| 13 Sep 2013 | NX3 Try-In Gel. The product is used as a tooth shade resin material. | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | Device | Class II | 1 |
| 11 Sep 2013 | Bean & Cheese Burrito Filling, 10 lb bags Labeled in part "13210 B 1 77220 13:38 KEEP FROZEN BEAN & CHEESE BURRITO FILLING***INGREDIENTS: COOKED PINTO BEANS, WATER, CHEDDAR CHEESE***SOYBEAN OIL***STARCH-MODIFIED, ONIONS, CHEESE SAUCE BASE***CONTAINS LESS THAN 2% OF CHILI PEPPER, SALT, CHICKEN BASE***SODIUM… (66262) | JTM Provisions Co Inc | Food | Class I | 1 |
| 9 Sep 2013 | Bevacizumab 1.25 mg/0.05 mL PF, Avella Specialty Pharmacy, Phoenix, AZ, 85085, 877-782-7684 | Avella of Deer Valley, Inc. | Drug | Class II | 2 |
| 6 Sep 2013 | Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800. | University Compounding Pharmacy | Drug | Class II | 5 |
| 6 Sep 2013 | Pills bury Cinnamon Rolls with Icing, CINNA BON, USPC 1800000501, 1800052230, 12.4 oz and 2-pack USPC 1800045675,2- 12.4 oz (351 G) CANS, NET WT 24.8 OZ (1 LB 8.8 OZ 703 G. | General Mills, Inc | Food | Class II | 1 |
| 5 Sep 2013 | Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561 (66198) | Northern New England Compounding Pharmacy LLC | Drug | Class II | 1 |
| 5 Sep 2013 | Olde Cape Cod Chipotle Ranch dressing, 16 oz. Item Number: 90997-11630 (66190) | Cains Foods L.P. | Food | Class I | 1 |
| 4 Sep 2013 | Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce intracranial pressure (ICP),… | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Device | Class II | 1 |
| 3 Sep 2013 | Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer. | Cincinnati Sub-Zero Products Inc | Device | Class II | 1 |
| 3 Sep 2013 | King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents. | King Systems Corp. | Device | Class III | 1 |
| 30 Aug 2013 | Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region. (66208) | Implantech Associates Inc | Device | Class II | 1 |
| 30 Aug 2013 | SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per dose, Rx only, a) 10 count blister (NDC 0597-0075-27), b) 30 count blister (NDC 0597-0075-41), c) 90 count blister (NDC 0597-0075-47), d) 5 count blister physician sample (NDC 0597-0075-75), Manufactured by: Boehringer Ingelheim (BI)… | Boehringer Ingelheim Roxane Inc | Drug | Class III | 1 |
| 30 Aug 2013 | Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Laboratories, Inc, Cocona, CA 92880, NDC 0591-2611-05. | Watson Laboratories Inc | Drug | Class III | 1 |
| 29 Aug 2013 | IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA. (66117) | Individual firm, name withheld | Drug | Class II | 1 |
| 29 Aug 2013 | Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, Dextromethorphan HBr 30mg, Doxylamine succinate 12.5mg), 12 fl oz (354 ml) bottles, Distributed by Procter & Gamble, Cincinnati, OH 45202, NDC 37000-807-12 | Procter & Gamble Co | Drug | Class II | 1 |
| 29 Aug 2013 | H-E-B Jumbo Butterfly Shrimp-10.5 oz Box, 20 units per case (66146) | The Seafood Exchange Of Fla | Food | Class II | 1 |
| 28 Aug 2013 | C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibular arch. | Camlog Usa | Device | Class II | 4 |
| 28 Aug 2013 | *** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA. Indicated for… | Carefusion 2200 Inc | Device | Class II | 1 |
| 28 Aug 2013 | Stonyfield Organic O Soy Yogurt Strawberry , 6 oz.cup, Refrigerated USPC code: 05215900603 (66130) | Individual firm, name withheld | Food | Class II | 1 |
| 28 Aug 2013 | Meyer Lemon Braising Base, 1lb. 8.5 oz, 12 jars/case | Premier Foods, LLC | Food | Class I | 4 |
| 26 Aug 2013 | Lidocaine 1% PF Sterile Injection, 30 mL Single Dose Vial, Pharmacy Creations, Randolph, NJ. | Pharmacy Creations | Drug | Class II | 2 |
| 26 Aug 2013 | Dextrose 50% Preservative Free SDV Injection Solution, 50 mL Single dose vial, IV Administration, Compounded by Leiter's Compounding Pharmacy, 1700 Park Ave., # 30, San Jose, CA 95126 | Leiter's Pharmacy | Drug | Class II | 4 |
