| 5 Oct 2016 | Gummy Frogs, 2.5oz, UPC 61054635210 | King Henry's, Inc. | Food | Class II | 2 |
| 3 Oct 2016 | PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25. Event 75260 | West-Ward Pharmaceutical | Drug | Class II | 1 |
| 30 Sep 2016 | Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217. | Amerisource Health Services | Drug | Class III | 1 |
| 30 Sep 2016 | Product is refrigerated Boar’s Head To Go (BTG) Superfood Wrap, sold at deli department. The wraps are made in store and the weight varies and they are sold as one each (wrap). The UPC is 41573 11053. Event 75343 | Fred Meyers Inc | Food | Class I | 1 |
| 29 Sep 2016 | Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given… | Elekta, Inc. | Device | Class II | 1 |
| 29 Sep 2016 | Fresh Express American Salad, 11 oz., Product Code G264A12B, Use-By Date OCT 05 | Fresh Express Incorpated | Food | Class I | 1 |
| 26 Sep 2016 | Sliced - Smoked ATLANTIC SALMON, Net Wt. 8 OZ (225.89), Keep Refrigerated 38°F or Below | K & P Marketplace Ltd. d.b.a Mt. Kisco Smokehouse Ltd. | Food | Class I | 2 |
| 25 Sep 2016 | Trader Joe’s, Veggie Flaxseed Tortilla Chips, Net Wt. 12oz. (340g), Distributed and Sold by Trader Joe’s, Monrovia, CA 91014. | R.W.Garcia Co., Inc. | Food | Class II | 10 |
| 24 Sep 2016 | BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection. Event 75273 | Surgical Specialties Mexico S DE RL DE CV | Device | Class II | 1 |
| 23 Sep 2016 | V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX. | Cardinal Health 200, LLC | Device | Class II | 1 |
| 23 Sep 2016 | OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance Product Usage: The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The… | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 23 Sep 2016 | Cut Green Beans packed under brand names of: Allens Cut Green Beans (Ejotes Cortados Lago Azul) Blue Lake . Allens Cracker Barrel Label (Both labels have same UPC # - different sodium content - 140 mg for Allens Cut Green Beans and 250 for Cracker Barrel label Peso Neto: 6 lbs 10 oz. (3.00 kg) UPC 0 34700 01224 7;… | Del Monte Research Center - Walnut Creek | Food | Class I | 2 |
| 22 Sep 2016 | Medtronic Navigation O-arm O2 Surgical Imaging System Product Catalog Number: BI-700-02000 Product Usage: The O-arm Surgical Imaging System is a multi-dimensional surgical imaging platform that is designed for use in spine, orthopaedic, and trauma-related surgeries. It provides real-time, intra-operative imaging of a… | Medtronic Navigation, Inc.-Littleton | Device | Class II | 1 |
| 22 Sep 2016 | PARICALCITOL Capsules, 1 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-7656-56. | Teva Pharmaceuticals USA | Drug | Class III | 3 |
| 22 Sep 2016 | BIKAJI Chowpati BHELPURI, NET WT : 300 g [ 10.58 OZ ], Item No: B022, PRODUCT OF INDIA Event 75238 | KRISHNA FOOD CORP | Food | Class I | 1 |
| 22 Sep 2016 | Cookies Bergen, Soft Baked Chocolate Brownie Cookies, NET WEIGHT: 4.44 OZ (126g), Produced by P.W. Sponmet Sp.l., Poland | Dollar General Corporation | Food | Class II | 1 |
| 21 Sep 2016 | CD79b PE (ASR), Catalog number 335816; Hematology: The CD79b antibody recognizes an epitope on the extracellular domain of a 36–40 kilodalton (kDa) type I membrane glycoprotein. Immunoglobulin (Ig) antigen receptors are composed of a non-covalently associated complex of Ig and two other proteins, Iga and Igb, which… | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 1 |
| 20 Sep 2016 | Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39 | Name withheld | Drug | Class II | 9 |
| 19 Sep 2016 | CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and;… | New Star Lasers, Inc. | Device | Class II | 3 |
| 19 Sep 2016 | Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is… | Philips Electronics North America Corporation | Device | Class II | 3 |
| 19 Sep 2016 | Kellogg’s Eggo Nutri-Grain Whole Wheat Waffles 12.3 oz (10 ct) retail carton 8, 12.3 oz retail cartons per case | Kellogg Company | Food | Class II | 1 |
| 16 Sep 2016 | RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput-T3), the Streamline OCT Occipito-Cervico-Thoracic System is intended for: degenerative disc disease (as… | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | Device | Class II | 1 |
