| 3 Sep 2016 | Southern Grove Cashews with Sea Salt, a 10 ounce stand up pouch bag with a UPC 0 38445 12286 5 and the date codes of Best By May 24 2017 KN and August 05 2017 KN | Kanan Enterprises, Inc. | Food | Class II | 1 |
| 31 Aug 2016 | GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device. | GE Healthcare, LLC | Device | Class II | 1 |
| 31 Aug 2016 | Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth. | Ormco/Sybronendo | Device | Class II | 1 |
| 29 Aug 2016 | TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended… | Trimed Inc | Device | Class II | 1 |
| 26 Aug 2016 | HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A | Philips Electronics North America Corporation | Device | Class II | 1 |
| 26 Aug 2016 | G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium. | The Anspach Effort, Inc. | Device | Class II | 4 |
| 26 Aug 2016 | SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. | Abbott Medical Optics Inc. (AMO) | Device | Class II | 10 |
| 25 Aug 2016 | Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the central circulatory system but they are… | Sorin Group USA, Inc. | Device | Class II | 1 |
| 25 Aug 2016 | Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Freezing Medium . Product Number: ART -8017 SAGE In Vitro Fertilization, Inc. A CooperSurgical Company 95 Corporate Drive Trumbull, CT 06611 USA | CooperSurgical, Inc. | Device | Class III | 2 |
| 24 Aug 2016 | WECK Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11” (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip Traditional, or Atrauclip ligating clips as… | Teleflex Medical | Device | Class II | 1 |
| 24 Aug 2016 | PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics. | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Device | Class II | 1 |
| 24 Aug 2016 | Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Device | Class II | 1 |
| 24 Aug 2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540. | Sandoz Inc | Drug | Class II | 2 |
| 24 Aug 2016 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product) CII 5 mg, 30 UD Tablets (5 x 6), Rx, Packaged and Distributed by: American Health Packaging, Columbus, OH --- Carton NDC 68084-874-25;… | Amerisource Health Services | Drug | Class II | 10 |
| 23 Aug 2016 | Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06 Event 75025 | Stason Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 22 Aug 2016 | Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies. | Hologic, Inc | Device | Class II | 1 |
| 19 Aug 2016 | Inland Market, Premium Blue Crab Spread, Net Wt. 7 oz. (198 g.) and 16 oz. (454g), Inland Market, 1667 Lewis Way, Stone Mountain, GA 30083. | Inland Seafood, Inc. | Food | Class II | 11 |
| 18 Aug 2016 | Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy. | Elekta, Inc. | Device | Class II | 1 |
| 18 Aug 2016 | NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 -… Event 75008 | Waismed Ltd | Device | Class II | 1 |
| 18 Aug 2016 | Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in… | NOVADAQ TECHNOLOGIES INC. | Device | Class II | 1 |
| 18 Aug 2016 | HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment. | Elekta, Inc. | Device | Class II | 1 |
| 18 Aug 2016 | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01, | West-Ward Pharmaceuticals Corp. | Drug | Class III | 1 |
| 18 Aug 2016 | Best Valu Cut/Cortado; Yellow Corn; Maiz Amarillo; Net Wt 14 OZ; Code: SSFF/R 10308; Best By: 04/11/18; Product of Canada; Distributed by Federated Group Inc., Arlington Heights, IL ; Laura Lynn Cut Corn; Net Wt 16 oz.; Cut Corn Fresh Frozen For Freshness Best By: 04/11/18, 05/09/18, 06/06/18; Product of Canada;… | CAMBRIDGE FARMS OF HANOVER LLC D | Food | Class II | 6 |
| 16 Aug 2016 | Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the outer cavity. The patient record label… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 16 Aug 2016 | Croissant; Sold in self service case labeled "Croissant" PLU 481976 or clam shell package of 4 - PLU 241593. Ingredient: Water, Wheat Flour, Sugar Butter (Pasteurized Cream, Salt), Milk (Powder Fat Whole), Salt, Yeast, Ascorbic Acid. Contains Wheat, Milk Whole Foods Market, Emeryville, CA | Bakers Of Paris, Inc. | Food | Class I | 2 |
| 16 Aug 2016 | Snack Factory , Pretzel Crisps Original, UPC 049508006008, 7.2 oz (204g). | Baptista's Bakery, Inc | Food | Class II | 2 |
| 15 Aug 2016 | CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity… | Biosense Webster, Inc. | Device | Class II | 1 |
| 15 Aug 2016 | DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20 | Hospira Inc. | Drug | Class II | 1 |
| 12 Aug 2016 | PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography). | Philips Electronics North America Corporation | Device | Class II | 1 |
| 12 Aug 2016 | The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to adapt a range of different head and… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 12 Aug 2016 | Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that… | Sorin Group USA, Inc. | Device | Class II | 2 |
| 12 Aug 2016 | ZATARAINS SOUTHERN STROGANOFF PASTA DINNER 6.5 OZ. PACKAGE | McCormick & Company - Corporate Headquarters | Food | Class II | 4 |
| 11 Aug 2016 | Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit. | DeRoyal Industries Inc | Device | Class II | 2 |
| 11 Aug 2016 | Siemens RAPIDPoint 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899,10321239,10322654,10324081, 10328803, 10331381, 10339634 | Siemens Healthcare Diagnostics Inc | Device | Class II | 7 |
| 11 Aug 2016 | Activia FIBER Lowfat Yogurt Strawberry/Pineapple Flavors 12 Packs of 4 OZ Cups UPC 3663202884 packaged in form fill seal plastic cups | The Dannon Company, Inc. | Food | Class II | 1 |
| 11 Aug 2016 | Archer Farms Corn & Black Bean Quinoa Blend with pineapple & red pepper packaged in a flexible plastic bag | Superior Foods | Food | Class II | 2 |
| 10 Aug 2016 | Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by… | ICU Medical, Inc. | Device | Class II | 24 |