| 26 Aug 2013 | First Street Coffee Cake Muffins (S 45398) 4 count 14 oz. UPC 0 4151210848 8 (66107) | KDK Management, Inc., dba Bubbles Baking Co. | Food | Class I | 1 |
| 26 Aug 2013 | Fresh Basil (Sweet Hawaiian and Thai) New Dream Team Inc. HI (66113) | New Dream Team | Food | Class III | 1 |
| 25 Aug 2013 | Kroger Break 'N Bake Chocolate Chip Cookie Dough, refrigerated dough, packaged in 16.0 oz. plastic package. | Conagra Inc | Food | Class I | 1 |
| 23 Aug 2013 | Dexpanthenol 250mg/ml PF, Qty: 1mL, WELLNESS PHARMACY, 1-800-227-2627 | Wellness Pharmacy, Inc. | Drug | Class II | 6 |
| 23 Aug 2013 | Methylcobalamin Injection 5 mg/mL, For IM or SC Administration, Sterile 30 mL Multiple Dose Vial, Park Compounding, Irvine, CA | South Coast Specialty Compounding, Inc. | Drug | Class II | 3 |
| 23 Aug 2013 | Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070. (66084) | Individual firm, name withheld | Drug | Class II | 1 |
| 23 Aug 2013 | Testosterone Cyp 200 mg/mL, W/Pres. (Benzyl ETOH), 3 mL, Medaus pharmacy 1-800-526-9183 | Medaus, Inc. | Drug | Class II | 8 |
| 23 Aug 2013 | Acetylcysteine 20% Solution, Preservative Free, 4 mL Sterile Single Dose Vial, Not for Injection, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS. | JCB Labs LLC | Drug | Class II | 5 |
| 23 Aug 2013 | Hawaii Fresh Sweet Basil Hawaii Fresh Thai Basil product of the USA Crown Pacific International, Inc. Hilo, HI (66109) | Crown Pacific Int'L Llc | Food | Class III | 1 |
| 22 Aug 2013 | Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer. | Baxa Corporation | Device | Class II | 1 |
| 22 Aug 2013 | Daily Chef, Tropical Fruit & Nut Blend, 44oz plastic bags, Distributed by SAMs West, Inc., Bentonville, AR 72716. (66118) | Ann's House of Nuts, Inc | Food | Class II | 1 |
| 21 Aug 2013 | Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria. | Siemens Healthcare Diagnostics, Inc. | Device | Class I | 11 |
| 21 Aug 2013 | buPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, 30-count tablets per bottle, Rx only, Distributed by: Actavis South Atlantic, LLC, Sunrise, FL 33325; Packaged by: American Health Packaging, Columbus, OH 43217, NDC 67767-142-30, UPC 3 67767-142-30 6. | Actavis South Atlantic LLC | Drug | Class III | 1 |
| 21 Aug 2013 | Frozen, 4/3 lb unlabeled bags contained in a master carton box labeled in part: "Portico Brand 4/3 lb 170585 Breaded Scallops***Net Wt 12 lb (5.44 kg)***Ingredients:Scallops, Bleached Wheat Flour, Water, Modified Corn Starch, Sugar, Yellow Corn Flour, Salt, Textured Soy Flour, Yeast, Dried Whole Eggs, Sodium… (66125) | Tampa Maid Foods, Inc. | Food | Class I | 1 |
| 20 Aug 2013 | "***SUPERPAN***Tu Pan Natural***" | Lucy's Kitchen, Inc. | Food | Class II | 2 |
| 19 Aug 2013 | Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology. | Lumenis, Inc. | Device | Class II | 1 |
| 19 Aug 2013 | ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 19 Aug 2013 | Professor Zim Zam's Extraordinary Sweets; Dark Chocolate with Sea Salt; All Natural, 55% Cocoa; Net Wt. 0.35 oz (9.9g) Go Picnic: Distributed by Go Picnic Brands, Chicago, IL 60613; Made in USA | G. Debbas Chocolatier, Inc. | Food | Class I | 3 |
| 17 Aug 2013 | See's Candies, Van Doren Dark Chocolate Blueberries; 8 oz. clear plastic packages. See's Candies Inc./See's Candy Shops Inc: South San Francisco, CA 94080/Los Angeles, CA 90016 | See's Candies Inc. | Food | Class I | 1 |
| 16 Aug 2013 | Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Waste Management Systems: The Neptune Waste management system is intended to be used in the Operating Room, Surgical Centers and Doctor's Offices to collect and dispose of surgical fluid waste as well as collect smoke… (66176) | Zeppessis Reprocessing, LLC | Device | Class II | 1 |
| 16 Aug 2013 | POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously. (66223) | Access Scientific Inc | Device | Class II | 1 |
| 16 Aug 2013 | Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous… | Covidien LLC | Device | Class II | 9 |