| 16 Sep 2016 | Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wire (OTW)… | Vascular Solutions, Inc. | Device | Class I | 3 |
| 16 Sep 2016 | Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50. | Hospira Inc., A Pfizer Company | Drug | Class II | 2 |
| 16 Sep 2016 | Hillcrest Farms Poultry Gravy Mix in 25lb brown poly-lined bags | National Foods Packaging Inc | Food | Class III | 3 |
| 15 Sep 2016 | Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 15 Sep 2016 | SDMS (SenTec Digital Monitoring System) | SenTec AG | Device | Class II | 1 |
| 15 Sep 2016 | PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91 | Pfizer Inc. | Drug | Class III | 1 |
| 15 Sep 2016 | Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10 | Mckesson Packaging Services | Drug | Class III | 1 |
| 15 Sep 2016 | Corra Lin Sheep Milk Cheese; Raw Sheep's Milk, Starter and Ripening Cultures, Salt and Rennet Sold in wheels, wt. range of 13.24 to 15.90 lb. Neal's Yard Dairy, London Neal's Yard Dairy - exporter Manufactured by Errington Cheese Ltd., South Lanarkshire, United Kingdom. Event 75203 | Name withheld | Food | Class I | 1 |
| 14 Sep 2016 | Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture… Event 75255 | Hand Biomechanics Lab Inc | Device | Class II | 1 |
| 13 Sep 2016 | Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016). The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic… | Varian Medical Systems, Inc. | Device | Class II | 1 |
| 13 Sep 2016 | LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including… Event 75163 | Tearscience, Inc | Device | Class II | 1 |
| 13 Sep 2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by Sun Pharmaceuticals Ind. Ltd. Halol- Baroda Highway, Halol-389 350, Gujarat, India. UPC 347335737868 NDC 47335-737-86 | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 1 |
| 13 Sep 2016 | mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01. | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 13 Sep 2016 | "Dr. O'z SALSA Black Bean and Corn Made with my Mom's secret recipe! Stir Before Serving Net Wt. 16oz (454g) All Natural No Preservatives www.ozturkfoods.com Distributed by Ozturk Foods 28872 S. Big Hollow Rd. Park Hill OK 74451 Refrigerate After Opening" Event 75188 | Ozturk Gardens | Food | Class II | 1 |
| 12 Sep 2016 | Blood Pressure Monitor UA-767PBT-Ci for small cuff. Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate. Event 75177 | A & D Enginering Inc | Device | Class II | 1 |
| 12 Sep 2016 | Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK | The Apothecary Shoppe LLC | Drug | Class II | 3 |
| 12 Sep 2016 | Federico's Mexican Cookies Excelente Variedad, Net Wt. 21oz, 10packs/case, UPC 9154450521. Event 75169 | Federico's Bakery | Food | Class II | 1 |
| 12 Sep 2016 | New Seasons Market Creamy Almond Butter 16oz; Label reads in part "***NEW SEASONS WILD FRIENDS FOODS PORTLAND, OR *** IT'S A JAR OF ALMOND BUTTER CREAMY A hint of Jacobsen Sea Salt***" UPC 4060010401; | NEW SEASONS MARKET | Food | Class I | 1 |
| 9 Sep 2016 | Zero-Gravity Radiation Protection System Radiology Personnel protective shield. Event 75240 | Contour Fabricators Inc | Device | Class II | 1 |
| 9 Sep 2016 | Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and… | Teleflex Medical | Device | Class II | 2 |
| 8 Sep 2016 | MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the skin into a vein or artery. | Argon Medical Devices, Inc | Device | Class II | 1 |
| 8 Sep 2016 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10 | Mckesson Packaging Services | Drug | Class III | 1 |
| 8 Sep 2016 | "VRINDAVAN" COW GHEE, Ingredients: 100% clarified butter Event 75269 | Pure Ghee, Inc. | Food | Class II | 1 |
| 8 Sep 2016 | Publix Apple Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802 | Gold Standard Baking, Inc. | Food | Class II | 17 |
| 7 Sep 2016 | Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008 | Banyan Medical, LLC | Device | Class II | 2 |
| 7 Sep 2016 | IgE Calibrator Series | Randox Laboratories Ltd. | Device | Class II | 1 |
| 7 Sep 2016 | Cytoplast Titanium-Reinforced Posterior Singles Membrane A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal bone defects. Event 75119 | Osteogenics Biomedical, Inc. | Device | Class II | 1 |
