| 19 Jul 2013 | Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880. | Watson Laboratories Inc | Drug | Class III | 1 |
| 18 Jul 2013 | ALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5. | Vi-Jon, Inc. | Drug | Class III | 1 |
| 12 Jul 2013 | Dried Oregano, cut and sifted; Organic; Product of Turkey, sold in 25 lb boxes High Quality Organics, Reno, NV | High Quality Organics, Inc. | Food | Class I | 1 |
| 10 Jul 2013 | Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site (65679) | Pemco Inc | Device | Class II | 1 |
| 8 Jul 2013 | Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number: 989803171211 Product Usage: IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips IntelliVue Information Center. MX40 Indicated for… | Philips Healthcare Inc. | Device | Class II | 1 |
| 3 Jul 2013 | Safety Lancets - Odyssey, Button Activated; Tri- Bevel Tip for Virtually Painless Sampling; Needle automatically retracts, No lancing device required. 26G - Single Use Only, Made In Korea Distributed by Hummingbird Medical, Savannah, GA 100 count Boxes; 40 boxes per case Blood collection by penetrating skin with… (65664) | KooJoo Trading Company | Device | Class II | 1 |
| 3 Jul 2013 | White plastic bottle with blue cap containing 90 capsules; Ashwagandha Extract; 450 mg; CODE 4603; Manufactured by NOW FOODS; 395 S. Glen Ellyn Rd., Bloomingdale, IL 60108, USA | NOW Foods | Food | Class II | 1 |
| 2 Jul 2013 | Somersault Pacific Sea Salt flavor, crunchy nuggets baked with sunflower seeds and toasted grains. 1 oz. packages sold in 6-count multi packs. Somersault Snacks co., LLC; Sausalito, Ca 94965 | Somersault Snack Co., LLC | Food | Class I | 1 |
| 1 Jul 2013 | Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery.… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 3 |
| 1 Jul 2013 | Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02 | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 28 Jun 2013 | Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications. (65600) | Individual firm, name withheld | Device | Class II | 1 |
| 28 Jun 2013 | Milagros Green Corn Tamales, packaged in plastic in quantities of one dozen (65628) | Los Milagros Tortilleria, LLC | Food | Class II | 1 |
| 27 Jun 2013 | Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20. | Hospira Inc. | Drug | Class II | 1 |
| 27 Jun 2013 | LA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM | Max Huber Research Labs, Inc. | Drug | Class III | 3 |
| 27 Jun 2013 | Canned Mushroom Sliced 6 cans, 53oz (65656) | C Pacific Food | Food | Class III | 1 |
| 26 Jun 2013 | ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 25 Jun 2013 | Talenti Gelato, Toasted Almond, One Pint (473ml), Crafted by: Talenti, Marietta, GA 30062 (65592) | Individual firm, name withheld | Food | Class II | 1 |
| 25 Jun 2013 | Shoreline Fruit Dark Chocolate Covered Dried Balaton Cherries Net Wt. 25 lbs Product of USA Traverse City, MI 49684 (65615) | GKI Foods, LLC | Food | Class II | 1 |
| 24 Jun 2013 | Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform Microdelivery Stent System is intended for use… (65654) | Individual firm, name withheld | Device | Class II | 1 |
| 24 Jun 2013 | Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01. | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 22 Jun 2013 | Sani Fresh Distribution brand MINI KAISER 10, Net Weight 13 OZ, Product of Canada, UPC 0 56931 51125 2 --- DISTRIBUTED BY SANI BAKERY INC. 28-24 STEINWAY ST., SUITE 108, ASTORIA NY 11103 --- The mini kaisers are packed in clear plastic sealed bags (contain 10 rolls per bag) which are placed in unmarked brown… (65581) | Sani Fresh Distribution | Food | Class I | 1 |
| 22 Jun 2013 | QFC Chicken Pesto Panini wrapped in polywrap packaging, 10.32 oz. in size, included with five (5) other types of sandwiches in a 6-count "variety pack" case. | Kroger Co | Food | Class I | 1 |
| 21 Jun 2013 | Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral… (65542) | Myoscience Inc | Device | Class II | 1 |
| 21 Jun 2013 | Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15 | Sandoz Incorporated | Drug | Class II | 1 |
| 21 Jun 2013 | Jacqueline's GOURMET COOKIES Almond Bursts COOKIES, Net Wt. 11 oz (8 units total) packed in clear plastic with white labeling----Shelf life is 12 months frozen and 7 days after baked. | Price Chopper Golub Corperisable Warehouse | Food | Class II | 3 |