| 16 Aug 2013 | Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12 | Hospira Inc. | Drug | Class II | 1 |
| 16 Aug 2013 | Maple Almond Butter 16 oz Jar (Unit USPC 894455000322, Case USPC 894455002135) | Individual firm, name withheld | Food | Class III | 2 |
| 16 Aug 2013 | Coffee Cake: queso/guava (cheese/guava) | Individual firm, name withheld | Food | Class II | 4 |
| 15 Aug 2013 | DMLC IV-ERGO - Beam shaping block for Radiation Therapy. | Elekta, Inc. | Device | Class II | 1 |
| 15 Aug 2013 | Buurma Farms Cilantro, fresh, 4 oz bunch, #4889 UPC 0 33383 80104 9 (66023) | Buurma Farms Inc | Food | Class I | 1 |
| 14 Aug 2013 | Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each, NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3,… (65979) | Novocol Pharmaceutical of Canada | Drug | Class II | 1 |
| 14 Aug 2013 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30 | Hospira Inc. | Drug | Class II | 1 |
| 13 Aug 2013 | Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662 | Ebi, Llc | Device | Class II | 1 |
| 13 Aug 2013 | AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during… | Tornier, Inc | Device | Class II | 1 |
| 13 Aug 2013 | CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 12 Aug 2013 | T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the… | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 12 Aug 2013 | Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids. | Churchill Medical Systems, Inc. | Device | Class II | 2 |
| 12 Aug 2013 | Steinmann Pin, packed in a clear tube with end caps, tubes packed in a sterile barrier pouch, 6 pouches/sales unit. Pouches are labeled in part ***MicroAire Surgical Instruments 3590 Grand Forks Blvd Charlottesville, VA LLC 22911*** Models: 1620-109 1636-509 1620-509 1640-509 1620-609 1648-509 1620-709 1648-509T… | MicroAire Surgical Instruments, LLC | Device | Class II | 2 |
| 12 Aug 2013 | Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3795-01 | Hospira, Inc. | Drug | Class II | 1 |
| 10 Aug 2013 | Sour Cherry Crostata, 1 pie Net. Wt. 1 lb. 6 oz (624 g) Whole Foods Market Inc., Emeryville, CA 94608 | Whole Foods Market | Food | Class I | 2 |
| 9 Aug 2013 | WASP (Walk Away Specimen Process). Automatic Planting and Streaking Instrument Catalog number: W086 WASP is a fully automated system used to process microbiological specimens in liquid phase for the investigation of infectious microbes. (65923) | Individual firm, name withheld | Device | Class III | 1 |
| 9 Aug 2013 | Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length. (66027) | Sonogage Inc | Device | Class II | 1 |
| 9 Aug 2013 | Dove Chocolate Discoveries Fruit Collection Dark Chocolate - Covered Cranberries, Blueberries, Cherries Net Wt. 18 oz. Distributed by Dove Chocolate Discoveries, LLC A subsidiary of Mars, Incorporated Hackettstown, NJ 07840-1503 USA Item #3265D Each 18 oz box of mislabeled Fruit Collection contains two clear 8 oz… (65956) | Dove Chocolate Discoveries Llc | Food | Class I | 1 |
| 9 Aug 2013 | Potter's Crackers, Classic White, Net Wt 5 ounces, UPC 6 80569 15877 2, Potters Fine Foods LLC, 100 S. Baldwin, Madison WI 53703., Ingredients, Wheat Flour, Milk, Butter, Cracked Wheat, Sugar, Crystal Salt, Baking Powder, Black Pepper. Allergen Information: wheat, dairy & tree nuts. (66018) | Potters Fine Foods, LLC | Food | Class III | 1 |
| 8 Aug 2013 | Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics. | Philips Healthcare Inc. | Device | Class II | 1 |
| 8 Aug 2013 | K EFFERVESCENT TABLETS, 25 meq POTASSIUM (977 mg), ORANGE FLAVORED, Potassium Bicarbonate Effervescent Tablets For Oral Solution, Rx only, 30 count, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, Manufactured by: Tower Laboratories Ltd., Centerbrook, CT 06409 | Qualitest Pharmaceuticals | Drug | Class II | 2 |
