| 8 Dec 2015 | Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Part No. 19075127YT1; Lot No. 45104 and 43054 Description: STRYK_76542K_19X75X1.27T General and Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in… | Synvasive Technology Inc | Device | Class II | 1 |
| 7 Dec 2015 | MAGNETOM systems, magnetic resonance diagnostic devices (MRDD). | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 4 Dec 2015 | Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The system is indicated… | Synaptive Medical, Inc. | Device | Class II | 1 |
| 3 Dec 2015 | Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Rx Only, For Oral Inhalation Only, Net Wt. 18 g, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0682-20 | GlaxoSmithKline, LLC | Drug | Class II | 1 |
| 2 Dec 2015 | Black Mamba Suture Passer | Biomet, Inc. | Device | Class II | 2 |
| 2 Dec 2015 | Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum… | Zimmer Manufacturing B.V. | Device | Class II | 1 |
| 2 Dec 2015 | Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D. Searle LLC, Division of Pfizer Inc, NY, NY 10017. | Pfizer Inc. | Drug | Class III | 1 |
| 1 Dec 2015 | Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients. | Draeger Medical, Inc. | Device | Class I | 1 |
| 1 Dec 2015 | UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is… | Beckman Coulter Inc. | Device | Class II | 3 |
| 1 Dec 2015 | Winn Dixie Old Fashioned Potato Salad, Net Wt. 16oz (1 LB) 454g. | Reser's Fine Foods Inc. | Food | Class II | 1 |
| 30 Nov 2015 | GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal… | Verathon, Inc. | Device | Class II | 2 |
| 25 Nov 2015 | MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Only. Manufactured by: Par Pharmaceuticals Companies Inc., Spring Valley, NY 10977. Packaged by: GSMS Incorporated, Carmarillo, CA 93012. NDC: 60429-204-10. | Golden State Medical Supply Inc. | Drug | Class III | 2 |
| 24 Nov 2015 | Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System. | Instratek, Incorporated | Device | Class II | 1 |
| 24 Nov 2015 | MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery. | Elekta, Inc. | Device | Class II | 1 |
| 24 Nov 2015 | Persona EM Proximal Tube, orthopedic manual surgical instrument for use with Persona Knee Prosthesis, item 42-5399-001-00, part of the Persona Tibial Resection System. | Zimmer, Inc. | Device | Class II | 2 |
| 23 Nov 2015 | Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 23 Nov 2015 | Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35. | Terumo Medical Corp | Device | Class II | 1 |
| 23 Nov 2015 | VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 1 |
| 20 Nov 2015 | A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones. | Biomet, Inc. | Device | Class II | 1 |
| 20 Nov 2015 | Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml… | MOOG Medical Devices Group | Device | Class II | 1 |
| 20 Nov 2015 | Cardinal Health Tiny Toes; 11470-010T Infant heel warmer | Philips Electronics North America Corporation | Device | Class II | 1 |
| 20 Nov 2015 | IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Catalog number: EPM4500N4; Cardiac: The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant… | Boston Scientific Corp | Device | Class II | 4 |
| 20 Nov 2015 | Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System. | DePuy Spine, Inc. | Device | Class II | 1 |
| 19 Nov 2015 | Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm, MP, CC H74939277545210 Guiding Sheath 6F, 45 cm, ST, CC H74939277645110 Guiding Sheath 6F, 45 cm, ST, TB… | Boston Scientific Corporation | Device | Class I | 1 |
| 19 Nov 2015 | VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain. | Cook Inc. | Device | Class II | 1 |
| 19 Nov 2015 | Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria. | Biomerieux | Device | Class I | 4 |
| 19 Nov 2015 | Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD. --- CLASSIFICATION NAME: Test, Qualitative and Quantitative Factor Deficiency | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 18 Nov 2015 | IBS - Osteosynthesis screws for bone fixation Model S25 ST014. | In2Bones, SAS | Device | Class II | 1 |