| 20 Jun 2013 | TDHistology/Cytology Classification name: Calculator/data processing module for clinical use (862.2100). Intended use: Laboratory Information System (L.I.S) (65652) | Individual firm, name withheld | Device | Class III | 1 |
| 20 Jun 2013 | TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies | Haemonetics Corporation | Device | Class II | 1 |
| 20 Jun 2013 | AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30. | Gilead Sciences, Inc. | Drug | Class II | 1 |
| 20 Jun 2013 | Granna's 412 Main, Bessie, Oklahoma 705 Tuna Mac, Italian Blend Vegetables & Spiced Apple Rings (65509) | Granna's, LLC | Food | Class I | 1 |
| 20 Jun 2013 | Wawa Black Forest Ham and Cheese on a Pretzel Roll with swiss cheese and country dijon honey mustard. Net Wt. 8.7 oz (247g). Distributed by Wawa, Inc., Wawa, PA 19063. (65500) | Taylor Farms New Jersey, NJ | Food | Class I | 1 |
| 19 Jun 2013 | Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field. | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 19 Jun 2013 | Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or… | Philips Healthcare Inc. | Device | Class II | 1 |
| 19 Jun 2013 | 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart. | Biosense Webster, Inc. | Device | Class II | 1 |
| 19 Jun 2013 | AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30. | Astellas Pharma US Inc | Drug | Class II | 1 |
| 19 Jun 2013 | LID: Archer Fames, Smoked Salmon dip, NET WT 11 OZ (312g). TUB: Archer Farms, Bacon Parmesan dip, NET WT 11 OZ (312g). UPC: 0 85239 99017 9 Distributed by Target corp., Minneapolis, MN. | Garden-Fresh Foods, Inc. | Food | Class II | 1 |
| 18 Jun 2013 | LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA The Hospira Symbiq Infusion… | Hospira Inc. | Device | Class II | 1 |
| 18 Jun 2013 | ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total… | Aesculap, Inc. | Device | Class II | 1 |
| 18 Jun 2013 | Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960. | Teva Pharmaceuticals USA, Inc. | Drug | Class III | 1 |
| 17 Jun 2013 | AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries. | LeMaitre Vascular, Inc. | Device | Class I | 17 |
| 14 Jun 2013 | See's Milk Raisins: Ingredients: Raisins, Sugar, Cocoa butter, milk chocolate, soy lecithin, Vanillin, Dextrin, Confectionery glaze.May contain traces of eggs, tree nuts and peanuts Sold in Net Wt. 8 oz (227 g) clear plastic packages or purchased by customer at counter in See's Stores. UPC 7 37666 08306 0… | See's Candies Inc. | Food | Class I | 2 |
| 13 Jun 2013 | GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear… | GE Healthcare, LLC | Device | Class I | 7 |
| 13 Jun 2013 | Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin | Bayer HealthCare Pharmaceuticals Inc. | Drug | Class III | 1 |
| 13 Jun 2013 | Broccoli Salad Kit No Dressing, packaged in plastic bags inside paper cartons, 4 bags per case. | Fresh Unlimited Inc | Food | Class I | 4 |
| 12 Jun 2013 | Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only. | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 12 Jun 2013 | The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by… | Physio Control, Inc. | Device | Class II | 1 |
| 12 Jun 2013 | Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or… | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 11 Jun 2013 | Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs | Church & Dwight Inc | Device | Class II | 1 |
| 11 Jun 2013 | AngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices. | Angiodynamics, INC | Device | Class II | 1 |
| 11 Jun 2013 | Bigliani/Flatow¿ The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic. | Zimmer, Inc. | Device | Class II | 1 |
| 11 Jun 2013 | Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b) Sodium Bicarbonate U.S.P. No. 1 Powdered, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co.,… | Church & Dwight Inc | Drug | Class II | 5 |
| 11 Jun 2013 | Pistachios, Salted in the Shell packaged in the following configurations: 1. Gurley's Golden Recipe Natural Pistachios in 2 oz., 2.25 oz., 12 oz., 3 lb., and 25 lb; 2. Mountain Country Natural Pistachios, in 2. 25 oz., and 3.5 oz.; 3. Rachael's Natural Pistachios in 2 oz. (65729) | Hearthside Food Solutions LLC | Food | Class I | 1 |
| 11 Jun 2013 | Roasted and Salted In Shell Pistachio Nuts, repackaged into 48 ounce red topped gift jars labeled "Orchard Fresh HINES"; 16 ounce trays labeled "Natural Pistachios, Roasted and Salted"; and 16 ounce bags labeled "Hines Natural Pistachios". | Hines Nut Co | Food | Class I | 1 |
| 11 Jun 2013 | Treasured Harvest-Roasted & Salted Pistachios, 5lbs, 12oz, 6oz | Western Mixers Produce & Nuts, Inc. | Food | Class I | 3 |