| 8 Aug 2013 | Frozen dough balls are sold under brand name Winco or Tasty Bake: Item # 04018 is 17 oz wheat dough ball, Winco brand, individually wrapped in plastic bag with label for retail use, UPC 0 31693 04018 9; Item # 00518 is 17 oz white dough ball, Winco brand, individually wrapped in plastic bag with label for retail use,… (66005) | Tasty Bake Inc | Food | Class II | 1 |
| 7 Aug 2013 | GE Ultrasound ViewPoint 6. Product Usage: ViewPoint is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images and generation of medical reports primarily for diagnostic… | GE Healthcare, LLC | Device | Class II | 1 |
| 7 Aug 2013 | E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar… | Megadyne Medical Products, Inc. | Device | Class II | 1 |
| 6 Aug 2013 | BIORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture; Part Number: 72200775 Biodegradable suture anchor | Smith & Nephew, Inc. Endoscopy Division | Device | Class II | 26 |
| 6 Aug 2013 | Propranolol Hydrochloride Tablets, USP, 10 mg, Rx Only, 1000 count bottles, Manufactured in Czech Republic by: Teva Czech Industries, sro, Opava komanov, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 50111-467-03 | Teva Pharmaceuticals USA, Inc. | Drug | Class II | 1 |
| 6 Aug 2013 | Benefiber, Fiber plus Calcium Supplement, Wild Berry Chewables 90ct, sugar free, chewable tablets bottle. Novartis Consumer Health, Inc, Parsippany, NJ. | Novartis Consumer Health | Food | Class III | 5 |
| 5 Aug 2013 | Outlook Safety Infusion System Burette Set. For intravenous fluid administration. | B. Braun Medical, Inc. | Device | Class II | 1 |
| 5 Aug 2013 | 3M Scotchcast, Wet or Dry Cast Padding, Catalog Numbers WDP2, WDP3, WDP4, and WDP6. Intended for use in constructing casts for either wet or dry immobilization. | 3M Company - Health Care Business | Device | Class II | 1 |
| 5 Aug 2013 | 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and… (65913) | 3M Company/3m Espe Dental Products | Device | Class II | 1 |
| 5 Aug 2013 | Cardboard BIN LABEL: 03808 LOT #: 09000101, MELON CANTALOUPE..., 80-90 CT , 07/22/13 cantaloupes themselves are not labeled. (65910) | Heeren Bros Inc | Food | Class I | 1 |
| 5 Aug 2013 | "***Que sos VACA NEGRA***CAP AEZ***Libre DE Lactose y Hormona R-BST***Quesos Vaca Negra, Carr 492 km 0.1, Hatillo, PR***" (65899) | Quesos Vaca Negra, Inc. | Food | Class III | 1 |
| 2 Aug 2013 | Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures | Villa Radiology Systems LLC | Device | Class II | 1 |
| 2 Aug 2013 | Chunky Spinach Artichoke and Parmesan Dip: Gluten Free, Trans Fat Free. Net WT. 10 oz., (.625 lb,284g Made with real cream cheese. Plastic square tub La Terra Fina Union City, CA 94587 (65873) | La Terra Fina USA, Inc. | Food | Class III | 1 |
| 1 Aug 2013 | NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images. | Nidek Inc | Device | Class II | 1 |
| 1 Aug 2013 | 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the glenoid, or damaging the glenoid. Pulling the… | Zimmer, Inc. | Device | Class II | 1 |
| 1 Aug 2013 | Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Vial, Rx only, Manufactured in the USA for Nexus Pharmaceuticals Inc, Lincolnshire, IL 60069, NDC 14789-300-02 (65853) | Nexus Pharmaceuticals Inc | Drug | Class II | 1 |
| 1 Aug 2013 | Baltic Sprats in Spicy Brine Net Wt. 15.8 oz. Prod. of Latvia Distributed by Zip International Group LLC 160 Raritan Center Parkway Unit #6 Edison NJ 08837 T 732-225-3600 UPC 4750217602547 | Zip International Group LLC. | Food | Class I | 1 |
| 31 Jul 2013 | VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach. (65999) | Spine Smith Holdings, LLC | Device | Class II | 1 |
| 31 Jul 2013 | Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irradiation: The Peripheral Cutting Balloon Catheters are indicated for Percutaneous Transluminal Angioplasty (PTA) of obstructive lesions of synthetic or native arteriovenous dialysis fistulae. 1) 4.00mm x 15mm Small Peripheral Cutting BalloonTM… | Boston Scientific Corporation | Device | Class II | 2 |