| 10 Aug 2016 | Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopotential signals from user supplied electrodes. Biopotential signals include: Electrocorticography (ECoG),… | Blackrock Microsystems, LLC | Device | Class II | 2 |
| 10 Aug 2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY 10605. Event 74883 | Allergy Laboratories, Inc. | Drug | Class II | 1 |
| 10 Aug 2016 | WTI (World Technology Ingredients) DV, All Natural, 35 lbs./15.9 kg, WTI, Inc., 281 MLK Ave., Jefferson, GA 30549. Event 74943 | WTI, Inc -World Technology Ingredients | Food | Class III | 1 |
| 9 Aug 2016 | Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for… | Mentor Texas, LP. | Device | Class II | 2 |
| 9 Aug 2016 | MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 – Made in China. Event 74952 | Global Healthcare Inc | Device | Class II | 1 |
| 9 Aug 2016 | MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months. | Mentor Texas, LP. | Device | Class II | 2 |
| 9 Aug 2016 | EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter | EKOS Corporation | Device | Class II | 1 |
| 9 Aug 2016 | ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test) | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 8 Aug 2016 | BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342. | Becton Dickinson & Company | Device | Class II | 1 |
| 8 Aug 2016 | SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is… | Nidek Inc | Device | Class II | 1 |
| 8 Aug 2016 | UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System). | Beckman Coulter Inc. | Device | Class II | 1 |
| 8 Aug 2016 | 3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only. | Biomet 3i, LLC | Device | Class II | 1 |
| 8 Aug 2016 | Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels. | Arrow International Inc | Device | Class II | 2 |
| 5 Aug 2016 | e.cam and Symbia E gamma camera systems with patient beds 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. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 5 Aug 2016 | Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers: 663BK 663BL 664BL 928BK Product Usage: For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery. | Riverpoint Medical, LLC | Device | Class II | 2 |
| 5 Aug 2016 | Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 5 Aug 2016 | 5 lb Living Alfalfa Sprouts. One package per case. Distributed by and/or Manufactured by Astec Ltd. dba Sprouts Extraordinaire Event 74882 | Sprouts Extraordinaire, LLC | Food | Class I | 1 |
| 5 Aug 2016 | Country Home Bakers, All Natural Chocolate Chunk with Salty Caramel Cookie Dough, Net Wt: 22.5 lbs (10.2 kg), Count: 240-1.5oz (43g) portions, Country Home Bakers, Atlanta, GA 30310, ready to bake. Event 74897 | Country Home Bakers | Food | Class II | 1 |
| 5 Aug 2016 | El Alteno Raisinettes Dovales 12 oz. UPC: 8 20202 00411 4 Event 74870 | Name withheld | Food | Class II | 1 |
| 5 Aug 2016 | El Alteno Coconut Shredded Coconut 8 oz. UPC: 8 20202 00362 9 Event 74869 | Name withheld | Food | Class II | 1 |
| 4 Aug 2016 | AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby” System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics,… Event 74963 | AirStrip Technologies, Inc. | Device | Class II | 1 |
| 4 Aug 2016 | INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Device | Class II | 1 |
| 4 Aug 2016 | UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slidemaker Stainer (DxH SMS) Instructions for Use (IFU) Part Number B26647AC The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a… | Beckman Coulter Inc. | Device | Class II | 1 |
| 4 Aug 2016 | Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For Subcutaneous Injection only, Manufactured by: Genzyme Corporation, 500 Kendall Street, Cambridge, MA 02142 A Sanofi Company Country of Origin : United Kingdom, NDC 0024-5862-01 Event 74968 | Genzyme Corporation / Genzyme Biosurgery | Drug | Class III | 1 |
| 4 Aug 2016 | buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories, NDC 68001-264-03 | Amerisource Health Services | Drug | Class III | 1 |
| 4 Aug 2016 | Apple Cider: Ricker Hill Orchards Apple Cider 1/2 GAL (64 FL OZ) 1.89 LITERS; NORTHLAND APPLES Pure SWEET MAINE CIDER 1 QUART 947.2ML, UPC: 074613 70009 1 and NORTHLAND APPLES Pure SWEET MAINE CIDER 12 FL. OZ. 355.2 ML, UPC: 0 74613 60009 | Ricker Hill Orchards | Food | Class II | 2 |
| 4 Aug 2016 | O Organics Vegetable Tray, 18 oz. (1 lb. 2 oz.) 510g plastic tray. Best If Used By: AUG 11 UPC (incorrect, which is on the tray): 021130984282 Product of USA & Mexico. | Mann Packing Company, Inc. | Food | Class I | 1 |
| 3 Aug 2016 | Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo Pharma USA, Inc 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit-VII (SE2), Mahaboob Nagar (Dt) - 509302, India , NDC 65862-0560-90 | Aurobindo Pharma USA Inc | Drug | Class II | 1 |
| 3 Aug 2016 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippany, NJ 07054-0224 UPC 363824951737 NDC 63824-207-60 | Reckitt Benckiser LLC | Drug | Class III | 1 |
| 3 Aug 2016 | Whole Food Market Thai Shrimp Salad Serving Size 8 oz. Distributed by Whole Foods Market Englewood Cliffs NJ 07632 UPC 8-2510-00081 Event 74865 | Whole Foods Market Northeast Regional Office | Food | Class II | 1 |
| 3 Aug 2016 | Vanilla Ice Cream Devils Food Rollcake-8941-Baskin Robbins. Cakes are sealed in plastic and packed in a labeled cardboard box. Roll cake is packed 8 per case. Product is frozen. | Superior Dairy Inc | Food | Class I | 10 |
| 3 Aug 2016 | Grassfields Gouda Cheese, cut and wrapped in clear plastic | Whole Foods Market | Food | Class I | 8 |
| 2 Aug 2016 | LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX Analyzer. It is run once a day before… | Alere San Diego, Inc. | Device | Class III | 1 |
| 2 Aug 2016 | Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 2 Aug 2016 | Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications | Bayer Healthcare | Device | Class II | 1 |
| 2 Aug 2016 | SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI. ILS-0914-20-OB (9G Introducer Localization Set (OB Model) for ATEC0914-20MR Handpiece) | Hologic, Inc | Device | Class II | 2 |