| 7 Sep 2016 | Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01 Event 75253 | Biocompatibles U.K., Ltd. | Drug | Class III | 1 |
| 7 Sep 2016 | The Baker's Scoop 100% WHOLE WHEAT FLOUR NET WT. 5 LB (2.27 kg) packaged in white paper bag Event 75131 | C. H. Guenther & Son, Inc.dba Morrison Milling | Food | Class III | 1 |
| 6 Sep 2016 | AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels. | Beckman Coulter Inc. | Device | Class II | 1 |
| 6 Sep 2016 | Syngo.plaza, Picture Archiving and Communication System | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 2 Sep 2016 | Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161 | Siemens Healthcare Diagnostics Inc | Device | Class III | 2 |
| 2 Sep 2016 | Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx Only, Manufactured for: Shire US, Inc., Lexington, MA 02421, NDC 59417-103-10 Event 75170 | Shire | Drug | Class III | 1 |
| 2 Sep 2016 | Wegmans ITALIAN CLASSICS RICOTTA & SPINACH STRIPED JUMBO RAVIOLI, NET WT 9 OZ. (255g), UPC 0-77890-38934, KEEP REFRIGERATED -- Distributed By: Wegmans Foods Markets, Inc. Rochester, NY 14603, Product of Canada --- Packaged in a plastic tray and sold in a refrigerated case in the dairy department. | Wegmans Food Markets, Inc. | Food | Class II | 1 |
| 1 Sep 2016 | RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 1 Sep 2016 | Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. | Leonhard Lang Medizintechnik GmbH | Device | Class I | 1 |
| 31 Aug 2016 | Yu Yee Brand Black Pepper Powder, Net Wt. 19.4 oz (550g), UPC 0 23452 06084 2, Packed for Summit Import Corp., Jersey City, NJ 07305, Product of China | Summit Import Corporation | Food | Class I | 1 |
| 30 Aug 2016 | Triana Family Brioche Donuts Bavarian Cream Net Wt. 0.75 LBS (340 g) 12 -24 Jabez St., Newark, NJ 07106 UPC 000260003995 packaged in a clear plastic clam shell container Event 75185 | Name withheld | Food | Class II | 1 |
| 30 Aug 2016 | Entenmann's Little Bites Chocolate Chip Muffins; 10 Pouches; Net Wt. 1 lb. 0.5 OZ. ; Bimbo Bakeries USA, Inc.; PO #976, Horsham, PA 19044. Best By: October 8, 2016/3098; UPC: 7203002111; Entenmann's Little Bites Chocolate Chip Muffins; 20 Muffins, 5 Pouches; Net Wt. 8.25 OZ. ; Bimbo Bakeries USA, Inc.; Horsham, PA… | BIMBO Bakeries USA Inc. | Food | Class II | 3 |
| 30 Aug 2016 | Diamond of California Chopped Macadamia Nuts 4oz | Snyder's-Lance Inc. | Food | Class I | 2 |
| 29 Aug 2016 | CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures. | ConMed Corporation | Device | Class II | 1 |
| 29 Aug 2016 | ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device. Event 75068 | LDR Spine USA, Inc. | Device | Class II | 1 |
| 29 Aug 2016 | ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81 Event 75162 | Name withheld | Drug | Class III | 1 |
| 26 Aug 2016 | Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation. | Teleflex Medical | Device | Class I | 1 |
| 26 Aug 2016 | Dietary Supplement Acidophilus Blend, 90 capsules, Product No. E-420, packaged in 225cc HDPE white bottle, room temp, sold individually Event 75151 | Complete Packaging & Manufacturing, LLC | Food | Class I | 1 |
| 25 Aug 2016 | Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs. | Spacelabs Healthcare Inc | Device | Class II | 2 |
| 25 Aug 2016 | The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007. | Natus Medical Incorporated | Device | Class II | 1 |
| 25 Aug 2016 | Merit Inflation Syringe Kit. Catalog Number KOS-02857 | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 24 Aug 2016 | SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 24 Aug 2016 | R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTFR1. | R & D Systems, Inc. | Device | Class II | 1 |
| 24 Aug 2016 | Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. | Philips Medical Systems | Device | Class II | 4 |
| 24 Aug 2016 | 0.2 Micron Filter, 50 mm Product Usage: The 0.2 Micron Filter is a bacteria and particulate filter for aqueous solutions. It attaches to a standard Baxter Pharmacy Pump Tube Set. | Baxter Corporation Englewood | Device | Class I | 1 |
| 24 Aug 2016 | Patti's good life PREMIUM APPLE PECAN CAKE, NET WT 20 OZ (1 LB 4 OZ) 567g, UPC 89028800290 Event 75026 | Creative Occasions, Inc. | Food | Class III | 1 |