| 31 Jul 2013 | "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 31 Jul 2013 | Morbier Les 3 Comtois, 11 lb. wheel; packaged in a cardboard case; one per case; refrigerated (65872) | Les 3 Comtois | Food | Class I | 1 |
| 30 Jul 2013 | ADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: ADVIA Chemistry A1c_3 Calibrators Shipping or unit package: Level 1: 2 x 0.5 g; Level 2: 2 x 0.5 g; Level 3: 2 x 0.5 g; Level 4: 2 x 0.5 g -- Siemens Healthcare Diagnostics, Inc. Tarrytown, NY 10591 --- System Information: The… | Siemens Healthcare Diagnostics | Device | Class II | 1 |
| 30 Jul 2013 | Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product Usage: Intended for fixation of complex intra-and extra-articular fractures and osteotomies of the distal radius and other small bones. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 30 Jul 2013 | ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: Comminuted fractures,… | Zimmer, Inc. | Device | Class II | 1 |
| 30 Jul 2013 | Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, nonpyrogenic, Product of Ireland Stryker Injectable Cement is a self-setting, calcium phosphate cement intended for… (65787) | Individual firm, name withheld | Device | Class II | 1 |
| 29 Jul 2013 | Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The… | GE Healthcare, LLC | Device | Class II | 1 |
| 29 Jul 2013 | SARKEN STAT! Multi-Drug Test Panel Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing) . | Sarken, Inc. | Device | Class II | 6 |
| 26 Jul 2013 | SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI | Beacon Hill Medical Pharmacy, P.C. | Drug | Class II | 86 |
| 26 Jul 2013 | Trois Comtois Morbier Cheese labeled as follows: Morbier Raw Milk PLU 293358; Morbier AOC Le Trois PLU 293608; Morbier Raw Milk French Cheese PLU 293358; and Morbier Les Trois Comtois PLU 293608, Whole Foods Market | Whole Foods Market | Food | Class I | 1 |
| 25 Jul 2013 | KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The… | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 25 Jul 2013 | ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 4 |
| 25 Jul 2013 | STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices. | Advanced Sterilization Products | Device | Class II | 1 |
| 25 Jul 2013 | Tortillas Lupita Flour Tortillas, Net Wt. 23oz, Manufactured By Tortilleria Lupita, 235 SW 25th St., Oklahoma City, OK 73109 (65811) | Tortilleria Lupita, Inc. | Food | Class II | 1 |
| 25 Jul 2013 | THRIVE 6 Grain Pancake Mix; There are two unit sizes: (1) 4 lb. #10/gallon can (6.03x 7.02 ) (the "Gallon Cans"); and (2) 1.17 lb. Pull-Top Pantry Cans (4.01x 5.08 ) (the "Pantry Cans"). Both units are packaged in metal cans. The Pantry Can has a metal pull-top lid and the Gallon Can has a metal lid that must be… (66003) | Thrive Foods LLC | Food | Class III | 1 |
| 22 Jul 2013 | Mc Kesson Anesthesia-Rx Model Number 8.0.2 & 8.0.1 with RapiDispense Product Usage: Automated anesthesia cart that monitors and controls the dispensing of medications, narcotics and supplies during surgical procedures. | MCKESSON TECHNOLOGIES INC | Device | Class II | 1 |
| 22 Jul 2013 | New Sun JLB Combination, Dietary Supplement, 100 capsule bottle, New Sun, Inc., Hendersonville, NC 1-800-544-0777 www.newsun.net Product No. 78-1 | New Sun Inc | Food | Class II | 2 |
| 19 Jul 2013 | ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis… | Instrumentation Laboratory Co. | Device | Class II | 7 |
| 19 Jul 2013 | Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. | Micro Therapeutics Inc, Dba Ev3 Neurovascular | Device | Class II | 1 |
| 18 Jul 2013 | PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 and Tabletop 550TxT, TT-S s/n 1001-1083. Product Usage: The intended use of the SIEMENS branded, ARTISTE , ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 17 Jul 2013 | Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery. | Integra Limited | Device | Class II | 1 |
