| 15 Mar 2017 | Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40 | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 1 |
| 8 Mar 2017 | Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, Rx only, Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109, NDC 70285-1920-1 | Isomeric Pharmacy Solution, LLC | Drug | Class II | 1 |
| 7 Mar 2017 | Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017 Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-10). | Pfizer Inc | Drug | Class III | 3 |
| 7 Mar 2017 | ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68645-493-54. | Legacy Pharmaceutical Packaging LLC | Drug | Class II | 1 |
| 6 Mar 2017 | ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 3 Mar 2017 | Panta Nail, Rx only, Sterile, | Integra LifeSciences Corp. | Device | Class II | 1 |
| 2 Mar 2017 | Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60 | Fougera Pharmaceuticals Inc. | Drug | Class II | 1 |
| 1 Mar 2017 | Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for covering bone defects and empty sockets. Event 76638 | Inion Ltd. | Device | Class II | 1 |
| 28 Feb 2017 | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance | Devicor Medical Products Inc | Device | Class II | 1 |
| 28 Feb 2017 | Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicator bottles (NDC 0472-0987-91) and b) 60 mL applicator bottles (NDC 0472-0987-92), Rx Only, Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080; Distributed by: Actavis Mid Atlantic LLC, 1877 Kawai Road,… | G & W Laboratories, Inc. | Drug | Class III | 1 |
| 27 Feb 2017 | Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 Event 76587 | CORENTEC CO., LTD | Device | Class II | 1 |
| 27 Feb 2017 | Artis Q and Q.Zen fluoroscopic x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 27 Feb 2017 | Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E ETBF2316C145E ETBF2313C145E ETBF2513C166E ETBF2313C166E ETBF2316C166E ETBF2313C124E ETBF2513C145E ETBF2516C124E ETBF2316C124E ETBF2513C124E. Cardiology: The Endurant family of stent graft systems is Intended… | Medtronic Vascular, Inc. | Device | Class II | 1 |
| 27 Feb 2017 | Fusia Asian Aspirations Szechuan Stir Fry; A delicious blend of premium vegetables with a savory sauce packed in a plastic bag: Sauce packet included. NET WT 21 oz. (1 lb 5 oz) 595 g Event 76618 | Versa Marketing | Food | Class II | 1 |
| 27 Feb 2017 | Whole Foods Market King Cake, sold in purple cardboard containers and labeled as Lonestar Bakeries Cream Cheese King Cakes PLU 44498 | Whole Food Market | Food | Class I | 1 |
| 24 Feb 2017 | Trader Joe’s Imported English Authentic Lemon Curd, 10.5oz (300g), 24 jars/case | Trader Joes Company | Food | Class II | 1 |
| 24 Feb 2017 | Trader Joe's All Natural Unsweetened Apple Sauce; 24 oz. glass jar. Best Before date stamped on top of lid. UPC: 00014359 Distributed by Trader Joe's, Monrovia, CA | Manzana Products Co., Inc. | Food | Class II | 3 |
| 24 Feb 2017 | Whole Foods Spinach Orzo Salad Our Chef's OWN, sold by weight PLU:beginning with 61159 | Whole Food Market | Food | Class I | 1 |
| 23 Feb 2017 | Brilliance BigBore Oncology CT - 728243 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 analysts and display equipment, patient and equipment supports,… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 2 |
| 23 Feb 2017 | 9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood… | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 23 Feb 2017 | Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Weddington Rd., Concord, NC 28027, NDC 63739-434-01. | Mckesson Packaging Services | Drug | Class II | 1 |
| 22 Feb 2017 | ARTIS Q, Interventional Fluroscopic x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 22 Feb 2017 | Edex (alprostadil for injection) 10mcg, packaged in a 2 pack carton, Rx only, Manufactured in Germany for: Actient Pharmaceuticals, LLC, Lake Forest, Illinois 60045; NDC 52244-010-02. | Endo Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 22 Feb 2017 | Great Shake Fortified Nutrition, Soy Formula, Chocolate Artificially Flavored, Packaged in 4 fl oz. (118 mL), and 6 fl oz. (177 mL). Store Frozen. | Hormel Foods Corporation | Food | Class II | 6 |
| 21 Feb 2017 | MicroAire K-Wires | MicroAire Surgical Instruments, LLC | Device | Class II | 1 |
| 21 Feb 2017 | OEC FlexiView 8800, Digital Mobile Imaging System, GE Medical Systems | GE OEC Medical Systems, Inc | Device | Class II | 1 |
| 21 Feb 2017 | A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981 | Bayer HealthCare Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 20 Feb 2017 | MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305 | CareFusion 303, Inc. | Device | Class II | 1 |
| 20 Feb 2017 | MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention… | CareFusion 303, Inc. | Device | Class II | 1 |
| 20 Feb 2017 | Terumo Advanced Perfusion System 1-Level Sensor II Pads, Product Usage: Ultrasonic couplant used to facilitate the transmission of sound energy between the level sensor and the reservoir. | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 20 Feb 2017 | Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular)… | Siemens Medical Solutions USA Inc. | Device | Class II | 4 |