| 11 Jun 2013 | Eagle Premium, Snack Shoppe, Pistachios, in-shell pistachios, packaged in 2-oz (UPC 4262500705) and 5.25-oz (UPC 42625000604) bags. Distributed by: Genco Marketing, Omaha, NE. (65419) | Palmer Candy Co | Food | Class I | 1 |
| 10 Jun 2013 | StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters. | Bard Access Systems | Device | Class II | 1 |
| 10 Jun 2013 | nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The IOL is to be implanted in the posterior chamber and in the capsular bag through a tearfree capsulorhexis. | Staar Surgical Co. | Device | Class II | 2 |
| 10 Jun 2013 | PISTACHIOS-INSHELL-R/S-21/25-6.25LB, Net Wt. 6.25 LB. Item number: 920. Product is packed in a clear plastic liner then in a white corrugated bag. Distributed by Nassau Candy 530 West John Street Hicksville, NY 11801. (65489) | Nassau Candy | Food | Class I | 1 |
| 8 Jun 2013 | da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use. | Intuitive Surgical, Inc. | Device | Class II | 4 |
| 7 Jun 2013 | Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony. | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 7 Jun 2013 | Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps. (65430) | Individual firm, name withheld | Device | Class I | 1 |
| 7 Jun 2013 | Spacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a… | Del Mar Reynolds Medical, Ltd. | Device | Class II | 1 |
| 7 Jun 2013 | MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine. | Codman & Shurtleff, Inc. | Device | Class I | 2 |
| 7 Jun 2013 | REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral… | Biomet, Inc. | Device | Class II | 30 |
| 7 Jun 2013 | Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous,… | Baxter Healthcare Corp. | Device | Class II | 2 |
| 7 Jun 2013 | Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications. | Baxter Healthcare Corp. | Device | Class II | 7 |
| 7 Jun 2013 | RAW SUNFLOWER KERNEL, DARK RAISIN 50/50 MIX 24/l0 oz packaged in clear plastic wrap. (65540) | Windy Acres Candy & Nut, Outlet Inc. | Food | Class I | 1 |
| 7 Jun 2013 | Torn and Glasser Brand Roasted & Salted Natural Pistachios, 8 oz. 24/8oz Case. Labeling reads in part:"TORN & GLASSER***ROASTED & SALTED NATURAL PISTACHIOS***NET WT. 8 OZ***Packed by:Torn & Glasser, Los Angeles, CA***" | Torn & Glasser Inc. | Food | Class I | 2 |
| 6 Jun 2013 | BD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this… | Becton Dickinson & Co. | Device | Class II | 8 |
| 6 Jun 2013 | 601009 ANTIOXIDANT SUPERSTAR MIX 100/2 OZ FLAT PACK, UPC 2052601009 601076 ANTIOXIDANT SUPERSTAR MIX 12/6 OZ BERGIN RED BAG, UPC 2052601076 601051 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL, UPC 2052601051 601051.03 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL KOWALSKI, UPC 2052601051 601049.01 ANTIOXIDANT SUPERSTAR… | Bergin Fruit And Nut Co Inc | Food | Class I | 10 |
| 5 Jun 2013 | Axiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 5 Jun 2013 | Butterfly Bakery Harvest Berry Muffins (four muffins per package) Net. Wt. 14.5 OZ (410 g) UPC 6 43482 60014 8 Manufactured by: Butterfly Bakery Inc.200 Clifton Boulevard, Clifton, NJ 07013 T: 973.815.1501 Packaged in a plastic clam shell. (65426) | Butterfly Bakery Inc. | Food | Class I | 1 |
| 5 Jun 2013 | KENTON'S CHEESE CO. Bianco A soft Brie-Style cheese Aged at least 60 days, Net Wt. 8 oz wheel. Distributed by Kenton's Cheese Company 5939 Burr Rd. Trumansburg, NY 14886. (65427) | Individual firm, name withheld | Food | Class III | 1 |
| 4 Jun 2013 | ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution. | Baxa Corporation | Device | Class II | 1 |
| 4 Jun 2013 | General Mills, Cinnamon Toast Crunch, 25% Less Sugar, Self-Serve Bowl, Net WT 1.0 oz ( 28g), Distributed by General Mills Sales, Minneapolis, MN 55440, Package UPC 00016000294448. Case: General Mills, BOWLPAK, Cinnamon Toast Crunch, Reduced Sugar, 96 - 1 oz (28g) containers, Distributed by General Mills Sales,… | General Mills, Inc | Food | Class I | 1 |
| 4 Jun 2013 | ARO Pistachios, Pistachios raw kernel - no salt; Sold in 9 oz. raw kernel, no salt airtight jar; 2.5 lb raw Kernel, no salt, air tight jar; 30 lb Bulk raw kernel, no salt. | ARO Pistachios, Inc. | Food | Class I | 4 |
| 4 Jun 2013 | Item Number: 101643 Item Description: TUB CHOC DD PEANUTS Case Pack: 12 Package Size: 8 OZ 2-Piece Clear Tub (Zoppity Label on Top, Nutritional Label on Bottom) UPC Number: 094776095575 | Lipari Foods, Inc. | Food | Class I | 52 |