| 23 Aug 2016 | Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves | Integra LifeSciences Corp. | Device | Class II | 6 |
| 22 Aug 2016 | The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable… | EKOS Corporation | Device | Class II | 1 |
| 19 Aug 2016 | Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate Product Usage: The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images. | Panoramic Rental Corp. | Device | Class II | 1 |
| 19 Aug 2016 | The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology. Event 75148 | Brathwaites Oliver Medical | Device | Class II | 1 |
| 19 Aug 2016 | Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05. | Unichem Pharmaceuticals Usa Inc | Drug | Class III | 1 |
| 18 Aug 2016 | Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 17 Aug 2016 | Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090 Product Usage: Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder and ankle procedures. These blades can be used with the… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 17 Aug 2016 | HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and… | HeartWare, Inc | Device | Class I | 1 |
| 17 Aug 2016 | 6 Five, Rice Noodles, Keep Refrigerated, Ingredients: Rice flour, water, salt and corn oil. Weight: 12 oz, Manufactured by: Mei Shun Noodle Inc, 610 W. 26th Street Chicago IL 60613, (312) 842-6500. Noodles on styrofoam tray visible through clear plastic wrap. Event 75182 | Louis Hong Inc Dba Mei Shun Noodle Inc | Food | Class I | 1 |
| 15 Aug 2016 | Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid… | Microgenics Corporation | Device | Class II | 1 |
| 15 Aug 2016 | BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location. | Prismatik Dentalcraft, Inc | Device | Class II | 1 |
| 14 Aug 2016 | Supermom’s Kitchen Roast Beef & Cheddar Melt, Net Wt. 3.7 oz (105g). Keep Refrigerated. UPC 63913-94236 Event 75200 | Northern Tier Bakery | Food | Class II | 1 |
| 12 Aug 2016 | Arthrex Suture Washer | Arthrex, Inc. | Device | Class III | 1 |
| 12 Aug 2016 | Ultra-Soy Imitation Bacon Flavored Bits-B163, packaged in a 25lb box, most responsible firm name on label is CHS Inc. Hutchinson, KS 67501 1-800-835-5006 | C H S Inc | Food | Class I | 10 |
| 11 Aug 2016 | 25 gauge VersaVit 2.0 Core Essentials Procedure Pack, Product/Part Number 70025E, packaged in HIPS rigid tray with a Tyvek lid sterile barrier system. | Synergetics Inc | Device | Class II | 4 |
| 11 Aug 2016 | VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides per sales unit), Unique Device Identifier No. 10758750009572, Rx ONLY, IVD --- For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and… | Ortho-Clinical Diagnostics | Device | Class II | 4 |
| 10 Aug 2016 | CANNIBAL RIOT, SUPER STIMULANT PRE-WORKOUT ENERGY COMPLEX, FIVE FINGER DEATH PUNCH, Chaos and Pain, DIETARY SUPPLEMENTS, NET.WT. 10.5 oz (300g), UPC 610563314652 | Name withheld | Food | Class II | 2 |
| 9 Aug 2016 | Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: ” Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. “ Correction of varus, valgus, or posttraumatic deformity. “ Correction or revision of unsuccessful… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 9 Aug 2016 | Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, and the fixation of… | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 9 Aug 2016 | Apple Streusel Muffin Mix, packaged in a plastic bag which is placed in a cardboard box, net wt. 15.9oz, UPC 010749011458 | Rabbit Creek Products Inc. | Food | Class I | 114 |
| 8 Aug 2016 | Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central… | CareFusion 303, Inc. | Device | Class II | 1 |
| 8 Aug 2016 | Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996) | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 8 Aug 2016 | Vanguard 360 Revision Knee System Knee prostheses | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 8 Aug 2016 | Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08. | Pharmatech LLC | Drug | Class II | 7 |
| 5 Aug 2016 | CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports… | Medtronic Inc. | Device | Class II | 1 |
| 5 Aug 2016 | Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86 | Teva North America | Drug | Class III | 1 |
