| 7 Apr 2016 | Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01. | Fresenius Kabi USA, LLC | Drug | Class III | 1 |
| 5 Apr 2016 | Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10 | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 31 Mar 2016 | Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on… | Biocare Medical, LLC | Device | Class III | 1 |
| 31 Mar 2016 | Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30. (73709) | Purdue Pharma L.P. | Drug | Class III | 1 |
| 31 Mar 2016 | Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33. | Amerisource Health Services | Drug | Class III | 2 |
| 29 Mar 2016 | Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); 3. L-DCL-8DINX (8 contacts: 1 terminal block with 8 connectors each); 4. L-DCL-16BDINX (16… | Ad-Tech Medical Instrument Corporation | Device | Class II | 1 |
| 28 Mar 2016 | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological,… | Philips Ultrasound, Inc. | Device | Class II | 1 |
| 28 Mar 2016 | The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor. | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 28 Mar 2016 | Boston Scientific, PT Graphix Magnet J-TIP Guidewire with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) . Boston Scientific PT Graphix Magnet Guidewire with ICE Hydrophilic Coating is a steerable guidewire available with a nominal diameter… | Boston Scientific Corporation | Device | Class II | 1 |
| 24 Mar 2016 | CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used… | Abbott Laboratories | Device | Class II | 1 |
| 24 Mar 2016 | Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134 (73699) | Biocon Inc | Drug | Class III | 1 |
| 24 Mar 2016 | Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30. | AbbVie Inc. | Drug | Class III | 1 |
| 24 Mar 2016 | GERBER Organic 2ND FOODS Pears, Carrots & Peas, 3.5 oz., film pouches, 6 pouches per display box/ 2 display boxes per case; Asst Ecom PK2 18 pc, 3.94 Lbs. | Nestle Infant Nutrition | Food | Class II | 2 |
| 22 Mar 2016 | Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 306. Product Usage: The Self-Cath intermittent urinary catheter discussed in this document is a pediatric size CH06 French catheter. The catheter is indicated for use by patients with chronic urine retention and patients with a post void… | Coloplast Manufacturing US, LLC | Device | Class II | 1 |
| 22 Mar 2016 | Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature. | Boston Scientific Corporation | Device | Class I | 1 |
| 22 Mar 2016 | Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear, Nose and Throat (ENT) Sonopet Portfolio. They are removable attachments intended to be used with the Sonopet Ultrasonic… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 22 Mar 2016 | SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 21 Mar 2016 | SurgiCounter scanner, part of the SurgiCount Safety-Sponge System. Model numbers 0694-097-000 and 0694-097-001. Product Usage: The SurgiCount Safety Sponge System is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges, and towels used during surgical… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 21 Mar 2016 | GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil Sterile; Model number: M0033471020SR0; Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that because of their morphology, their location, or the patients general medical condition are considered by the treating… | Individual firm, name withheld | Device | Class II | 2 |
| 18 Mar 2016 | BD-Retic-Count Reticulocyte Reagent System; Hematology: Used for in vitro diagnostics | Becton, Dickinson and Company, BD Biosciences | Device | Class III | 1 |
| 18 Mar 2016 | RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | Device | Class II | 1 |
| 17 Mar 2016 | Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthroplasty. REF 42-5114-005-14 | Zimmer Manufacturing B.V. | Device | Class II | 2 |
| 17 Mar 2016 | Cygnus Medical First StepBedside ADDWATER Kit,non-sterile. First Step in cleaning flexible endoscopes. SKU# EP-6W (The First Step 500 ml ADD WATER Kit comes with concentrated Simple2" Enzymatic Detergent and a cleaning pad in a re-sealable stand-up pouch). (73568) | Cygnus Medical | Device | Class III | 1 |
| 17 Mar 2016 | Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02 | Impax Laboratories, Inc. | Drug | Class III | 2 |