| 2 Aug 2016 | Acecide-C High Level Disinfectant & Sterilant 875 mL. Packaging is 6 inner cartons in one master carton;1 inner carton consists of a set of two liquids (1 acid & 1 buffer) banded together. Event 74862 | Best Sanitizers Inc | Device | Class II | 1 |
| 2 Aug 2016 | Good Neighbor Pharmacy Cranberry Tablets, Cranberry Supplement 450mg. Urinary Health. Tablets are packed in a labeled carton, 50 tablets per carton. Distributed by Amerisource Bergen 1300 Morris Drive Chesterbrook, PA 19087. Event 74854 | Reese Pharmaceutical Company | Food | Class III | 1 |
| 1 Aug 2016 | Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to fully seat the implant onto the bone and… | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 1 Aug 2016 | Split Cooked King Crab Leg & Claw, repacked by Odyssey, net wt. 20 lbs. per box, keep frozen. UPC 28575 96323 The label is read in parts: "***SPLIT COOKED KING CRAB LEG & CLAW***PRODUCT OF RUSSIA***PACKED IN U.S.A. ***NET WT. 20 LBS***KEEP FROZEN***PACKED FOR: ODYSSEY BY: NORTHWEST SEAFOOD PROCESSORS INC***206 SW… Event 74848 | Odyssey Enterprises Inc | Food | Class II | 1 |
| 29 Jul 2016 | White Sponge Cake 8x12 30 lb case 20, 24oz cakes per case | Minnie Marie Bakers, Inc. dba Awrey's Bakery | Food | Class I | 4 |
| 29 Jul 2016 | SimplyNature Organic Chipotle Ranch Dressing, Net Wt. 12 FL OZ (354mL), UPC: 0 41498 21862 1 Event 74829 | Drews LLC | Food | Class II | 1 |
| 29 Jul 2016 | JUST Chocolate Chunk Muffin Mix; NET WT 20.8 oz. (1 lb 4.8 oz) 590 g); UPC 8 54829 00656 5. Ingredients: Muffin Mix: Enriched flours, {bleached (wheat flour, niacin, reduced Iron, thiamine mononitrate, riboflavin, folic acid), unbleached (Wheat flour, malted barley flour, niacin, reduced Iron, thiamine monomonitrate,… | Hampton Creek Foods | Food | Class I | 6 |
| 28 Jul 2016 | Alcon AcrySof IQ IOL with ULTRASERT Delivery System Product Usage: The Alcon AcrySof IQ Intraocular Lens (IOL) is an acrylic foldable singlepiece posterior chamber lens for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients following cataract surgery. This material is… | Alcon Research, Ltd. | Device | Class II | 1 |
| 28 Jul 2016 | LAUREATE World Phaco System | Alcon Research, Ltd. | Device | Class II | 1 |
| 28 Jul 2016 | Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended to facilitate networked communication between compatible computer systems and Hospital infusion… | Hospira Inc., A Pfizer Company | Device | Class II | 1 |
| 28 Jul 2016 | AZ House Granola MANUFACTURED BY: Azar Nut Company El Paso, TX 79912 packaged in 5 pound plastic bags; 1 case containing one 5 pound bag | Mount Franklin Foods LLC | Food | Class I | 1 |
| 27 Jul 2016 | 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists… | OrthoPediatrics Corp | Device | Class II | 2 |
| 27 Jul 2016 | SODIUM BICARBONATE, CAS # 144-55-8, USP/FCC GRADE 1, NET WEIGHT 50 lbs./22.68 kg --- Natrium Products, Inc. 58 Pendleton Street, Cortland, NY 13045 Event 74821 | Natrium Products Inc | Food | Class III | 1 |
| 26 Jul 2016 | AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion in patients with… | Howmedica Osteonics Corp. | Device | Class II | 3 |
| 25 Jul 2016 | Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled containing Coated Tubing as follows: This product is intended for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. This product is a sterile, disposable kit, intended for one-time… | Terumo Cardiovascular Systems Corp | Device | Class II | 1 |
| 25 Jul 2016 | Prime Foods / Kramer Farms - Salad Grade Hard Cooked Eggs. Hard cooked eggs in 20 lb. modified atmospheric packaging. 2, 20 lb. units per case Event 74802 | Prime Foods, Inc. LLC | Food | Class I | 1 |
| 25 Jul 2016 | Chili Dog, Low Fat/Low Sodium Product ID 952000 | Name withheld | Food | Class I | 9 |
| 25 Jul 2016 | MEIJER MACARONI SALAD 1 LB. plastic retail container | Meijer Distribution, Inc | Food | Class I | 8 |
| 23 Jul 2016 | Panera Bread Balsamic Vinaigrette Dressing, NET 20 FL OZ (1.25 PT) 591 mL, most responsible firm on the label is Panera Bread St. Louis, MO 63127 PaneraAtHome.com. Product packaged in plastic bottles and shrink wrapped as a twin pack (2 bottles together). UPC code is 018959753168 for the single bottle. The UPC code… Event 74807 | Arcobasso Foods | Food | Class III | 1 |
| 23 Jul 2016 | 10 oz flexible plastic bag containing 12 individually wrapped mozzarella cheese sticks. The product is packaged in a Blue and clear bag with white and black lettering. UPC number: 0 71040 00060 2 | Pollio Italian Cheese Company | Food | Class II | 2 |
| 22 Jul 2016 | Primo Fresh Serrano Peppers Distributed by Warren Produce, 824 W. Monte Cristo Rd, Edinburg, TX packaged in 1/4 bushel waxed cardboard boxes, 1 1/9 bushel waxed cardboard boxes, 10 lb waxed cardboard boxes, 5 lb waxed cardboard boxes and 35 lb RPC crates. Event 74789 | Warren Produce Co., LLC | Food | Class I | 1 |
| 21 Jul 2016 | SMR allen wrench 5 mm, product code 9013.50.210 Event 74827 | Name withheld | Device | Class II | 1 |
| 21 Jul 2016 | RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 21 Jul 2016 | FPS 35mm x 3.5 mm non-locking screw | Ortho Solutions Inc | Device | Class II | 1 |
| 21 Jul 2016 | Kitchen Cravings Strawberry Parfait, Net Wt. 8.25 oz (234 g). UPC 39779-18435 Creamy Parfait Base, Strawberries with Sweetened Granola. Keep Refrigerated. | Kwik Trip, Inc. | Food | Class I | 2 |
| 20 Jul 2016 | ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) results when HbA1c values are reported in International Federation of Clinical Chemistry (IFCC) equivalent units (HbA1cR). The ADVIA Chemistry XPT System is an automated, clinical… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 19 Jul 2016 | Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in… Event 74837 | Thermo Finnigan LLC | Device | Class II | 1 |
| 19 Jul 2016 | Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 19 Jul 2016 | Smoked Herring Slow Food (Quality: Polar Golden Presidia), Net weight 0.378 (others may vary slightly), Produced by: Njardar AS 6094 Leinoy, Product of Norway | Misono Food Ltd | Food | Class II | 2 |