| 20 Feb 2017 | AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids. | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. | Device | Class II | 1 |
| 20 Feb 2017 | Syngo.plaza, Picture Archiving and Communications System (PACS) Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 20 Feb 2017 | Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310 b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310 c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312 d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312 e) Poly… | Medtronic Sofamor Danek USA Inc | Device | Class II | 4 |
| 20 Feb 2017 | Plastic Heart Tubes with Chocolate Lentils, Net Wt. 1.7oz (48g), UPC 0-73563-00805-9, 24 count tubes per case Event 76522 | Bee International, Inc. | Food | Class I | 1 |
| 17 Feb 2017 | .045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407ST and has a 7 inch length and 0.054 inch diameter. These guide wires are an orthopedic manual surgical instrument. | Acumed LLC | Device | Class II | 1 |
| 17 Feb 2017 | Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 17 Feb 2017 | Nachmans Native Seafood Smoked Fish spread in 1/2-pound, 5 pounds, and 7.5 pounds plastic containers) Event 76592 | Nachman's Native Seafood, Inc. | Food | Class II | 1 |
| 17 Feb 2017 | Organic IQF Dark Sweet Cherries, 900 cartons per lot Event 76520 | Sunrise Growers, Inc | Food | Class I | 1 |
| 17 Feb 2017 | Kroger French Style Green Beans, Net Wt. 12 oz (340g), UPC 11110-89731 | Lakeside Foods, Inc | Food | Class II | 3 |
| 17 Feb 2017 | Pan Molido Sazonado Seasoned Bread Crumbs, Net Wt. 6oz and 12oz | Name withheld | Food | Class II | 2 |
| 17 Feb 2017 | Baking Powder Net Wt. 5 lbs. (2.27 kg) packaged 6 bags per case, under the following brand names: Chef's Companion UPC 50719098580015, Diamond Crystal Brands, Inc. Savannah, GA 31405; and Sysco UPC 10074865238813, distributed by Sysco Corporation, Houston, TX 77077-2099. | Diamond Crystal Brands Inc | Food | Class II | 3 |
| 17 Feb 2017 | Jugos La Morovea, China (Orange),Elaborado y Envasado por Jugos La Morovea, Carr 634 km 5.1, Bo. Franquez, Morovis PR 00687 | Jugos y Agua La Morovena Inc. | Food | Class III | 9 |
| 16 Feb 2017 | MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R. Event 76687 | Crossroads Extremity Systems Llc | Device | Class II | 1 |
| 16 Feb 2017 | HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729 | Allegiant Health | Drug | Class II | 1 |
| 16 Feb 2017 | Box Mill Farm Pasteurized Apple Cider in 1 gallon containers and Half-Gallon containers Event 76512 | Name withheld | Food | Class II | 1 |
| 16 Feb 2017 | Grove Fresh Pasteurized Apple Juice from concentrate, 4-ounce cartons, 100 % Pure. Event 76586 | Dairy Maid Dairy, LLC | Food | Class I | 1 |
| 16 Feb 2017 | Pepper Sauce, Fish and Vita, Net Weight: 8 oz. Packed by: Dukarani Food Processing, Inc., 1729 Lyndale Ave. north, Mpls, MN 55411. Storage: Keep in cool dry place. | Dukarani Food Processing, Inc | Food | Class II | 3 |
| 16 Feb 2017 | Food City Colby Longhorn Cheese, 12 oz. package; also sold in random weight sizes. (Bashas' brand) sold at retail stores) Also sold in 4/13# in Bashas' and Lakeview labels; and RW EW case 36#, no label for Bashas' ;20/1# CW Banquet label and Colby Longhorn Cheese 16 oz. Yokes Fresh Market brand. Banquet is a Lakeview… | Lakeview Cheese Co Llc | Food | Class I | 6 |
| 15 Feb 2017 | Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India,NDC 55111-137-81 | Name withheld | Drug | Class III | 4 |
| 15 Feb 2017 | Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13 | AVKARE Inc. | Drug | Class II | 1 |
| 15 Feb 2017 | Pepper Jack Cheese Half Moons, 15pkgs/case UPC 78279600895 | Papa John's Salads & Produce, Inc. | Food | Class I | 4 |
| 15 Feb 2017 | Cashew Clusters 32 oz | Snak King Corporation | Food | Class I | 1 |
| 15 Feb 2017 | Ditos Heart shaped plastic Platter of Strawberries with Dip of Chocolate Frosting- Refrigerated. Net wt. 32 oz. UPC 8 93268 00142 7. The label is read in parts: "***Heart Platter Strawberries w/ Dip***32 oz.*** Strawberries USA (dip)***by Dito's LLC, Anchorage, AK 99518***". | Dito's - A Sysco Company | Food | Class I | 2 |
| 14 Feb 2017 | Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 14 Feb 2017 | ARTISTE" MV System | Siemens Medical Solutions USA, Inc | Device | Class II | 4 |
| 14 Feb 2017 | Hass Avocado 32 1 Index Fresh- USA Hass Avocado 36 1 Index Fresh- USA Hass Avocado 40 1 Index Fresh- USA Hass Avocado 48 1 Index Fresh- USA Hass Avocado 60 1 Index Fresh- USA Hass Avocado 70 1 Index Fresh- USA | Index Fresh | Food | Class II | 3 |
| 14 Feb 2017 | Veggie Noodle Co. Butternut Spirals in 10.7 ounce clear plastic containers, UPC: 852287006059 Manufactured By Veggie Noodle Co., LLC. Austin TX 78744 Event 76496 | Veggie Noodle Co | Food | Class I | 1 |
