| 11 Nov 2014 | White and Wild Medley/Garden Vegetable 12/36 oz; Product number 10410. Product contains 4 oz. plastic bags of Garden Vegetable Seasoning mix: Ingredients; Maltodextrin, Dehydrated Onion, Dehydrated carrots, Hydrolyzed Corn Protein, Sun-Dried Tomato, Salt, Autolyzed Yeast Extract, Sugar. contains 2%$ of less of each… | InHarvest, Inc. | Food | Class I | 5 |
| 10 Nov 2014 | InHarvest Garden Vegetable Seasoning, Item 61104, Net Wt 4 oz. | Karlsburger Foods, Inc. | Food | Class I | 1 |
| 7 Nov 2014 | Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured by Hospira, Inc. Lake Forest, IL 60045, NDC 0409-6533-01. | Hospira Inc. | Drug | Class III | 1 |
| 6 Nov 2014 | Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model… | Fisher & Paykel Healthcare, Ltd. | Device | Class II | 1 |
| 3 Nov 2014 | MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. | Elekta, Inc. | Device | Class II | 1 |
| 3 Nov 2014 | Pride of Africa brand Semo "Semolina", Net Wt. 5 lb., UPC 016712016918 --- A Product of Raymond-Hadley Corp. Spencer, NY 14883 1-800-252-5220 | Raymond-Hadley Corp. | Food | Class II | 2 |
| 2 Nov 2014 | Wawa Garden Rotini Salad with Lite Creamy Caesar Dressing, Net Wt 8 oz. (227 g) Bottom of container - Wawa Kale & Quinoa Salad Distributed by: Wawa, Inc. Wawa, PA 19063 UPC 726191066402 Event 69661 | Taylor Farms New Jersey, NJ | Food | Class I | 1 |
| 31 Oct 2014 | CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. | Accuray Incorporated | Device | Class II | 1 |
| 31 Oct 2014 | Avocado label: Unity Groves Avocados # 4221 Born in the USA Box label: Pride of the Redlands brand 32ct Green skin avocados, packaged in 1/2 BU Box Event 69664 | Unity Groves Corporation | Food | Class I | 1 |
| 30 Oct 2014 | Avocados packed in a brown cardboard box with green print. Unity Groves Pride of the Redlands Florida Avocados 25399 SW 157 Ave Homestead, FL 33031 Event 69647 | Latin Specialties, Inc | Food | Class I | 1 |
| 29 Oct 2014 | 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur | Synthes, Inc. | Device | Class II | 1 |
| 29 Oct 2014 | Mt. Olive, Kosher Dill Chips in 1 gallon glass jars, UPC 09300 12841, Mt. Olive, Corner of Cucumber & Vine, P.O. Box 609, Mt Olive, NC 28365-0609. Event 69641 | Mt. Olive Pickle Company Inc | Food | Class II | 1 |
| 29 Oct 2014 | Taro Toast, Net Wt 20 oz.. (1.25 lb) 99 Ranch Market 338 Barber Ln, Milpitas, CA 95035 | Welcome Market Inc | Food | Class I | 11 |
| 27 Oct 2014 | Saxon Creamery Greenfields Monastery Washed Rind Wisconsin Handcrafted Cheese, 7 lb wheel. Ingredients: Pasteurized Cow's Milk, culture, salt, enzymes, contains milk. Keep Refrigerated. Event 69639 | Saxon Cheese, LLC | Food | Class II | 1 |
| 26 Oct 2014 | Whole Foods Vegan Gingersnap Cookies, 6pk (10-oz), packaged in flexible plastic with twist tie | Whole Food Market | Food | Class I | 1 |
| 24 Oct 2014 | Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the humeral head. | Integra LifeSciences Corp. | Device | Class II | 1 |
| 24 Oct 2014 | Lundberg Rice Chips (Croustilles de Riz), Sea Salt (Sel Marin) 6 oz. (170 g) package; Wheat Free, Gluten Free (Sans Ble, Sans Gluten); US product number: F11070; Canadian Product number: F11160. Ingredient: Organic Whole Grain Brown Rice, Organic Rice Flour (Organic Whole Brown Rice Flour, Organic Rice Flour),… | Wehah Farms | Food | Class I | 1 |
| 24 Oct 2014 | Exotic Superfoods 100% Raw Young Thai Coconut Water, 32 oz. SKU: 7 05105 50171 0 Exotic Superfoods 100% Raw Young Thai Coconut Water, 11.7 oz. SKU: 7 05105 50161 1 Description of the Product: - 32 oz (1 quart): - The product is consumed in individual clear plastic bottles. - Each bottle has a white label. - There are… Event 69643 | Exotic Superfoods New York, Inc. | Food | Class II | 1 |