| 18 Nov 2015 | FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A fastidious bacteria broth for the enriched cultivation of Neisseria spp., Haemophilus spp., Streptococcus spp., Corynebacterium spp., and other fastidious bacteria from clinical specimens. | Hardy Diagnostics | Device | Class II | 1 |
| 18 Nov 2015 | Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingredients: A.S.A. (Acetylsalicylic Acid) + Eugenol | Rainbow Specialty & Health Products | Device | Class II | 2 |
| 17 Nov 2015 | BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. Product Usage: BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine… | Becton Dickinson & Company | Device | Class II | 1 |
| 17 Nov 2015 | Syngo Imaging XS is a Picture Archiving and Communication System (PACS) | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 17 Nov 2015 | Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA50042A ENDOEYE HD II 10 mm, 30 degree, W7100603 Repair cable 10 mm 0/30 degree. The ENDOEYE video Telescopes are used with other supporting equipment for endoscopy and endoscopic surgery within the thoracic and abdominal… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 16 Nov 2015 | 1 Step 12 Panel Cup, Item No. NBCA-12M-W | Ameditech Inc | Device | Class III | 59 |
| 16 Nov 2015 | Organic blenditup Protein + Plant Based Smoothie Mix, No Dairy, Vitamin Fortified, 100% Vegan, Mild Natural Flavor with a Hint of Sweetness, Net Wt. 24 oz (682g), packaged in plastic canister, 12 packages per case. Distributed by: Blenditup, 504 W. Buena Vista, Suite 1, Washington, UT 84780 (72663) | Thrive Foods LLC | Food | Class II | 1 |
| 13 Nov 2015 | Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227 | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 13 Nov 2015 | Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only. | STERILMED, INC. | Device | Class II | 1 |
| 13 Nov 2015 | GE Healthcare Optima CL323i Product Usage: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR… | GE Medical Systems, LLC | Device | Class II | 2 |
| 13 Nov 2015 | Honey Mustard Pretzel Mix sold under the following brand and size: Girl Scouts, NET WT 7 oz. (198g). | A. L. Schutzman Company, Inc. | Food | Class I | 2 |
| 12 Nov 2015 | Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries installed, a Quick Start Guide, and an… (72686) | Bestmed, LLC | Device | Class II | 1 |
| 12 Nov 2015 | Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. | Draeger Medical, Inc. | Device | Class I | 1 |
| 12 Nov 2015 | Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). | CareFusion 303, Inc. | Device | Class II | 1 |
| 12 Nov 2015 | 219772 509998 MARKET DISTRICT APRICOT LOG | Giant Eagle, Inc. | Food | Class I | 2 |
| 11 Nov 2015 | Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy Repack, Inc, 625 Kolter Dr, Indiana, PA 15701, NDC 52125-0415-08 | RemedyRepack Inc. | Drug | Class II | 7 |
| 11 Nov 2015 | Wegmans Premium Dark Chocolate Pistachio Toffee, NET WT 9 OZ (255 g), UPC 0 77890 12698 1, Distributed By: Wegmans Food Markets, Inc., Rochester, NY 14603, Product contains tan and brown labels fixed to the top and bottom of the clear plastic tubs and shipped 12 units per case. | First Source Llc | Food | Class II | 1 |
| 11 Nov 2015 | David's Gourmet Chocolate Chunk Pecan Cookie 10 count NET WT 15 oz (0.94 lb) packed in white cardboard box (72638) | Brookshire Brothers LTD-Central Bakery Plant | Food | Class II | 1 |
| 10 Nov 2015 | Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland | Zimmer, Inc. | Device | Class II | 2 |
| 10 Nov 2015 | Mobile X-ray system MobileDaRt Evolution/FDR Go Software The device is a mobile X-ray system and allows a technician to take a general digital radiography of patients in the hospital or medical facility who cannot move and outpatients in emergency. | Shimadzu Medical Systems | Device | Class II | 1 |
| 10 Nov 2015 | Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates,… | Siemens Healthcare Diagnostics Inc. | Device | Class II | 4 |