| 17 Mar 2016 | Thai Fusion Outpost, net weight 5.1 oz. UPC 0 99853 34255 9. Thai Fusion Bulk bag, packaged in a ziploc plastic bag, net weight 3 lbs. UPC 0 99853 35255 8. Thai Fusion On the Go, packaged in microwave able paper cup with plastic lid, net wt. 3.4 oz. UPC 0 99853 38255 5. (73558) | Paradise Farm Organics Inc | Food | Class I | 1 |
| 17 Mar 2016 | Chicken of the Sea 5 Oz. Canned Chunk Light Tuna in Oil, 48 cans per case, UPC code is 0 4800000195 5 | Tri-Union Seafoods, L.L.C dba Chicken of the Sea. | Food | Class II | 2 |
| 16 Mar 2016 | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic: iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior… | Optovue, Inc. | Device | Class II | 1 |
| 16 Mar 2016 | da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory. Product Usage: The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic… | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 16 Mar 2016 | Hill Country Fare Chunk Light Tuna in pure vegetable oil NET WT. 5 OZ (142g) packaged in a metal can. | HEB Retail Support Center | Food | Class II | 1 |
| 16 Mar 2016 | Bumble Bee Chunk Light Tuna in Water, 48cans/case, 5oz, UPC 8660000020 | Bumble Bee Foods LLC | Food | Class II | 3 |
| 15 Mar 2016 | MEVION S250 for Proton Radiation Therapy | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 15 Mar 2016 | Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side. | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 14 Mar 2016 | CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In… | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 14 Mar 2016 | Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine. | Ossur H / F | Device | Class II | 6 |
| 14 Mar 2016 | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. | Meditech Laboratories, Inc | Drug | Class II | 7 |
| 14 Mar 2016 | Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10 | Impax Laboratories, Inc. | Drug | Class II | 2 |
| 11 Mar 2016 | Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 11 Mar 2016 | TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis | Smith & Nephew, Inc. | Device | Class II | 15 |
| 11 Mar 2016 | SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05 | Jubilant Draximage Inc | Drug | Class III | 1 |
| 11 Mar 2016 | All Day Energy Greens (ADEG), Original Flavor, Net Wt 11.36 oz (322g), UPC Code 893320002096 | Naturmed Inc DBA Institute for Vibrant Living | Food | Class II | 2 |
| 10 Mar 2016 | Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis… | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 10 Mar 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 10 Mar 2016 | #2473 CINCINNATI STYLE CHILI Savory Net Wt. 4 lbs (1.8kg) UPC 0 90939 12473 1 GOLD MEDAL PRODUCTS 10700 MEDALLION DRIVE CINCINNATI, OHIO 45241 (73457) | Gold Medal Products Co | Food | Class I | 1 |
| 10 Mar 2016 | Favorites Natural Pistachios, roasted & salted, 4.5 oz (128g) pouch UPC 0 38445 12286 5 Proudly distributed by Circle K Stores, Inc. P.O. Box 52085 Phoenix, AZ 85072 www.circlek.com | Kanan Enterprises, Inc. | Food | Class I | 1 |
| 10 Mar 2016 | The product is labeled as follows: PediaSure Grow & Gain Vanilla, Unit size : 8 oz. , Container description : Metal Can, Total package size : 24 cans per case . | Abbott Nutrition | Food | Class II | 1 |
| 10 Mar 2016 | Korea chopped Kimchee packaged in 1 gallon, 1/2 gallon, 1/4 gallon, and 1/8 gallon packaged in glass jars inside plastic containers with multi colored label and black lettering. | Individual firm, name withheld | Food | Class I | 3 |
| 9 Mar 2016 | All instrumentation associated with the Prelude PF Resurfacing Knee System. | Biomet, Inc. | Device | Class II | 1 |
| 9 Mar 2016 | Cheesy Pepper Jack Wrapped In A Battered Flour Tortilla For Institutional Use Only. Net Weight 4.5 lb 2 kg packaged in a cardboard box with black inkjet printing. (73482) | Ruiz Food Products Inc | Food | Class II | 1 |
| 8 Mar 2016 | Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures. (73460) | Pelton & Crane / Marus / DCI Equipment / KaVo | Device | Class II | 1 |
| 8 Mar 2016 | Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient. | ICU Medical, Inc. | Device | Class II | 6 |
| 8 Mar 2016 | Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5 | Hospira Inc. | Drug | Class II | 6 |
| 8 Mar 2016 | DUTCH FARMSTEAD CHEESE SMOKED PLAIN GOUDA (73478) | Individual firm, name withheld | Food | Class I | 1 |