| 3 Jun 2013 | Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 3 Jun 2013 | Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner package are STERILE. The Medtronic Model 8578… | Individual firm, name withheld | Device | Class I | 4 |
| 3 Jun 2013 | CMC Saddle Product Usage: The Ascension CMC is intended to resurface the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteo-arthritis, or post-fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.… | Integra LifeSciences Corp. | Device | Class III | 1 |
| 3 Jun 2013 | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion system include the… | Individual firm, name withheld | Device | Class I | 2 |
| 3 Jun 2013 | Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II infusion… | Individual firm, name withheld | Device | Class I | 2 |
| 31 May 2013 | Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone… | Synthes USA HQ, Inc. | Device | Class II | 1 |
| 31 May 2013 | 27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragments during treatment. The coaxial catheters will also allow simultaneous drainage of urine or infusion of other solutions. | Karl Storz Endoscopy America Inc | Device | Class II | 1 |
| 31 May 2013 | BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings. | Becton Dickinson & Co. | Device | Class III | 1 |
| 31 May 2013 | Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV Elastomeric Infusion Device is a… | Greatbatch Medical | Device | Class II | 1 |
| 31 May 2013 | Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11 | Pfizer Inc. | Drug | Class III | 2 |
| 31 May 2013 | Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schuyler County, SCHUYLER Gouda aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGEN ROAD TRUMANBURG, NY 14886. Ingredients: raw milk, rennet, calcium chloride, culures, salt | Finger Lakes Farmstead Cheese Company Llc | Food | Class I | 2 |
| 30 May 2013 | GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical | DeRoyal Industries Inc | Device | Class II | 1 |
| 30 May 2013 | ***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures. | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 2 |
| 30 May 2013 | TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings… | Hill-Rom, Inc. | Device | Class II | 1 |
| 30 May 2013 | Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature. | Terumo Medical Corporation | Device | Class II | 2 |
| 30 May 2013 | Sarns " TCM II Temperature Control Module The Sarns" TCM II Temperature Control Module is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and is indicated for controlling and monitoring patient temperature | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 30 May 2013 | Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821 | Pharmalucence, Inc. | Drug | Class III | 1 |
| 30 May 2013 | Fudge Buttercream Frosted Peanut Butter cookies, some of which were mislabeled by being wrapped in Buttercream Frosted Cinnamon Pumpkin cookie wrappers, 1.6oz (45g) in size, 1 cookie per package, 100 cookies per case. (65378) | Cheryls | Food | Class II | 1 |
| 29 May 2013 | Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Systems with BEAMVIEW capability. The intended use of the SIEMENS branded MEVATRON", ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 29 May 2013 | Acetyl-D-Glucosamine w/Chondroitin 200 mg/ml, compounded by Olympia Pharmacy, Orlando, FL | Lowlite Investments, Inc. D/B/A Olympia Pharmacy | Drug | Class II | 105 |
| 29 May 2013 | Wholly Immune Powder, Total Immune Nutrient Support; 300 gram (10.6 oz) and 900 gram ( 31.7 oz.) containers. Also packaged as Complete Immune Powder and packed in 300 and 900 gram containers. Suggested use: As a dietary supplement, 1 level scoop one or two times daily, mixed with desired liquid or as directed by a… (65396) | Allergy Research Group | Food | Class II | 1 |
| 28 May 2013 | Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is… | Boston Scientific Corporation | Device | Class II | 1 |
| 28 May 2013 | Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation. | Zeiss, Carl Inc | Device | Class II | 1 |
| 28 May 2013 | RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia. | Boston Scientific Corporation | Device | Class III | 1 |
| 28 May 2013 | NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract. | Boston Scientific Corporation | Device | Class II | 2 |
| 28 May 2013 | VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis. | DJO, LLC | Device | Class II | 1 |