| 22 Oct 2014 | Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Event 69572 | Prometheus Laboratories Inc. | Drug | Class II | 1 |
| 21 Oct 2014 | The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants. | Medacta Usa | Device | Class II | 1 |
| 21 Oct 2014 | Carbamazepine Tablets USP, 200 mg, 1000 Tablets per Bottle, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 26110 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4005-3. | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class III | 1 |
| 21 Oct 2014 | Bulk packed Wheat Cheese Calzone 48 Servings KEEP FROZEN NET WEIGHT 15.00 lbs Inspected By The U.S. Dept of Agriculture Distributed by: Giorgio Foods, Inc., PO Box 96, Temple, PA 19560 Manufactured 3/27/2014 Best by 3/27/2015 Product 8512 Lot 14086 Event 69591 | Giorgio Foods Inc | Food | Class II | 1 |
| 21 Oct 2014 | Vanilla Pro-Med. 100, Vanilla Pro, High Protein Instant Shake, Net Weight .0935 oz, Distributed by Our Life Health, Savannah, GA Event 69559 | Health Wise | Food | Class II | 1 |
| 21 Oct 2014 | Raw Serrano Peppers packed in white cardboard box with label reading: John Vena, Inc. Serrano 5 lb Product of Mexico Packed by John Vena, Inc. Philadelphia, PA 19153 101570 or 101619 Event 69571 | John Vena, Inc. | Food | Class I | 1 |
| 20 Oct 2014 | IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE Systems Analyzers — for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in the diagnosis and treatment of diseases… | Siemens Healthcare Diagnostics, Inc. | Device | Class III | 1 |
| 20 Oct 2014 | Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, Powder, NET: 22 KG, Packaged in double plastic liners in a single fiber carton, FOR MANUFACTURING, PROCESSING OR REPACKING, BASF Corporation, Florham Park, NJ Event 69611 | Nanophase Technologies Corporation | Drug | Class III | 1 |
| 20 Oct 2014 | Bailey Farms, Fresh Serrano Chile Peppers, Oxford, NC 27565. Event 69623 | Bailey Farms, Inc. | Food | Class I | 1 |
| 20 Oct 2014 | Serrano Chili, 38 lbs. Event 69543 | Pacific Sun Distributing | Food | Class I | 1 |
| 19 Oct 2014 | ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603. | Biosense Webster, Inc. | Device | Class II | 1 |
| 17 Oct 2014 | Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 17 Oct 2014 | Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli. | Siemens Healthcare Diagnostics, Inc. | Device | Class I | 2 |
| 17 Oct 2014 | Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella. | Remel Inc | Device | Class II | 1 |
| 17 Oct 2014 | Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36 Event 69569 | Obagi Medical Products | Drug | Class II | 1 |
| 17 Oct 2014 | M & M brand Number 2 Florida Avocados, packed in 50 lb cardboard boxes Event 69606 | M & M Farm Inc. | Food | Class I | 1 |
| 16 Oct 2014 | Etest Ceftaroline (CPT32) WW B30. Etest (Antimicrobial Susceptibility Testing) is a quantitative technique for determining the antimicrobial susceptibility of Gram negative and Gram positive aerobic bacteria. | Biomerieux | Device | Class III | 5 |
| 16 Oct 2014 | Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, Rx ONLY, Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-4788-10 | Pharmaceutical Associates Inc | Drug | Class II | 1 |
| 16 Oct 2014 | Candesartan Cilexetil Tablets, 4 mg, 30-count bottle, Rx Only, Manufactured by Apotex Research Pvt. Ltd., Bangalore- 560 099, India, Manufactured for Apotex Corp., Weston, FL 33326, NDC 60505-3618-3 | Apotex Inc. | Drug | Class III | 4 |
| 16 Oct 2014 | The Market Basket Asian 7 Rice Cracker Mix Net Wt. 12 oz. (340 g) Distributed by Demondas Supermarkets, Inc. Tewksbury, MA 01876 UPC # 04970540898 | United Natural Trading | Food | Class II | 2 |
| 16 Oct 2014 | Publix Asian Mix, 14 oz. clamshell containers Event 69520 | Publix Bakery Plant | Food | Class II | 1 |