| 8 Mar 2016 | Tuna Salad Sandwich, Net Wt. 4.5 oz (128g) sold under the following brands and UPC: 1. SuperMom's Bakery, UPC: 76391380124; 2. TakeAway Cafe, UPC: 76391310702; 3. Express Cafe, UPC: 76391380124 Keep Refrigerated. | Northern Tier Bakery (dba\ Super Mom's) | Food | Class I | 1 |
| 7 Mar 2016 | MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated | Viewray Incorporated | Device | Class II | 1 |
| 7 Mar 2016 | VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated. | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK | Device | Class II | 1 |
| 7 Mar 2016 | Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estradiol antibodies (rabbit) 2.5 ng/m and 4.5 ng/mL Mesterolone 130 ng/mL; R2 Estradiol derivative, labeled with ruthenium… | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 4 Mar 2016 | The Spectra-System Dental Implant 2008 system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. GoDirect Implants Part Number: 423011, 423013, 424708, 424710, 424713,433010,433710 | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 4 Mar 2016 | Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human… | Vascular Solutions, Inc. | Device | Class I | 1 |
| 4 Mar 2016 | BARD ArcticGel Pads Product Usage: The Arctic Sun Temperature Management System is intended for monitoring and controlling patient temperature. ArcticGel Pads are only for use with an Arctic Sun Temperature Management System Control Module. | C.R. Bard, Inc. | Device | Class II | 1 |
| 4 Mar 2016 | Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH. Provides software applications used to process, analyze, and display medical images/data. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 3 |
| 4 Mar 2016 | Novo Bnei Darom Green Olives in Jar, 48 cases, 6 jars, 1.04kg, UPC Code 7290002016175 (73476) | International Trading & Import I | Food | Class III | 1 |
| 4 Mar 2016 | Wellco Super Elixir Pouches The Super Elixir 150g, 300g (73501) | Healthy Solutions LLC | Food | Class I | 1 |
| 4 Mar 2016 | DELPHI GREEK PEPPERONCINI; Peppers, Water, Salt, Vinegar, Citric Acid, Sodium Benzoate. INTERNATIONAL FOODS, INC. BURLINGTON, VT 05401 NET Weight 3 lb. 8 oz. Product is stored at ambient temperature. (73415) | Constantine Poulos and Company dba International Foods, Inc. | Food | Class II | 1 |
| 4 Mar 2016 | VA Kit Roasting Brussel Sprouts, Item #72893. Each case contains 2/6.15 lb. bags. The UPC is 0 20728 72893 2 | Pacific Coast Fruit Company | Food | Class I | 1 |
| 4 Mar 2016 | 33 Kopobbi A WHOLE MILK CHEESE, Ricotta, Net Weight: 17.14 lb. (73447) | Delicious Food Distributors Inc | Food | Class I | 1 |
| 4 Mar 2016 | Puredesi Whole Milk Yogurt in 5 lb. plastic containers Patidar Whole Milk Yogurt in 5 lb. plastic containers Puredahi Whole Milk Yogurt in 5 lb. plastic containers Sell by: 5/08/2016 | JRZ Dairy Products Inc. | Food | Class II | 2 |
| 4 Mar 2016 | GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, 6 x12, 1 x 18, 1 x 48, 1 x100, 36 x 4, Mighty Mango Fruit & Veggies on the Go, (Apple/Mango/ButternutSquash) Flavor Variety | Materne North America Corp | Food | Class II | 17 |
| 3 Mar 2016 | TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01 | ArthroCare Corporation | Device | Class II | 1 |
| 3 Mar 2016 | Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle, Rx Only, Mfd. By: Gland Pharma Limited D.P. Pally - 500 043 INDIA NDC 55111-688-52 (73527) | Individual firm, name withheld | Drug | Class II | 1 |
| 3 Mar 2016 | Hidden Valley Original Ranch dressing, 16 fl oz. ( 473 ml). plastic bottles; Ingredients: Vegetable oil (soybean and/or Canola oil) water, egg yolk, sugar, Salt, Cultured non fat buttermilk, natural flavors (milk, soy), less than 1% spiced, dried garlic, dried onion, vinegar, phosphoric acid, xanthan gum, modified… (73446) | Clorox Co (The) | Food | Class III | 1 |
| 2 Mar 2016 | Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body. Computed tomography (CT) x-ray system. | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 2 Mar 2016 | MAGGI Chicken Flavor Bouillon 6Tab, 12Tab UPC Codes: 028000247959, 028000115678, 028000115678 | Nestle USA | Food | Class II | 1 |
| 2 Mar 2016 | Starbuck's Cheese & Fruit Bistro Box NET WT 5.3 OZ/150g packaged in non-flexible plastic container. (73490) | Flying Foods LLC | Food | Class II | 1 |
| 2 Mar 2016 | L'Bri Pure N' Natural Nutri Aloe Health Juice Drink 960 mL 32 FL. OZ. and L'Bri Pure N' Natural Nutri Aloe Health Juice Drink 1 FL OZ./29 mL (73443) | Cosmetic Labs LP | Food | Class III | 1 |