| 13 Feb 2017 | CELL-DYN Ruby System: List Number: 08H67‐01; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories | Abbott Laboratories | Device | Class II | 1 |
| 13 Feb 2017 | PreviDent 5000 ppm, DRY MOUTH, 1.1% Sodium Fluoride, PRESCRIPTION STRENGTH TOOTHPASTE, SLS Free Formula, SOOTHING MINT, 3.4 FL OZ (100 mL), Colgate Oral Pharmaceuticals, Inc., New York, NY 10022 --- NDC 0126-0016-61, UPC 3834110622 Event 76516 | Colgate Palmolive Co | Drug | Class III | 1 |
| 13 Feb 2017 | Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Yeruham, Israel, Distributed By Perrigo Allegan, MI 49010, NDC 45802-237-01, UPC 3 45802-237-01 9. | L. Perrigo Company | Drug | Class III | 2 |
| 13 Feb 2017 | Theravits 100, container sizes: 30, 60, 90, 180, Product Code: 0783-30, 0786-60, 0789-90, 0788-180; The Supreme One, Container sizes: 30,60,90,180, Product Code: 680-030, 680-060, 680-090, 680-180. The Supreme One and Theravits 100 product is sold under the brand names of Nature’s Concept, VP Discount, Clark’s… Event 76480 | World Organic Corp. | Food | Class II | 1 |
| 13 Feb 2017 | McCormick & Co., Inc., Stubb’s Barbecue. 18oz Best By Date of January 17, 2020. Event 76462 | McCormick & Co Inc. Spice Mill Plant | Food | Class II | 1 |
| 13 Feb 2017 | Pharmanex BioGinkgo. Mental Sharpness. 60 Tablets | Nu Skin Enterprises Inc. | Food | Class II | 3 |
| 10 Feb 2017 | Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31 | Sandoz Inc | Drug | Class II | 1 |
| 10 Feb 2017 | METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible Container, Rx only, For IV Use, Hospira Inc., Lake Forest, IL --- NDC 0409-7811-24 | Hospira Inc., A Pfizer Company | Drug | Class II | 1 |
| 10 Feb 2017 | Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 92117 (855) 792-6676 | Name withheld | Drug | Class II | 81 |
| 10 Feb 2017 | Choice Farms Pizza Style Portabella Mushrooms 8 oz. INDIVIDUAL SHRINK-WRAPPED TRAYS | Del Monte Fresh Produce N.A., Inc. HQ | Food | Class II | 3 |
| 10 Feb 2017 | Country Fresh Creations Tuscan Style Portabella Mushrooms Net Wt. 8oz (227g) Distributed by Country Fresh, LLC., Houston, TX 77090 UPC: 074641072115 | Country Fresh Inc. | Food | Class I | 5 |
| 10 Feb 2017 | Sargento Ultra Thin Sliced Longhorn Colby, 6.84 oz., UPC 4610000228, with Sell By dates of 12APR17B, 02FEB17F, 01MAR17B, 16MAR17F and 10MAY17B. | Sargento Foods, Inc. | Food | Class I | 17 |
| 9 Feb 2017 | Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 9 Feb 2017 | Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033, | Remel Inc | Device | Class II | 1 |
| 9 Feb 2017 | Turon Impaction Fixture | Encore Medical, Lp | Device | Class II | 2 |
| 9 Feb 2017 | NSM, Extra Fine Granulated Sugar, Net Wt. 50 lbs. (22.7 kg), in a poly liner. Event 76470 | National Sugar Marketing LLC | Food | Class II | 1 |
| 8 Feb 2017 | Arkon Anesthesia Delivery System, Model 99999. Product Usage: Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the… | Del Mar Reynolds Medical, Ltd. | Device | Class II | 1 |
| 8 Feb 2017 | BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01 | Medtronic | Device | Class II | 5 |
| 8 Feb 2017 | CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25 | Amerisource Health Services | Drug | Class II | 1 |
| 8 Feb 2017 | Thornton's Hollow Milk Chocolate Jolly Santa, 200g, Barcode: 5016346234721 Event 76413 | LBB IMPORTS | Food | Class II | 1 |
| 7 Feb 2017 | LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU) REF# e2400-50 | LeMaitre Vascular, Inc. | Device | Class II | 12 |
| 7 Feb 2017 | Raindrop Near Vision Inlay, Model# RD1-1 Event 76422 | Revision Optics Inc | Device | Class II | 1 |
| 7 Feb 2017 | Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY 11707, NDC 50383-283-05 | Actavis Inc | Drug | Class III | 1 |
| 7 Feb 2017 | Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in boxes of 30, Rx only, Manufactured by: G&W Laboratories Inc. South Plainfield, NJ 07080, Distributed by Iroko Pharmaceuticals, LLC Philadelphia, PA 19112, NDC 42211-0102-43 | G & W Laboratories, Inc. | Drug | Class II | 1 |
| 7 Feb 2017 | Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack, Indiana, PA 15701, NDC 52125-0764-02 | RemedyRepack Inc. | Drug | Class II | 1 |
| 7 Feb 2017 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottles, Rx Only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5721-56 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 7 Feb 2017 | (a) Mahatma(R) Saffron YELLOW seasonings & LONG GRAIN RICE; Net Wt. 5 oz. (UPC 17400-10505) (b) Mahatma(R) Saffron YELLOW seasonings & LONG GRAIN RICE; Net Wt. 10 oz. (UPC 17400-10507) (c) Mahatma(R) Saffron YELLOW seasonings & LONG GRAIN RICE; Net Wt. 16 oz. (UPC 17400-10502) | Riviana International, Inc | Food | Class II | 2 |
| 7 Feb 2017 | Krispy Kreme Doughnuts Choc Iced Glazed, 2 count boxes (UPC 0 72470 00003 3), 6 count boxes (UPC 0 72470 00226 6), Single served (UPC 004-01155-001). | krispy kreme doughnut corporation | Food | Class II | 4 |