| 15 Oct 2014 | ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 15 Oct 2014 | NEW HOPE MILLS GLUTEN FREE CHIA PANCAKE & WAFFLE MIX, NET WT 16 OZ (1 LB) 454g, UPC 074703530126. Packed as 8 units per carton. Each unit is held within a red and white front box. Made in the USA. | New Hope Mills Mfg., Inc. | Food | Class I | 1 |
| 15 Oct 2014 | Saba Shark Cartilage Complex Dietary Supplement, 500 mg, 60 Capsules, Distributed by Saba 711 NE 39th Street, Oklahoma City, OK 73105 Event 69498 | AMS Health Sciences | Food | Class I | 1 |
| 15 Oct 2014 | Strawberry flavored gelatin mix desert | U.B.C Food Distributors, LLC | Food | Class II | 2 |
| 14 Oct 2014 | St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 | St Jude Medical | Device | Class II | 1 |
| 14 Oct 2014 | GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY, H3000WZ, H3000YF, H3000YG, H3000YM,… | GE Healthcare, LLC | Device | Class II | 6 |
| 14 Oct 2014 | Organic Steam Treated Ginger Tea Bag Cut Item number 1641 USDA Organic Net Weight: 30 lbs. . High Quality Organics Reno, NV 89506 | High Quality Organics, Inc. | Food | Class I | 1 |
| 14 Oct 2014 | Herbally Grounded Hello Blossom 120 ct Vegetarian Capsule Formula, bottle in 20cc food grade amber glass bottle. Manufacturer: Herbally Grounded LLC., Curtiss Harris 7023640090 3744 W. Meade Ave. Ste. 11a Las Vegas, NV 89102 | Herb Garden Productions | Food | Class I | 3 |
| 13 Oct 2014 | Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K Event 69488 | Name withheld | Device | Class II | 1 |
| 10 Oct 2014 | Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory. Event 69487 | Silver Star Brands | Device | Class II | 1 |
| 10 Oct 2014 | Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 10 Oct 2014 | The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. | Steris Corporation | Device | Class II | 1 |
| 10 Oct 2014 | AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures through the glans to place the AM3-700… | American Medical Systems, Inc. | Device | Class II | 1 |
| 10 Oct 2014 | Assured Naproxen Sodium Tablets, USP 220 mg., 15 count bottle, Repackaged by Contract Packaging Resources, Inc 8009 Industrial Village Road Greensboro, NC 27409 Distributed by Greenbrier International, Inc Chesapeake, VA 23320 Event 69554 | Contract Packaging Resources Inc. | Drug | Class II | 1 |
| 10 Oct 2014 | TORISEL Kit (temsirolimus) injection, 25 mg/mL, 1 vial of TORISEL 25 mg/mL and 1 vial of 2.2 mL DILUENT per carton, Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101; Diluent – MADE IN ITALY; NDC 0008-1179-01. | Pfizer Inc. | Drug | Class III | 1 |
| 10 Oct 2014 | 365 Organic Raisin Granola in 17 ounce (482 gram) cardboard cartons; 12 cartons per case. UPC: 099482448738 | Whole Foods Market Brand 365, Llc | Food | Class II | 1 |
| 9 Oct 2014 | MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 9 Oct 2014 | TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system. | Trumpf Medical Systems, Inc. | Device | Class II | 1 |
| 9 Oct 2014 | Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System Event 69463 | Cynosure, Inc. | Device | Class II | 1 |
| 9 Oct 2014 | Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: “ Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. “ Collagen disorders, and/or avascular necrosis of the femoral condyle. “ Post-traumatic loss of joint… | Zimmer, Inc. | Device | Class II | 1 |
| 9 Oct 2014 | GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540 | Micro Labs Usa, Inc S | Drug | Class II | 1 |
| 9 Oct 2014 | Williams Sonoma Pumpkin Seed Pesto 8 oz. glass jar Event 69481 | California Olive and Vine, LLC | Food | Class II | 1 |