| 2 Mar 2016 | Wild Smoked Pink Salmon, 4-7 ounce portions in clear plastic package. No UPC. Label is read in parts: "***Smoked PINK SALMON***KEEP REFRIGERATED BELOW 38F***LOKI FISH CO***SEATTLE-WA***". (73437) | Loki Fish Company | Food | Class I | 1 |
| 2 Mar 2016 | Prosupps Dr. Jekyll INTENSE PUMP PRE WORKOUT, 30 SERVINGS, WATERMELON NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 11.1 OZ (315 GRAMS) packaged in red plastic jars with black lids. | ProSupps USA LLC | Food | Class II | 5 |
| 1 Mar 2016 | SIGNA Pioneer MR Systems Product Usage: The SIGNA Pioneer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic… | GE Medical Systems, LLC | Device | Class II | 1 |
| 1 Mar 2016 | VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the… | Alcon Research, Ltd. | Device | Class II | 1 |
| 1 Mar 2016 | Seasons Choice Prince Edward Medley Net Wt. 16 oz. Distributed by: Aldi Inc. Batavia, IL 60510 Product of Netherlands UPC will be entered. (73496) | Camericam International Inc | Food | Class II | 1 |
| 1 Mar 2016 | Almonds, dry roasted, not salted, packaged in 25 lb. cardboard cartons | Specialty Commodities, Inc. | Food | Class II | 1 |
| 29 Feb 2016 | ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL (72921) | Karl Storz Endovision, Inc. | Device | Class II | 1 |
| 29 Feb 2016 | Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant. | Cardinal Health | Device | Class II | 1 |
| 29 Feb 2016 | Whole Foods Market Maytag Blue Cheese, Maytag Blue Raw Milk, Maytag Iowa Blue Cheese cut and wrapped in clear plastic wrap, Dist. by Whole Foods Market 550 Bowie Street Austin, TX 78703, PLU: 0293308 | Whole Foods Market | Food | Class I | 1 |
| 29 Feb 2016 | Linda's Salsa Mild in 16 oz. glass jars | Flowers For Less | Food | Class II | 4 |
| 26 Feb 2016 | system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 26 Feb 2016 | The E.CAM gamma camera system Product Usage: The E.CAM gamma camera system is a SPECT system and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body | Siemens Medical Solutions USA, Inc. | Device | Class II | 2 |
| 26 Feb 2016 | Fresenius Hemoflow F3 Dialyzer Part Number: 0520165A Indicated for Acute and Chronic Hemodialysis | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 25 Feb 2016 | TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest… (73381) | Scottcare Corporation | Device | Class II | 1 |
| 25 Feb 2016 | 74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341. | ICU Medical, Inc. | Device | Class II | 8 |
| 25 Feb 2016 | Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4. (73466) | Torrent Pharmaceuticals Limited | Drug | Class III | 1 |
| 25 Feb 2016 | Air dried Organic Spinach Powder packaged in 50 lb. polyethylene liner inside of a cardboard box. | R.J. Van Drunen & Sons Field Facility | Food | Class I | 2 |
| 24 Feb 2016 | IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries, contamination and infection. To be used in… (73324) | Individual firm, name withheld | Device | Class II | 1 |
| 24 Feb 2016 | Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide protection from debris or impact to the patella while a patient participates in motocross activities. | Ossur H / F | Device | Class II | 14 |
| 24 Feb 2016 | Jack and the Green Sprouts, Alfalfa Sprouts, Net Wt 5 oz (142 g), UPC 7 6324719891 5 Retail: 5 oz clam shell (cup) . Shipping cases hold 12 x 5 oz or 6 x 5 oz clam shells. | Jack And The Green Sprouts, Inc. | Food | Class I | 2 |
| 23 Feb 2016 | Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously. | Medtronic Inc. | Device | Class II | 1 |
| 23 Feb 2016 | QUADROX-i oxygenators Custom tubing packs for the oxygenator | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 4 |
| 23 Feb 2016 | Titanium Low Profile Neuro Screw, Self Drilling, 3mm, part numbers: 400.833, 400.833E Product Usage: The Low Profile Neuro Plating System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla… | Synthes (USA) Products LLC | Device | Class II | 2 |
| 23 Feb 2016 | X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. | X-NAV Technologies, LLC | Device | Class II | 1 |
| 23 Feb 2016 | Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes. | Dexcom Inc | Device | Class I | 6 |
| 23 Feb 2016 | Original Hummus 9oz container | True Nature LLC | Food | Class II | 3 |
