| 15 Dec 2016 | AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01 | Amgen, Inc. | Drug | Class II | 1 |
| 15 Dec 2016 | Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP Event 76027 | Meta Pharmacy Services | Drug | Class II | 1 |
| 11 Dec 2016 | White Fudge Oreo, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz. and 16 oz. | Name withheld | Food | Class II | 9 |
| 7 Dec 2016 | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone | Stanmore Implants Worldwide Ltd. | Device | Class II | 5 |
| 7 Dec 2016 | Heihujiaoyupai, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g) | Midwest International Corp | Food | Class II | 3 |
| 6 Dec 2016 | CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. | Accuray Incorporated | Device | Class II | 1 |
| 6 Dec 2016 | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48. | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 6 Dec 2016 | FAIRWAY LIKE NO OTHER MARKET brand CANDY CORN, of varying weight, Item Code 228402 XXXXXX -- The product is packaged in clear, plastic cello bags of varying weights, each weighing less than one pound. --- PACKAGED BY FAIRWAY MARKET 2284 12TH AVE., NEW YORK, NY 10027 Event 75896 | Fairway Group Holding Corp dba Fairway Bakery LLC | Food | Class II | 1 |
| 5 Dec 2016 | EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe… | PerkinElmer Health Sciences, Inc. | Device | Class III | 1 |
| 2 Dec 2016 | MOSAIQ Oncology Information System The product is used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be use wherever radiotherapy and chemotherapy are prescribed. | Elekta, Inc. | Device | Class II | 1 |
| 2 Dec 2016 | Phil-Am Smoked Mackerel (Hasa Hasa) Net. Wt. 200g (7.05 oz.) packaged: Clear flexible plastic pouch and is topped by a predominantly red tag affixed to the top seal which has the product’s information. | Phil-Am Trading, Inc. | Food | Class I | 1 |
| 1 Dec 2016 | Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 1 Dec 2016 | Trader Joe's Mediterranean Hummus SKU #90642 | Two Chefs On A Roll, Inc | Food | Class I | 2 |
| 30 Nov 2016 | 8450-107-530 3.0MM Precision Match Head, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connected to the… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 7 |
| 30 Nov 2016 | Ecolab, Microtek Rolled Probe Cover PC0907NB, Rx Only. | Ecolab Inc | Device | Class III | 1 |
| 29 Nov 2016 | Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument | Synthes (USA) Products LLC | Device | Class II | 1 |
| 29 Nov 2016 | Preferred Meals, Cook and Serve, Creamy Red Pepper Sauce and Cheese Tortellini with Parmesan Cheese, 54 9.25 OZ units (NET WEIGHT 31.22 LBS) KEEP FROZEN INSTITUTIONAL USE ONLY | Preferred Meal Systems, Inc. | Food | Class II | 2 |
| 28 Nov 2016 | Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray | Cook Inc. | Device | Class II | 1 |
| 23 Nov 2016 | AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected… | Radiometer America Inc | Device | Class II | 1 |
| 23 Nov 2016 | Dai Yu, 80g, Hairtail, NET WT: 2.8 oz (80g), Item #D526 | Midwest International Corp | Food | Class II | 1 |
| 23 Nov 2016 | MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# ARREZZIO IMPERIAL; UPC: 0 74865 30185 5 Saputo code: #101379 ; | Saputo Cheese USA, Inc. | Food | Class II | 14 |
| 23 Nov 2016 | Green Dirt Farm "Ruby" blended milk cheese packaged in cases of 6, 10 - 12 oz.. units, sold by case weight. Made by Green Dirt Farm, LLC, Weston, MO 64098. | Green Dirt Farm, LLC | Food | Class II | 2 |
| 23 Nov 2016 | DMAA (1,3-Dimethylamylamine) Net Weight 500g Product is packaged in approximately 8" x 11” silver and clear mylar ziplock bags that contain 500g of DMAA. Event 75762 | NATURECOM INC | Food | Class II | 1 |
| 23 Nov 2016 | DRIED VEGETABLE, NET WT: 17.6oz (500g) | Midwest International Corp | Food | Class II | 1 |
| 23 Nov 2016 | You-ka Fresh Ramune Net Wt. 3.87oz (110g), Item No. 23925, 20 packs/case | J F C International Inc | Food | Class II | 2 |
| 22 Nov 2016 | RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization | Teleflex Medical | Device | Class II | 1 |
| 22 Nov 2016 | Optimus Fixed Awl | Amendia, Inc | Device | Class II | 1 |
| 22 Nov 2016 | Zeus-P Lumbar Interbody Device | Amendia, Inc | Device | Class II | 1 |
| 22 Nov 2016 | K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part Number 9080B-18T;… | Amendia, Inc | Device | Class II | 3 |
| 22 Nov 2016 | Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region | Amendia, Inc | Device | Class II | 2 |
| 22 Nov 2016 | AbbVie PEG Kit 20 FR | AbbVie Inc. | Device | Class II | 1 |
| 22 Nov 2016 | CyberKnife Robotic Radiosurgery System using software version 10.6; Catalog/Part Number: 54000 UDI: M658053301 0 Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere… | Accuray Incorporated | Device | Class II | 1 |
| 22 Nov 2016 | Tom’s of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950 Event 75791 | Les Emballages Knowlton Inc. | Drug | Class III | 1 |
| 22 Nov 2016 | Jalapeno Peppers, 40lbs (19 kg) per case, 1 1/9 Bushel Box, 49 cases per pallet Event 75806 | Coliman Pacific Corp | Food | Class I | 1 |
| 22 Nov 2016 | Plush Puffs Marshmallows Toasty Coconut 4oz. and 2lb bulk bag Event 75778 | To Your Heart's Content | Food | Class II | 1 |