| 19 Jul 2016 | Honey Peanuts Net Wt. 25 lbs (11.360g) Ing:peanuts, seasoning***honey, wheat starch***Allergen Statement: Contains peanuts and wheat. Manufactured on equipment that processes and packages peanuts and other tree nuts.May contain trace amounts of other nuts. UPC 0 74249 29186 4 Mfg. By: Trophy Nut Co. Tipp City, OH 48371 | Trophy Nut Co Inc | Food | Class I | 1 |
| 18 Jul 2016 | NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ray System - Europe, Part Number 08500013; NOMAD Pro X-Ray System, Remote Config., Part Number 08500017; NOMAD Pro Packaged X-Ray System JP, Part Number 08500019 | Aribex Inc | Device | Class II | 2 |
| 18 Jul 2016 | Theo Chocolate Salted Almond 70% Dark Chocolate bars are wrapped in a white paper envelope, weighs 3 oz., UPC is 8 74492 00170 4, and stored at room temperature Event 74726 | Theo Chocolate Inc | Food | Class I | 1 |
| 18 Jul 2016 | Original Bacon Flavored Seasoning Salt, Big Pig brand, 16oz plastic jars, 3 jars per case. UPC 98300 00110 Event 74762 | J&D's Down Home Enterprises, Inc. | Food | Class I | 1 |
| 18 Jul 2016 | Bake'n Joy Sanding Sugar Net Wt. 16 lbs. pail Product Number: 0209416 | BAKE N JOY FOODS, INC. | Food | Class II | 1 |
| 16 Jul 2016 | PF Chang's Home Menu Brand Shrimp Lo Mein, UPC 3100067005, 22 oz bag, 4 bags per case, ConAgra Foods, Omaha, NE 68102 Event 74717 | ConAgra Frozen Foods, Inc | Food | Class II | 1 |
| 15 Jul 2016 | Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight… | Hill-Rom, Inc. | Device | Class II | 1 |
| 14 Jul 2016 | STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General,… | Intuitive Surgical, Inc. | Device | Class II | 3 |
| 14 Jul 2016 | Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702. | Ecolab Inc | Device | Class II | 1 |
| 14 Jul 2016 | Fresh Cucumbers GROWN & PACKED BY ZACHARY R HEIKEN PILESGROVE, N.J. 08098 856-297-5183 UPC Code: 4062 Item Number: 14138 Event 74728 | Big Y Foods, Inc. | Food | Class I | 1 |
| 14 Jul 2016 | Molly's Kitchen Hotzzarella Cheese Sticks, 12 lbs., Item No. 582648; Fred's Hotzzarella Cheese Sticks, 12lbs., Item No. 0204320. Event 74695 | Ajinomoto Windsor Inc., Golden Tiger Plant | Food | Class II | 1 |
| 14 Jul 2016 | Poppers brand Mozzarella Cheese Sticks Net Wt. 32 oz. (2 lb) 970 g. Keep Frozen. Cook Thoroughly. UPC 46704-88920. Distributed by: Heinz Event 74697 | Monogram Appetizers, Inc | Food | Class I | 1 |
| 13 Jul 2016 | Marie Callender's Cheese Biscuit, Restaurant Style; Packaged in 7 oz. and 14 oz. Stand-up pouches. UPC - 7 oz. 075968-14015-0, Item number 14015D; UPC 14 oz. 075968-170110-9, Item number 17011 Event 74692 | ICC/Marie Callender's Products | Food | Class I | 1 |
| 13 Jul 2016 | Prime CAP Sugar, S 95-135, Encapsulated Sugar. Ingredients: Sugar and Hydrogenated Palm Oil, #10040870, Net WT. 125 lbs. Poly lined cardboard drum. DIFP, Inc., 2125 Airport Dr., Ferial, MN 55021 Event 74908 | Innovative Food Processors, Inc. | Food | Class II | 1 |
| 12 Jul 2016 | McKesson Radiology, versions 12.1.1 and 12.2 McKesson Radiology (MR) is a Picture Archiving Communication System (PACS). It is a medical image and information management application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and… Event 75194 | Mckesson Medical Imaging Group | Device | Class II | 1 |
| 12 Jul 2016 | Breaded stuffed Jalapenos poppers labeled in part: Anchor breaded Fiesta Bold Poppers, breaded stuffed jalapenos, keep frozen. The product is packaged in a green 4 lb. box with white, green and orange lettering. | McCain Foods USA | Food | Class II | 2 |
| 12 Jul 2016 | Product label reads in part: "Maga PANCAKES EL ORIGINAL***PANCAKE & WAFFLE MIX***Peso Neto/Net Weight 16 oz (454.8gr)***Productos La Finca, Inc.*** Zona Ind. Machuchal*** Avenida Quilinchini #61***Sabana Grande, Puerto Rico 00637" | Productos La Finca, Inc. | Food | Class II | 11 |
| 11 Jul 2016 | Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only. | C.R. Bard, Inc. | Device | Class II | 2 |
| 11 Jul 2016 | Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | Device | Class III | 1 |
| 11 Jul 2016 | Betty Crocker Delights Super Moist Carrot Cake Mix, NET WT 15.25 OZ (432 g), Package UPC 1 00 16000 40987 0, Carton UPC: 000-16000-40987 0. | General Mills, Inc | Food | Class I | 3 |
| 11 Jul 2016 | ULTRA PROTEIN VANILLA“ 948 grams, packaged in 2500cc White HDPE Canister | HVL, LLC | Food | Class II | 3 |
| 8 Jul 2016 | Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus),… | Nakanishi Inc. | Device | Class II | 3 |
| 8 Jul 2016 | Medical Linear Accelerator | Elekta, Inc. | Device | Class II | 1 |
| 7 Jul 2016 | Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper FD20/20 , 722038; Allura Xper FD20/20 biplane OR… | Philips Electronics North America Corporation | Device | Class II | 2 |
| 7 Jul 2016 | T2Candida Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartridge base). A qualitative T2 Magnetic Resonance (T2MR) assay for the direct detection of Candida species in EDTA human whole blood specimens. Event 74732 | T2 Biosystems Inc | Device | Class II | 1 |
| 7 Jul 2016 | Tortilla Encrusted Breader for Tilapia, Net Wt. 40 lbs, Sm# 1000323591, MFG For High Liner Foods, Newport News, VA 23603. Event 74646 | Southeastern Mills Custom Seasoning Solutions | Food | Class II | 1 |
| 7 Jul 2016 | Bulk packaged flour based "breader" packaged in 25, 35, and 50 lb. bags. | Newly Weds Foods Inc | Food | Class I | 2 |
| 7 Jul 2016 | Krusteaz Blueberry Pancake Mix, 28 oz. carton, UPC code 041449001289 Krusteaz Blueberry Pancake Mix, 3.5 lb. bag, UPC code 041449001487 Event 74641 | Continental Mills (Corporate Office) | Food | Class I | 1 |
| 6 Jul 2016 | 7-Eleven, Fresh To Go, Walnut Fudge Brownie Net weight: 3.8 Ounces, Number of units per package: One Shelf life: Three Days Expiration date: 0708 (July 8, 2016) Event 74667 | Bakery Express - Mid Atlantic, Inc. | Food | Class II | 1 |
| 1 Jul 2016 | The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is… | Circulatory Technology Inc | Device | Class II | 1 |