| 8 Oct 2014 | Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct ventriculotomy with entry into the left atrium… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 8 Oct 2014 | Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 2 |
| 8 Oct 2014 | Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects. | Davol, Inc., Subs. C. R. Bard, Inc. | Device | Class II | 1 |
| 8 Oct 2014 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972-02. 0555-0972-02, lot #s 34016373A, 34016377A, exp. dated 7/2016. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 8 Oct 2014 | Mexican Cheddar Dip 10oz non-flex plastic, distributed by Taylor Farms Salinas, CA 93902. The label will show UPC 0 3022300960 9 or UPC 0 30223 00952 8 | Real Foods of Seattle, LLC | Food | Class I | 1 |
| 7 Oct 2014 | Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle, shaft and basket. It is intended to use in… | C.R. Bard, Inc. | Device | Class II | 1 |
| 6 Oct 2014 | Access 2 Immunoassay Systems, Catalog No. 81600N, 386220, Instructions for Use Part No. B14253A. Product Usage: The Access 2 Immunoassay system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. | Beckman Coulter Inc. | Device | Class II | 2 |
| 6 Oct 2014 | UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical… | Zimmer Surgical Inc | Device | Class II | 1 |
| 6 Oct 2014 | ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur, Centaur XP, Centaur CP Systems; Catalog Numbers: Cat No. 02816138/SMN 10309044 (100 test) 02816634/SMN 10309045 (500 test) | Siemens Healthcare Diagnostics, Inc | Device | Class III | 1 |
| 6 Oct 2014 | Laksell Gamma Knife Perfexion | Elekta, Inc. | Device | Class II | 1 |
| 6 Oct 2014 | ALPROSTADIL, 10 mcg/mL, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070. | Oregon Compounding Centers, Inc. dba Creative Compounds | Drug | Class II | 56 |
| 6 Oct 2014 | JINGA brand PANFRIED ANCHOVY(S), NET WT. 2 oz. and 4 oz., KEEP REFRIGERATED -- JINGA 44-28 55TH AVE., MASPETH, NY 11378 --- The product is packaged in clear, hard plastic containers. Event 69435 | H. A. R. Maspeth Corp. | Food | Class I | 1 |
| 6 Oct 2014 | Fiesta Breakfast Scramble, Product # 73EN510. Net Weight 11.4 lbs. 24 - 7.60 oz. portions. Keep Frozen. For Institutional Use Only. Production Facility Buddy's Kitchen, Inc., Burnsville, MN 55337 Event 69453 | Buddy's Kitchen, Inc. | Food | Class II | 1 |
| 3 Oct 2014 | SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the brain. The NeuroBlate System… | Monteris Medical Corp | Device | Class II | 2 |
| 3 Oct 2014 | OEC UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures | GE OEC Medical Systems, Inc | Device | Class II | 4 |
| 3 Oct 2014 | CVS pharmacy, Pain Relieving Antiseptic Spray. Benzalkonium Cl 0.13% Lidocaine HCl 2.5% 5 FL OZ (148 mL), OTC, Distributed by CVS Pharmacy, Inc., Woonsocket RI 02895 NDC 68093-6150-1 Event 69497 | Wisconsin Pharmacal Company | Drug | Class II | 1 |
| 2 Oct 2014 | VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured for VersaPharm Incorporated Marietta, GA 30065-1509 Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 61748-011-01 | West-Ward Pharmaceutical Corp. | Drug | Class II | 1 |
| 2 Oct 2014 | Family Gourmet Long Grain Enriched White Rice in 32 oz. clear plastic bags (SKU: 1218898) and 80 oz. clear plastic bag (SKU: 1218870). Event 69544 | Name withheld | Food | Class III | 1 |
| 1 Oct 2014 | APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna. Event 69433 | Medartis, Inc. | Device | Class II | 1 |
| 1 Oct 2014 | IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient. Event 69265 | IMRIS Inc | Device | Class II | 1 |
| 1 Oct 2014 | Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as… | Zimmer Dental Inc | Device | Class II | 2 |
| 1 Oct 2014 | Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations. | Nellcor Puritan Bennett Inc. (dba Covidien LP) | Device | Class I | 1 |