| 22 Nov 2016 | Handy Seafood, Blue Crab Cake Mini, Mini Crab Cakes, 0.5oz per Cake/12 Cakes per Tray, Skin Packed Tray, 12 Trays per Case, 2 Year Shelf Life, Best By Nov 9, 2018. Event 75799 | HANDY SEAFOOD INCORPORATED | Food | Class II | 1 |
| 21 Nov 2016 | Acuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVC’s are designed for single use venipuncture on all patient populations where access to the veins and arteries are required. The catheter has a Safety Needle Assembly (SAN)… | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 21 Nov 2016 | Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General… | Northgate Technologies, Inc. | Device | Class II | 1 |
| 21 Nov 2016 | Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic… Event 75770 | Oculus Innovative Sciences, Inc. | Device | Class II | 1 |
| 21 Nov 2016 | Miravalle Pan Rallado Bread Crumbs Net Wt. 7 oz., 8 oz. Event 75772 | Miravalle Foods, Inc. | Food | Class I | 1 |
| 21 Nov 2016 | Snow Monkey Subzero Superfood Cacao 8oz. | FMIF Holdings, LLC dba Snow Monkey | Food | Class I | 2 |
| 20 Nov 2016 | FRESH TO GO Mediterranean Chicken with Hummus sandwich, close-face ready-to-eat sandwich, refrigerated, packed in plastic clam shell, net wt. 8 oz. The UPC is 0 52548 58888 5. Event 75779 | LSG Sky Chefs, Inc. | Food | Class I | 1 |
| 20 Nov 2016 | 7-Eleven Chicken with Hummus Sandwich. Keep Refrigerated; NET WT. 8.0 OZ.; LSG Sky Chefs, Coraopolis, PA 15108 packed in plastic clam shell. Best By: 1119, 1120, 1121. Event 75787 | Name withheld | Food | Class I | 1 |
| 20 Nov 2016 | Fresh to Go Mediterranean Chicken Hummus Sandwich, Fresh Refrigerated Net Wt 8 oz (227g). Packaged in sandwich wedge plastic container. Event 75783 | GREENCORE USA | Food | Class I | 1 |
| 20 Nov 2016 | 7-Eleven Fresh to Go Chicken and Hummus Sandwich; Net Wt. 8.0 oz. (227 g). Sold in Clamshell package UPC 052548588885 Event 75790 | LSG Sky Chefs #1393 | Food | Class I | 1 |
| 19 Nov 2016 | Taylor Farms Veggie & Hummus Bistro Box: Baby Carrots, Hummus Dip, Grape Tomatoes, Flatbread squares, Celery Sticks. NET WT 6.8 oz. (193 g) Perishable, Keep Refrigerated. UPC: 0 30223 01037 1 Distributed by Taylor Farms. Also packed as Schnucks Vegetable & Hummus Snack Tray: Hummus dip, baby carrots, grape tomatoes,… | Taylor Farms Pacific Inc. (MacArthur Facility) | Food | Class I | 1 |
| 18 Nov 2016 | OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw | OrthoPediatrics Corp | Device | Class III | 1 |
| 18 Nov 2016 | AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids. | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. | Device | Class II | 1 |
| 18 Nov 2016 | IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 18 Nov 2016 | WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical… | Teleflex Medical | Device | Class II | 1 |
| 18 Nov 2016 | Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37 | Cantrell Drug Company | Drug | Class II | 21 |
| 18 Nov 2016 | Streit's Quinoa with Mushrooms & Herbs, Net Wt. 7.7 oz (220g). Product of Israel Event 75864 | ARON STREIT INC | Food | Class II | 1 |
| 18 Nov 2016 | Cre 8 It, Inc. Stuffing, 011951311916 in covered aluminum foil pans. Net Weight 2/4 lb. (3.63kg) containers per shipping case Event 75759 | Cre 8 It, Inc. | Food | Class II | 1 |
| 18 Nov 2016 | Topnotch Foods Regular Bread Crumbs 2,000 lb. bulk bag, 50 lb. bulk bag, and 10 lb. bulk bag Event 75766 | Topnotch Foods Inc | Food | Class I | 1 |
| 18 Nov 2016 | Chocolate Hazelnut Butter CLIF Nut Butter Filled Energy Bars; NET WT: 1.76 oz (50 g). Packages in boxes of 12 individual bars. UPC - bar: 7 22252 26800 6; UPC - 12 count box: 7-22252-36800-3; UPC-case: 00722252-56800-7 Distributed by Clif Bar & Company, Emeryville, CA Made in Canada Event 75879 | Clif Bar & Company | Food | Class II | 1 |
| 18 Nov 2016 | HEB Baby Pear Carrot Blueberry 4 ounce cups, 2 pack packaged in plastic cups with a cardboard sleeve | H-E-B GROCERY COMPANY LP DBA HEB | Food | Class II | 6 |
| 17 Nov 2016 | UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations. | Ultradent Products, Inc. | Device | Class II | 1 |
| 17 Nov 2016 | Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. | Elekta, Inc. | Device | Class II | 1 |
| 17 Nov 2016 | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmaceutica (Portugal,) SA Distributed by: Westward Eatowntown NJ 07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01 | West-Ward Pharmaceuticals Corp. | Drug | Class III | 1 |
| 17 Nov 2016 | Ariels OM Grown Granola. Product number GR200, net wt. 5 lb., packaged in bulk bag inside plastic bucket. Product number GR201, net wt.15 lb., packaged in bulk bag inside plastic bucket. Product number BAG-GR200, net wt. 8 oz., packaged in cellophane bag with cardstock label. Product number SBAG-GR200, net wt. 4 oz.,… | Hummingbird Wholesale | Food | Class II | 1 |
| 17 Nov 2016 | Chocolate Sea Salt Probiotic Granola, Purely Elizabeth, 8oz, PET/LLDPE Pouch, 6 units/case, Event 75730 | Name withheld | Food | Class II | 1 |
| 16 Nov 2016 | DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum | PerkinElmer Health Sciences, Inc. | Device | Class III | 1 |
| 16 Nov 2016 | Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites. | Teleflex Medical | Device | Class II | 1 |