| 10 Nov 2015 | Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; Aesculap AG These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems. | Aesculap, Inc. | Device | Class II | 4 |
| 10 Nov 2015 | Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53 | Northwind Pharmaceuticals LLC | Drug | Class III | 1 |
| 10 Nov 2015 | French Style Green Beans packaged under the following labels: 1. Giant Eagle, Net Wt. 16 oz (1 LB) 454 g, UPC 30034-00978; 2. Shur fine, Net Wt. 16 oz, 1 LB (454 g), UPC 11161-13478 | Lakeside Foods, Inc | Food | Class II | 1 |
| 9 Nov 2015 | Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker. | Medtronic Inc. | Device | Class II | 1 |
| 9 Nov 2015 | My Spice Sage Ground Flax Seed Meal under the following labels: 1) NET WT 4 oz. (113g) UPC# 00575004, 2) NET WT 16 oz. (454g) UPC# 00575016, 3) NET WT 50 pounds UPC# 00575111. (72588) | Zenobia Co. | Food | Class I | 1 |
| 6 Nov 2015 | Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle (72616) | Myco Medical Supplies Inc | Device | Class II | 1 |
| 6 Nov 2015 | Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes. | Remel Inc | Device | Class II | 1 |
| 6 Nov 2015 | MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient device. When the MicroCutter XCHANGE 30… | Cardica, Inc. | Device | Class II | 2 |
| 6 Nov 2015 | 1.) Essential EVERYDAY Chocolate Flavored Dairy Whipped Topping, Made with Real Cream, Ultra-Pasteurized Grade A, NET WT 13 OZ (368g); 2.) HyVee Chocolate FLAVORED WHIPPED TOPPING ULTRA-PASTEURIZED GRADE A - SWEETENED, NET WT 13 OZ (368g); 3.) Lucerne DAIRY FARMS Chocolate Whipped Topping MADE WITH REAL CREAM, NET WT… (72640) | Saputo Dairy Foods USA, LLC | Food | Class II | 1 |
| 5 Nov 2015 | Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. | CareFusion 303, Inc. | Device | Class II | 1 |
| 5 Nov 2015 | Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source. | ConMed Corporation | Device | Class II | 1 |
| 5 Nov 2015 | Kroger 100% natural apple FROM CONCENTRATE 64FL OZ. INGREDIENTS: APPLE JUICE FROM CONCENTRATE (FILTERED WATER, APPLE JUICE CONCENTRATE, ASCORBIC ACID (VITAMIN C). DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 82161 0 | The Kroger Co | Food | Class II | 1 |
| 5 Nov 2015 | Virginia Diner, Happy Holidays labeled, Pecan Turtledoves, Chocolate Caramel Pecan Cluster, 10 oz, can, UPC 0 85582 01155 2, 10A Lot: 092915 PNT, Best By: 09 23 16. (72633) | Virginia Diner, Inc. | Food | Class I | 1 |
| 4 Nov 2015 | Thin-Flex Venous Cannula, Model Number:TF292902A | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 4 Nov 2015 | Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement. | Ormco/Sybronendo | Device | Class II | 1 |
| 4 Nov 2015 | Metro Irresistibles Gluten Free Cheese Ravioli 6- 9 ounce bags Use By 020317; Imported for Metro Brands, Montreal Quebec, H1C 1V6, Toronto (Ontario) M9B 1B9 UPC 059749935609 | Contes Pasta Company, Inc. | Food | Class II | 5 |
| 4 Nov 2015 | Kozy Shack Indulgent Salted Caramel | Land O' Lakes, Inc | Food | Class I | 1 |
| 4 Nov 2015 | Melissa's Italian Pine Nuts, 2oz (57g), 12 cartons/case, UPC 0 45255 14351 5 Melissa's Profit Strip Pine Nuts Italy, 2oz (57g), 12 cartons/case, UPC 0 45255 14351 5. | World Variety Produce Inc. | Food | Class I | 2 |
| 3 Nov 2015 | MYLA CLINIC PATCH 3.2.0 CD Product Usage: MYLA is a computer application ( Middleware ) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)). | bioMerieux, Inc. | Device | Class II | 7 |
| 2 Nov 2015 | OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in… | Insulet Corporation | Device | Class I | 2 |
| 2 Nov 2015 | Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 2 Nov 2015 | AMS 4674 Custom Pack. For use in a general clinical procedure. | Windstone Medical Packaging, Inc. | Device | Class II | 2 |
| 2 Nov 2015 | 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 30 Oct 2015 | BD CD64 APC-R700; Analyte Specific Reagent; Model 657701; Lot No. 4344945, 5037611 and 5063945. Hematology - used as analyte specific reagent - contamination leads to possibility of unexpected staining pattern. | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 1 |