| 7 Feb 2017 | Xanthium & Siler Combo (Bi Yan Pian) DIETARY SUPPLEMENT, Net cont: 100 tablets (300mg each), Net Wt. 1.06oz (30g) Event 76404 | Kingsway Trading Inc | Food | Class I | 1 |
| 7 Feb 2017 | COUSINS PRODUCTS(R) Creole Tomato SALAD DRESSING, NET WT. 16 OZ (473 ML), Event 76491 | Cousins Products LLC | Food | Class I | 1 |
| 6 Feb 2017 | Private Selection, Salted Caramel Chocolate Almond Pie, NET WT 34 OZ ( 2 LB 2 OZ) 963g, UPC 1111054021. Container: In a labeled pie dome and base. Pies are distributed frozen. Some stores sell refrigerated and some sell frozen. Event 76415 | Name withheld | Food | Class II | 1 |
| 6 Feb 2017 | Fred Meyer 100% Whole Wheat Bread 16 oz plastic bag DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 10294 2 | The Kroger Co | Food | Class I | 1 |
| 4 Feb 2017 | Colby Cheese packaged as follows: (a) AMISH CLASSICS, DELI HORN, Item 55209, NET WT 6 LBS, UPC 0 08 28653 55209 3 (b) AMISH CLASSICS, FULLMOON(R), Item 55241, approximately 8 oz, UPC 828653552413 (c) AMISH CLASSICS EW FULL MOON, ITEM 55245, 8 oz, UPC 828653552451 (d) 8/2# RW Deli Readi Colby Mini Cheese Slices, ITEM… | MDS Foods Inc | Food | Class I | 17 |
| 3 Feb 2017 | CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0 | Apotex Inc. | Drug | Class II | 1 |
| 3 Feb 2017 | GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21), Individual dose (NDC 68084-395-11), Rx Only, Packaged and Distributed by American Health Packaging, Columbus, Ohio 43217, NDC 68084-295-21 | Amerisource Health Services | Drug | Class II | 1 |
| 2 Feb 2017 | Smith & Nephew Dyonics Saw Blade, Standard, Product Number 3701 | Smith & Nephew, Inc. | Device | Class II | 6 |
| 2 Feb 2017 | ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur XPT System is a stand-alone, continuous operation, immunochemistry analyzer that performs the following functions: aspirates and dispenses samples; Performs dilutions; Adds reagents; Incubates reaction vessels;… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 2 Feb 2017 | Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Covered Yankauer, 2 Suction Toothbrush packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing Oral Rinse, and 2 Suction Oral Swab packages with Corinz (cetylpyridinium chloride) Antiseptic Cleansing and Moisturizing… | Sage Products Inc | Drug | Class III | 1 |
| 2 Feb 2017 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540. | Sandoz Inc | Drug | Class II | 1 |
| 1 Feb 2017 | Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film sterilizable outer pouch. Introducers are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. | Cook Inc. | Device | Class II | 7 |
| 1 Feb 2017 | VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Code 1632660 (18 slide format, 90 slides per sales unit) and REF/Catalog Number/Product Code 8318925 (60 slide format / 300 slides per sales unit), Unique Identifier Nos. 10758750009466 and 10758750004720, RX ONLY, IVD --Ortho Clinical… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 1 Feb 2017 | Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength… | Nidek Inc | Device | Class II | 1 |
| 31 Jan 2017 | PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy | Synthes (USA) Products LLC | Device | Class II | 1 |
| 31 Jan 2017 | Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage. | Degania Silicone, Ltd. | Device | Class II | 1 |
| 31 Jan 2017 | 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for single or dual detector nuclear imaging accommodating a range of ECT studies. In addition it can be used to perform planar static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT, gated SPECT (circular and… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 3 |
| 31 Jan 2017 | AngioJet Ultra 5000 A Console:Foot Switch Material number (U PN) 105650 Cardiovascular: The Console is a multiple-use device that controls the Thrombectomy Set. It drives the pump, regulates fluid inflow and outflow, provides the operator with Ultra System set-up prompts, total infused saline volume, and Ultra… | Boston Scientific Corporation | Device | Class II | 1 |
| 30 Jan 2017 | Hidrex USA DP450 | Hidrex GmbH | Device | Class III | 3 |
| 30 Jan 2017 | EliA Sample Diluent, Article number, 83-1023-01 | Phadia US Inc | Device | Class II | 1 |
| 30 Jan 2017 | A-series lift - A625 Manual w/Load Cell & Wi-Fi, Omni Part No. 324124. Prism Medical. | ErgoSafe Products, LLC (DBA) Prism Medical | Device | Class II | 2 |
| 30 Jan 2017 | iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: ketones, blood, protein, glucose,… | Beckman Coulter Inc. | Device | Class II | 1 |
| 30 Jan 2017 | LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile Event 76365 | Tearscience, Inc | Device | Class II | 1 |
| 27 Jan 2017 | VASOVIEW HEMOPRO VH-3500 ENDOSCOPIC VESSEL HARVESTING SYSTEM Product Usage: The VASOVIEW HEMOPRO VH-3500 is designed for use in conjunction with the 7-mm Endoscope and is intended for specific use with the VASOVIEW HEMOPRO Power Supply. | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 27 Jan 2017 | Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20 | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class II | 1 |