| 16 Nov 2016 | LightMix Zika rRT-PCR Test The LightMix Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC… | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 16 Nov 2016 | Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance1 Biosurface is intended for use in an extracorporeal perfusion… | Medtronic Inc | Device | Class II | 1 |
| 16 Nov 2016 | HARVEST SNAPS, SNAPEA CRISPS, BLACK PEPPER FLAVORED GREEN PEA CRISPS, NET WT 3.3 OZ (93g) Event 75805 | Calbee North America, LLC | Food | Class I | 1 |
| 15 Nov 2016 | Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure. | Encore Medical, Lp | Device | Class II | 1 |
| 15 Nov 2016 | CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549. | Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables | Device | Class II | 3 |
| 15 Nov 2016 | SOMATOM Definition AS System, x-ray, tomography, computed 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 | 3 |
| 15 Nov 2016 | Spearmint candy canes, Net wt. 1.4 oz. The UPC is 8 54502 00321 8 Event 75717 | Name withheld | Food | Class II | 1 |
| 15 Nov 2016 | 4C All Natural Parmesan Grated Cheese, UPC 41387-33126, 6 oz | 4 C Foods, Corp. | Food | Class I | 8 |
| 15 Nov 2016 | GFS Cheese Manicotti in tomato sauce. retail 68 oz. pan. 4 retail units per case Event 75726 | Request Foods Inc. | Food | Class I | 1 |
| 14 Nov 2016 | IQon Spectral CT is a Computed Tomography X-Ray System 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 | 2 |
| 14 Nov 2016 | Cellfina Prep Pack, Part No. CP1 Event 75682 | Ulthera Inc | Device | Class II | 1 |
| 14 Nov 2016 | The Popcorn Shoppe Popcorn Balls (4) 5 oz balls, sold under the brand names of Olde Tyme Recipe, Edwards Orchards & Edwards Orchards West. Event 75701 | The Popcorn Shoppe | Food | Class I | 1 |
| 13 Nov 2016 | Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007. Event 75832 | Name withheld | Drug | Class I | 1 |
| 12 Nov 2016 | Brilliance 64 728231 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. These devices may include signal analysis and display equipment, patient and equipment supports, components, and… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 5 |
| 12 Nov 2016 | Weight Watchers Smart Ones, Chocolate Chip Cookie Dough Sundae, Keep Frozen, 4 Individual Sundaes, 4-2.11 OZ (60g), NET WT. 8.44 OZ (239g) | KRAFT HEINZ FOODS COMPANY | Food | Class I | 1 |
| 11 Nov 2016 | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures. | Stryker Sustainability Solutions | Device | Class II | 1 |
| 11 Nov 2016 | Wegmans Milk Chocolate Covered Pretzels, NET WT 9.5 OZ (269g) | First Source, LLC | Food | Class III | 1 |
| 10 Nov 2016 | Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids. | OraSure Technologies, Inc. | Device | Class III | 1 |
| 10 Nov 2016 | ev3, PowerCross .018 OTW PTA Dilatation Catheter, Sterile EO. The PowerCross .018 OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis… | Medtronic Inc | Device | Class II | 1 |
| 10 Nov 2016 | Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile. | Halyard Health | Device | Class II | 1 |
| 10 Nov 2016 | GNC, Women’s Ultra Mega, Dietary Supplement, 180 Caplets, Event 75738 | Nutra Manufacturing | Food | Class I | 1 |
| 10 Nov 2016 | "***NORTHERN CLASSICS NATURAL SMOKED SALMON. Net WT. is filled in on a separate white label. Product is frozen and vacuum packed. Product also referred to as SALMON HOT SMKD SIDE ATL SK-ON. | Northern Fish Products, Inc. | Food | Class II | 11 |
| 10 Nov 2016 | Agave Dream Lavender 1 Pint UPC Code 8 9934900206 2 | Name withheld | Food | Class I | 5 |
| 10 Nov 2016 | Ultimate Chocolate Chip Cookie Dough Pie, refrigerated/frozen. A 9-inch pastry shell with a layer of chocolate chip cookie dough baked in the bottom followed by a layer of French silk. Finished with whipped cream, chocolate drizzle and chocolate chip cookie dough bites distributed across the top of pie. 39 oz. Event 75729 | American Blue Ribbon Holdings DBA Legendary Baking | Food | Class I | 1 |
| 9 Nov 2016 | GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 9 Nov 2016 | RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: 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 expected during the proposed… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 9 Nov 2016 | Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm],… Event 75632 | Elana, Inc. | Device | Class II | 1 |
| 9 Nov 2016 | Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear Screen (Sterile), Product Code 44968… | Halyard Health, Inc | Device | Class II | 1 |
| 9 Nov 2016 | Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material | Ivoclar Vivadent, Inc. | Device | Class II | 3 |
| 9 Nov 2016 | Rissois De Camarao Cong. Frozen Shrimp Cakes, Frozen 50 count. Net Weight: 4,50Kg (2 x 2,25Kg) Country of Origin: PORTUGAL Event 75809 | Linnane & Co | Food | Class II | 1 |
| 9 Nov 2016 | Nancy's Fancy Butterscotch Budino Gelato 16 oz. UPC Code 51005 00329 | ISB Food Group, LLC | Food | Class I | 4 |
| 8 Nov 2016 | LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 8 Nov 2016 | Performance-LOAD Ambulance Cot Fastener Stretcher, Wheeled | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 8 Nov 2016 | ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow… | Teleflex Medical | Device | Class II | 5 |