| 1 Jul 2016 | Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers | Sysmex America Inc | Device | Class II | 1 |
| 1 Jul 2016 | Huberts Lemonade Strawberry, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780. | Coca-Cola Company (The) | Food | Class II | 4 |
| 30 Jun 2016 | Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic… | Stryker Howmedica Osteonics Corp. | Device | Class II | 2 |
| 30 Jun 2016 | Case: Beyond Meat Vegetarian Indian Curry with Beyond Chicken, GMI Item # 46671000, Frozen. Net WT 5 lbs (2.2 KG) 8 - 10 oz (263 g). Individual items: 21 Grams of Plant Protein, Vegetarian Indian Curry with Beyond Chicken, Net WT 10 oz (263 g), UPC is 000-16000-46671 , Keep Frozen. | General Mills, Inc | Food | Class I | 1 |
| 29 Jun 2016 | ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients. | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | Device | Class II | 1 |
| 29 Jun 2016 | Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2 | Carefusion 2200 Inc | Device | Class II | 2 |
| 29 Jun 2016 | Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multi‐dose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, | Isomeric Pharmacy Solution, LLC | Drug | Class II | 1 |
| 29 Jun 2016 | Organic Hot Finger Peppers (Florida), sold in 0.5-1 lb plastic bags. Each case will hold approximately 15-20 bags. Event 74541 | Sanwa International Wholesale Foods, LLC | Food | Class I | 1 |
| 27 Jun 2016 | The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis. | Cardinal Health | Device | Class II | 1 |
| 27 Jun 2016 | Intermediate carton label reads in part as: "Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 (3 x 50)***REF 371712***LOT 0088464." Intended for tissue separation and other procedures that require a sharp surgical blade to puncture or cut. Event 74584 | Aspen Surgical Puerto Rico Corp. | Device | Class II | 1 |
| 27 Jun 2016 | Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-count bottle (NDC 57664-242-13), 1000-count bottle (NDC 57664-242-18), Rx Only Manufactured by: ALKALOIDA Chemical Company Zrt 440 Tisavasvari Kabay Janos u. 29 Hungary, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 4 |
| 24 Jun 2016 | Snack Shoppe, 16 OZ Hot & Spicy Cajun Snack Mix in a foil bag that is contained in a tin box. The foil bags are marked with the lot number. | Figi's, Inc | Food | Class I | 2 |
| 23 Jun 2016 | Euro Custard Cake, Plastic wrapped cardboard container (Net Wt. 7.20 oz.) | Eastland Food Corporation | Food | Class I | 1 |
| 22 Jun 2016 | Brand Name: Evie’s Cheddar Potato Macaroni Salad Net Weight: 6 oz. container Units per package: 1 Units per case: 6 containers per case Package Type: clear plastic container Event 74571 | Gilbert Foods Inc. | Food | Class I | 1 |
| 21 Jun 2016 | 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems. | Omega Medical Imaging, Inc. | Device | Class II | 1 |
| 21 Jun 2016 | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee… | MicroPort Orthopedics Inc. | Device | Class I | 11 |
| 21 Jun 2016 | KC (Kill Cliff) Strawberries & Cream Protein Bars, 2.1oz (60g) individually wrapped bar (in cases of 12-2.1 oz (60g) bars). Event 74530 | Name withheld | Food | Class II | 1 |
| 21 Jun 2016 | EAT Barbeque Zero to Hero, a Sweet Rub, packaged in 6.5oz bottles (mislabeled). The responsible firm named on the label is Pellet Envy, LLC in Kansas City, USA. UPC code is 859849005024. The correct label should read 6.7oz. Bottles are packed in cases of 6. Event 74471 | Old World Spices & Seasonings Inc | Food | Class III | 1 |
| 20 Jun 2016 | Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter. | Anthogyr | Device | Class II | 2 |
| 20 Jun 2016 | Calcium Gluconate 1% -- 1000 mL VIAFLEX IV BAG, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377 | W & C dba The Apothecary | Drug | Class II | 5 |
| 17 Jun 2016 | Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a single use, sterile device used to treat acute Achilles tendon ruptures. The Achillon Suture System is a mini-invasive procedure indicated to teat acute Achilles tendon ruptures: Acute rupture of the Achill… | Integra LifeSciences Corp. | Device | Class II | 1 |
| 17 Jun 2016 | ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton). | Teva North America | Drug | Class II | 4 |
| 17 Jun 2016 | Product is a 32-ounce Key Lime pie sold at the firm's retail outlet only. Pie is packed in a cardboard carton with an aluminum pie pan and a plastic dome lid. Retail pie is not labeled. Customers are provided the flavor of pie they select for purchase. | Gardner Pie Company | Food | Class II | 2 |
| 17 Jun 2016 | Tippins 8" Key Lime Pie packaged in aluminum pie plates with plastic covers. The responsible firm listed on the label is TGP, LLC Kansas City, KS 66106. UPC code is 680816050057. Packaged in 8 pies per case. Shipped frozen. | Tippin's Gourmet Pies, LLC | Food | Class II | 5 |
| 17 Jun 2016 | Sweet Pea Pasta Salad 10 lb cardboard case (2, 5lb plastic bags), 2 lb rigid plastic container, 14 oz. rigid plastic container Keep Refrigerated Event 74476 | Dutch Treat Salads Inc. | Food | Class I | 1 |
| 17 Jun 2016 | Earnest Eats Chewy Granola Dark Chocolate Almond UPC 891048001636 5-1.2 oz (35g) BARS NET WT 6.2 oz (175g) Distributed by Earnest Eats Solana Beach, CA 92075 Event 74457 | Annona Company, LLC | Food | Class I | 1 |
| 15 Jun 2016 | A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. Part numbers 0632F-PA0000X (US domestic) and 0632B-00014 (international) | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 15 Jun 2016 | Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias. | Boston Scientific Corporation | Device | Class II | 1 |
| 15 Jun 2016 | Globespun Gourmet Thai, net wt. 8 oz, plastic wrapped. UPC 32328 00405. | Essential Foods Inc. dba Globespun Gourmet | Food | Class I | 4 |
| 15 Jun 2016 | Label reads in part as: "BELCA***Soy Sauce***HECHO EN PUERTO RICO (Made in Puerto Rico)***Contenido Neto (Net Content): Un Galn (one gallon)***128 fl. oz***DISTRIBUIDO POR (Distributed by): MISTER PRICE INC. SAN JUAN, PR 00936". | Gasco Industrial | Food | Class II | 3 |