| 17 Jul 2013 | Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: This product is indicated for use in the extracorporeal circuit during cardiopulmonary surgery. | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 3 |
| 17 Jul 2013 | Frozen Hot Smoked Vacuum Packed Salmon (65767) | Mike's Quality Meats, Inc. | Food | Class II | 1 |
| 16 Jul 2013 | BRAINLAB; FRAMELESS SRS QA TARGET POINTER Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or radiotherapy procedures. The Frameless Radiosurgery Components are a device used for fixation, localization and… | Brainlab AG | Device | Class II | 1 |
| 16 Jul 2013 | TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0142/12, Stem size 00, prox. Stem dia. 12 mm, Length 210 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg | Waldemar Link GmbH & Co. KG (Corp. Hq.) | Device | Class II | 21 |
| 16 Jul 2013 | DiaScreen Liquid Urine Controls: Positive and Negative Assayed Liquid Quality Controls for use with Dipsticks in Routine Urinalysis; Product Number D76004 (4x12 mL bottles) consists of: 2x12mL Positive controls [and] 2x12mL Negative controls; Manufactured for ARKRAY USA, Inc.; Minneapolis, MN 55439 Diascreen liquid… | Assuramed | Device | Class II | 3 |
| 15 Jul 2013 | HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue… | HemoCue AB | Device | Class II | 1 |
| 15 Jul 2013 | DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only 6) REF 28-0212H… | DeRoyal Industries Inc | Device | Class II | 1 |
| 15 Jul 2013 | El Basham Weight 400 g Ingredients: Natural Apricot Juice, Glucose, Sugar, Oil. Made by: For the Owner of the Trade Mark ABU Ode h Bros Co. Amok St. Aman -Jordan Tel +962 6 4914961 Fax +962 6 4907878 Remaining information is in Arabic. (66035) | Greenland Trading Corp | Food | Class III | 1 |
| 12 Jul 2013 | Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It… | Ormco/Sybronendo | Device | Class II | 1 |
| 12 Jul 2013 | OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution containing MgCl2 (80 ¿M) and KCL (300 ¿M. 10.0ml.) PN: 50003300; Store at d - 15¿C. Product Usage: General Purpose Reagent for laboratory use. (65874) | Celera Corporation | Device | Class III | 1 |
| 10 Jul 2013 | Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by Medical Indicators from 3M) and labeling in 806,… (65905) | Medical Indicators, Inc. | Device | Class II | 1 |
| 10 Jul 2013 | BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood. | Becton Dickinson & Company | Device | Class II | 1 |
| 9 Jul 2013 | Liquid Yeast Cream, Bulk, in tanker truck quantities, refrigerated 33F-45F (65901) | American Yeast Corporation | Food | Class II | 1 |
| 8 Jul 2013 | Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 8 Jul 2013 | PrepStain AG. For use in the screening and detection of cervical cancer. | Becton Dickinson & Co. | Device | Class II | 3 |
| 5 Jul 2013 | Brilliance CT 6, M/N 728256; Brilliance CT 16 M/N 728246; Brilliance CT 40, M/N 728235 & Brilliance CT 64 M/N 728231, Philips Healthcare, Cleveland, OH 44143. Intended to produce cross-sectional images of the body by computer reconstruction. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 2 Jul 2013 | Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 28 Jun 2013 | Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. | Alphatec Spine, Inc. | Device | Class II | 1 |
| 26 Jun 2013 | ADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 120 is a hematology system that utilizes the principles of flow cytometry in order to provide complete blood counts. | Siemens Healthcare Diagnostics | Device | Class II | 1 |
| 26 Jun 2013 | PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits; For in vitro… | Siemens Healthcare Diagnostics | Device | Class II | 1 |
| 24 Jun 2013 | SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions. | Stelkast Co | Device | Class II | 1 |
| 21 Jun 2013 | LeGoo¿ Endovascular Occlusion Gel-0.25 mL LeGoo with 3 Cannula Pouch Product Number: CS-25 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary… | Genzyme Corporation, A Sanofi Company | Device | Class II | 18 |