| 30 Oct 2015 | Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional Fluoroscopic X-ray for angiographic procedures. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 30 Oct 2015 | RBT, Internal Implant, Laser-Lok, 5.0 x 15mm, 5.7 Platform, REF LPBR5015, Rx only, Sterile R, BIOHORIZONS(R), Dental Implant | BioHorizons Implant Systems Inc | Device | Class II | 1 |
| 30 Oct 2015 | IQF FLAV-R-PAC Cut Wax Beans, there are 12/2 lbs. bags per case. Catalog # 07570. Product was distributed to Food Service accounts. The label has Cooking Directions and Safe Handling Instructions. The UPC 0 48800 07570 5 is observed on the bag. The Item No. 10048800075702 is observed on master case. The product is… (72573) | Norpac Foods, Inc. (Plant #8) | Food | Class II | 1 |
| 29 Oct 2015 | NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis. | NxStage Medical, Inc. | Device | Class II | 3 |
| 29 Oct 2015 | Brilliance 64 Computed Tomography X-ray system | Philips Medical Systems (Cleveland) Inc | Device | Class II | 6 |
| 29 Oct 2015 | NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 | NxStage Medical, Inc. | Device | Class II | 2 |
| 29 Oct 2015 | Skippy Creamy 25% Less Fat Reduced Fat Peanut Butter Spread Net Wt. 16.3 OZ (1 lb 0.3 OZ) 462g in plastic jars, UPC: 037600105002 | Hormel Foods Corporation | Food | Class II | 1 |
| 29 Oct 2015 | Natures Promise Organic Shelled Edamame, 16 oz., UPC 68826712764. Product is frozen. | Green Organic Vegetables Incorporated | Food | Class I | 2 |
| 28 Oct 2015 | DA-2006P - Defibrillator / Pacer Analyzer; Product Usage: Intended to measure the output of a defibrillator or transcutaneous pacemaker. (72619) | BC Group International Inc | Device | Class III | 1 |
| 28 Oct 2015 | rainbow Reusable Sensors. RAINBOW DCI-DC3, SpO2/SpCO/SpMet, Part No. 2201; RAINBOW DCI-dc8, SpO2/SpCO/SpMet, Part No. 2407; RAINBOW DCI, SpO2/SpCO/SpMet, Part No. 2696; RAINBOW DCIP, PED, SpO2/SpCO/SpMet, Part No. 2697. rainbow reusable sensors are indicated for spot check or continuous non-invasive monitoring of… | Masimo Corporation | Device | Class II | 1 |
| 28 Oct 2015 | DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. A manufactured device that adds a 6mm extension for a 25mm and 28mm tissue height capability suitable for individual patient needs. The thru hole in the DGDE allows existing surgical drills to be inserted and locked in place. | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 28 Oct 2015 | Syngo Imaging VB36D_HF02. Radiological image processing system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 28 Oct 2015 | ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular. | Baylis Medical Corp * | Device | Class II | 1 |
| 28 Oct 2015 | Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment. | Quest Medical, Inc. | Device | Class II | 1 |
| 27 Oct 2015 | IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation. | Carl Zeiss Meditec AG | Device | Class II | 2 |
| 27 Oct 2015 | Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their… | Lab Vision Corporation | Device | Class III | 1 |
| 27 Oct 2015 | U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic… (72596) | Procedure Products, Inc. | Device | Class II | 1 |
| 27 Oct 2015 | Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251. (72479) | Steris Corp | Drug | Class II | 1 |
| 27 Oct 2015 | Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550 | Geritrex Corp | Drug | Class II | 4 |
| 27 Oct 2015 | Doria AUTHENTIC ITALIAN GOODNESS, Amaretti BISCUITS, Net Wt. 8.81 oz (250g), UPC 799540801696, BAULI S.p.A Via Verdi, 31 37060 Castel d'Azzano (VR) Stabilimento di Via Pontebbana, 32 Orsago (Treviso) Italia. PRODUCT OF ITALY (72526) | Bauli | Food | Class II | 1 |
| 26 Oct 2015 | PROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. | Merz North America, Inc. | Device | Class II | 2 |
| 26 Oct 2015 | Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds. | Merz North America, Inc. | Device | Class II | 1 |
| 23 Oct 2015 | GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial… | GE Medical Systems, LLC | Device | Class II | 1 |