| 28 May 2013 | SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s), UniCel¿ DxC 600/800 System(s) and Synchron¿ Systems Multi Calibrator, is intended for the quantitative determination of lactate concentration in human plasma and cerebrospinal fluid… | Beckman Coulter Inc. | Device | Class II | 1 |
| 28 May 2013 | INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic | Medtronic Sofamor Danek USA Inc | Device | Class II | 7 |
| 25 May 2013 | "***JENSEN'S SEATTLE STYLE SMOKED WILD PACIFIC SALMON ***JENSEN'S SMOKEHOUSE, INC.***10520 GREENWOOD AVE N***SEATTLE, WA 98133*** (206) 364-5569** SOCKEYE LOX Net Wt. 4 oz***". | Salmolux (A Pacific Seafood Group Company) | Food | Class I | 6 |
| 24 May 2013 | S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument to add further compression of the Inserter into the Implant during implantation of S-LIF Intervertebral Body Fusion Devices using bone graft to facilitate fusion of the spine of skeletally mature patients. Model: SI50003 RevA | SpineFrontier, Inc. | Device | Class II | 1 |
| 24 May 2013 | Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 24 May 2013 | Soy Protein Isolate; 79 bulk raw material lots and 52 finished product lots. Soy Protein Isolate was sold in bulk to two customers, both sausage manufacturers not under FDA jurisdiction. Also sold 48 bags of 34.875 bags to a third sausage manufacturer. Finished product was made for Nurti-Cology - Allergy Research… (65327) | ABCO Laboratories, Inc. | Food | Class II | 1 |
| 23 May 2013 | Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorly and exposing the entire glenoid surface. | Zimmer, Inc. | Device | Class II | 2 |
| 23 May 2013 | Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights. | Etac Supply Center Ab | Device | Class II | 1 |
| 23 May 2013 | Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery. | Abbott Medical Optics, Inc. | Device | Class II | 1 |
| 23 May 2013 | INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, www.inkeeze.com | Indelicare LLC | Drug | Class II | 2 |
| 23 May 2013 | Mother Earth Products, Veggie Burger, Textured Vegetable Protein, packaged in 2-cup mylar bags, 1-quart mylar bags, 1-quart plastic jar, 1-gallon mylar bags, 5-lb mylar bags, 15-lb bulk bag, 25-lb bulk box and TVP Variety Sample Pack. (65262) | Mother Earth International LLC | Food | Class II | 1 |
| 23 May 2013 | Vegetarian Burger Mix, Item #VB 100, Pack size: 25lbs. (59566) | Good Source Incorporated | Food | Class II | 1 |
| 22 May 2013 | "***DIETARY SUPPLEMENT 4HB STACK Mealtime***78 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***". | Florida Nutri Labs, LLC | Food | Class II | 2 |
| 22 May 2013 | FLAV-R-PAC IQF Chopped Spinach, packaged in a 32 oz. bag, NORPAC Catalog #30238-01. The UPC is 0 48800 30238 2 The product is labeled in parts: "***FLAV R PAC***Classic Vegetables***Chopped Spinach***INGREDIENTS: Spinach***NET WT 32 OZ (2 LB)***PRODUCT OF USA***Keep frozen until ready to use***Distributed by Norpac… (65261) | Norpac Foods, Inc. | Food | Class II | 1 |
| 21 May 2013 | Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 21 May 2013 | 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015 | Baxter Healthcare Corp. | Drug | Class II | 6 |
| 21 May 2013 | Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11 | Fresenius Kabi USA, LLC | Drug | Class III | 1 |
| 21 May 2013 | Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of… | Sun Pharmaceutical Industries Inc. | Drug | Class II | 1 |
| 21 May 2013 | BIG COUNTRY BREAKFAST, CASE WEIGHT 26 LBS., MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087 | Food Concepts | Food | Class II | 3 |
| 20 May 2013 | STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures. | Steris Corporation | Device | Class II | 1 |
| 17 May 2013 | BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine. | SpineFrontier, Inc. | Device | Class II | 1 |
| 17 May 2013 | Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair. (65361) | RF Technologies, Inc. | Device | Class II | 1 |
| 16 May 2013 | Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound. Indicated as an adjunct to mammography for breast cancer screening. (65371) | U-systems Inc | Device | Class II | 1 |
| 16 May 2013 | CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin. | Roche Diagnostics Operations, Inc. | Device | Class II | 4 |
| 16 May 2013 | West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Eatontown, N.J., 07724 | West-Ward Pharmaceutical Corp. | Drug | Class II | 2 |