| 19 Jun 2013 | GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the… | GE Healthcare, LLC | Device | Class II | 1 |
| 19 Jun 2013 | Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. In vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 19 Jun 2013 | Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant. | Zimmer, Inc. | Device | Class II | 5 |
| 17 Jun 2013 | ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9. (65484) | Advance Pharmaceutical Inc | Drug | Class I | 1 |
| 11 Jun 2013 | Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York | Bethel Nutritional Consulting, Inc | Drug | Class I | 1 |
| 10 Jun 2013 | Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: 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 loading… | Biomet 3i, LLC | Device | Class II | 2 |
| 7 Jun 2013 | 1) terrafina Natural Roasted Salted Pistachios, Net wt. 2.25 oz(63g) UPC 847938032112, 2) terrafina Natural Roasted Salted Pistachios, Net wt. 10 oz (283g) UPC 8497938103218, 3) terrafina Natural California Salted Pistachios, Net wt. 13 oz (368g) UPC 847938063215, 4) terrafina Natural California Salted Pistachios,… | Terrafina | Food | Class I | 2 |
| 6 Jun 2013 | AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed growth pattern, however, this category is… (66110) | Sybron Dental Specialties | Device | Class II | 1 |
| 31 May 2013 | Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 25 May 2013 | Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50 | Fresenius Kabi USA, LLC | Drug | Class I | 1 |
| 18 May 2013 | Tres Leches cake sold under the following brand names: 1) "****Tres Leches***Postres D'Aqui***D'Aqui Manufacturing Products Corp***Peso Neto 3oz***"; 2) "****Tres Leches***Fresh Star***Distribuido por Karelly's Food***PO Box 634 Sabana Seca PR 00952***Peso Neto 3 oz***" (65699) | D'Aqui Manufacturing Products, Corp., Dba Postres de Aqui | Food | Class II | 1 |
| 17 May 2013 | Butter (salted). 8oz round clear plastic tub and 5 gallon pail. UPC Code 7 93573 09802 3. (65325) | Contoocook Creamery | Food | Class II | 1 |
| 14 May 2013 | StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients. (65968) | Spine Wave, Inc. | Device | Class II | 1 |
| 13 May 2013 | HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests. | Life Technologies Corporation | Device | Class II | 1 |
| 10 May 2013 | Responder 5 is a nurse call communication system that connects patients with staff in a hospital. The nurse call system also connects team members and departments from radiology, physical therapy, transport, environmental services and more. Responder 5 is used in hospitals and long term patient care facilities to… (65657) | Rauland-Borg Corp | Device | Class II | 1 |
| 1 May 2013 | SexVoltz All Natural Herbal Supplement, packaged in 1 & 2 capsule blister packs and 4, 10 and 12 capsule bottles, Manufactured For: BeaMonstar Products, Queen Creek, AZ | Beamonstar Products | Drug | Class I | 2 |
| 26 Apr 2013 | Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 26 Apr 2013 | Nature's Earthly Choice Organic Quinoa Distributed by Nature's Earthly Choice Eagle, ID 83616 Product of Bolivia a) Net Wt 2 lbs. - UPC 897034002267 b) Net Wt 4 lbs.- UPC 897034002021 packaged in re-sealable bags (66002) | Global Juices & Fruits LLC | Food | Class III | 1 |
| 18 Apr 2013 | Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 17 Apr 2013 | CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures. | DePuy Spine, Inc. | Device | Class II | 3 |
| 17 Apr 2013 | Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across… (64965) | Xlumena, Inc. | Device | Class II | 1 |
| 3 Apr 2013 | GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. | GE Healthcare, LLC | Device | Class II | 3 |
| 1 Apr 2013 | 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction… (65080) | Fresenius Medical Care Holdings, Inc. dba Renal Solutions | Device | Class II | 1 |