| 5 Aug 2016 | Eastern Feast, Green Raisin, 7 oz plastic container. Event 74984 | Commerce International Inc. | Food | Class I | 1 |
| 3 Aug 2016 | Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 3 Aug 2016 | Gouda 12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound. Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac. Refrigerated, Organic raw milk cheese. | Grassfields Cheese, LLC | Food | Class I | 10 |
| 2 Aug 2016 | Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant into the humeral canal after the fracture… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 2 Aug 2016 | Randox Lipase (Colorimetric) Product Usage: A lipase test system is a device intended to measure the activity of the enzyme lipase in serum and plasma. Lipase measurements are used in the diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. | Randox Laboratories Ltd. | Device | Class II | 1 |
| 1 Aug 2016 | Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen and extremities and may be used on pediatric, adult and bariatric… | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 1 Aug 2016 | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) | Ethicon, Inc. | Device | Class II | 1 |
| 29 Jul 2016 | Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a… | Zyno Medical LLC | Device | Class II | 4 |
| 29 Jul 2016 | Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials). | Teva Pharmaceuticals USA | Drug | Class II | 2 |
| 26 Jul 2016 | ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 26 Jul 2016 | Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402 | Pharmacy Plus, Inc. dba Vital Care Compounder | Drug | Class II | 21 |
| 25 Jul 2016 | DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma. | Microgenics Corporation | Device | Class II | 1 |
| 24 Jul 2016 | Wegmans ITALIAN CLASSICS Organic BLUSH SAUCE, NET WT 23.5 OZ (1 LB 7.5 OZ) 667g Event 75045 | LiDestri Foods, Inc. | Food | Class III | 1 |
| 21 Jul 2016 | Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, Rx Only, 20 tablets per carton (ten 2 count blister packs), Distributed by Arbor Pharmaceuticals, LLC Atlanta, GA 30328, NDC 24338-700-10. | Arbor Pharmaceuticals Inc. | Drug | Class I | 1 |
| 21 Jul 2016 | Gourmet Blueberry Monster Muffins (4 count) | Weis Markets, Inc., Ice Cream Division | Food | Class II | 30 |
| 20 Jul 2016 | BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is… | Cardinal Health | Device | Class II | 1 |
| 19 Jul 2016 | GFS Honey Roasted Peanuts, 38 oz PET (Polyethylene terephthalate) plastic jar marked with lot number 176-16 stamped above the UPC code 093901252562 and GFS reorder number Event 74748 | Krispak Inc | Food | Class I | 1 |
| 19 Jul 2016 | Artichoke Heart Breaded with Goat and Cheddar Cheese : Pack Size: 240 ea. per case; UPC: 13014-03 Keep Frozen: Gourmet Foods, Hayward, CA | Gourmet Foods, Inc. | Food | Class II | 8 |
| 15 Jul 2016 | Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses | Ethicon Endo-Surgery Inc | Device | Class II | 2 |
| 15 Jul 2016 | Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85 | The Harvard Drug Group | Drug | Class I | 1 |
| 15 Jul 2016 | Frozen cinnamon rolls packaged under the following labels: (1) Fetting's Cinnamon Rolls, packaged in 15-oz. plastic bags, 8 rolls per bag, 15 bags per case, product #79211, UPC #075812792115. The firm name on the label is Top Taste, Inc., Finley, ND; and (2) Abby's Bakery Homestyle Cinnamon Rolls, packaged in 23-oz.… Event 74709 | Top Taste, Inc | Food | Class I | 1 |
| 15 Jul 2016 | No-Salt-Added Black Beans, 15 oz. (425 g), packaged under the following brands: 1. HEB, UPC 41220-91262; 2. Kuner's UPC 72273-13613. Distributed by Kuner-Empson, Division of Faribault Foods, Inc., 128 NW 18th Street, Faribault, MN 55021; 3. Mrs. Grimes, UPC 71891-47607. Distributed by: Mrs. Grimes, Division of… | Faribault Foods, Inc | Food | Class II | 1 |
| 15 Jul 2016 | Cabbage/nappa shredded, Label states "Joe's Pride" and bears the address 9705 I Street, Omaha, NE 68127. Product is packaged in poly bags inside cardboard boxes. All have a best by date of 7 days after the production date. | Greenberg Fruit Co | Food | Class I | 10 |