| 16 May 2013 | Eco-Cuisine Betty Brownie Mix with Vanilla, Pack size 1.09 lb bag, 10 bags per case or 25 lbs bulk, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO. | Eco-Cuisine | Food | Class II | 12 |
| 16 May 2013 | Solbar Q Soy Protein Isolates. Item No. / Item Description: 22843 / Solbar Q 843 GMO, 22910 / Solbar Q 910 GMO, 22942 / Solbar Q 842 GMO, 22943 / Solbar Q 842 NGMO, 3323912 / Solbar Q 910, 3323920 / Solbar Q 920, 3323932 / Solbar Q 842, and 3323973 / Solbar Q 842 IP | Chs Inc | Food | Class I | 4 |
| 15 May 2013 | Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including… | Baxter Healthcare Corp. | Device | Class II | 3 |
| 15 May 2013 | Enzyme Solutions, A Dietary Supplement, Formula 29, 8 oz. (226.8g), UPC Code 697706041408. Distributed by: Enzyme Formulations, Inc., Madison, Wisconsin, 53719. (65293) | Enzyme Formulations, Inc. | Food | Class II | 1 |
| 14 May 2013 | Delta Vaporizer An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient. (65286) | Penlon, Ltd. | Device | Class II | 1 |
| 14 May 2013 | MAQUET GETINGE GROUP Arterial Cannula OD Used to introduce blood and sterile solutions into the systemic circulation during pediatric extracorporeal circulation procedures. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 13 May 2013 | Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations.… | Microgenics Corporation | Device | Class II | 1 |
| 13 May 2013 | Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10 | West-ward Pharmaceutical Corp. | Drug | Class III | 1 |
| 10 May 2013 | Hot Dog Buns 8 Count Earthgrains Baking companies, Inc. Horsham, PA 19044 | BIMBO Bakeries USA | Food | Class II | 20 |
| 9 May 2013 | Integra PANTA Arthrodesis Nail System. Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. | Integra LifeSciences Corporation | Device | Class II | 1 |
| 9 May 2013 | VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and… | Ortho-Clinical Diagnostics | Device | Class III | 2 |
| 9 May 2013 | Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of… (65407) | ConBio, a CynoSure Company | Device | Class II | 1 |
| 7 May 2013 | InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for… | SpineFrontier, Inc. | Device | Class II | 1 |
| 7 May 2013 | Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04. | Hill Dermaceuticals, Inc. | Drug | Class III | 1 |
| 6 May 2013 | 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides,… | Ortho-Clinical Diagnostics | Device | Class II | 5 |
| 4 May 2013 | Hannaford Gourmet Oatmeal Raisin Cookies (9 oz. package) UPC # 0004126872715 | Delhaize America (Hannaford Bros) | Food | Class I | 2 |
| 3 May 2013 | -Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal Tunnel Release Hook Blade. REF 2055 Lot 122669 -Linvatec CTS Relief Kit. REF 9971, lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release (White). REF 200060. Lot 122504 and Lot 123190. -KMI… | Surgical Instrument Service And Savings, Inc. | Device | Class II | 22 |
| 3 May 2013 | Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2 (53558) | Kareway Product Inc | Drug | Class II | 1 |
| 3 May 2013 | Master Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup Packs | Green Mountain Coffee Roasters | Food | Class II | 1 |
| 2 May 2013 | Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA. | Hospira Inc. | Drug | Class II | 1 |
| 1 May 2013 | BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications. | Becton Dickinson & Company | Device | Class II | 1 |
| 26 Apr 2013 | MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of X-ray equipment. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 26 Apr 2013 | Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator (65462) | Cardio Medical Products | Device | Class II | 1 |
| 25 Apr 2013 | Hydra Vision DR 60/80 System, Models 700539 and 700540, Liebel-Flarshiem Company. The System is used in radiologic imaging procedures. (65176) | Leibel-Flarsheim Company LLC | Device | Class II | 1 |
| 25 Apr 2013 | B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g.… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 17 Apr 2013 | Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access. (65449) | Bryan Medical Inc | Device | Class I | 1 |
| 15 Apr 2013 | Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 15 Apr 2013 | DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient | Medrad Inc | Device | Class II | 1 |
| 12 Apr 2013 | Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems. (65088) | Paa Laboratories Inc | Device | Class II | 1 |