| 25 Mar 2013 | Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing. | Remel Inc | Device | Class III | 1 |
| 11 Mar 2013 | Avastin, (0.05 ml, 1.25 mg/0.05ml), single unit dose syringes, Clinical Specialties Compounding Pharmacy, Augusta, GA (65253) | Clinical Specialties Compounding Pharmacy | Drug | Class II | 1 |
| 14 Feb 2013 | Garbanzo Iced Lemon Grass Ginger Tea 3 oz foil portion packs | Custom Co-Pak, LLC | Food | Class II | 2 |
| 13 Feb 2013 | ebA*(TM) Multivitamin Supplement, 180 tablets in plastic bottles, Distributed by Saratoga Therapeutics, LLC, North Wales, PA. (65032) | Saratoga Therapeutics, LLC | Food | Class I | 1 |
| 5 Feb 2013 | SpineNet Anterior Cervical Cage, Lordotic, Peek (originally submitted as Daytona Anterior Cervical Cage) Product Usage: Is indicated for use in skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level (65917) | SpineNet | Device | Class II | 1 |
| 4 Feb 2013 | SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow. (65914) | SpineNet | Device | Class II | 1 |
| 18 Dec 2012 | Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment. | Leica Microsystems (Schweiz) Ag | Device | Class II | 2 |
| 5 Dec 2012 | Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and… | B Braun Medical, Inc. | Device | Class II | 1 |
| 30 Nov 2012 | Chocolate covered raisinsin 4 oz flexible bags labeled in part "***Pennsylvania Dutch Candies***Chocolate Covered Raisins***NET WT 4 OZ (113g)***Packed for Pennsylvania Dutch Candies Camp Hill, PA***Manufactured In A Facility That Also Processes Peanuts***". (63799) | The Warrell Corporation | Food | Class I | 1 |
| 14 Nov 2012 | Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and… | B Braun Medical, Inc. | Device | Class I | 1 |
| 7 Nov 2012 | Clinical LIVE Dietary Supplement Immune Support 694.325 mg 90 capsules Distributed by Reaction Nutrition, LLC., Carnegie, PA. (65982) | Reaction Nutrition LLC | Food | Class I | 1 |
| 2 Nov 2012 | Synthes Trauma Nail System. The devices are indication for bone fixation. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 31 Oct 2012 | Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and… | B Braun Medical, Inc. | Device | Class II | 1 |
| 24 Oct 2012 | Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid container is lower than the pump), and… | B Braun Medical, Inc. | Device | Class II | 1 |
| 20 Sep 2012 | GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality… | GE Healthcare, LLC | Device | Class II | 1 |
| 31 Aug 2012 | 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23 | Hospira Inc. | Drug | Class I | 1 |
| 19 Jul 2012 | Laserworld RGB & Piko Nano RGB Models All models are laser light show projectors, and will be used as such. (62624) | Laserworld Usa Inc | Device | Class II | 1 |
| 12 Jul 2012 | GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient… | GE Healthcare, LLC | Device | Class II | 1 |
| 6 Jul 2012 | Round Fresh Tomatoes sold in bulk boxes, 20 lbs (62529) | Combs Produce | Food | Class II | 1 |
| 16 Apr 2012 | OPERON D850 Surgical Table Product Usage: Surgical Table | Berchtold Corp. | Device | Class II | 1 |
| 27 Mar 2012 | GE Healthcare, Advantage Workstation, READY View Application. Image analysis software. | GE Healthcare, LLC | Device | Class II | 1 |
| 20 Jul 2011 | GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility. | GE Healthcare, LLC | Device | Class II | 1 |
| 1 May 2011 | Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the… (66046) | Cardiogenesis Corporation | Device | Class II | 1 |
| 12 Jun 2008 | Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS, N750-BMKXT-FS, N750-BMKLT-FS, N750-DIS-FS, N750-DISXT-FS. Product Usage: Usage: The Benchmark product lines are intended to automatically stain histological or cytological specimens on microscope slides with specific immunohistochemistry or in situ… | Ventana Medical Systems Inc | Device | Class II | 1 |
| 29 Oct 2007 | Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000 | Respironics California Inc | Device | Class II | 1 |