| 8 Nov 2016 | Cucumber, whole, fresh, 1 1/9 Plain, 1 1/9 Large, 6/10 36's, 5/10 36's Especial, Item#1472554. sold in Tan cardboard case with Red and Green Print. Case reads in part "***CUCUMBERS***PRIME TIME***CUCUMBERS***6/10 BUSHEL Event 75631 | Prime Time International | Food | Class I | 1 |
| 8 Nov 2016 | CANNIBAL FEROX AMPED, FACE-MELTING NOOTROPIC, PRE-WORKOUT ENERGY COMPLEX, STRAWBLOODY KIWI CRUSH, DIETARY SUPPLEMENT, NET. WT. 9.9 OZ (280g), Chaos and Pain, UPC 1056331460 Event 75907 | Name withheld | Food | Class II | 1 |
| 8 Nov 2016 | Cucumber Coins are sliced cucumbers, packaged in 5 lb plastic bags, refrigerated. The product is labeled with a white stickers and it read in parts: "***5 LB CUCUMBER COINS*** PACKED: 10/30/16***KEEP REFRIGERATED***". | Mary's Harvest Fresh Foods, Inc. | Food | Class I | 1 |
| 7 Nov 2016 | TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis | DeRoyal Industries Inc | Device | Class II | 2 |
| 7 Nov 2016 | Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6Ms model 10436113. Radiology: The ACUSON SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 7 Nov 2016 | BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure | Becton Dickinson & Company | Device | Class II | 1 |
| 7 Nov 2016 | Meijer Almonds Salted Caramel, 14 oz. packaged in plastic pouches | Meijer, Inc. | Food | Class I | 1 |
| 7 Nov 2016 | Salted Caramel Almonds Event 75636 | R & J Almonds, Inc. dba Jonny Almond Nut Co. | Food | Class I | 1 |
| 7 Nov 2016 | MTR MASALA Sambar Powder, Net Quantity: 200g Event 75621 | Shri Shiva Foods Inc | Food | Class I | 1 |
| 4 Nov 2016 | MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar fasciitis who fail conservative therapy. Event 75630 | Thayer Intellectual Property, Inc. | Device | Class II | 1 |
| 4 Nov 2016 | Premium Norwegian Salmon, Smoked, slice 8oz (227g), UPC # 856687004288, Keep refrigerated | OLMA-XXI INC. | Food | Class I | 2 |
| 4 Nov 2016 | Bagel and Cream Cheese wrapped in clear film, 5. oz. | Crescent Vending Co. Inc. | Food | Class II | 20 |
| 3 Nov 2016 | HF Cable WA00014A, Endoscopic electrosurgical unit and accessories | Olympus Corporation of the Americas | Device | Class II | 1 |
| 3 Nov 2016 | Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347. | Terumo BCT, Inc. | Device | Class II | 1 |
| 3 Nov 2016 | Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy. | Elekta, Inc. | Device | Class II | 1 |
| 3 Nov 2016 | GE Healthcare, Avance, Avance CS2, Amingo. | GE Healthcare, LLC | Device | Class II | 1 |
| 2 Nov 2016 | Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10 | Ascend Laboratories LLC | Drug | Class II | 1 |
| 2 Nov 2016 | BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 | Zydus Pharmaceuticals USA Inc | Drug | Class III | 1 |
| 2 Nov 2016 | PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110. | Fallon Wellness Pharmacy, L.L.C. | Drug | Class II | 2 |
| 2 Nov 2016 | CROISSANT 6 PK | Whole Foods Market Brand 365, Llc | Food | Class I | 3 |
| 2 Nov 2016 | McConnell's Fine Ice Cream Dutchman's Chocolate | McConnell's Ice Cream, Inc. | Food | Class I | 7 |
| 2 Nov 2016 | Manila Sky Purple Yumm Ice Cream 16 oz. Event 75590 | AC Creamery | Food | Class I | 1 |
| 1 Nov 2016 | Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile | Synthes (USA) Products LLC | Device | Class II | 1 |
| 1 Nov 2016 | IVEA 500A Intended for Med-Surg patient care. Event 75571 | Firefly Medical, Inc. | Device | Class II | 1 |
| 1 Nov 2016 | Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples). | Teva Pharmaceuticals USA | Drug | Class III | 2 |
| 1 Nov 2016 | BON APPETITO WALNUT LADIES FINGER, Net Wt.: 10oz. (340g), UPC 6 44744 69876 7 Event 75572 | Golden Star International Inc. | Food | Class I | 1 |
| 31 Oct 2016 | Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval… | Sorin Group USA, Inc. | Device | Class II | 1 |
| 31 Oct 2016 | Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to… | Owens & Minor Distribution, Inc. | Device | Class II | 1 |
| 31 Oct 2016 | MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose,… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 31 Oct 2016 | Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery… | Spectranetics Corporation | Device | Class II | 3 |
| 28 Oct 2016 | Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299… | Natus Medical Incorporated | Device | Class II | 1 |
| 28 Oct 2016 | Rochester-Pean Hemostatic Forceps 61/4, Curved, Sterile. The Rochester-Pean Hemostatic Forceps 61/4 Curved are single-use sterile surgical instruments intended for cutting and grasping tissue in general surgical procedures. | Integra York PA, Inc | Device | Class II | 2 |
| 28 Oct 2016 | Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle Event 75537 | Name withheld | Drug | Class I | 1 |
| 28 Oct 2016 | Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830. | Nationwide Laboratories, LLC | Drug | Class II | 4 |
| 28 Oct 2016 | Nabisco Oreo Fudge Creme Original Variety, Net Wt. 11.3 oz Distributed by: Mondelez Global LLC East Hanover, NJ UPC 044000026943 | Mondelez International | Food | Class I | 2 |
| 27 Oct 2016 | Olympus Scientific Solutions Americas Corporation (“OSSA”) Model: VANTA Analytical X-Ray System | Olympus Scientific Solutions Americas | Device | Class II | 1 |
| 27 Oct 2016 | LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is… | Teleflex Medical | Device | Class II | 7 |