| 12 Apr 2013 | LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that… | Ethicon Endo-Surgery Inc | Device | Class II | 3 |
| 11 Apr 2013 | 365 Organic 100% Apple Juice from concentrate with Vitamin C and Calcium in 6.75 fl oz (UPC 0 99482 42095 6) and 64 fl oz. (UPC 0 99482 42096 3) Distributed by: Whole Foods Market, Austin, TX 78703; 8 units peer shipping case | Whole Foods Market | Food | Class II | 1 |
| 10 Apr 2013 | ARNETT'S PLAIN CORN MEAL NET WT. 24 OZ. (1lb. 8 oz)(680g | Hoover Mill, Inc. | Food | Class II | 3 |
| 9 Apr 2013 | HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy. | Instrumentation Laboratory Co. | Device | Class II | 1 |
| 9 Apr 2013 | Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo. | National Biological Corp | Device | Class III | 1 |
| 8 Apr 2013 | Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo. | National Biological Corp | Device | Class III | 1 |
| 8 Apr 2013 | Endopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6… | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 3 Apr 2013 | TOSHIBA Kalare Diagnostic X-Ray System K110785 | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 3 Apr 2013 | R.L. Schreiber Batter Mix, 2.5 lb packaged in white flexible plastic bag, 12 bags per case. (65575) | R.L. SCHREIBER INC - LEBANON | Food | Class III | 1 |
| 22 Mar 2013 | Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (65541) | Watson Laboratories, Inc.-(Actavis) - Florida | Drug | Class II | 1 |
| 21 Mar 2013 | Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 20 Mar 2013 | Acetylcysteine 10 % Solution, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907 | Clinical Specialties Compounding Pharmacy | Drug | Class II | 49 |
| 18 Mar 2013 | TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty. (65343) | Loma Vista Medical | Device | Class II | 1 |
| 18 Mar 2013 | HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy. | Clorox Healthcare Holdings, LLC (dba HealthLink) | Device | Class II | 3 |
| 18 Mar 2013 | Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0. | Apotex Corp. | Drug | Class I | 1 |
| 15 Mar 2013 | Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67 | Teva Pharmaceuticals USA, Inc. | Drug | Class III | 4 |
| 15 Mar 2013 | Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58 | Teva Pharmaceuticals USA, Inc. | Drug | Class III | 2 |
| 14 Mar 2013 | Magnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712 | Med Prep Consulting, Inc. | Drug | Class I | 2 |
| 6 Mar 2013 | Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra. (65391) | Advanced Orthogonal Equipment, Incorporated | Device | Class II | 1 |
| 6 Mar 2013 | GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures | Linvatec Corp. dba ConMed Linvatec | Device | Class II | 1 |
| 4 Mar 2013 | Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified… | Steris Corporation | Device | Class II | 1 |
| 28 Feb 2013 | Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 27 Feb 2013 | CDI Blood Parameter Monitoring System 500 with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PCO2, PO2, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are… | Terumo Cardiovascular Systems Corporation | Device | Class II | 5 |
| 27 Feb 2013 | 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11 | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 25 Feb 2013 | Vanilla almond granola, Net WT 16 oz(454g), UPC 0 71725 71239 4, Distributed by American Importing Co., Inc, Minneapolis, MN 55414. Vanilla Almond Granola, Net Wt 16 oz (454g), UPC 7 25439 20038 7, Distributed by DZA Brands LLC, Salisbury,NC 28147. Hy-Vee Granola Vanilla Almond, 24 oz, UPC 71725 71239 Amport,… | American Importing Co, Inc | Food | Class II | 3 |
| 1 Feb 2013 | Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint. | Integra LifeSciences Corp. | Device | Class II | 1 |
| 31 Jan 2013 | Siemens AXIOM Artis zee/zeego systems equipped with generator A100 Plus Product Usage: Angiographic x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 27 Jan 2013 | Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients. (65193) | Prism Medical Services USA | Device | Class II | 1 |
| 14 Jan 2013 | GE Healthcare Senographe Essential System. The Senographe 2000D system generates digital mamnmographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional film-based mamnmographic systems. | GE Healthcare, LLC | Device | Class II | 1 |
| 3 Jan 2013 | Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA. (64018) | Mobius Therapeutics LLC | Drug | Class I | 1 |