| 1 Oct 2014 | Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. Transport Rollator is a wheeled rollator with an additional push bar… Event 69367 | Roscoe Medical Inc | Device | Class II | 1 |
| 1 Oct 2014 | Emtriva (emtricitabine) Oral Solution, 10 mg/mL, 170 mL bottles, Rx only, Manufactured for Gilead Sciences, Inc., Foster City, CA NDC 61958-0602-1 Gilead Sciences, Inc. Foster City, CA 94404. | Gilead Sciences, Inc. | Drug | Class II | 1 |
| 1 Oct 2014 | Salmon Chowder, sold under brand Heather's Choice. The product is labeled in parts: "***Salmon Chowder***HEATHER'S CHOICE***meals for adventuring***ingredients: salmon + peas + carrots + potatoes+ coconut milk powder***directions: cover food with hot water + let sit for 15 minutes***". | Heather's Choice | Food | Class II | 2 |
| 30 Sep 2014 | Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package: All Pulse Oximetry cables are shipped… | Masimo Corporation | Device | Class II | 1 |
| 30 Sep 2014 | CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary incontinence. This treatment option is a… | CooperSurgical, Inc. | Device | Class III | 2 |
| 30 Sep 2014 | Elk shaped pasta Ekologiska PASTA-ALGAR Pasta elks, organic NET WT 17.6 OZ (500 g) IKEA PRODUCED IN GERMANY FOR: IKEA FOOD SERVICES | Ikea North America Srvcs Inc | Food | Class II | 2 |
| 29 Sep 2014 | Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 29 Sep 2014 | CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory… | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 29 Sep 2014 | Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag. | Coloplast Manufacturing US, LLC | Device | Class II | 1 |
| 29 Sep 2014 | ***Oro Candy*** Vanilla Cookies (Mantecaditos) Nt. Wt. 3 oz. (85 g) Event 69410 | Oro Candy Distributors | Food | Class II | 1 |
| 26 Sep 2014 | Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for… | Cook Medical Incorporated | Device | Class II | 1 |
| 26 Sep 2014 | Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 26 Sep 2014 | Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 26 Sep 2014 | Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes. | Tecan US, Inc. | Device | Class II | 1 |
| 26 Sep 2014 | Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma Global Inc. Dubai, United Arab Emirates by Sun Pharmaceutical Industries Limited, Halol, India Event 69370 | Sun Pharma Global Inc. | Drug | Class II | 1 |
| 26 Sep 2014 | Cases of refrigerated Pillsbury Biscuits Buttermilk 4pk. (6 - 4pk / case) | General Mills, Inc. | Food | Class II | 2 |
| 25 Sep 2014 | COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological | Iba Dosimetry Gmbh | Device | Class II | 1 |
| 25 Sep 2014 | Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc. Event 69347 | Bausch & Lomb Inc- Greenville Solutions Plant | Device | Class II | 1 |
| 25 Sep 2014 | ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated for the treatment of insulin requiring… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 24 Sep 2014 | Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. Event 69400 | Joerns Healthcare | Device | Class II | 1 |
| 24 Sep 2014 | Straumann Bone Level Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021.4308 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are… | Straumann USA, LLC | Device | Class II | 1 |
| 24 Sep 2014 | siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diagnosis and treatment… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 24 Sep 2014 | Anti-Aging Naturals GENE STRENGTH Purple Longevity Dietary Supplement, 60 Vegetarian Capsules. Manufactured for Anti-Aging Naturals Venetia, Pennsylvania 15367 USA. | Formulations For Life | Food | Class II | 3 |