| 27 Oct 2016 | Back to Nature, Gluten-Free, Chocolate Delight Granola, 11 oz.(311g) pouches, 6 per case. UPC 8-19898-01201-5. | Back To Nature Foods, Llc | Food | Class I | 4 |
| 26 Oct 2016 | VITROS CRP Slides: 1) VITROS Chemistry Products CRP Slides (250 slides per sales unit), Catalog # 1926740 and 2), VITROS Chemistry Products CRP Slides (90 slides per sales unit), Catalog # 1926740 | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 26 Oct 2016 | 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgical application where electrosurgery is… | 3M Company - Health Care Business | Device | Class II | 1 |
| 26 Oct 2016 | 100% Org. Sesame Seeds natural, 50 LBS, Product of Uganda The sesame seeds are packed in multi ply paper bags. Event 75538 | DFI Organics | Food | Class I | 1 |
| 26 Oct 2016 | Homestyle Texas Toast. 1 lb. 8 oz. Clear Plastic Bag. 1 loaf | Pastian's Bakery | Food | Class II | 8 |
| 25 Oct 2016 | Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit | Exactech, Inc. | Device | Class II | 1 |
| 25 Oct 2016 | MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. | Beckman Coulter Inc. | Device | Class II | 1 |
| 25 Oct 2016 | A&W Cream Soda, 20 FL OZ, Caffeine Free Event 75500 | Chesterman Co | Food | Class II | 1 |
| 24 Oct 2016 | Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL… | Ansell Healthcare Products LLC | Device | Class II | 1 |
| 24 Oct 2016 | FMsealer Open Shears. Model FM3001 Event 75627 | Domain Surgical, Inc. | Device | Class II | 1 |
| 24 Oct 2016 | Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90 | Burel Pharmaceuticals Inc | Drug | Class II | 8 |
| 21 Oct 2016 | 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001 | SynCardia Systems Inc. | Device | Class I | 1 |
| 21 Oct 2016 | Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring. | Centurion Medical Products Corporation | Device | Class I | 1 |
| 21 Oct 2016 | ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 20 Oct 2016 | SOMATOM Force, System x-ray, tomography, computed | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 20 Oct 2016 | Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices,… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 19 Oct 2016 | Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes | Ultroid Technologies, Inc. | Device | Class II | 4 |
| 19 Oct 2016 | Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02 Event 75642 | Inventia Healthcare Private Limited | Drug | Class II | 1 |
| 18 Oct 2016 | ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device. | ConforMIS, Inc. | Device | Class II | 1 |
| 14 Oct 2016 | Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099 | Covidien LLC | Device | Class II | 1 |
| 13 Oct 2016 | PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01 NGS… Event 75588 | PerkinElmer, Inc | Device | Class II | 1 |
| 13 Oct 2016 | Neera’s Spicy Thai Sauce and Marinade, Net Volume 150ml/5 fl. oz.., 12 units/case, or 6 units/partial case, 2.0 gallon pail. Event 75411 | Cinnabar Specialty Foods, Inc. | Food | Class II | 1 |
| 12 Oct 2016 | McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140 Event 75638 | CYPRESS MEDICAL PRODUCTS | Device | Class II | 1 |
| 12 Oct 2016 | Ben & Jerry’s Brownie Batter Core Ice Cream One Pint (473 mL). Case UPC- 10076840529879 Consumer UPC - 7684052987 Paper carton 8 units per shrink-wrapped case Frozen | Unilever United States, Inc. | Food | Class II | 1 |
| 11 Oct 2016 | Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit; Algovita Spinal Cord Stimulation… Event 75459 | Nuvectra | Device | Class II | 1 |
| 11 Oct 2016 | Radiation Therapy Treatment Planning System Product Usage: 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 expected during the proposed treatment, and may be used to… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 11 Oct 2016 | Slow Roasted Ham and Swiss Croissant, 5.6 oz. | Greencore USA, Inc. | Food | Class II | 2 |
| 11 Oct 2016 | Cookie Dough Ice Cream packed under the following brand names and sizes: 1. Chocolate Shoppe Ice Cream Company, 3 gallons, UPC 40994-42109 2. Chocolate Shoppe Ice Cream Company, pint; UPC 40994-12109 3. The Baked Bear, 3 gallons; UPC 40994-72093 | Chocolate Shoppe Ice Cream Co., Inc. | Food | Class I | 5 |
| 10 Oct 2016 | Soylent Food Bars, Net Wt. 2.12 oz (60g), 12 pack. Event 75488 | Rosa Foods HQ | Food | Class II | 1 |
| 10 Oct 2016 | Kuster's Dairy Foods Three Blend Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated | Kuster's Inc. | Food | Class I | 10 |
| 5 Oct 2016 | OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. | Oscor, Inc. | Device | Class II | 30 |
| 5 Oct 2016 | Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous multiple image viewing is required | Steris Corporation | Device | Class II | 1 |
| 5 Oct 2016 | Travoprost Ophthalmic Solution USP, 0.004%, a) 2.5 mL and b) 5 mL bottles, Rx only, FOR USE IN THE EYES ONLY, Made in India, Distributed by: Par Pharmaceutical Cos., Inc, Spring Valley, NY 10977 | Par Pharmaceutical, Inc. | Drug | Class II | 1 |
| 4 Oct 2016 | Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens | Medtronic | Device | Class II | 2 |
| 3 Oct 2016 | Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger, an AC power supply and power cord (Model… Event 75458 | Name withheld | Device | Class II | 1 |