| 22 Oct 2015 | Avocado Leaves (Hoja De Aguacate), Net Wt. 10lbs (72706) | Santa Maura Spice & Garlic Co, Inc. | Food | Class I | 1 |
| 22 Oct 2015 | Curry Chicken Salad, Our Chefs Own, sold by weight UPC Code : 285551 | Whole Foods Market Group Inc. | Food | Class I | 10 |
| 21 Oct 2015 | Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes. | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution | Device | Class II | 1 |
| 21 Oct 2015 | LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicated for the removal of arterial emboli and thrombi. | LeMaitre Vascular, Inc. | Device | Class II | 13 |
| 20 Oct 2015 | Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate | Smith & Nephew, Inc. | Device | Class II | 2 |
| 20 Oct 2015 | SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary… | Pega Medical Inc. | Device | Class II | 1 |
| 20 Oct 2015 | Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98 (72607) | Teva Pharmaceutical Industries | Drug | Class III | 1 |
| 19 Oct 2015 | HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 600103-001 (Private Label), 2.0 mL in 3-mL Syringe, OASIS Medical Inc, 514 South Vermont Avenue Glendora, CA 91741 | Oasis Medical, Inc. | Drug | Class III | 3 |
| 19 Oct 2015 | Prostin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938 | Western Drug | Drug | Class II | 91 |
| 15 Oct 2015 | Cranberry Chipotle Spread, 10.5 oz, packed in glass jar with metal lid, inside a cardboard box (72487) | Something Special Deli-Foods Ltd. | Food | Class III | 1 |
| 14 Oct 2015 | Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation. | Philips Electronics North America Corporation | Device | Class II | 1 |
| 14 Oct 2015 | Palindrome" Chronic Catheter Kit Symmetrical Tip, Tal VenaTrac" Stylet 14.5 Fr/Ch (4.8mm) X 33 cm Item Number: 8888145042 The Palindrome chronic catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters grater than 40 cm implant… | Covidien LLC | Device | Class II | 5 |
| 14 Oct 2015 | HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only. | DeRoyal Industries Inc | Device | Class II | 1 |
| 14 Oct 2015 | Red Bull Total Zero Energy Drink, 12 fl.oz. (355ml), UPC CODE(S): ON THE CAN: 6 11269 62373 4; ON THE CASE: 6 11269 61505 0 (72444) | Red Bull North America Inc | Food | Class III | 1 |
| 13 Oct 2015 | Two-stage and three-stage I.V. poles are shipped as an optional accessory to a bed or stretcher. The I.V. poles are stationary, height adjustable stands intended to hold infusion liquids, infusion accessories, and/or other medical devices. They may be used on the following parent devices: Model 2030 (EPIC II),… | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 13 Oct 2015 | ALBACORE TUNA, sold under brand The Garibaldi Cannery, metal can, net weight 8 oz. (227 gram). No UPC | The Garibaldi Cannery, LLC | Food | Class II | 10 |
| 9 Oct 2015 | Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond,… | Qualgen | Drug | Class II | 2 |
| 9 Oct 2015 | Albacore Tuna in gold pouches with stick-on label reading in part: ***SKIPANON BRAND SEAFOOD ALBACORE TUNA***INGREDIENTS: Albacore Tuna, Sea Salt. NET WT. 48 OZ. ***" UPC: 58071 00148 Code on pouch beginning with OCK TUNA 3#. Label has green, yellow and blue background with multiple color lettering. Canned Albacore… | Skipanon Brand Seafoods LLC | Food | Class II | 15 |
| 8 Oct 2015 | Heng Cheong Loong Co., Net Wt: 10 oz. (5g), Plastic Bag, Product of U.S.A, UPC 6-930481-211418 | Tristar Food Wholesale Co Inc | Food | Class I | 1 |
| 7 Oct 2015 | Meijer Caramel Corn, packed in 10 oz. bags, ( 283 g), 12 bags per case | Meijer Distribution, Inc | Food | Class II | 1 |
| 6 Oct 2015 | Fat Bastard Gourmet Chick Dip Honey Roasted Hickory Smoke Sassy Barbecue, Net Wt. 12 Fl. Oz. (375 ml), UPC 8 91929 12702 8. The responsible firm name on the label is The Family Jewels, Montreal, MO 65591. (72307) | Individual firm, name withheld | Food | Class II | 1 |
| 6 Oct 2015 | Wylwood Mixed Vegetables Steam Bag Keep Frozen Net Wt / Peso 12 oz (340 g) , UPC 0 51933 02030 6. Product is packed in cases of 18-12 oz. bags. Distributed by/for: Save-A-Lot Food Stores Ltd., Earth City, MO 63045. | Save-A-Lot Food Stores Inc | Food | Class II | 2 |