| 22 Feb 2016 | Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#: M3-175) GL-Single Plate 230mm2 (IOP reorder#: M3-230) (73386) | Innovative Ophthalmic Products, Inc | Device | Class II | 1 |
| 21 Feb 2016 | H-E-B Tartar Sauce 8 oz. UPC: 41220 33244 (73347) | Fresh Creative Foods | Food | Class I | 1 |
| 19 Feb 2016 | AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 19 Feb 2016 | CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information | Medtronic MiniMed Inc. | Device | Class II | 1 |
| 19 Feb 2016 | Cios Alpha, mobile X-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 19 Feb 2016 | Sweetwater Sprouts 100% Pure Sprouted Alfalfa packaged in the following configurations: 4 oz. plastic bags (UPC 7 56733 00104 2) packed 12 per case; 16 oz. (1 lb.) plastic bags; and 5 lb. bulk boxes The product is shipped in cardboard cases labeled with product and lot number. The responsible name on the label is… | Sweetwater Farms LLC | Food | Class I | 3 |
| 18 Feb 2016 | Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires… | Synthes (USA) Products LLC | Device | Class II | 1 |
| 18 Feb 2016 | AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed… | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 18 Feb 2016 | Kroger Brand Chicken Salad Croissant Sandwiches packaged in individual clear rigid plastic clamshell containers packaged in 6 brown corrugated card board boxes, 6 to a case, for a total of 36 sandwiches. Cases identified with white stick on label with black ink printing reading "Chicken Salad Croissant Sandwich … (73358) | Mt Perry Foods Inc | Food | Class I | 1 |
| 18 Feb 2016 | Country Life Natural Foods Labeled SHELLED PISTACHIOS RAW NET WT. 2lb (906 g) plastic bags item 030244 and Batch 1357 batch number 1357 in the lower left corner of the label | Oak Haven, Inc dba Country Life Natural Foods. | Food | Class I | 2 |
| 18 Feb 2016 | Chef Hon brand STEAMED BUNS WITH SEAFOOD & VEGETABLE, Net Wt. 1 lb. 8 oz. (682g), UPC 7 47518 00156 2, Product Code # 69, KEEP FROZEN --- Peking Food LLC Brooklyn, NY | Peking Food LLC | Food | Class I | 2 |
| 17 Feb 2016 | Acorn 180 Curved Stairlift (73509) | Acorn Stairlifts Inc | Device | Class II | 1 |
| 17 Feb 2016 | GE Healthcare, Aisys CS2 anesthesia.. | GE Medical Systems, LLC | Device | Class II | 2 |
| 16 Feb 2016 | Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument | Synthes (USA) Products LLC | Device | Class II | 1 |
| 16 Feb 2016 | VITROS 5600 Integrated System, Unique Device Identifier No. 10758750002740 & 10758750007110. Intended for use in the in vitro measurement of a variety of analytes of clinical interest. | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 16 Feb 2016 | Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and embedding of histological and cytological… | Richard-Allan Scientific Company | Device | Class III | 1 |
| 16 Feb 2016 | CIOS ALPHA (Image-intensified fluoroscope x-ray system) Product Usage: The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 16 Feb 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11. | Actavis Elizabeth LLC | Drug | Class II | 4 |
| 15 Feb 2016 | Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. | Siemens Medical Solutions USA, Inc | Device | Class II | 8 |
| 15 Feb 2016 | Blue Ridge Farms Vinegar & Oil Cole Slaw, 03010, Net Weight: 1 X 10 LB., Keep Refrigerated; Use by: 3/09/16, 3/20/16, 3/20/16; Lot # 425, 429, 436; Packed by Winter Gardens Quality Foods, Inc, New Oxford, PA 17350 Picnic Cole Slaw; 2493 Net Weight: 10lbs; Keep Refrigerated; Use By: 03/22/16, 03/23/16; Lot #438, 439;… | Winter Gardens Quality Foods, Inc. | Food | Class II | 10 |
| 12 Feb 2016 | 10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in… | Biomet Spine, LLC | Device | Class II | 1 |
| 12 Feb 2016 | Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. | Apace KY LLC | Drug | Class III | 1 |
| 12 Feb 2016 | Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04 | Walter's Pharmacy | Drug | Class II | 13 |
| 12 Feb 2016 | 45532-ATL : Atlantic Food Distributors Premium Clear Liquid Fry Shortening 35 lb. ; 45531-ATL : Atlantic Food Distributors Premium Creamy Liquid Fry Shortening 35 lb. ; 45531-CHP : Chef's Pride Creamy Liquid Fry Shortening 35 lb. ; 45531-UBA : Creamy Liquid Fry Shortening 35 lb. ; 45532-FAR : Frosty Acres… | Ventura Foods Calttn Hq Ap Bulk Oil | Food | Class II | 4 |
| 12 Feb 2016 | Burger King Liquid Frying Oil, Net Wt. 35 LB (15.9 kg), Miami, Florida 33126, UPC 2 06 75258 06956 3 | Stratas Foods Llc | Food | Class II | 5 |