| 24 Sep 2014 | THE ORIGINAL SOUPMAN Lobster Bisque, Net Wt 17 oz (482 g). Product is packed as a tetra pak and ships as a pack of 12 or 6 containers per carton. Distributed exclusively by: SoupMan Inc. Staten Island, NY 10314 Event 69297 | Name withheld | Food | Class II | 1 |
| 23 Sep 2014 | Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 22 Sep 2014 | Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0. Event 69373 | C P Medical, Inc. | Device | Class II | 1 |
| 22 Sep 2014 | GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement. | Medacta Usa | Device | Class II | 1 |
| 22 Sep 2014 | LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540. NDC 42571-110-10 | Micro Labs Usa, Inc S | Drug | Class II | 1 |
| 22 Sep 2014 | CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun Pharmaceuticals, Fort Worth, TX 76155 and repackaged by Physicians Total Care, Inc., Tulsa, OK 74146-6233 | Physicians Total Care, Inc. | Drug | Class II | 1 |
| 20 Sep 2014 | Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs). | Trivascular, Inc | Device | Class I | 1 |
| 19 Sep 2014 | 1) Nature's Place Organic Campfire Trail Mix; Net. Wt. 12 oz. (340 g); Distributed by DZA Brands LLC 2110 Executive Drive Salisbury, NC 28147; UPC 725439951920 2) Nature's Promise Organic Campfire Trail Mix; Net. Wt. 12 oz. (340 g); Distributed by Foodhold USA LLC Landover, MD 20785; 1-877-846-9949; UPC 688267066092… | United Natural Trading | Food | Class II | 1 |
| 18 Sep 2014 | Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014 Event 69535 | Name withheld | Device | Class II | 1 |
| 17 Sep 2014 | ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue 6) which is added to make the lens more visible for handling. | Cooper Vision Caribbean Corp. | Device | Class III | 1 |
| 16 Sep 2014 | Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures. | Baxter Healthcare Corp | Device | Class I | 2 |
| 12 Sep 2014 | ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic use with the ADVIA Centaur systems) Catalog Number: 112748 (Siemens Material Number (SMN): 10310041 The Cleaning Solution is a component of the ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP instruments,… | Siemens Healthcare Diagnostics, Inc | Device | Class III | 1 |
| 12 Sep 2014 | Prescription eyeglass safety lenses. Vision correction Event 69345 | Eyemart Express Ltd | Device | Class II | 1 |
| 12 Sep 2014 | Oven Fresh Lemon Pound Cake, Net Wt. 5 oz., Oven Fresh Baking, LLC, 70 Clinton Road. Fairfield, NJ 07004, UPC 089595901145 Event 69556 | MASIERO BROS.INC | Food | Class III | 1 |
| 8 Sep 2014 | Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide… | Coloplast Manufacturing US, LLC | Device | Class III | 1 |
| 28 Aug 2014 | FLUOCINONIDE GEL USP, 0.05%, Rx only, For External Use Only, Not For Ophthalmic Use, a) NET WT 15 gram tubes and b) NET WT 60 grams tubes, E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0135-15 (15 g) and NDC 0168-0135-60 (60 g) | Fougera Pharmaceuticals Inc. | Drug | Class II | 1 |
| 27 Aug 2014 | Acetylcysteine 10% (PF) inhalant solution packaged in either a 3 mL or 7 mL vial, Martin Avenue Pharmacy, 1247 Rickert Dr, Naperville, IL. | Martin Avenue Pharmacy, Inc. | Drug | Class II | 118 |
| 27 Aug 2014 | Chiclets Assorted Variety Multipak - Fruit Flavor Gum, 6-10 piece packages (60 pieces), 6 PAK, Retail UPC 0 12546 10102 8; 2)Chiclets Assorted Variety Multipak - Fruit Flavor Gum, 7-6 PAK packages (420 pieces), Retail UPC 0 12546 0 | Mondelez Global Llc | Food | Class II | 5 |
| 26 Aug 2014 | Mama Tere Arepa de Chocolo Sweet Corn Patty 10.5 oz/300g 4 units Product of Colombia Importado Por: Family Food Distributors, Inc. 969 Newark Turnpike, Unit D, Kearny, NJ 07032 | Name withheld | Food | Class II | 3 |
| 25 Aug 2014 | Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4 | Actavis Inc | Drug | Class II | 2 |
