC | Device | Class I | 1 |
| 10 Apr 2012 | Carbon Dioxide, USP, Medical Gas, packaged in a) size EA aluminum, CGA940 (CDUSPEA), b) size E CGA 940 (CDUSPE), c) 50 lb CGA320 (CDUSP50, CD USP50S), d) size 160 liter (CD USP160LT350) cylinders, Rx only, Airgas, Puritan Medical, Distributed By: Airgas USA, LLC, Radnor, PA. Event 61947 | Airgas Inc | Drug | Class II | 1 |
| 9 Apr 2012 | Bliss Bros. Dairy Chocolate Peanut Butter Cookie Dough Ice Cream, 3-gallon round paperboard,: frozen | Bliss Bros Dairy, Inc. | Food | Class III | 2 |
| 6 Apr 2012 | Liquid Peanut Butter Topping under the Brand name: Superior Nut Company, Murray's, Dairy Queen packaged in 6.5 lb., 45 lb. Event 61600 | Superior Nut Co. Inc. | Food | Class II | 1 |
| 5 Apr 2012 | Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24. | Hospira, Inc. | Drug | Class III | 1 |
| 5 Apr 2012 | 1) Crispy Pistachio Cookies is labeled in part: "***VEGETARIAN***NO EGG***CRISPY***By TWI Foods***PISTACHIO COOKIES***Just Baked!***Biscuit Pistache***Net Wt./Poids Net 200g/7oz***TWI FOODS INC***1869 Cage Court, Mississauga, ON Canada L5S 1S3. 1-866-9-CRISPY*** ; 2) Crispy Pistachio Cookies is labeled in part:… | House of Spices (India) Inc. | Food | Class I | 3 |
| 4 Apr 2012 | "***Queso Blanco del Pais***TRIDAS***Receta Original***" | Pr Supplies Co., Inc. | Food | Class II | 3 |
| 23 Mar 2012 | Salsa in 12 oz., 16 oz., and 5 lb. plastic containers. The product labels reads as follows: “PREMIUM QUALITY Private Selection Natural***SALSA NO PRESERVATIVES KEEP REFRIGERATED NET WT 12 OZ (340g)***INGREDIENTS: Tomatoes***Jalapeno***DISTRIBUTED BY: INTER-AMERICAN PRODUCTS, CINCINNATI, OHIO… | Club Chef LLC | Food | Class I | 1 |
| 22 Mar 2012 | PrepStain Syringing Pipettes 240 (Catalog #490517) | Tripath Imaging, Inc. | Device | Class III | 5 |
| 20 Mar 2012 | DermaZinc Spray, 0.25% zinc pyritione, topical OTC, 4 fl oz bottle Distributed By: Dermallogix Partners, Inc. Scarborough, ME 04070 Event 61518 | Quadrant Chemical Corporation | Drug | Class III | 1 |
| 22 Feb 2012 | TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated… | American Optisurgical Inc | Device | Class II | 1 |
| 21 Feb 2012 | Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplastics or osteotomies… Event 61332 | Aesculap Implant Systems | Device | Class II | 1 |
| 8 Feb 2012 | Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0 | Physicians Total Care, Inc. | Drug | Class II | 1 |
| 6 Feb 2012 | VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow System’s intended for use with human whole blood and verify now… | Accumetrics Inc | Device | Class II | 2 |
| 29 Dec 2011 | Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 4 Nov 2011 | Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13***REF IOSM313 LOT*** OSSEOTITE Certain Implant***3.25 x 13mm***CE 0086***Use by yyyy-mm***Sterile by radiation*** STERILE R***Do not re-sterile***RX only Caution: Law prohibits dispensing… | Biomet 3i, LLC | Device | Class II | 1 |
| 19 Oct 2011 | Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide | Philips Healthcare Inc. | Device | Class II | 1 |
| 11 Oct 2011 | Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis… | Integra LifeSciences Corp. | Device | Class II | 2 |
| 19 Sep 2011 | Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians total Care, Inc., Tulsa, OK 74146. | Physicians Total Care, Inc. | Drug | Class II | 1 |
| 6 Jul 2011 | Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of intravenous… | Baxter Healthcare Corporation | Device | Class I | 1 |
| 6 Jul 2011 | Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15 | Bausch & Lomb, Inc. | Drug | Class II | 1 |
| 5 Jul 2011 | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven… | Noven Pharmaceuticals, Inc. | Drug | Class II | 4 |
| 19 Apr 2011 | better batter brand Gluten Free Pancake & Biscuit Mix packaged in chip board box, in 20 oz. (UPC 8 96439 00207 0) and in 2.5 lb sizes (UPC 8 96439 00203 2). The 20 oz. product is labeled in part, "*** better batter PANCAKE & BISCUIT MIX *** 20 OZ *** UPC 8 96439 00207 0***". The 2.5 lb. product is labeled in part,… | Raymond Hadley Corporation | Food | Class I | 5 |
| 15 Mar 2011 | CONCENTRATED SODIUM CHLORIDE INJECTION, USP, 23.4% a) 30 mL SINGLE DOSE VIAL, (NDC 0517-2930-25), b) 100 mL PHARMACY BULK PACKAGE (NDC 0517-2900-25), Rx Only, AMERICAN REGENT, INC. SHIRLEY, NY 11967. Event 58410 | Luitpold Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 8 Dec 2010 | Country Fresh Ovens Cheese Coffee Cake, Net Wt 5 oz (142g). Dist. by Country Fresh Ovens, St. Paul Park, MN 55071 Event 57449 | Name withheld | Food | Class II | 1 |
| 10 Nov 2010 | Morphine Sulfate Extended Release tablet, 30 mg, 60 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, Ok 74146-6234, NDC 54868-4033-00 | Physicians Total Care, Inc | Drug | Class I | 2 |
| 12 Oct 2010 | Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging. | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 20 May 2010 | HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling. | App Pharmaceuticals Llc | Device | Class II | 2 |
| 7 Jun 2008 | popchips Cheddar Potato, Popped Chip Snack, 0.8 oz, UPC 0 82666 78800 3 | Sonora Mills Foods | Food | Class II | 3 |
| 31 May 2006 | GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 Model numbers: 2259988-2 & 2351505. The Revolution XR/d Digital Radiographic Imaging System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in all… | General Electric Med Systems LLC | Device | Class II | 3 |