| 27 Jan 2017 | Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 mL syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466 | Pharmedium Services, LLC | Drug | Class III | 1 |
| 27 Jan 2017 | MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxide-12.50%,1 oz. (28 g) tube, Made in China, Distributed by Cherry Hill Associates, Chesapeake, VA 23320, NDC 69020-205-28 | Cherry Hill Sales Co. | Drug | Class II | 5 |
| 27 Jan 2017 | Assorted chocolate truffles, packaged in Kraft colored boxes with the Batch PDX sticker. Boxes contain 5, 8, 12, 18, 24 or 32 pieces with any combination of the following 14 flavors: 1. Vietnamese Iced Coffee 2. Raspberry 3. Spicy Passion 4. Bull Run Bourbon 5. Mint Meltaway 6. Almond Crisp 7. Yuzu Gimlet 8. Ghost… Event 76345 | Batch International Llc | Food | Class III | 1 |
| 27 Jan 2017 | Falafel King Tzatziki Sauce. 10 ounce. Plastic container Event 76361 | Falafel King Ent, Inc. | Food | Class II | 1 |
| 27 Jan 2017 | Goulibeur - Large pure butter shortbread with flaked almonds, in neutral gift wrapping Net weight 13.5 oz | GOULIBEUR | Food | Class II | 6 |
| 26 Jan 2017 | ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood. | Radiometer America Inc | Device | Class II | 2 |
| 26 Jan 2017 | Pharmanex ageLOC TR90 Protein Boost. Protein Powder. Net wt. 1.59 lbs (720g). 30 Servings. Natural Vanilla Flavor. Lactose, Gluten, & Soy Free. Plant Protein/Vegetarian. Event 76341 | NSE Products, Inc. | Food | Class I | 1 |
| 26 Jan 2017 | White Chocolate Toffee, 2.2oz pouches, 6oz pouches, 7oz boxes, one pound boxes | Name withheld | Food | Class II | 3 |
| 25 Jan 2017 | OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right Event 76356 | Matrix Surgical Holdings, LLC | Device | Class II | 1 |
| 25 Jan 2017 | Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests | Quidel Corporation | Device | Class II | 1 |
| 25 Jan 2017 | DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN. | DeRoyal Industries Inc | Device | Class III | 2 |
| 25 Jan 2017 | The UNI-CP System; Model Number: 330230SND. | Integra LifeSciences Corp. | Device | Class III | 1 |
| 25 Jan 2017 | PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer | Siemens Medical Solutions USA, Inc | Device | Class II | 6 |
| 25 Jan 2017 | Sunmba Frozen Ajiaco (Vegetable Mix), 2 lbs. Event 76336 | Barberi International Inc. | Food | Class II | 1 |
| 24 Jan 2017 | Bakery Fresh Goodness Carrot Cupcakes sold in 6 ct. 12 ct. and 25 ct. hard plastic container. Bakery Fresh Goodness Carrot Cupcakes, 6 count package, UPC 41573-27731; Bakery Fresh Goodness Carrot Cupcakes, 12 count package, UPC 41573-27732; Bakery Fresh Goodness Carrot Cupcakes, 25 count package, UPC 41573-27733. Event 76324 | Fred Meyers Inc | Food | Class I | 1 |
| 23 Jan 2017 | Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures | Covidien LLC | Device | Class II | 2 |
| 23 Jan 2017 | RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound. Use in dental, spine and orthopedic applications | RTI Surgical, Inc. | Device | Class II | 1 |
| 23 Jan 2017 | Wegmans Organic Dark Red Kidney Beans, Net Wt. 15 OZ Event 76387 | Hanover Foods Corporation | Food | Class II | 1 |
| 23 Jan 2017 | Hot Barbecue Sauce; Net wt. 16 ounces; Manufactured by Carriage House Creations, 544 Gordon Alley, Reynoldsville, PA 15851; | Carriage House Creations | Food | Class II | 4 |
| 22 Jan 2017 | Trader Joe's Harvest Whole Wheat Bread; NET WT 24 oz. (1 lb. 8 oz.) SKU 00132; UPC: 0000 1328. Distributed and sold exclusively by: Trader Joe's, Monrovia, CA 91016 Event 76308 | Athens Baking Company | Food | Class I | 1 |
| 20 Jan 2017 | CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect… | Metrex Research, LLC. | Device | Class II | 1 |
| 20 Jan 2017 | Specialty Commodities, Inc., Almond, Dry RNS, SKU 0020034064 Item number ALMO-033, 25 lb carton. Event 76311 | Archer Daniels Midland Company | Food | Class II | 1 |
| 19 Jan 2017 | AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal (NG/NI) tubes. | Applied Medical Technology Inc | Device | Class III | 2 |
| 19 Jan 2017 | Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 19 Jan 2017 | Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040 | LEO PHARMA INC | Drug | Class II | 1 |
| 19 Jan 2017 | glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 0378-0342-10 | Mylan Pharmaceuticals Inc. | Drug | Class II | 1 |
| 18 Jan 2017 | ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria | BioMerieux SA | Device | Class II | 1 |
| 18 Jan 2017 | ADM Polar Bear Flour, Bleached/Enriched, NET WT 50LB Event 76287 | ADM Milling Co. | Food | Class I | 1 |
| 17 Jan 2017 | Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients.… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 17 Jan 2017 | Nature's Wonderland Sinus & Lung Care, 60 VCaps (Capsules), PET bottle Event 76423 | Penn Herb Company, Ltd. | Food | Class III | 1 |