| 3 Oct 2016 | Yellowfin Tuna Ground Meat, 22 lbs./case, 5500 lbs Two boxes per case, 11 one pound packages per box, 22 one pound packages per case Event 75797 | Taiwan Seafood & Fish Corporation | Food | Class II | 1 |
| 3 Oct 2016 | Jumbo Pershing (Cinnamon) Rolls; NET WT 11.25 and 16.1 Pounds; Approximate Unit Count [Per Case]: 6-8 Dozen; Brands: Mel-O-Cream and Hy-Vee | Mel-O Cream Donuts International, Inc. | Food | Class II | 9 |
| 1 Oct 2016 | Chicken eggs packaged in the following configurations 1) Premium Farm Fresh White Eggs, packaged in 6 count, 10 count, 12 count, and 18 count styrofoam cartons 2) Farm Fresh Eggs, packaged in 15 dozen and 30 dozen cardboard boxes. Event 75308 | Good Earth Egg Company | Food | Class I | 1 |
| 30 Sep 2016 | Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V… Event 75460 | GF Health Products, Inc | Device | Class II | 1 |
| 28 Sep 2016 | ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041… | Angiodynamics, Inc. | Device | Class II | 7 |
| 28 Sep 2016 | sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and 35700BAXR, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Sigma, LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump.… | Baxter Healthcare Corp. | Device | Class II | 3 |
| 28 Sep 2016 | Brownwood Farms Yankee Bourbon BBQ Sauce. 19oz glass bottles and 1 gallon | Brownwood Farms | Food | Class II | 7 |
| 28 Sep 2016 | Label reads in part "***SUN-DRIED TOMATO & ROASTED GARLIC TROUT FILLETS *** Product of USA *** CONTAINS: FISH (TROUT), WHEAT, MILK. *** UPC 10 070765 08761 2 Individual retail packages are mostly green with information panel in white with black lettering. Cases are 10 lbs and contain 26-29 portions (pieces)… Event 75310 | Clear Spring Foods Specialty Products Plant Inc. | Food | Class II | 1 |
| 27 Sep 2016 | Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue | North American Rescue LLC. | Drug | Class II | 9 |
| 26 Sep 2016 | Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term acute care as well as transfer of patients… | Hamilton Medical, Inc. | Device | Class II | 1 |
| 26 Sep 2016 | GoPicnic Turkey Slices & Cheddar Cheese; 4 Individually Packed Snacks; GLUTEN FREE; Best by: 31 JAN 2017 Event 75568 | SSI-GoPicnic LLC | Food | Class II | 1 |
| 23 Sep 2016 | Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only Event 75268 | Guardian Pharmacy Services | Drug | Class I | 1 |
| 21 Sep 2016 | Good Sense Trail Mix, Cranberries 'N More, Net Wt. 6 oz. (170g). Cranberries, Sunflower Nuts, Cashews, Pumpkin Seeds, Almonds, Apples. UPC 30243-86343. Event 75285 | Waymouth Farms, Inc | Food | Class II | 1 |
| 19 Sep 2016 | Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial… | Tornier, Inc | Device | Class II | 1 |
| 19 Sep 2016 | Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant | Encore Medical, Lp | Device | Class II | 1 |
| 16 Sep 2016 | The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP,… | Randox Laboratories | Device | Class II | 1 |
| 16 Sep 2016 | Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number xxxx004283 or greater) have protection built in to… | Natus Medical Incorporated | Device | Class II | 1 |
| 14 Sep 2016 | BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation | Biomet 3i, LLC | Device | Class II | 36 |
| 14 Sep 2016 | Field Day Organic Ranch Dressing packaged in an 8 fl. oz. glass bottle, UPC #042563600242. The lot code is located on the back of the bottle above the label. Specifically, the front label of the affected product is correctly labeled Field Day Organic Ranch Dressing, 8 fl oz. The issue is some bottles have an… Event 75176 | Drews LLC | Food | Class I | 1 |
| 12 Sep 2016 | Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-0108-01 Distributed by: SAFECOR HEALTH, 317 NEW BOSTON STREET, WOBURN, MA | Safecor Health, LLC | Food | Class III | 1 |
| 10 Sep 2016 | BEDEMCO INC. WORLDWIDE BRAZIL NUTS, SMALL BROKEN, Net Weight: 44 lb., Product of Bolivia, Packed Exclusively for BEDEMCO INC. White Plains, NY (USA) | BEDEMCO IMPORT EXPORT INC. | Food | Class I | 3 |
| 9 Sep 2016 | Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002 Event 75278 | Cadila Pharmaceuticals Limited | Drug | Class II | 1 |
| 9 Sep 2016 | Apple Tree Goat Dairy Chevre, Net Wt. 8 oz. shrink wrap and wt. 5 lb blocks, Richfield, PA 17086. | Apple Tree Goat Dairy | Food | Class I | 5 |
| 9 Sep 2016 | A-PAC Farm Raised Shrimp, A Product of Vietnam, Keep Frozen At 0 Degrees F (-18 Degrees Celsius), Net Weight 4 lbs (64 oz). Above UPC Code: APAC 8/12 ct Headless Tiger Shrimp | Censea Inc | Food | Class I | 2 |
| 8 Sep 2016 | GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15 | Novo Nordisk Inc | Drug | Class I | 1 |
| 8 Sep 2016 | Meijer brand No Salt Added Original Kettle Cooked Potato Chips, 8.5oz bag. 15 bags per case. | Shearers Foods, Llc | Food | Class I | 1 |
| 8 Sep 2016 | Publix Danish Apple Coffee Cake Strip, 15 oz. UPC 002-19562-00000 | Publix Super Markets, Inc. | Food | Class II | 6 |
| 7 Sep 2016 | ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar waveform. Event 75351 | Ellman International, Inc. | Device | Class II | 1 |
| 7 Sep 2016 | ISLAND SOUPS, MANNISH WATER, NET WT. 16 OZ (28.4G) | Island Soups Company Inc. | Food | Class II | 6 |
| 2 Sep 2016 | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10. | Name withheld | Drug | Class I | 3 |