| 14 Jun 2016 | Mill House Salad Dressing & Gourmet Sauce 12 FL OZ Plastic Bottles Ingredients: canola oil, garlic, lemon juice, water, salt, pepper. Event 74421 | Van Vogt Creations | Food | Class II | 1 |
| 14 Jun 2016 | China Garden Bourbon Sauce (for Chicken) 5.25 lb plastic bag Ingredients: SUGAR, OYSTER FLAVORED SAUCE***SWEET RICE, WATER, ALL PURPOSE FLOUR WHITE BLEACHED ENRICHED***DRIED YEAST. Contains: (Soy, Wheat). FOR INSTITUTIONAL USE ONLY SUNRISE FOODS, INC. COLS, OHIO 43204 | Sunrise Foods Inc | Food | Class II | 5 |
| 14 Jun 2016 | molly&drew The Beer Bread Company, Beer Bread Mix, NET WT. 19.75 OZ, UPC 8 55290 00300 8, molly & drew Sac City, IA. Packed in paper bags. Event 74411 | Big L Brands Inc DBA molly&drew The Beer Bread Company | Food | Class I | 1 |
| 14 Jun 2016 | Caraway Multigrain PAN Bread 3 lbs. SLC; The 3lb designation is for dough weight, not net wt. No ingredient statement on label. No labeling agreement with consignees. Sliced breads are individually wrapped in in plastic and labeled only with a label that shows the product's name and company name. Unsliced, whole… | Golden Crown Bakery, Inc. dba Panzanella Bread Company | Food | Class II | 12 |
| 14 Jun 2016 | COMBOS CHEDDAR CHEESE PRETZEL Net Wt. 6.30 oz (178.6 g) Mars Chocolate North America, LLC Hackettstown, NJ 07840-1503 USA UPC 41419420058 | Mars Chocolate North America | Food | Class II | 16 |
| 13 Jun 2016 | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma. | Biomet Microfixation, LLC | Device | Class II | 1 |
| 13 Jun 2016 | Not Ready to Eat, IQF green peas. Products' labels contains Cooking Instructions. Products are sold under various brands and various net weight. Bountiful Harvest Green Peas, item # 22486-11904, case UPC & label UPC 30822486119042 and 2248611904, net wt. 12/2.5 LB C&W Early Harvest Petite Peas, item # 70332-00159,… | National Frozen Foods Corporation | Food | Class II | 4 |
| 9 Jun 2016 | FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast… | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 7 Jun 2016 | Dollywood Cajun Mix packaged in a clear 9 ounce plastic bag with grey sticker label reading in part "Dollywood Candy Kitchen". UPC code 4 9000 503302 Event 74364 | Rucker's Makin Batch Candies, Inc. | Food | Class I | 1 |
| 6 Jun 2016 | Colostrum6 Capsules 500mg, Item No 9901, 180 ct. Sold under the brands: Immune Tree, Immune Pro-6 (Not purchased since 8/25/2014), Surthrival, Good For You Canada. Packaged using HDPE White bottle, except Surthrival which uses a Brown HDPE Bottle | Immune Tree, Inc (formerly ITG, Inc.) | Food | Class II | 5 |
| 6 Jun 2016 | Nature Made(R) adult gummies Multi, 90 count, UPC 0-31604-02841-1 | Pharmavite | Food | Class II | 14 |
| 3 Jun 2016 | Hostess Chocodile Twinkies, chocolate covered sponge cake with creamy filling, packaged in 9-ct multi-packs of individual cakes, net wt. 13.02 oz (396 g), UPC 888109110499; and 6-ct. single serving fun size snack packs, individual pack net wt. 2.89 oz (82 g), UPC 888109010492. The responsible firm name on the label… | Hostess Brands, LLC | Food | Class II | 11 |
| 3 Jun 2016 | Post Great Grains Protein Blend, Honey, oats & seeds cereal. Net Wt. 13.5 oz (382 g) carton with plastic liner. UPC 84912-00456. Post Foods LLC, 1 Upper Pond Road, Parsippany, NJ 07054 Event 74392 | Post Consumer Brands | Food | Class I | 1 |
| 2 Jun 2016 | Atlantic Spice Sunflower Seeds Roasted Salted, packaged in a 16 oz, clear plastic bag; #746 | Atlantic Spice Co., Inc. | Food | Class I | 3 |
| 2 Jun 2016 | Nature Valley Simple Nut Bars, Almond, Cashew & Sea Salt, Carton UPC 000-16000-46474, Case UPC 100-16000-46474, 4 bars/carton, 4 1.17 OZ (33 g) BARS, NET WT 4.68 OZ (132 g). Nature Valley Simple Nut Bars, Almond, Cashew & Sea Salt, Carton UPC 000-16000-41301, Case UPC 000-16000-47734, 25 bars/carton. | General Mills, Inc | Food | Class I | 4 |
| 1 Jun 2016 | Publix Nuts, Seeds and Raisins Mix in the following sizes: 16.2 oz. Plastic Clamshell Box, 5.06 oz. Plastic Go-cup and 25 lbs. Bags | Publix Super Markets, Inc. | Food | Class I | 1 |
| 1 Jun 2016 | Aldi's Millville protein chew bars, dark chocolate peanut butter packaged 5 bars to a box in a yellow and brown box with brown and white lettering. | Schulze & Burch Biscuit Co | Food | Class I | 2 |
| 31 May 2016 | Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. | Pentax of America Inc | Device | Class II | 1 |
| 31 May 2016 | 25 lb Uncle Julios Tortilla Flour Bleached, Malted, Enriched Unit UPC 100-16000-50257 Code Dates/Production Dates 18NOV2015KC, 19NOV2015KC | General Mills, Inc | Food | Class I | 10 |
| 27 May 2016 | Matdongsan Peanuts Crunch Snack, Net Wt. 80g, 325g Event 74365 | Name withheld | Food | Class II | 1 |
| 25 May 2016 | BrightView X, model #882478; gamma camera designed for single or dual detector nuclear imaging | Philips Medical Systems (Cleveland) Inc | Device | Class II | 3 |
| 25 May 2016 | PRESIDENT brand Authentic Pub Cheese SPREADABLE CHEESE, Cheddar & Porter Ale, Net Wt. 8 oz. (226g), UPC 070153229047 --- Dist. by Lactalis American Group, Inc. Buffalo, NY 14220 --- The product is manufactured approximately every 5 weeks (from 11/02/2015 to 04/06/2016). Event 74438 | Lactalis American Group, Inc. | Food | Class II | 1 |
| 23 May 2016 | BLAIN'S FARM & FLEET, The BIG GAME PARTY TRAY B 25 OZ, UPC 034952822434, Item # 612547. 7/15/16, 6/17/16. | Eillien's Candies, Inc. | Food | Class I | 15 |
| 20 May 2016 | ULTIMATE NUTRITION AMINO GOLD TABLETS SUPER WHEY FORMULA Dietary Supplement 1500 mg 325 tablets | Ultimate Nutrition, Inc. | Food | Class I | 3 |
| 19 May 2016 | Cookies and Cream, “Produced for King Soopers,” 6.6 oz. Packaged: Plastic clam shell, Individual unit, King Soopers, Denver CO Event 74277 | Chelsea Food Service Division of United Airlines | Food | Class I | 1 |
| 19 May 2016 | Product is packed in a corrugated box with poly line blue bag. For 25lbs bag labeled as "LOT NO 0545*****" "SUNFLOWER ROASTED & SALTED" " NET WT 25 LBS (11.33 KG)" "Ingredients: Sunflower Seeds, Soybean Oil, Salt." "Tarrier Foods Corp. Columbus, Ohio, 43228 USA" and for 10lbs. bag labeled as "LOT NO 0540*****"… Event 74214 | Tarrier Foods Corp | Food | Class I | 1 |