| 11 Feb 2016 | USE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by US Endovascular, St. Louis, MO. (73171) | Individual firm, name withheld | Device | Class II | 1 |
| 11 Feb 2016 | MicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No. 10638819, 10638820, 10638823, 10638824, 10638825,10638826, 10714149,10714159, 10805072, 10805073, 10975000, 10975001, 6000-0008, 6000-0026. Japan: 10638819 LabPro v4.11 Software Update Kit 10638820 LabPro v4.11 System Software… | Beckman Coulter Inc. | Device | Class II | 1 |
| 11 Feb 2016 | Trio¿ Low Sodium Brown Gravy, 16 ounce, flexible pouch, NET WT 16 OZ CONTAINS: MILK, SOY, WHEAT, INGREDIENTS MAY CONTAIN EGGS DISTRIBUTED BY: NESTLE PROFESSIONAL NORTH AMERICA SOLON, OH 44139 | Nestle USA | Food | Class II | 1 |
| 10 Feb 2016 | Simplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452, MOL1455) Model Number: MOL2150, MOL1451, MOL1452, MOL1455 | Focus Diagnostics Inc | Device | Class I | 3 |
| 10 Feb 2016 | evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur | Philips Electronics North America Corporation | Device | Class II | 2 |
| 10 Feb 2016 | Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18 | Pfizer Inc | Drug | Class III | 1 |
| 10 Feb 2016 | Pistachio Raw Whole Shelled 9-oz. retail plastic tub or 5-lb. bulk plastic bag. 12, 9-oz tubs per case. 1, 5# bag per case. | Lipari Foods, Inc. | Food | Class I | 2 |
| 9 Feb 2016 | Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide. (73426) | Individual firm, name withheld | Device | Class II | 1 |
| 8 Feb 2016 | MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula | MicroAire Surgical Instruments, LLC | Device | Class II | 1 |
| 8 Feb 2016 | MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device | MicroAire Surgical Instruments, LLC | Device | Class II | 1 |
| 5 Feb 2016 | Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer | Biomet, Inc. | Device | Class II | 1 |
| 5 Feb 2016 | Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes | Philips Medical Systems (Cleveland) Inc | Device | Class II | 6 |
| 5 Feb 2016 | Cittero Mortadella, packaged in deli bags. This is a deli service item. | Bj Wholesale Club | Food | Class I | 71 |
| 4 Feb 2016 | Bard TruGuide Disposable Coaxial Biopsy Needle Product Usage: The TruGuide Disposable Coaxial Biopsy Needles are intended for use as a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 1 Feb 2016 | Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. . (73468) | Laserex Systems Inc. | Device | Class II | 1 |
| 27 Jan 2016 | Figi's Classic Marzipan, item 100-0034-200, 8 ounce | Figi's, Inc | Food | Class I | 1 |
| 26 Jan 2016 | AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who cannot absorb adequate nutrition through the stomach. | Applied Medical Technology Inc | Device | Class II | 1 |
| 26 Jan 2016 | Brians Cauliflower 83 oz Imported by EUROPEAN NATURAL FOOD & TRADING CO. Inc, 72 Lehigh Avenue Paterson, NJ 07593 UPC 858567002421 (73186) | European Natural Foods & Trading Company, Inc. | Food | Class I | 1 |
| 18 Jan 2016 | A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 15 Jan 2016 | OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device. | OraSure Technologies, Inc. | Device | Class III | 1 |
| 15 Jan 2016 | VPro Raw Plant Protein, Mocaccino. Packaged in a plastic bottle with green, white, and black adhesive label. Packaged in 1 lb (15 serving) and 2 lb (30 serving). | NutraKey, Inc. | Food | Class I | 4 |
| 15 Jan 2016 | Trader Joe's Nuts Raw Cashew Pieces NET Wt. 18 oz (1 LB) UPC Code: 0050 5154 Product of Thailand, Vietnam, & India Packaged in Thailand (73089) | Heritage International | Food | Class I | 1 |
| 13 Jan 2016 | The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit) (73157) | PMBS, LLC | Device | Class II | 1 |
| 12 Jan 2016 | MATLAW'S Raw - EZ Peel - Deveined - Shell On Shrimp. NET WT. 2 LBS (32 OZ.) .907 KG (8-12 COUNT PER POUND), packaged in a plastic bag. The plastic bags are shipped in a cardboard master carton, which is labeled in part " MATLAW'S INDIVIDUALLY QUICK FROZEN FROZEN SHRIMP Farm Raised Product of: Vietnam Distributed by:… (73065) | National Fish & Seafood, Inc. | Food | Class I | 1 |
| 11 Jan 2016 | Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 11 Jan 2016 | Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixation post, a distribution bridge or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons. | Arthrex, Inc. | Device | Class II | 1 |