| 12 Jul 2016 | Trokendi XR (topiramate) extended-release capsule, 50mg, 30-count blister pack, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850, NDC 17772-102-15 | Supernus Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 10 Jul 2016 | Mobile Column TruSystem 7500, Material Number 1717023; Mobile Column TruSystem 5500, Material Number 1607822 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the… | Trumpf Medical Systems, Inc. | Device | Class II | 4 |
| 7 Jul 2016 | Walrus Arterial Embolectomy Catheter The arterial embolectomy catheter is intended for use in removing arterial emboli. | Arrow International Inc | Device | Class II | 1 |
| 6 Jul 2016 | Jake’s Candy Assorted Starlight Kisses, Product label(s):“***Jake’s Candy *** ASST. STARLIGHT KISSES *** Net Wt. 1.5 oz. *** Exp. 7/2019 *** INGREDIENTS: Corn syrup, citric acid, natural and artificial flavor, artificial flavors may contain citric acid or including FD&C yellow 5 & yellow #6. ***” o Product… | Four Brothers Packaging Inc. | Food | Class II | 3 |
| 6 Jul 2016 | COZY SHRIMP, 200 CT, Prepared by: Kabobs, 54234 North Lake Dr. Lake City, GA 30260. | Kabobs Inc | Food | Class II | 27 |
| 5 Jul 2016 | FI Dry Blueberry / Strawberry Blend, Product Code 21585. 40 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA | QualiTech, Inc | Food | Class I | 18 |
| 1 Jul 2016 | The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump. | Circulatory Technology Inc | Device | Class III | 1 |
| 1 Jul 2016 | Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle | Name withheld | Drug | Class II | 3 |
| 30 Jun 2016 | TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512. | Allergan Sales, LLC | Drug | Class II | 2 |
| 29 Jun 2016 | TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment. | Winco Mfg., LLC | Device | Class II | 3 |
| 28 Jun 2016 | TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing. | Trividia Health | Device | Class II | 4 |
| 27 Jun 2016 | CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures. | ConMed Corporation | Device | Class II | 7 |
| 24 Jun 2016 | Light Adaptor for Small Battery Drive and Small Battery Drive II. | The Anspach Effort, Inc. | Device | Class I | 2 |
| 23 Jun 2016 | OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector | Olympus Corporation of the Americas | Device | Class II | 1 |
| 23 Jun 2016 | NeolifeBar: Fruit & Nuts; 10 g Protein; 5 g Fiber. 320 mg Omega-3s. Net Wt. 1.6 oz. (45 g). Product is sold as a package of 15 bars: Distributed by GNLD International, LLC, Fremont, CA. Not sold in retail stores Event 74543 | Natural Formulas | Food | Class I | 1 |
| 9 Jun 2016 | Taylor Farms Cranberry Walnut Salad; Salad kit for one: Baby Lettuce Blend, Feta Cheese, Flat Bread Chips, Dried cranberries and Walnuts and Raspberry Vinaigrette dressing. Distributed by: Taylor Farms Inc., Salinas, CA. | Taylor Fresh Foods Inc | Food | Class II | 1 |
| 8 Jun 2016 | HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft… | Heartware, Inc. | Device | Class I | 1 |
| 8 Jun 2016 | US - Bounce Apple Cinnamon Protein Punch Energy Balls (old name), net wt. 1.48 oz. (42g). Product UPC Codes are 852949003723 (individual packs) and 852949003730 (12-unit boxes). US - Bounce Apple Cinnamon Protein Energy Balls (new name), net wt. 1.48 oz. (42g). Product UPC codes are 852949003723 (individual packs)… | Bounce Life Style HQ | Food | Class I | 3 |
| 7 Jun 2016 | Label reads in part as " GOYA ***HONEY WITH COMB***PURE ALL NATURAL***NET WT. 16 OZ (1LB)***15173***GOYA FOODS, INC. SECAUCUS, NJ 07096" | Tradewind Foods de Puerto Rico Inc. | Food | Class III | 1 |
| 4 Jun 2016 | Nature's One, Organic PediaSmart Dairy Vanilla complete nutrition beverage for kids 1 to 13 years NET WT 12.7 oz (360 G) can Contains: milk, soy & coconut UPC 7 16514 88101 0 Manufactured for: Natures One, 8754 Cotter Street, Lewis Center, OH 43035 Event 74330 | Natures One Inc | Food | Class II | 1 |
| 2 Jun 2016 | Quaker Quinoa Granola Bars, chocolate nut medley packaged in a multi colored box with brown lettering. Wrapper UPC: 000 30000 00243 8 | The Quaker Oats Company | Food | Class I | 2 |
| 1 Jun 2016 | Meadow Gold Dairy Pure Fresh Half & Half One Quart (946 mL) | Dean Foods, Inc. | Food | Class II | 3 |
| 30 May 2016 | Radiation Therapy Treatment Planning System, Model 5.0 | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 27 May 2016 | Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain | Ivoclar Vivadent, Inc. | Device | Class II | 21 |