| 13 Jan 2017 | Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a patient with a blockage or potential blockage of the nasal cavity or nasopharynx. | Teleflex Medical | Device | Class II | 1 |
| 13 Jan 2017 | The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator. | Physio-Control, Inc. | Device | Class I | 1 |
| 13 Jan 2017 | Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 mL cassette, 7 cassettes per carton, Rx Only, AbbVie Inc., North Chicago, IL 60064 --- NDC 0074-3012-07 | AbbVie Inc. | Drug | Class II | 1 |
| 12 Jan 2017 | GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites. | Vascular Solutions, Inc. | Device | Class II | 1 |
| 12 Jan 2017 | Chocolate almond bark packaged in 4 oz. (UPC 026133400000) and 12 oz. (UPC 021633300000) plastic tray containers for retail sale, labeled with Hy-Vee scale ticket. The product was labeled HyVee West Des Moines, IA. | Hy-Vee Stores Inc | Food | Class I | 8 |
| 11 Jan 2017 | L-Varlock Cage/Trial Implant Holder, Reference HD0060, Kisco International, France. Product Usage: The L-Varlock Lumbar Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is… Event 76494 | Name withheld | Device | Class II | 1 |
| 11 Jan 2017 | Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media. | Arrow International Inc | Device | Class II | 1 |
| 11 Jan 2017 | N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 11 Jan 2017 | Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B. | Windstone Medical Packaging, Inc. | Device | Class II | 124 |
| 11 Jan 2017 | Golden Flake (R) HOT THIN & CRISPY POTATO CHIPS, NET WT. 5 OZ. (141.8g), Golden Flake Snack Foods, Inc., Birmingham, AL 35201, UPC 0-72080-00240-3 Event 76250 | Golden Flake Snack Foods Inc | Food | Class I | 1 |
| 11 Jan 2017 | Gift Sets with Pretzel Twists | Robert Rothschild Farm LLC | Food | Class II | 2 |
| 10 Jan 2017 | Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF) | Siemens Healthcare Diagnostics, Inc | Device | Class II | 3 |
| 10 Jan 2017 | DARK CRUNCH Chip 'n Dipped Chocolatier DARK CHOCOLATE CRUNCH, NET WT. 2.9oz 82g, UPC 892470002246 | Name withheld | Food | Class I | 8 |
| 9 Jan 2017 | Holiday White Peppermint Hostess Twinkies, cream-filled snack cakes, Net Wt. 13.02 oz. (369 g), UPC 888109111571. | Hostess Brands, LLC | Food | Class II | 1 |
| 9 Jan 2017 | A) Palmer's Candies Chocolate Almond Bark , NET WT 9 OZ (255 g) packaged in plastic clamshell container, UPC 77232-17250; B) Publix Bakery Almond Bark with Cocoa, NET WT 10 OZ (283 g), packaged in paper bags, UPC 77232-22691; C) Palmer's Candies Chocolate Almond Bark, 10 lbs. Net Weight (4.54 kg) | Palmer and Company, dba Palmer Candy Co | Food | Class I | 18 |
| 6 Jan 2017 | C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon” Ablation… Event 76358 | C2 Therapeutics, Inc. | Device | Class II | 1 |
| 6 Jan 2017 | Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear. Event 76279 | The See Clear Company | Device | Class II | 1 |
| 5 Jan 2017 | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs). | Haag-Streit USA Inc | Device | Class II | 1 |
| 5 Jan 2017 | Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, Gujarat, India, NDC 47335-956-88. | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 1 |
| 4 Jan 2017 | ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista System. Progesterone measurements are used in the diagnosis and treatment of disorders… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 4 |
| 27 Dec 2016 | Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures | Villa Sistemi Medicali S.P.A. | Device | Class II | 4 |
| 23 Dec 2016 | CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons | Maquet Datascope Corp - Cardiac Assist Division | Device | Class II | 1 |
| 22 Dec 2016 | MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery. | Mako Surgical Corporation | Device | Class II | 1 |
| 22 Dec 2016 | Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reporting Software is an application which serves as middle ware between the Tosoh Automated HPLC G8 analyzer and an LIS or as a stand alone data repository for the analyzer. It is designed to store and manage the received data and make reports as… | Tosoh Smd Inc | Device | Class II | 1 |
| 21 Dec 2016 | Soureliette cheese, Net Wt 3.969 lb (case)/ Net Wt 1.323 lb per unit, Item number 707116 | FROMI USA CORP C/O NATIXIS PRAME | Food | Class I | 2 |
| 20 Dec 2016 | Eclipse Hypodermic Needle | Becton Dickinson & Company | Device | Class II | 1 |
| 20 Dec 2016 | foxy's rather thoughtful vanilla 1 Pint | Altijira Murray Products, LLC | Food | Class I | 6 |
| 19 Dec 2016 | Route 11 Sour Cream & Chive Potato Chips—2 oz bag (30/cs) Route 11 Sour Cream & Chive Potato Chips—6 oz bag (12/cs) Event 76051 | Small Fry Inc. | Food | Class II | 1 |
| 16 Dec 2016 | Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung… Event 76299 | Parker Medical | Device | Class II | 1 |
| 15 Dec 2016 | ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious… | BioMerieux SA | Device | Class II | 12 |
| 13 Dec 2016 | Roth Net Polyp Retrieval | US Endoscopy Group Inc | Device | Class III | 1 |