| 2 Sep 2016 | Airheads Mini Bars 12oz bags of assorted flavors. 12 - 12oz bags are included in cardboard cartons. Assorted flavors include Cherry, Watermelon, Blue Raspberry, and White Mystery. Event 75112 | Perfetti Van Melle USA Inc | Food | Class III | 1 |
| 1 Sep 2016 | Girl Scout Peanut Butter Sandwich, NET WT 8 0Z (227 g). UPC 0 20200 07007 8, ABC Bakers/Interbake Foods LLC, Richmond, VA 23233. | Interbake Foods | Food | Class II | 2 |
| 30 Aug 2016 | Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757. | ErgoSafe Products, LLC (DBA) Prism Medical | Device | Class II | 1 |
| 29 Aug 2016 | Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but… | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 3 |
| 26 Aug 2016 | Willis Eagle brand MUT GUNG SWEETENED GINGER, NET WEIGHT 200 g (7 oz), UPC 8935129760691 Event 75047 | Willis Ocean Inc. | Food | Class I | 1 |
| 19 Aug 2016 | Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA | Impax Laboratories, Inc. | Drug | Class I | 1 |
| 19 Aug 2016 | G72642 Ham Pump 35%, 41.92 LB bag composed of one 39.67 LB bag of seasoning and one 2.25 LB bag of cure. | Newly Weds Foods Inc | Food | Class III | 1 |
| 16 Aug 2016 | Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818 Event 74878 | Sperian Eye & Face Protection, Inc | Drug | Class I | 1 |
| 8 Aug 2016 | BD 23 G x .75 in. BD Vacutainer Push Button Blood Collection Set with 12 in. Tubing Catalog # 367342 Intended for venipuncture to obtain blood specimens from patients. | Becton Dickinson & Company | Device | Class II | 1 |
| 5 Aug 2016 | Eastern Feast, Green Raisin, 7 oz, 11 oz, and 14 oz plastic containers. Event 75605 | Commerce International Inc. | Food | Class I | 1 |
| 5 Aug 2016 | 12 Gourmet Variety Pack Cookies - Net Wt. 15 oz UPC 289786003997 Gourmet Variety Pack Cookies Net Wt. 30 oz UPC 289772006995 | Wakefern Food Corp. | Food | Class II | 19 |
| 4 Aug 2016 | MISAGO RX Self Expanding Peripheral Stem | Terumo Medical Corp | Device | Class II | 1 |
| 4 Aug 2016 | Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02 | Hospira Inc., A Pfizer Company | Drug | Class I | 1 |
| 3 Aug 2016 | BARD Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip… | C.R. Bard, Inc. | Device | Class II | 4 |
| 2 Aug 2016 | Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468 MMP3100CHA04 T11506 MMP3100CHA13 T10281 MMP3100CHA04 T8044 ~MMP3100CHA04… | Greatbatch Medical | Device | Class I | 1 |
| 1 Aug 2016 | Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502 Event 74938 | Town and Country Compounding and Consultation Services | Drug | Class I | 1 |
| 29 Jul 2016 | Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures | B. Braun Medical, Inc. | Device | Class II | 1 |
| 29 Jul 2016 | COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per… | Sage Products LLC | Drug | Class I | 3 |
| 29 Jul 2016 | Taste of Inspirations Classic Red Skin Potato Salad; Creamy redskin potatoes & white onion in a tangy dressing. Net Wt. 16 OZ. Sell By: 08-01-16 4238 | ASK Foods Inc | Food | Class I | 1 |
| 28 Jul 2016 | C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067 | Colonia Care Pharmacy | Drug | Class II | 2 |
| 25 Jul 2016 | Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR | US Compounding Inc | Drug | Class I | 1 |
| 21 Jul 2016 | INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders. | Inovo, Inc | Device | Class II | 1 |
| 5 Jul 2016 | R.L. SCHREIBER Demi-Glace Brown Sauce Mix 18 oz (510 G)white plastic bag INGREDIENTS: Enriched Bleached Wheat Flour***CONTAINS: Wheat, Soy, Milk Produced in a facility with Egg Event 74598 | RL Schreiber Inc | Food | Class I | 1 |
| 29 Jun 2016 | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01 | Hospira Inc. | Drug | Class III | 1 |
| 29 Jun 2016 | Label reads in part "***Oregon RAIN Natural VIRGIN WATER***" The product is packaged in a blue colored plastic bottle. 16.9 FL OZ. Case contains 12/16.9 FL OZ. or 24/16.9 FL OZ. Event 75369 | Eola Bottling Company Inc. | Food | Class II | 1 |
| 24 Jun 2016 | Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01 ,… Event 75508 | PerkinElmer, Inc | Device | Class II | 1 |
| 21 Jun 2016 | Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head | MicroPort Orthopedics Inc. | Device | Class III | 7 |
| 17 Jun 2016 | Fresh Express Kit Caesar salad, Net Wt. 7.6 oz. (215g), Fresh Express Incorporated, 550 S. Caldwell St. Charlotte, NC 28202, packed in clear flexible plastic bags. Product Code: G163B13A | Fresh Express Incorpated | Food | Class II | 1 |
| 16 Jun 2016 | Pesto Pasta Salad with Arugula, Net Wt. 16oz, UPC 857898004333 Event 74450 | Green Cuisine, Inc. | Food | Class I | 1 |
| 13 Jun 2016 | Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14. | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 8 Jun 2016 | Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term… | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 2 |
| 8 Jun 2016 | AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150 Event 74368 | Amd-Ritmed, Inc. | Device | Class II | 1 |
| 2 Jun 2016 | Five Star Gourmet Foods Energizer Box Item Code: FG10144 Event 74455 | Five Star Gourmet Foods, Inc. | Food | Class I | 1 |
| 31 May 2016 | Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial… | Pentax of America Inc | Device | Class II | 1 |