| 8 Jan 2016 | Medix NatalCare ST-LX Intensive Care Incubator. Neonatal incubator. | Natus Medical Incorporated | Device | Class II | 1 |
| 7 Jan 2016 | Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device Product Usage: Clear Vue Prone Breast Treatment Table and Access ClearVision Prone Breast Device is a medical charged-particle radiation therapy system. A breast radiation therapy patient support, is an accessory for medical linear… (73543) | Wfr/aquaplast Corp | Device | Class II | 1 |
| 7 Jan 2016 | Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | Customed, Inc | Device | Class II | 100 |
| 7 Jan 2016 | 1) COMPOUNDED ASAFOETIDA POWDER L.G.¿, NET WT. 50g (1.75OZ.), MANUFACTURED BY: LALJEE GODHOO & CO. 213, Samuel Street, Mumbai - 400 003, (INDIA) MANUFACTURED AT: LALJEE GODHOO & CO. Plot No. 53/4, Road 7/15, M.I.D.C.,Andheri (E). Mumbai - 400 093. (INDIA) Lot No., Pkd & Best Before See Bottom LOT NO. 2323" 2)… (73020) | SHAKTI GROUP USA LLC | Food | Class I | 1 |
| 6 Jan 2016 | Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879 | Synthes (USA) Products LLC | Device | Class II | 1 |
| 31 Dec 2015 | Cucumbers packed in 1 1/9 cardboard bushel boxes (~55-lb) and 1000-lb cardboard bins. Refrigerate at 40-60 degF. Pick date of 12/15/2015. (73001) | Thomas Produce Co. | Food | Class I | 1 |
| 23 Dec 2015 | SERVATii Pastry Shop & Deli 12" Christmas Cookie Tray INGREDIENTS: ***Butter, Margarine***Nuts***1.51lb(682gr) EUROPEAN SPECIALTIES Cincinnati, Ohio 45227 UPC 0 36746 03992 9 (72875) | Servatii Inc | Food | Class II | 1 |
| 22 Dec 2015 | CA500 Epix Universal Clip Applier Product Usage: The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. | Applied Medical Resources Corp | Device | Class II | 4 |
| 22 Dec 2015 | Uoriki Octopus Salad Net Weight 2.5 lbs Two 2.5lbs pack per case packaged in Black trays covered w/cryovac 10k film no barcode. packaged at Wegman's deli counter for further consumption. (72940) | Uoriki Fresh Inc | Food | Class I | 1 |
| 21 Dec 2015 | The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use. | Arjo, Inc. dba ArjoHuntleigh | Device | Class II | 1 |
| 21 Dec 2015 | The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX¿… (73012) | Therakos Inc | Device | Class II | 1 |
| 21 Dec 2015 | NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep). | Northeast Laboratory Services, Inc. | Device | Class II | 2 |
| 18 Dec 2015 | BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure. | C.R. Bard, Inc. | Device | Class II | 3 |
| 17 Dec 2015 | VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305 | Virtus Pharmaceuticals, Llc | Drug | Class III | 1 |
| 17 Dec 2015 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51 (72819) | Bio-pharm, Inc. | Drug | Class III | 1 |
| 17 Dec 2015 | Native Catch Salmon Bacon, Traditional flavor. UPC 7 83583 27965 9. Traditional Salmon Bacon is ground and seasoned skinless/boneless salmon, extruded, peppered, smoked, cooled and vacuum packed in 8 oz., 14 oz., and 5 lbs. clear vacuum bags. Label states keep refrigerated or frozen". | Swinomish Fish Company, Inc | Food | Class II | 2 |
| 16 Dec 2015 | Cardiosave Hybrid and rescue IABP | Maquet Datascope Corp - Cardiac Assist Division | Device | Class II | 1 |
| 16 Dec 2015 | GE Inspection Technologies, LP, Cabinet X-ray system used for industrial quality control. | GE Inspection Technologies, LP | Device | Class II | 1 |
| 8 Dec 2015 | SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults. | Synthes (USA) Products LLC | Device | Class II | 5 |
| 8 Dec 2015 | Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx Only, Manufactured by Genzyme Corportation, Cambridge, MA 02142, NDC 58468-0160-1 | Genzyme Corporation | Drug | Class III | 1 |
| 7 Dec 2015 | Morrison's Premium White Corn Meal Enriched NET WT 5 LB (2.27 kg); Morrison's Premium White Corn Meal Self-Rising Mix Enriched NET WT 5 LB (2.27 kg); Hill Country Fare Enriched White Cornmeal NET WT. 32 OZ (2 LBS); Great Value Self-Rising White Corn Meal Mix Enriched NET WT 5 LB (2.27 kg); Pioneer Enriched White Corn… | C. H. Guenther & Son, Inc.dba Morrison Milling | Food | Class III | 81 |
| 4 Dec 2015 | Chuka Ika Sansai ECO - International name and Natural Chuka Ika Sansai for US (Seasoned Squid Salad); Net Wt.: 4.4 lbs. (2 kg) for US customer: 2.2 lbs. (1 kg) for European customer. Second lot: Net Wt. 2.2 lbs (8 pkg/1 kg) for European customer 4.4.lbs (2 kg) Shelf life is 24 months for US, 18 months for EU customer… | Azuma Foods International Inc USA | Food | Class I | 1 |