| 13 Dec 2016 | Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immune Cellular Restoration Program. Event 76109 | Pacific Medical Solutions | Drug | Class I | 1 |
| 12 Dec 2016 | URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope | Olympus Corporation of the Americas | Device | Class II | 1 |
| 12 Dec 2016 | Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-V2/V2R endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter and kidney. | Olympus Corporation of the Americas | Device | Class II | 1 |
| 10 Dec 2016 | Deep River Sour Cream & Onion Krinkle Kettle Chips 2 oz bag UPC 8 50668 00049 8 & 5 oz bag UPC 8 50668 00099 3 | Shearers Foods, Llc | Food | Class I | 6 |
| 9 Dec 2016 | The Sweet Dessert Corp., Cheesecake Cherry, Peso Neto (Net Weight) 3oz and 4 oz., Carr. 173 Km 7.1 Bo. Sumidero, Aguas Buenas, P.R. 00703 | Sweets & Desserts, Inc. | Food | Class II | 7 |
| 7 Dec 2016 | DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or… | Cardiovascular Systems Inc | Device | Class II | 1 |
| 7 Dec 2016 | Original Cheddar Cheese Seasoning, #117059, Net Weight 1600 lbs. bulk tote | Gamay Foods Inc | Food | Class II | 2 |
| 2 Dec 2016 | McKesson Radiology 12.2 - Picture Archive Communication System (PACS) Event 76500 | Mckesson Medical Imaging | Device | Class II | 1 |
| 30 Nov 2016 | Strawberry Gelato, 5 Liter, 1 unit/case | Dolce Dolci LLC dba Villa Dolce Gelato | Food | Class I | 2 |
| 23 Nov 2016 | Domperidone capsules 10 mg, compounded, dispensed in 60, 90, and 360 count bottles, Jeffreys Drug Store 1 North Central Ave. Canonsburg, PA Event 75741 | Jeffreys Drug Store | Drug | Class I | 1 |
| 22 Nov 2016 | Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condoms 3 ct UPC 3-02340-30042-04-1 3 ct - Walmart UPC 02340-70042-04 12ct - UPC 3-02340-30274-08-6 24 ct - UPC 302340-302190-04 (contacting firm for label) | Reckitt Benckiser LLC | Device | Class II | 1 |
| 22 Nov 2016 | PROTONIX I.V. (pantoprazole sodium) for Injection, Equivalent to 40 mg pantoprazole per vial, For I.V. infusion only, Rx Only, Distributed by Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc, Philadelphia, PA 19101, Under license from Takeda GmbH, D78467 Konstanz, Germany, MADE IN FRANCE; packaged in A) Pfizer… | Pfizer Inc. | Drug | Class III | 1 |
| 18 Nov 2016 | Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the Giraffe OmniBed, incubators and warmers… | Ohmeda Medical | Device | Class II | 11 |
| 11 Nov 2016 | Cedar Crest Chocolate Chip Cookie Dough Ice Cream packaged in the following sizes: Pint, 1.5 Quarts, and 3 Gallon | Cedar Crest Specialties, Inc. | Food | Class I | 3 |
| 7 Nov 2016 | Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. | Tosoh Bioscience, Inc. | Device | Class II | 1 |
| 6 Nov 2016 | Ogo (Seaweed) packaged in plastic bags. Label contains the product name, date of shipment, weight of the order, toute number, order number and Distributed By True World Foods Portland LLC. Event 76468 | True World Foods Portland, LLC | Food | Class I | 1 |
| 1 Nov 2016 | Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System. | CareFusion 303, Inc. | Device | Class II | 1 |
| 31 Oct 2016 | CADD Solis VIP Ambulatory Infusion Pump, Model 21-21210, Reorder 21-2120-0102-15, | Smiths Medical ASD, Inc. | Device | Class II | 1 |
| 28 Oct 2016 | Boulder Ice Cream Strawberry. 2.5 gallon tub with white top. Keep frozen at -20F. Event 75593 | Altamira Specialty Food Service | Food | Class I | 1 |
| 28 Oct 2016 | Life Rising TT Side Head Regulator, Chinese Herbal Supplement, 60 Tablets; Manufactured for: Ton Shen Health (USA), Chicago, IL, 60616; Made in China | Life Rising Corp S | Food | Class I | 1 |
| 26 Oct 2016 | Strawberry Cream gelato, 5 Liter & 4 Liter pans | Name withheld | Food | Class I | 10 |
| 25 Oct 2016 | SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the… | MED-EL Elektromedizinische Gereate, Gmbh | Device | Class II | 1 |
| 8 Oct 2016 | Ciao Bovina Italian Strawberry. 1 Pint (473 ml). Non-Dairy Gelato. No GMO's. Coconut Free. Soy Free. Event 75678 | Ciao Bovina, LLC | Food | Class I | 1 |
| 3 Oct 2016 | Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable Pump is… Event 75486 | Name withheld | Device | Class I | 1 |
| 27 Sep 2016 | Strawberries Whole IQF, Fresas IQF 1024439, Net Wt. 30 LB (13.6g), 20lbs, 10lbs | The Int'l. Company For Agricultural Production & Processing | Food | Class I | 3 |
| 20 Sep 2016 | CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc. | Custom Medical Specialties, Inc. | Device | Class II | 1 |
| 14 Sep 2016 | Product is packaged in a white plastic bottle with green lettering. The label reads in part LIFE RISING, Chinese Herbal Supplement, BRAIN-ECM, Brain E-Calm, 54 Capsules, Life Rising to Higher Well Being. Manufactured for: Life Rising Corp., Willowbrook, IL 60527 | Life Rising Corp S | Food | Class I | 1 |
| 12 Sep 2016 | Levothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only, Moore's Pharmacy Compounding, Corpus Christi, TX Event 76235 | MOORE'S COMPOUNDING PHARMACY | Drug | Class II | 1 |