| 23 May 2016 | BACKROAD COUNTRY CRANBERRY NUT DELIGHT MIX, Net Wt. 9 oz (256g) Product Code 15359 BEST IF USED BY 05/2017 | Troyer Cheese Inc | Food | Class I | 5 |
| 23 May 2016 | FITNESS MIX sold under the following labels: 1) 15 LBS ALPINE VALLEY FITNESS MIX, packed as 1 per case, 2) Wegmans square tub FITNESS MIX, 20 oz, packed as 12 per case, Flave! FITNESS MIX, NET WT 8OZ (226g), packed as 12 per case, 4) FITNESS MIX, NET WT 5 OZ (141g), shipped 6 packs per case & 5) fitness MIX, NET WT.… | First Source Llc | Food | Class I | 10 |
| 19 May 2016 | Product is packaged into a plastic bag and placed into cardboard box. Product is labeled as "D'ALLESANDRO SALT-FREE ROASTED SUNFLOWER SEEDS". Product was packaged into 5 & 40 lb boxes. | Woodland Foods | Food | Class I | 6 |
| 19 May 2016 | Cheese Stick w/Beef Stick Meal Break, Item #61406 | E S Foods | Food | Class I | 20 |
| 17 May 2016 | Galliker's Lemon Iced Tea Flavored, 1 GAL and Galliker's Lemon Flavored Iced Tea, 1/2 GAL Event 74298 | Galliker Dairy Co. | Food | Class II | 1 |
| 16 May 2016 | Clear plastic cup labeled as: The Farmers Market Buffalo Hot Peanuts; Net Wt. 5 oz.; UPC 3003499846; Best By 10/25/2016 | Giant Eagle, Inc. | Food | Class II | 1 |
| 5 May 2016 | Club Chef Broccoli & Raisin Salad Kits, in 7.625 lb cases, containing 1bag (4.8 oz) of Raisin Sunflower Mix per case. | Club Chef LLC | Food | Class I | 1 |
| 4 May 2016 | Roasted & Salted Sunflower Kernels under the following brand names: AMISH FARMS SALEM, OHIO 44460 5.5 oz plastic bag UPC 8 55993 20018 6, heinen's Warrensville Heights, OH 44128 NET WT 10 oz tub UPC 0 36232 07703 9, Hickory Harvest FOODS Akron, OH 44319 5 oz plastic tube UPC 0 36232 07704 6, 7 oz plastic tube UPC 0… | Ohio Hickory Harvest Brand Products Inc. | Food | Class I | 6 |
| 29 Apr 2016 | BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C. | Making It a Lifestyle | Drug | Class I | 3 |
| 24 Apr 2016 | Old Home Kitchens, 14 oz. Sliced Lemon Creme Cake, Winn-Dixie, 14 oz. Sliced Lemon Creme Cake, Winn-Dixie, 32 oz. Sliced Lemon Creme Cake, and Winn Dixie, 32 oz. Lemon Creme Cake | Benson's Old Home Kitchens Bakery Division | Food | Class II | 7 |
| 14 Apr 2016 | Magnesium on RX Imola analyser IVD | Randox Laboratories, Limited | Device | Class II | 1 |
| 14 Apr 2016 | Thomas' Buns Bread Net Weight 1.5 lbs. (682 grams) . Thomas Star Bakery of Ohio Event 73872 | Thomas Star Bakery of Ohio | Food | Class I | 1 |
| 14 Apr 2016 | 1 GAL PAIL SYSCO IMP. TROPICAL SALAD - LS, UPC 7486563429 | Simply Fresh Fruit | Food | Class I | 26 |
| 13 Apr 2016 | Mary's Home Made Vegetable Soup; 16 FL. OZ. (1 Pint) OR 32 FL. OZ. (1 Quart); Heat and Serve Event 73863 | Name withheld | Food | Class II | 1 |
| 8 Apr 2016 | Bindi USA Vanilla Bean Gelato 1.24 Gal Container (4.8 L) UPC 815073016557 | Bindi North America | Food | Class II | 4 |
| 31 Mar 2016 | Dr. Pepper Cherry, 12oz (12 pack cans), Manufactured under the authority of Doctor Pepper Company, 5301 Legacy Drive, Plano, TX. | The Coca-Cola Company | Food | Class II | 1 |
| 28 Mar 2016 | Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 28 Mar 2016 | Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 12 Feb 2016 | BD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095, 491096, and 491097. SurePath Preservative Fluid is designed for use with the PrepStain System. SurePath Preservative Fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial… | Becton Dickinson & Co. | Device | Class II | 1 |
| 30 Jan 2016 | Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate connection to external applications | Merge Healthcare, Inc. | Device | Class II | 1 |
| 19 Oct 2015 | QUALI FRY PREMIUM BUTTERY PAN AND GRILL, ARTIFICIALLY FLAVORED OIL, NET/NETO 1 GAL (3.79 L) INGREDIENTS: SOYBEAN OIL, HYDROGENATED SOYBEAN OIL***TBHQ***DIMETHYLPOLYSILOXANE***CONTAINS: SOY, UPC 7 58108 45416 3 | Cargill, Inc Corporate Headquarters | Food | Class II | 5 |
| 8 Oct 2015 | Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 1 Oct 2015 | Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM Structured reporting, text files or optical… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 22 Jul 2015 | Apple Orchard Crisp Apple Hard Cider Three packages sizes: Loose case = 24 – 12 oz bottles 12 pack = 12 – 12 oz bottles, shipped as 2 – 12 packs per case 4 – 6 pack = 6 – 12 oz bottles per pack, shipped as 4 – 6 packs per case Event 71879 | Samuel Adams Brewery Co | Food | Class II | 1 |
| 25 Aug 2014 | Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 | Hi-Tech Pharmacal Co., Inc. | Food | Class III | 1 |
| 1 Aug 2014 | ST CKERT Heater‐Cooler System 3T; Item Number 16‐02‐81, Heater‐Cooler 3T, 240V/60Hz; Item Number 16‐02‐82, Heater‐Cooler 3T, 208V/60Hz; Item Number 16‐02‐85, Heater‐Cooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a Stckert S3 heart lung machine and / or any other heart lung machine featuring a separate… | Sorin Group USA, Inc. | Device | Class II | 1 |
| 28 Jul 2014 | Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 | Hi-Tech Pharmacal Co., Inc. | Food | Class III | 1 |
| 30 Apr 2014 | Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 11 Mar 2010 | The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX | Physio-Control, Inc. | Device | Class II | 1 |