| 17 May 2016 | CLINIQUE moisture surge tinted moisturizer broad spectrum SPF 15, 1 FL. OZ.LIQ./30 ml bottle within a carton, Clinique Labs., Dist. New York, N.Y., 10022; New York, London W1K 3BQ; Paris, UPC No. 20714-47476-8, Shade 01 (VF-N) | Clinique International | Drug | Class III | 6 |
| 13 May 2016 | Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters. Event 74649 | Innovision A/S | Device | Class II | 1 |
| 10 May 2016 | Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures. Event 74190 | Medical Vision Ab | Device | Class II | 1 |
| 10 May 2016 | Jugo Moringa Plus Antiox 32 oz Distributed By: GMJ Natural Products Anaheim, CA 92801 UPC Code: 14465 77631 Event 74456 | GMJ Natural Products, Inc. | Food | Class I | 1 |
| 9 May 2016 | Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06 | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 9 May 2016 | Product labeled in part "Trader Joe's Kale & Edamame Salad with sweetened dried cranberries, grape tomatoes, almonds, scallions and lemon herb dressing, Net Wt. 10 oz (284g)" packaged in a clear plastic 10 oz container with yellow sticker and green lettering. | World Class Distribution, Inc. | Food | Class I | 1 |
| 9 May 2016 | Kale, 4/ 1 lb, & 1 /2 lb shredded packaged in plastic, keep refrigerated | Pearson Foods Inc. | Food | Class I | 2 |
| 9 May 2016 | Woodstock Cape Cod Cranberry Mix, 25lbs. Item #250575 The product also goes by the following trades names: 1). 1897 Cape Cod Cranberry Mix 7oz 2). Ciao Cape Cod Cranberry Mix 7oz 3). Farmers Market Cape Cod Cranberry Mix 7oz 4). Grounded In Cape Cod Cranberry Mix 7oz 5). La Tapenade Cape Cod Cranberry Mix 7oz 6).… Event 74145 | Hmshost | Food | Class I | 1 |
| 6 May 2016 | Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1.5T/3T MRI Systems. | Invivo Corporation | Device | Class II | 1 |
| 6 May 2016 | Frozen cut green beans labeled as: 1. Kroger(R) Cut Green Beans, NET WT 32 OZ (2 LB) 907g, UPC1111081914 BEST IF USED BY: Feb 2016 through Oct 2017; with Mfg Code ### # K # # 6 units per case 2. Kroger(R) Cut Green Beans, NET WT 12 OZ. (340g), DISTRIBUTED BY THE KROGER CO.,CINCINNATI, OH 45202, UPC 1111089730 BEST IF… | The Pictsweet Company | Food | Class I | 12 |
| 6 May 2016 | Labeled in part "Dollywood". Dollywood sweet and salty trail mix packaged in an 11 oz clear plastic bag with a grey sticker label containing red lettering. UPC 490000503272 Event 74101 | Rucker's Makin Batch Candies, Inc. | Food | Class I | 1 |
| 6 May 2016 | Woodstock Farms Mfg. Cape Cod Cranberry Mix Net Wt. 25 Lbs. Distributed by Woodstock Farms Mfg. Edison, NJ 08817 UPC C250575 | United Natural Trading | Food | Class I | 11 |
| 6 May 2016 | IQF Green Beans, packed in a 10 oz. (US) and a 283 g (Canadian) kraft paper bag with food grade liner, 12 bags to a case. The UPC code 6 38882 00053 7. The cooking instructions on the label is read: How To Prepare Stovetop: Place frozen green beans into a small amount of boiling water. Cover, steam for 3 to 5 minutes… Event 74100 | Stahlbush Island Farms, Inc. | Food | Class I | 1 |
| 6 May 2016 | WAHOO-BATTERED VEGGIE FRIES, 6/2 lb. bags, Product # 229650 | Ajinomoto Windsor Inc., Golden Tiger Plant | Food | Class II | 19 |
| 5 May 2016 | Watts Brothers Farms Organic Mixed Vegetables, UPC 681241053484. ************Foodservice Products******************** Watts Tote 4-Way Mixed Vegetables, item 3902 Watts Brothers 5 Way Mixed Vegetables, item V5173 Watts Brothers 4 Way Mixed Vegetables, item V5218 Watts Brothers 5 Way Mixed Vegetables, item V5246 Watts… | ConAgra Foods Inc | Food | Class I | 4 |
| 5 May 2016 | Popsalot Moroccan Mystique 3.5 oz Event 74132 | POPSALOT, LLC | Food | Class II | 1 |
| 3 May 2016 | Carfagna’s Mild Chili Ready Sauce in 32 oz. glass jars. | Carfagnas Inc | Food | Class II | 2 |
| 2 May 2016 | 1. Roasted & Salted Sunflower Kernel, 0.7 oz plastic bag, Distributed by Newport Ingredients, Los Angeles, CA 90036; 2. Planters Sunflower Kernels, Net Wt 3 oz. (85g) plastic bag; 3. Dakota's Best! Biggy'z Roasted & Salted Kernels, Net Wt 16 oz (454g) plastic bag; 4. Roasted & Salted Sunflower Kernels, 5 lbs (2.25… | SunOpta Food and Grain, Inc. | Food | Class I | 16 |
| 29 Apr 2016 | Organic Turmeric Ginger Spice of Life Green Tea; Organic Blend of Tumeric, Spices, Natural Honey Flavor and Fine China Green Tea 50 CT Tin: Net Wt. 2.65 oz.. (75G) UPC: 7-42676-40355-5. The Republic of Tea | Republic Of Tea | Food | Class II | 2 |
| 21 Apr 2016 | Chocolate Chunk Cookies prepared in store and sold in bakery cases for self-service. | 7-Eleven, Inc. | Food | Class I | 3 |
| 19 Apr 2016 | The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry… | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 15 Apr 2016 | VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The… Event 73989 | Biomerieux France Chemin De L'Or | Device | Class III | 1 |
| 15 Apr 2016 | IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor I (IGF-I) in serum or heparinized plasma. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 6 Apr 2016 | Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA. | Lupin Pharmaceuticals Inc. | Drug | Class III | 2 |
| 30 Mar 2016 | Wonder Meal Net Weight 455 grams 15.75 oz UPC Code: 6 03808 12813 Event 73697 | FKC International, Inc. | Food | Class II | 1 |
| 30 Mar 2016 | Cobblestone Bread Co. Wheat English Muffins, 12 oz. (6 count)plastic bag (340g) UPC: 0 72250 01316 1 | Flowers Foods | Food | Class I | 1 |
| 25 Mar 2016 | Novus Snack brand Golden Raisins, Net 10 oz., Product of U.S.A. --- Firm on label: Packed for Ryszard food Distributor, Inc. Event 73915 | Ryszard Food Distributor, Inc. | Food | Class I | 1 |
| 25 Mar 2016 | Fresh Food Market Cranberry Chicken Salad, UPC 207063-4XXXX, various package sizes. Product sold both from bulk service case and self-service case random weight in deli cups. Product is privately labeled and the address is shown as QFC, 10116 NE 8th, Bellevue, WA 98004. | The Kroger Co | Food | Class I | 1 |