| 2 Dec 2015 | Gutierrez Distributor, (a) Tarugo con chile spicy tamarind, 349 Chestnut Street, Passaic, NJ 07055 UPC 8527050000904 (b) Dulce de pulpa 100% de Tamarindo, Betamex, Alamos No.7 STA. Maria Aztahuacan Deleg. Iztapalapa C.P. 09500 Mexico, D.F. (72850) | Gutierrez Distributors, LLC | Food | Class III | 1 |
| 2 Dec 2015 | Crispers Honey Lime Dressing, 1 GL, Distributed by Bay Valley Foods, LLC, Oak Brook, IL 60523 (72771) | Bay Valley Foods | Food | Class I | 1 |
| 19 Nov 2015 | Teriyaki hot smoked Atlantic salmon, Teriyaki hot smoked King salmon, Teriyaki hot smoked Sockeye salmon, Teriyaki hot smoked salmon (no species listed). Product was packed in bulk cases, 10 lbs. each, sold in bulk bin. There are no retail packages and NO UPC. (72722) | Jensens Old Fashioned Smokehouse Inc | Food | Class II | 1 |
| 10 Nov 2015 | Colostrum Powder, Dietary Supplement, Allergen statement: contains dairy. Colostrum (bovine) packaged in the following sizes and brand names: 1. PerCoBa Extra Edge Net Weight 150 grams, UPC 90576-00099. 3,000 mg Colostrum (bovine) per 2 teaspoons. Immuno-Dynamics, Inc., 1800 Dodge Street, Fennimore, WI 53809; 2.… | Immuno - Dynamics, Inc | Food | Class II | 5 |
| 9 Nov 2015 | Wild Mushroom Soup packaged in a 24 oz clear plastic container with green and white label and green lettering. | Brett Anthony Foods | Food | Class I | 1 |
| 6 Nov 2015 | YumEarth Organics Gummy Bears 5 oz. Distributed by YummyEarth Inc., Ramsey, NJ 07446 UPC 810165018310 | Yummy Earth Inc | Food | Class II | 3 |
| 4 Nov 2015 | Peru Food Mote Corn Maiz Mote Net Wt. 15 oz. Imported and distributed by: Peru Food Import Inc.PO Box 419 West New York, NJ 07093 UPC 812125009628 (72579) | PERU FOOD IMPORT INC | Food | Class I | 1 |
| 3 Nov 2015 | NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK, REF Catalog No. 651919311, UPN Product No. H7496519193111 Product Usage - This needle is intended to be placed over the guidewire to enlarge the opening in the vessel, and is then removed before sliding the catheter over the guidewire | AngioDynamics Inc. | Device | Class II | 4 |
| 12 Oct 2015 | Sebastian Super Lump Pasteurized Crab Meat, Blue Swimming Crab Meat, Wild Caught, 16 ounce (73185) | Halperns' Steak & Seafood Company LLC | Food | Class II | 1 |
| 16 Sep 2015 | UN1002 Air, Compressed, Breathing Grade, USP, Distributed by Praxair Distribution, Inc. Roseville, MN 55113, NDC 59579-006. | Praxair Inc. | Drug | Class III | 2 |
| 27 Aug 2015 | Dough base/premix packaged in 30-lb. poly-lined cardboard boxes, manufactured under the following labels: (1) Heartland Products, Inc. Fancy Breads Italian Base, 090108. Manufactured by Heartland Products, Inc., Des Moines, IA; and (2) Northern Lights Pizza, 090108, Manufactured by Heartland Products, Inc., Des… | Heartland Products Inc. | Food | Class III | 6 |
| 26 Aug 2015 | Sara Lee Delightful 100% Whole Wheat made with Real Honey Bread 20oz On bag: AUG 29 UPC: 7294571589; Sara Lee Honey Wheat Bread; 20 oz; On bag: SEP 01 UPC: 7294560136; Sara Lee Honey Wheat Bread Twin pack 2 lbs 8oz On bag: SEP 01 UPC: 7294561159; | BIMBO Bakeries USA Inc. | Food | Class II | 4 |
| 16 Jul 2015 | Phenobarbital/Hyoscyamine/ Atropine/Scopolamine 16.2/0.1037/0.0194/0.0065 mg DONNATAL ELIXIR, 5 ml Cup grape, Alcohol 23.8%, Rx Only, MFG: Concordia, PKG BY: SAFECOR HEALTH, WOBURN, MA, C5921242304. | Safecor Health, LLC | Drug | Class II | 1 |
| 3 Jun 2015 | Smart Lipo Dietary Supplement capsules, 950 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011 (73632) | Individual firm, name withheld | Food | Class II | 1 |
| 7 Nov 2014 | Mung bean sprouts are packaged 1 lb., 5 lbs., 10 lbs., 15 lbs., or 30 lbs. per plastic bag. (69794) | Wholesome Soy Products | Food | Class I | 1 |
| 24 Sep 2014 | Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional… | Philips Medical Systems, Inc. | Device | Class II | 2 |
| 30 Apr 2014 | Robotic Arm Interactive Orthopedic System (RIO) | Mako Surgical Corporation | Device | Class II | 1 |
| 10 Oct 2013 | VariAx Compression Plating System | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 9 Oct 2013 | Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX (73410) | Neurotherm, Inc. | Device | Class II | 1 |