| 5 Dec 2012 | Oxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071 (65621) | Oklahoma Respiratory Care Inc | Drug | Class II | 1 |
| 30 Nov 2012 | Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger (3701) provides the capability to recharge the IPG Battery. The charger transmits RF energy through… | St. Jude Medical | Device | Class II | 1 |
| 21 Nov 2012 | Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended… | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 20 Nov 2012 | The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data… | GE Healthcare It | Device | Class II | 1 |
| 6 Nov 2012 | VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451, | Alkermes, Inc. | Drug | Class II | 1 |
| 10 Oct 2012 | QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01 | American Health Packaging | Drug | Class II | 1 |
| 1 Oct 2012 | ALYMAQ EXTRA FINE GRANULATED SUGAR AIB, www.alymaq.com, NET WT. 50 LBS. (22.68KG), KEEP IN A COOL AND DRY PLACE. Multi-wall polyethylene lined bag. 55 bags per pallet. (63455) | Alymaq Inc | Food | Class III | 1 |
| 20 Sep 2012 | Mango (Fresh Cut): Del Monte brand slices, 32 oz., UPC 7-62357-07532-1, 32 oz., UPC 7-17524 72503-5; 16 oz., UPC 7-17524-71902-7, 8 oz., UPC 7-17524-72506-7, UPC 7-17524-72506-6; Del Monte brand chunks, 7 oz., 7 Eleven brand chunks, 6 oz., UPC 0-52548-52070-0 | Del Monte Fresh Produce North America, Inc | Food | Class I | 9 |
| 18 Sep 2012 | Item # H996189 Mango Diced 1/2" 5 LB, Ingredients: Mango Packed By: Riley's Dallas, Texas 75226 Product of Mexico | Individual firm, name withheld | Food | Class I | 3 |
| 15 Sep 2012 | Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated Island Medley Net Wt. 1 lb (454g) Renaissance Food Group LLC Rancho Cordova, CA 95670 www.gardenhighway.com Ingredients: Pineapple, Mango, Papaya Packed in its own juice, UPC Code: 826766201044 | GHSW, LLC | Food | Class I | 5 |
| 14 Sep 2012 | Tomorrow's Tropicals Mangos Distributed by FoodSource A C.H. Robinson Company Edinburg, Texas 78539 (63209) | Food Source, Inc | Food | Class I | 1 |
| 26 Jul 2012 | Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.… | St. Jude Medical | Device | Class II | 2 |
| 20 Jul 2012 | CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility on adult, pediatric, and neonatal patients and on one patient at a time. The system is indicated for monitoring of… | GE Healthcare, LLC | Device | Class II | 1 |
| 14 Jun 2012 | Christian Cheese Ranch Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, and Ranch Dressing. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each. | Christian Cheese, LLC | Food | Class II | 6 |
| 15 May 2012 | Caribena Brand papayas packed in 35 lb. cartons marked with the brand "Caribena" and "Product of Mexico" stamped on the side. Each papaya bears a label which states "3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO www.grandeproduce.com" Papayas are packed in boxes of 8-12 papayas per box (61892) | Caribe Produce | Food | Class I | 1 |
| 4 May 2012 | 0.9% Sodium Chloride Injection, USP, Polyolefin Flexible Container, a) 500 mL (NDC 0409-7983-30), b) 1000 mL (NDC 0409-7983-48), c) 250 mL (NDC 0409-7983-02), d) 150 mL (NDC 0409-7983-61), Rx Only, by Hospira, Inc., Lake Forest, IL 60045 | Hospira Inc. | Drug | Class II | 9 |
| 27 Mar 2012 | PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye. (65688) | Topcon Medical Laser Systems, Inc | Device | Class II | 1 |
| 24 Feb 2012 | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack. (65410) | BRAEMAR, INC. | Device | Class II | 1 |
| 30 Dec 2011 | KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component… | SpineFrontier, Inc. | Device | Class II | 1 |
| 24 Jun 2011 | ***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (approximately 72,000 RPM) in the free running state when using the optional Hand Control. The low Motor Handpiece RPM would only be experienced in the Free running state (Hand Control… | The Anspach Effort, Inc. | Device | Class II | 3 |
| 16 May 2011 | GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventional procedures. | GE Healthcare, LLC | Device | Class II | 1 |
| 2 May 2011 | Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack. (65423) | BRAEMAR, INC. | Device | Class II | 1 |
| 31 Jul 2009 | Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through… | Baxter Healthcare Corp. | Device | Class II | 3 |
| 8 May 2008 | Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study. (65148) | SagaTech Electronics, Inc. | Device | Class II | 1 |