| 19 Aug 2014 | Simvastatin Tablets, USP, 10 mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Princeton, NJ 08540, NDC 42571-010-90 | Micro Labs Usa, Inc S | Drug | Class III | 1 |
| 18 Aug 2014 | Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 | Integra LifeSciences Corp. | Device | Class II | 1 |
| 14 Aug 2014 | SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture. Event 69395 | Sam Medical Products | Device | Class II | 1 |
| 14 Aug 2014 | Dimension Vista HbA1c | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 13 Aug 2014 | Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy… | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 8 Aug 2014 | CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals Inc., Lexington, MA 02421, USA, NDC 67919-011-01 | Cubist Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 6 Aug 2014 | Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers. | Parker Laboratories, Inc. | Device | Class II | 1 |
| 22 Jul 2014 | Carob Supergreens Chunks of Energy (10# UPC 7-69270-10009-7); also, Carob Supergreens Chunks of Energy and Rave BItes Brand Carob Supergreens (7 oz UPC 7-69270-70008-8). | Dancing Star LLC | Food | Class I | 3 |
| 22 Jul 2014 | Lightly Roasted Organic Carob Powder, 1lb and 5lb bags Event 69507 | Z Natural Foods | Food | Class I | 1 |
| 18 Jul 2014 | Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568. | Spectrum Laboratory Products | Drug | Class II | 1 |
| 8 Jul 2014 | Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive… | Philips Medical Systems, Inc. | Device | Class II | 2 |
| 25 Jun 2014 | MediChoice Dual-Release Folding Walker with 5" wheel | Owens & Minor Distribution, Inc. | Device | Class II | 1 |
| 10 Jun 2014 | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. | Animas Corporation | Device | Class II | 1 |
| 5 Jun 2014 | DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device. Event 64774 | Briggs Medical Service Company d.b.a. Mabis | Device | Class II | 1 |
| 5 Jun 2014 | APLENZIN (bupropion hydrobromide), extended-release tablets, 174 mg, 7-count HDPE bottle, Rx Only, Manufactured by Valeant Pharmaceuticals International, Inc. Steinbach MB, Canada R5G 1Z7, NDC 0024-5810-07. | Valeant Pharmaceuticals North America LLC | Drug | Class III | 3 |
| 5 May 2014 | Good Herbs, Inc., LYMPH HEALTH, 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works | Good Herbs, Inc. | Food | Class II | 118 |
| 5 May 2014 | Good Herbs, Inc., FLOWER ESSENCE HEATHER, 1 & 4 oz bottle, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works | Good Herbs, Inc. | Food | Class II | 118 |
| 30 Apr 2014 | HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration… | Abbott Laboratories | Device | Class II | 1 |
| 24 Apr 2014 | BAG 9732315 MOUSE STERILE 15 PK | Medtronic Navigation, Inc. | Device | Class II | 25 |
| 18 Apr 2014 | Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody… | Leica Microsystems, Inc. | Device | Class II | 1 |
| 14 Apr 2014 | HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC 63323-469-01 | Fresenius Kabi USA LLC | Drug | Class III | 1 |
| 8 Apr 2014 | GRANDMA'S perogies POTATO & BACON PEROGIES, NET WEIGHT 907 g (32 oz/2 lb), UPC 8 92691 00112 7. Product packed in plastic bag with pink label and contains 14 - 2 lb bags per case. Manufactured by S&A Grandma's Food Inc. 196-44 Fasken Drive Toronto, ON M9W 5M8 (416) 679-8444, www.grandmafoods.com. Product of Canada. Event 67945 | BUFFALO SAV, INC. | Food | Class I | 1 |
| 7 Apr 2014 | Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system. | Abbott Laboratories, Inc | Device | Class II | 1 |
| 1 Apr 2014 | HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, ALSO LABELED AS HydrOXYzine HCl Oral Solution, USP, 10 mg / 5 mL, Net Wt 16 fl oz (473 mL), NDC 10702-052-16, Rx Only, Manufactured for:… | Hi-Tech Pharmacal Co., Inc. | Drug | Class II | 1 |