| 2 Sep 2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20 | United Exchange Corporation | Drug | Class I | 4 |
| 18 Aug 2016 | Frozen Raw Bay Scallops, packaged in a clear 5 lbs. bag, (six bags per case or total 30 lbs. case), food service product item, product of Philippines. There are three different sizes: size 120/150 (count per pound) size 150/200 (count per pound) size 200/300 (count per pound) Event 74983 | Sea Port Products Corp | Food | Class I | 1 |
| 17 Aug 2016 | Tasty Sawa Ground Turmeric, 50 lb bag. Manufactured by Spices USA. Event 75282 | Spices USA Inc. | Food | Class I | 1 |
| 2 Aug 2016 | Ground Turmeric packaged as follows: a) FOOD LOCKER(R) , 16 oz, PHENIX FOOD SERVICE, PHENIX CITY, AL 36867 b) Ground Turmeric, Net Wt. 4 oz., Event 74866 | J M Exotic Foods Inc | Food | Class I | 1 |
| 2 Aug 2016 | Hot/Spicy Curry Powder. Packaged under the names: Blue Mountain Country Hot Jamaican Curry Powder, Jamaican Choice Jamaican Hot Curry Powder, Ocho Rios Jamaica Nice Spicy Hot Curry Powder Seasoning, Ocho Rios Hot ‘N Spicy Jamaican Style Curry Powder, Oriental Brand Grade A Jamaican Curry Powder Hot & Spicy, Grace… | Oriental Packing Co., Inc. | Food | Class I | 4 |
| 28 Jul 2016 | 1) Ground Tumeric item #73535 Net Wt 50 lbs Distributed by Gel Spice Co., Inc 48 Hook Road, Bayonne, NJ 07002 2) Spice Supreme Ground Turmeric Net Wt 2 oz. (56 g) Packed in the USA by Gel Spice Co., Inc. Bayonne, NJ 07002 UPC 076114364628 3)Clear Value Ground Turmeric Net Wt. .75 oz (21 g) Distributed by TopCo… | Gel Spice Co, Inc. | Food | Class I | 1 |
| 22 Jul 2016 | IQF Cut Green Beans; Net Weight 20 lb; Dist. by JML Ingredients, East Petersburg PA, 17520; Packed by: The International Co. for Agri Production & Processing. - ICAPP; Exporter's Address Industrial Zone A - 2 (Lot W) - 10th of Ramadan City - Egypt. Event 74813 | Name withheld | Food | Class I | 1 |
| 22 Jun 2016 | Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button. | Stanley Security Solutions Inc | Device | Class II | 1 |
| 19 May 2016 | Toshiba Kalare DREX-KL80 X-ray generator | Toshiba American Medical Systems Inc | Device | Class II | 2 |
| 8 Apr 2016 | DR Systems Unity PACS software, now known as Merge Unity PACS. Product Usage: Merge Unity PACS is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 8 Apr 2016 | DR Systems Unity PACS software, now known as Merge Unity PACS | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge Healthcare. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Merge Hemo software. Product Usage: Merge Hemo is a hemodynamic monitoring system that records and displays physiological data. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Merge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Merge PACS software. The firm name on the label is Merge Healthcare. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Merge Eye Station Import Utility (ESIU). The firm name on the labeling is Merge Healthcare. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Merge Cardio software. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | Merge Cardio software using EchoIMS. The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 28 Mar 2016 | Merge Eye Station Import Utility (ESIU) when used with Merge Eye Station and Merge Eye Care PACS. The firm name on the labeling is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 24 Feb 2016 | PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous,… Event 76571 | Purewick Corporation | Device | Class II | 1 |
| 5 Jan 2016 | Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial Knee System | Biomet U.K., Ltd. | Device | Class II | 24 |
| 22 Sep 2015 | Merge Cardio software with Issuer of Patient ID (IPID). The firm name on the label is Merge Healthcare, Hartland, WI. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 22 Sep 2015 | Merge Cardio software. Product Usage: 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… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 27 Aug 2015 | BD AffirM VPIII Microbial Identification Test | Becton Dickinson & Co. | Device | Class II | 1 |
| 7 Jul 2015 | TASTY DELICIOUS brand Sugar Bun, Net Wt. 227 Grams (8 Ounces), UPC Code 8 59253 0045 7 Event 72034 | Tasty Delicious Bakery Inc. | Food | Class I | 1 |
| 27 May 2015 | The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually. | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 16 Apr 2015 | Hitachi Oasis MRI System | Hitachi Medical Systems America Inc | Device | Class II | 3 |
| 5 Jan 2015 | Titan" Stabilizer Attachment and Titan TM 360 Stabilizer Attachment | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 25 Aug 2014 | EpiCenter Plus Microbiology Data Management System software version 6.20A, when used in conjunction with the MALDI BioTyper System . Product Usage: The EpiCenter system is a clinical data management system designed for use with certain BD instrument systems. The EpiCenter system provides advanced capabilities in data… | Becton Dickinson & Co. | Device | Class II | 1 |