| 24 May 2016 | TriFoillmaging Triumph/Triumph II Research CT scanners. Event 74838 | Name withheld | Device | Class II | 1 |
| 18 May 2016 | Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes | US Endoscopy Group Inc | Device | Class II | 1 |
| 17 May 2016 | Calix P PEEK Lumbar System, PLIF Rasp | X Spine Systems Inc | Device | Class II | 4 |
| 12 May 2016 | Tiger-X, 1200 mg, 1 capsule per pack , 24 single packs per box | SOS Telecom Inc. | Drug | Class I | 4 |
| 12 May 2016 | Product in cans of 4 1/4 oz (111g) and 8 1/4 oz (220g) net weight. Label reading in part as: "Coloso***PULPO EN ACEITE***OCTOPUS IN OIL***NET WEIGHT ***Fabricado en España (Manufactured in Spain)***Packed by: POYO PONTEVEDRA SPAIN***PACKED FOR COLOSO FOODS, INC.*** MERCADO CENTRAL PUERTO NUEVO SAN JUAN PUERTO RICO". | Ballester Hermanos, Inc. | Food | Class II | 4 |
| 10 May 2016 | Birdy 3 in 1 Robusta Coffea Mix, 445.5 g in a red sealed plastic bag, Product of Thailand, UPC 8850250007425 Event 74159 | Food Gusto, Inc. | Food | Class I | 1 |
| 10 May 2016 | Four Seasons Pecan Tarts; 202 4T0867 ; Sel By: 09/10/2016, 09/15/15, 10/13/16,10/28/16; and 12/10/15, 12/15/15, 01/13/16, 01/28/16 (lot numbers). 180 Pieces; Weight 8#; Packed exclusively for International Market Brands, Cleveland, Ohio 44146. Event 74116 | Charlie's Specialties, Inc. | Food | Class II | 1 |
| 6 May 2016 | Kroger Broccoli Raisin Salad, INGREDIENTS: Broccoli, dressing***sugar,. contains less than 2% sunflower seeds, golden raisins, raisins, lime juice, xanthan gum. DIST BY THE KROGER COMPANY CINCINNATI, OHIO 45202 UPC 002871 58200 0. | The Kroger Co | Food | Class I | 1 |
| 4 May 2016 | Dark Cocoa Nom Noms 4.5oz. (128g) UPC: 8 54557 00533 5 Lot 16083 Product is shipped directly to customers per individual order or to corporate customers in 20 x 4.5 oz. bags cases. Ingredients: Rolled Oats, Almonds. For address freshness (Grape juice, rice dextrin), honey, sugar, canola oil, dark chocolate flavored… | NatureBox, Inc. | Food | Class I | 1 |
| 3 May 2016 | Sunflower Kernels packaged in the following brands and sizes: UPC 041498206680, Southern Grove Roasted and Salted Sunflower Kernels, Best by/Date: 3/1/2017, 3/2/2017, 2/28/2017, 3/15/2017,3/28/2017, 4/29/2017 . UPC 071725727497, Natures Harvest Roasted and Salted Sunflower Kernels, Best by/Date: 11/25/2016,… | Treehouse Foods | Food | Class I | 55 |
| 29 Apr 2016 | Coca-Cola, 16 fl. oz. can/12 pack, UPC 049000054318; Coca-Cola, 12 oz. can/12 pack, UPC 049000028904; Coca-Cola Zero, 12 oz. can/12 pack, UPC 049000042559; Diet Coke, 12 oz. can/24 pack, UPC 049000010633; Diet Coke, 12 oz. can/12 pack, UPC 049000028911; Cherry Coke, 12 oz. can/12 pack, UPC 049000031034 | Coca-Cola Company (The) | Food | Class II | 3 |
| 29 Apr 2016 | Doctor Kracker Pumpkin Seed Cheddar Crispbreads Net Wt. 7 oz. (200g) in cardboard container. | Kracker Enterprises, LLC | Food | Class II | 2 |
| 28 Apr 2016 | ADVIA Centaur XPT Immunoassay System | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 25 Apr 2016 | Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner. | Toshiba American Medical Systems Inc | Device | Class II | 4 |
| 7 Apr 2016 | Package contains a business card for "***BAGEL SHOP***" "***Cinnamon Raisin: Flour, Filtered Water, Organic Shortening, Olive Oil, Malt, Sea Salt, Sugar, Yeast, Cinnamon, Raisin***" 2 bagels per package - plastic bag with twist tie. | Union Bagel Shop | Food | Class I | 15 |
| 5 Apr 2016 | HEB Ready Fresh Go Sliced Red Apples 22.5 oz UPC 4122018603 packaged in clear plastic bag and Value Pack Sliced Apples 28 oz. UPC 4279796149 packaged in clear non-flexible plastic bowl and Large Sliced Red Apples 17 oz. UPC 4122087646 packaged in a clear non-flexible plastic container. | Fresh From Texas Inc. | Food | Class I | 12 |
| 25 Mar 2016 | 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32 | B. Braun Medical Inc | Drug | Class I | 1 |
| 11 Mar 2016 | Awareness Boost Tea Dietary Supplement Passion Fruit Net Wt 7.4 oz. Distributed by & for all inquiries: Awareness Corporation P.O. Box 2289 Chandler, AZ 85244 Event 73526 | Awareness Corporation | Food | Class I | 1 |