| 27 Mar 2014 | Proteus 235 Proton Therapy System for cancer treatment. | Ion Beam Applications S.A. | Device | Class II | 1 |
| 25 Mar 2014 | Good Herbs, Inc. ADRENAL HEALTH, Capsules, 1 & 4 oz bottles, 550 Oliver Dr Troy, MI 48084 The Quality Herb That Works | Good Herbs, Inc. | Food | Class II | 117 |
| 24 Mar 2014 | AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking. Event 69619 | Soma Access Systems LLC | Device | Class II | 1 |
| 3 Feb 2014 | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC. | Hospira Inc. | Device | Class I | 2 |
| 3 Feb 2014 | KFI SWEETENED GINGER CANDY (Mut Gung), NET WEIGHT: 8.8 oz (250 g) - PRODUCT OF VIETNAM - UPC 8 935001 201304 -- Distributed by: K-FAT INC. 13 MEADOW STREET, BROOKLYN, NY 11206, USA TEL: 718-381-0306 FAX: 718-381-0089 --- The product is packed in a clear, hard plastic container. Event 67423 | K-Fat Inc. | Food | Class I | 1 |
| 13 Dec 2013 | LONG AID Curl Activator Gel, NET WT. 16.4 OZ. (464.9g), KEYSTONE LABORATORIES, 1103 KANSAS STREET, MEMPHIS, TN 38106, UPC 070596003655 | Keystone Laboratories Inc | Food | Class III | 1 |
| 11 Dec 2013 | GOLDEN LION brand DRIED ZIZIPHUS JUJUBA MILL (DRIED DATES), NET WT. 12 oz (340 g), UPC 7 34765 04008 6 -- PRODUCT OF CHINA -- PACKED FOR AND EXCLUSIVELY DISTRIBUTED BY: BLOOMING IMPORT INC. 45 BOWNE STREET BROOKLYN, N.Y. 11231 --- The product is packaged in a sealed flexible plastic bag. --- Nutrition Facts: Serving… | Blooming Import Inc. | Food | Class I | 1 |
| 13 Sep 2013 | Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy. Event 69446 | CooperSurgical, Inc. D.B.A. Lone Star Medical Products | Device | Class II | 1 |
| 11 Sep 2013 | Loratadine 24 HR-OTC,10 mg, 30-count bottle, Manufactured by Novartis Consumer Health, Parsippany, NJ 07054, Distributed by Physicians Total Care, Tulsa OK 74146, NDC 54868-5268-00 | Physicians Total Care, Inc. | Drug | Class III | 1 |
| 9 Aug 2013 | CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613 | Specialty Compounding, LLC | Drug | Class I | 2 |
| 31 May 2013 | Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231. | Abrams Royal Pharmacy | Drug | Class I | 1 |
| 24 May 2013 | MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases. | Nidek Inc | Device | Class II | 1 |
| 13 May 2013 | Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sodium), 0.9% Benzyl alcohol in water for injection, Rx Only, Compounded Medication, ABRAMS ROYAL Compounding Pharmacy,… | Abrams Royal Pharmacy | Drug | Class I | 1 |
| 19 Apr 2013 | Lidocaine 18.18 mg/mL/Bupivacaine 2.27 mg/mL/Epinephrine 0.0022 mg/mL/Hyaluronidase13.64 u/mL, supplied in 11 mL Sterile Syringes, Rx only, Compounded med, Single use only, (Red Block) ABRAMS ROYAL Compounding Pharmacy, Dallas, TX | Abrams Royal Pharmacy | Drug | Class I | 1 |
| 25 Oct 2012 | Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes. | Animas Corporation | Device | Class II | 1 |
| 24 Oct 2012 | Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases. | Nidek Inc | Device | Class II | 1 |
| 9 Oct 2012 | ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack) | Siemens Healthcare Diagnostics, Inc | Device | Class II | 3 |
| 21 Sep 2012 | Pure Whey Vanilla , Dietary Supplement Packaged under the labels: Maine Natural Health and Stronger Faster Healthier Packaged in: 2 lb (32 oz), 10 oz. and 30 gram sizes | Maine Natural Health, Inc. | Food | Class I | 21 |
| 6 Aug 2012 | Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control. | Nidek Inc | Device | Class II | 1 |
| 9 Mar 2011 | LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1. | Biomet Spine LLC. | Device | Class II | 1 |
| 1 Mar 2011 | Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4:1… | Terumo Cardiovascular Systems Corp | Device | Class II | 6 |