| 1 Oct 2015 | The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants. (72436) | Powers Medical Devices, LLC | Device | Class II | 1 |
| 30 Sep 2015 | Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista System. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 29 Sep 2015 | Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction. | Alcon Research, Ltd. | Device | Class I | 1 |
| 28 Sep 2015 | Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook,… | Perrigo Company PLC | Drug | Class III | 1 |
| 27 Sep 2015 | Canned albacore tuna, Dungeness Seaworks brand, net weight 6 oz., packaged in metal cans. No UPC. | Individual firm, name withheld | Food | Class II | 5 |
| 25 Sep 2015 | MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous… | Medtronic MiniMed Inc. | Device | Class II | 2 |
| 24 Sep 2015 | ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, and XPT Chemistry Systems. For in vitro diagnostic use in the quantitative determination of Hemoglobin A1c, a diabetes marker, in whole blood on the ADVIA Chemistry systems. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 24 Sep 2015 | Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700. (72848) | Airways Development LLC | Device | Class II | 1 |
| 23 Sep 2015 | Daily Chef Peanut Butter Bars, Net Wt. 27 oz (1 lb 11 oz) 765g, Made in Canada, Manufactured for: CSM Bakery Products NA, Inc., Tucker, GA 30084 | CSM Bakery Products NA | Food | Class II | 1 |
| 22 Sep 2015 | Goodcents deli fresh subs Fresh Baked Giant Cookie, Chocolate Chip Cookie, Serving Size: 1 Cookie, Approx. NET WT. 2.5 oz. Frozen cookie dough is manufactured by Custom Foods Inc. De Soto, KS 66018. (72261) | Individual firm, name withheld | Food | Class I | 1 |
| 22 Sep 2015 | Founders Pride Chocolate Chip Cookies 120 - 2.5 oz frozen dough pieces packaged per case, Net Wt. 18.75 lbs. (8.50 Kg.) The responsible name on the label is Custom Foods, Inc., DeSoto, KS 66018. (72248) | Custom Foods Inc. | Food | Class I | 1 |
| 21 Sep 2015 | Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 18 Sep 2015 | Curley Parsley 4/5 lb packaged in cardboard box, UPC code 740695801109 (72222) | Individual firm, name withheld | Food | Class III | 1 |
| 18 Sep 2015 | HCC Basil Pesto FS and S; Houston Culinary Center Basil Pesto | Individual firm, name withheld | Food | Class III | 18 |
| 15 Sep 2015 | Basma 3 Chris Court Dayton, New Jersey 08810 Tel.:7323559600 Fax: 7323559644 16 oz package This golden raisin product is labeled in a foreign language. | UNITED TRADING CENTER INC | Food | Class I | 2 |
| 14 Sep 2015 | Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole | Valeant Pharmaceuticals North America LLC | Device | Class II | 1 |
| 14 Sep 2015 | CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices. (72197) | Biochemical Diagnostics Inc | Device | Class III | 1 |
| 11 Sep 2015 | One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. | Boston Scientific Corp | Device | Class II | 1 |
| 10 Sep 2015 | DeRoyal sterile custom surgical kits: 1) Emergency CABG Pack Pgybk, ref 89-7859.01 2) Emergency CABG Pack Pgybk, ref 89-7859.02 3) Open Heart Pack A&B Pgybk, ref 89-7750.02 4) Open Heart Pack A&B Pgybk, ref 89-7750.03 5) Intl-Cardiac Surgery Pack A&B Pgybk, ref 89-8514.02 GEO-MED sterile custom surgical kits: 1) Open… | DeRoyal Industries Inc | Device | Class II | 1 |
| 10 Sep 2015 | Texas Style HEB Charro Beans NET WT. 15 OZ (425g) in metal cans UPC: 041220927142. Texas Style HEB Charro Beans NET WT. 31 OZ (1.94 LB) 879g in metal cans UPC: 041220543692. | Durrset Amigos Ltd. | Food | Class II | 3 |
| 8 Sep 2015 | M&M Old Fashioned Gourmet Cookie Dough NET WT. 3 lb. (48 oz.) Distributed By: Tower Cafe, Okarche, OK 73762 packaged in plastic tub. | Tower Cafe Inc. DBA Okarche Bakery | Food | Class I | 4 |
| 4 Sep 2015 | Refine 3-Day Cleanse, a juice kit that contains Lean Green, 16 oz (6 bottles), Beet It, 16 oz (6 bottles), Almond Milk, 8 oz (3 bottles) and Wheat grass juice, 8 oz (2 bottles) (72148) | Individual firm, name withheld | Food | Class I | 1 |