| 24 Mar 2016 | Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01 | Lupin Limited | Drug | Class III | 1 |
| 18 Mar 2016 | Roasted & Salted Pistachios, size: 2.5 oz, 4 oz, 7.5 oz., UPC 1578600108, 1578600135, 1578600123 Event 73618 | American Gourmet | Food | Class I | 1 |
| 16 Mar 2016 | PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath | Terumo Medical Corporation | Device | Class II | 1 |
| 11 Mar 2016 | Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan… | Integra LifeSciences Corporation | Device | Class II | 1 |
| 3 Mar 2016 | Whole wheels and cuts of Maytag blue cheese re-packaged in foil or clear plastic wrap with scale labels in various weights. Product was labeled as Maytag Blue Raw Milk, Maytag Blue, or Maytag Iowa Blue Cheese with PLU numbers beginning with 854089001. | Hy-Vee Stores Inc | Food | Class I | 2 |
| 29 Feb 2016 | Maytag Blue cheese cut and wrapped in clear plastic wrap at store level, sold in various sizes (approximately 3-4 oz pieces), labeled with company issued Maytag Blue cheese label and Schnuck Markets scale label, UPC 0021806200000. | Schnucks Markets Corporate Office | Food | Class I | 1 |
| 19 Feb 2016 | Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Goa 403 722 INDIA, NDC 68180-750-09 | Lupin Limited | Drug | Class III | 2 |
| 18 Feb 2016 | Michel Cordon Bleu, Inc. Fresh Smoked Trout Plain, sold in various sizes | Michel Cordon Bleu Inc | Food | Class I | 2 |
| 17 Feb 2016 | Catheter, Intravascular, Therapeutic, Long Term Greater than 30 days. An access kit only, contains no base components | Arrow International Inc | Device | Class II | 4 |
| 11 Feb 2016 | Sam International Bulk Raw Whole Pistachio 80% VP Net Wt. 30 lb Packaged in Boxes | International Foodsource, LLC | Food | Class I | 4 |
| 9 Feb 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. Image processing system. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 9 Feb 2016 | Deer Cumin Powder 7 oz.., UPC 714760027497 14 oz UPC 714760027503 Packed for: Best Foods Inc. Edison, NJ 08817 | Best Foods NJ, Inc. | Food | Class II | 1 |
| 2 Feb 2016 | Rajbhog Foods No Eggs Butter Cookies 5 oz. Distributed by Rajbhog Foods (NJ) Inc., Jersey City NJ 07304 UPC 735426355066 item B006 Event 73493 | Rajbhog Foods (NJ) Inc. | Food | Class II | 1 |
| 1 Feb 2016 | Lysander's Premium Teriyaki Marinade, 1 oz (28 g), polypropylene and clamshell style card, 12 units per case. Manufactured by Geneva Foods, LLC. | Geneva Foods, LLC | Food | Class II | 3 |
| 1 Feb 2016 | Family Gourmet, Sugar Wafers, Vanilla, Net Wt 8 OZ (227 g), Distributed By: Family Dollar Services, Inc. Charlotte, NC 28201 USA Product of Canada | Shearer's Snacks | Food | Class III | 4 |
| 30 Jan 2016 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. | Merge Healthcare, Inc. | Device | Class II | 2 |
| 30 Jan 2016 | Merge Cardio software. Product Usage: Merge Cardio is an integrated cardiovascular information system classified as a picture archiving and communications system. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 7 Dec 2015 | True North Gutted Farmed Whole Atlantic Salmon, various weights from 8 to more than 16 lbs. packaged in plastic in styrofoam container, 50 lbs/case. Product of Canada. Product Code: DHON 8¿10 50# DHDN 10¿12 5O#, DHON 14¿16 50#, DHON 16+ 5O# Event 72803 | True North Salmon | Food | Class II | 1 |
| 3 Dec 2015 | MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia. | Teleflex Medical | Device | Class II | 1 |
| 12 Nov 2015 | Campbell's SpaghettiOs Original Pasta in Tomato and Cheese Sauce Net Wt. 14.2 ounces in metal cans, NDC: 0-51000-22432-3 | Campbell Soup Supply Co., LLC | Food | Class II | 1 |
| 11 Nov 2015 | McGriddles Hot Cakes 192/1.75 oz packaged in brown cardboard box Event 72656 | Pioneer Frozen Foods, Inc | Food | Class III | 1 |
| 19 Oct 2015 | The system provides the ability to transmit patient data files for storage, viewing and analysis at distributed locations via the intranet or Internet, or may function as a stand-alone device. | Invivo Corporation | Device | Class II | 1 |
| 17 Sep 2015 | Philips DuraDiagnost stationary X-ray system | Philips Electronics North America Corporation | Device | Class II | 1 |
| 30 Jul 2015 | Whole Foods Market, CC & FP HSH Coconut Curry Cauliflower Salad, SOLD BY THE POUND, CLEAR PLASTIC CONTAINERS. | Whole Foods Market | Food | Class I | 1 |
| 9 Apr 2015 | Merge RadSuite software. Radiological image processing system. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 3 Feb 2015 | GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap Event 74851 | Allergy Laboratories, Inc. | Device | Class II | 1 |
| 15 Jan 2015 | ReliaMed Silver Alginate/CMC. Each dressing is packed in a pouch (primary packaging), each pouch is packed in a carton (secondary packaging) holding multiple (depending on stock keeping unit) pouches and each carton contains one (1) Instructions For Use (IFU) leaflet. | Advanced Medical Solutions Ltd. | Device | Class II | 2 |
| 14 Sep 2014 | Philips Expression Information Portal (IP5) Model 865471. The IP5 is intended to be used as a secondary display control unit for the Expression MRI Patient Monitoring System and the Expression MR200 MRI Patient Monitoring System. | Invivo Corporation | Device | Class II | 1 |
| 6 May 2013 | RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 8 Mar 2013 | LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications. | Hospira Inc. | Device | Class II | 2 |
| 6 Feb 2013 | Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices. | Hospira Inc. | Device | Class II | 9 |
| 14 Dec 2012 | Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access device. | Baxter Healthcare Corp. | Device | Class II | 1 |
| 20 Nov 2012 | Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical… | GE Healthcare It | Device | Class II | 1 |
| 16 Nov 2012 | Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical… | Ge Healthcare It | Device | Class II | 1 |
| 1 Nov 2012 | 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 |