| 9 Mar 2016 | 365 Everyday Value Mango Frozen Fruit Bars 4 Bars-4 fl. oz. (118 mL) each-Net 16 fl. oz. (472 mL) in a cardboard carton, UPC: 0-99482-41344-6, Distributed By: Whole Foods Market Austin, Texas 78703 | Whole Foods Market | Food | Class II | 1 |
| 8 Mar 2016 | Ducal Apple Nectar, 5.3 oz cans. Event 73541 | Global Garlic, Inc. | Food | Class II | 1 |
| 22 Feb 2016 | Uncle Buck's Maple Nut candy packaged in a clear plastic 2.7 oz. bag with attached green, orange, and white label with Organe and black writing. | Rucker's Wholesale & Service Co., Inc. | Food | Class I | 2 |
| 16 Feb 2016 | Sausage, Egg, and Cheese on English Muffin, Fully Cooked, Keep Frozen, Perishable-30/case Manufactured Exclusively for Starbucks Coffee Company, Seattle, WA 98134 Product Date: 10/FEB/2016 SKU: 11041857 Not Labeled for Retail Sale Event 73394 | Progressive Gourmet Inc. | Food | Class II | 1 |
| 11 Feb 2016 | CARAMEL CORN PEANUT BUTTER DELIGHT CRYSTAL SHORT (18 oz..) & Tall (22 oz..) | Savory Foods, Inc. | Food | Class I | 3 |
| 8 Feb 2016 | Mitica brand PECORINO AGED IN WALNUTS LEAVES (PECORINO FOGLIE di NOCI), SEMI-HARD SHEEP'S MILK CHEESE, Minimum Weight 2 lbs. -- Product of Romagna - Italy --- Imported by Forever Cheese, L.I.C., NY 11106 --- There are 2 wheels of cheese per shipping case. Event 73306 | Name withheld | Food | Class I | 1 |
| 8 Feb 2016 | Adwe Naturals Prenatal Vitamin Manufactured for: Adwe Laboratories 1274 49 Street Brooklyn, NY 11219 UPC 040168805079 Event 73845 | DNE Nutraceuticals Inc. | Food | Class II | 1 |
| 30 Jan 2016 | CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 8 Jan 2016 | Shell eggs, various sizes, packaged in the following ways: 6-count cartons, 10-count cartons, 12-count cartons, 18-count cartons, 15 dozen cases, and 30 dozen cases; under the brand name Good Earth Egg Company and MO license # D-01124. The responsible firm name is Good Earth Egg Company, Bonne Terre, MO Event 73028 | Good Earth Egg Company | Food | Class I | 1 |
| 23 Dec 2015 | La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA | Name withheld | Drug | Class I | 3 |
| 11 Dec 2015 | CDI H/S Cuvette The intended use for the CDI H IS Cuvette is as follows: The CDI H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired. | Terumo Cardiovascular Systems Corporation | Device | Class III | 1 |
| 15 Oct 2015 | Elegant sophistication gift basket containing apple cidar in glass bottles. The label on the back of the gift basket is white with black lettering. Event 72470 | DesignPac Gifts Inc LLC | Food | Class II | 1 |
| 21 Sep 2015 | TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters. Event 75350 | Biocompatibles U.K., Ltd. | Device | Class II | 1 |
| 23 Jul 2015 | Trader Joe’s Freshly Made Original Hummus Dip (Tahini Free), packaged in 16 oz. clear plastic cups SKU: 00299091 Event 71810 | Tribe Mediterranean Foods Inc. | Food | Class II | 1 |
| 17 Jul 2015 | atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324. | Pharmedium Services, LLC | Drug | Class I | 69 |
| 22 Apr 2015 | Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room | Windstone Medical Packaging, Inc. | Device | Class II | 150 |
| 10 Oct 2014 | PREMIUM PROTEIN III For kids Nutritional Supplement, NET WT 16 OZ (454g), Manufactured for Celwa Biotech Brooklyn, NY 11219. Made in USA | Triceutical Inc./Zhang | Food | Class III | 21 |
| 22 Aug 2013 | *** 1) Fish hot dogs total 1 lb in weight vacuum packaged in plastic bags; Label reads in part: TWIN FIN DELI; Franks; Net WT. 1lb (453g); Kosher Fish Products Inc. Fulton, IL FDA# 1481764; *** 2) Fish hot dogs total 15 lbs in weight packaged 120 x box with a poly liner | Schafer Fisheries | Food | Class II | 3 |
| 16 Aug 2013 | Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT component is intended to produce corss-sectional images of the… | Siemens Medical Solutions USA, Inc. | Device | Class II | 2 |
| 28 Oct 2011 | Fusion Workstation.; Indicated for the transmission and review of radiological images. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 19 Oct 2011 | CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 29 Dec 2009 | Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head. Event 75160 | Spiegelberg Gmbh & Co. KG | Device | Class II | 1 |