| 3 Sep 2015 | AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity. | Summit Medical, Inc. | Device | Class II | 1 |
| 3 Sep 2015 | Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 3 Sep 2015 | Sprinkle King, Lime Green Sanding Sugar, 30611201.00N, UPC #30763089281012, NET WT: 150 lb (68.182 kg) | Kerry Foods | Food | Class II | 12 |
| 31 Aug 2015 | Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes. | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 28 Aug 2015 | GORGEOUS MEMORY brand Daylily, NET WT: 10.6 oz. (300 g), UPC 6 932960 968806, Product of China --- MINHANG FOOD CO., LTD, 103 Eldridge St., New York City, NY 10002 --- Nutrition Facts: Serving Size: 1 tbsp (100g), Servings Per Container: 4 (72414) | A & S Food Trading Inc. | Food | Class I | 1 |
| 28 Aug 2015 | DR. VENESSA'S FORMULAS ULTIMATE ANTIOXIDANT TABLETS DIETARY SUPPLEMENT, 120 count bottles, UPC 606851551205 (72074) | VRVK Nutraceuticals, LLC | Food | Class I | 1 |
| 25 Aug 2015 | Cumin Ground Product of India 50 lbs C/7784 (72295) | SHAKTI GROUP USA LLC | Food | Class II | 1 |
| 21 Aug 2015 | Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10 | Nephron Pharmaceuticals Corp. | Drug | Class II | 2 |
| 20 Aug 2015 | Salted Smoked Split Herring in bulk wooden boxes, Net Wt. 18 lbs., Product of Canada --- No label provided for bulk product. (72445) | P East Trading Corporation | Food | Class I | 1 |
| 20 Aug 2015 | The product is in the form of a salad kit. It contains two plastic bags and one plastic container. The contents are; salad 3.7 lbs/bag, arugula 2.5 oz/bag, and a 1.2 lb cup of dressing. | Brett Anthony Foods | Food | Class II | 1 |
| 17 Jul 2015 | Taco de Camar¿n con Imitaci¿n de King Crab (Shrimp with Imitation King Crab Taco). Label reads in part : " *** Soto Fabrica & Confecciones"*** Tacos de Camarones*** Mantenganse Congelado"*** Peso Neto 5 lbs(2.3 kg)*** Manufacturado por: Fabrica Confecciones Soto, Inc. calle Autonomia #81 Canovanas, PR 00729***" (71873) | Fabrica Confecciones Soto, Inc. | Food | Class I | 1 |
| 29 Jun 2015 | Vancomycin Screen Agar | Becton Dickinson & Co. | Device | Class II | 2 |
| 8 Jun 2015 | 2-DEOXY-D-GLUCOSE Powder, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Life Science Pharmacy Inc | Drug | Class II | 23 |
| 8 May 2015 | Del Pasado Dice Green Chiles 100% Fire Roasted and Peeled NET WT. 6 LB 3 OZ (2.81 kg) packaged in #10 steel cans (72135) | Bruce Foods Corporation | Food | Class II | 1 |
| 14 Apr 2015 | Philips Healthcare Brilliance 64 Computed Tomography X-ray system | Philips Electronics North America Corporation | Device | Class II | 4 |
| 27 Mar 2015 | The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display… (70931) | Visicu, Inc. | Device | Class II | 1 |
| 3 Feb 2015 | Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics,… | Philips Medical Systems, Inc. | Device | Class II | 9 |
| 19 Dec 2014 | Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip… | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 21 Aug 2014 | Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system. | Philips Medical Systems, Inc. | Device | Class II | 1 |
| 19 Aug 2014 | Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037 | Philips Medical Systems, Inc. | Device | Class II | 2 |
| 9 Jun 2014 | Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001). (72695) | Arthrosurface, Inc. | Device | Class II | 1 |
| 17 Apr 2014 | Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column | Teleflex Medical | Device | Class II | 1 |
| 11 Apr 2014 | GOLDEN SMELL brand Hot Pot Meat Ball Medly, NET WT:1 LB (454g), UPC 8 881028 964381, Product of China -- Distributor: Strong America Ltd., 2-39 4th Ave., Long Island City, NY 11101 --- Nutrition Facts information: Serving Size: 1 oz (28g), Servings Per Container: 16 (68258) | Strong America Limited | Food | Class I | 1 |
| 3 Mar 2011 | Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running version 2.6.0. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 25 Apr 2006 | Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |