| 13 Jul 2020 | Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10 | Fresenius Kabi USA, LLC | Drug | Class III | 1 |
| 13 Jul 2020 | Wegmans PECAN BLEND Supreme Pecans, Cashews & Pistachios NET WT 16 OZ(1 LB) 454g plastic bag Ingredients: Pecans, Cashews, Dry Roasted Pistachios, Peanut Oil, Salt. Distributed By: Wegmans Food Markets, Inc. Rochester, NY 14603 UPC 0 77890 31040 3 | Flagstone Foods LLC | Food | Class II | 1 |
| 10 Jul 2020 | Auryxia (ferric citrate) tablets 210 mg, Rx Only, 200 tablets per bottle, Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc., 245 First Street Suite 1400, Cambridge, MA 02142, NDC: 59922-631-01. Event 86008 | Keryx Biopharmaceuticals, Inc. | Drug | Class II | 1 |
| 7 Jul 2020 | Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01 | Lupin Pharmaceuticals Inc. | Drug | Class II | 4 |
| 7 Jul 2020 | ***KIND HEALTHY GRAINS***Oats & Honey Granola with Toasted Coconut***INGREDIENTS: Oats, tapioca syrup, brown rice, cane sugar, honey, millet, oat flour, coconut, canola oil, buchwheat, amaranth, molasses, quinoa, brown rice syrup, sea salt, Vitamine E***May contanin peanuts, tree nuts, soy and sesame seeds***";… | KIND LLC | Food | Class II | 1 |
| 6 Jul 2020 | Sysmex PS-10 Sample Preparation System Catalog number:BQ716341 - Product Usage: is a fully automated, user configurable, open system intended for use to prepare human specimens for subsequent analysis on flow cytometers. | Sysmex America, Inc. | Device | Class II | 1 |
| 6 Jul 2020 | WinCo Foods Tater Bites Shaped, Shredded Potatoes, frozen product. Retail 32 oz. poly bag has UPC 0 70552 30303 4. The master case contains 12/32 oz. bags (net wt. 24 lbs.), identified as WinCo Foods Tater Bites WN420, 1 00 70552 30303 1. The 32 oz. retail package label is read in parts: "***Tater Bites, sharped,… | Lamb Weston Inc | Food | Class II | 1 |
| 3 Jul 2020 | Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bottle (NDC 70010-492-01) and 500 ct. bottle (NDC 70010-492-05), Manufactured for: Granules Pharmaceutical Inc., Chantilly, VA, Manufactured by: Granules India Limited, Hyderabad - 500-081, India | Granules Pharmaceuticals Inc | Drug | Class II | 1 |
| 2 Jul 2020 | Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 1 Jul 2020 | Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals, Inc., The Physicians Solutions. | Preferred Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 30 Jun 2020 | IntelliVue MX800 patient monitor, model no. 865240 | Philips North America, LLC | Device | Class II | 2 |
| 29 Jun 2020 | Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1 Event 85938 | EMD Serono, Inc. | Drug | Class II | 1 |
| 29 Jun 2020 | Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antiseptic Hand Rub, Non-sterile Solution, Extra strength Formula*, 8.45 fl. oz. (250 ml) bottle, Labeled with green or blue labels, Manufactured by Mystic Intl S.A. de C.V. UPC barcode: 7 87790 33952 6 Event 85957 | Transliquid Technologies, LLC | Drug | Class I | 1 |
| 29 Jun 2020 | Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose. | RemedyRepack Inc. | Drug | Class II | 1 |
| 29 Jun 2020 | Freshness Guaranteed Five Cheese Stuffed Shells Traditional Italian Ricotta Filled Shells with Marinara Sauce 10.76 ounces UPC 7874235174 Event 85953 | Garland Ventures, LTD DBA Bally Plus | Food | Class II | 1 |
| 25 Jun 2020 | IntelliVue G7m Anesthesia Gas Module, Model no. 866173, Firmware Version 04.12.00, System Codes 453564477391, 453564477401, 866173 | Philips North America, LLC | Device | Class II | 1 |
| 25 Jun 2020 | Red Velvet Layered Cheesecake is one whole cake (9" round cake) that has been pre-sliced into 14 slices and packaged in a white case box. Cheesecake is wrapped in a white band, ran through a shrink wrap machine and then put in a white case pack. Net weight: 82 oz. UPC 603812924900. Product must be stored frozen until… Event 85941 | Chuckanut Bay Foods LLC | Food | Class II | 1 |
| 25 Jun 2020 | Garlic Shrimp Poke weighed and packed in plastic containers in the deli section per customer request. Cooked Shrimp is received in 10 lb. boxes. Event 85935 | HKH JVC LLC. | Food | Class I | 1 |
| 24 Jun 2020 | syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 24 Jun 2020 | TRIGEN, Intramedullary nail - Product Usage: is intended to provide resistance for screw back-out. It provides additional friction to help hold the screws in place. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 24 Jun 2020 | Enlightened Dairy-Free Chocolate Peanut Butter Frozen Dessert, one Pint (473 ml). Case GTIN: 1-08-52109-33106-9. Item UPC:8-52109-33150-5. Produced exclusively for: Beyond Better Foods, LLC, Bronx, NY Event 85917 | Beyond Better Foods Llc | Food | Class I | 1 |
| 24 Jun 2020 | Whole Foods Market Red Velvet Layered Cheesecake Slice PLU: 78620 packaged in plastic clam shell with scale label applied | Whole Foods Market | Food | Class II | 1 |
| 23 Jun 2020 | MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 23 Jun 2020 | Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc., Cambridge, MA 02142, NDC 64406-006-02 Event 85906 | Biogen MA Inc. | Drug | Class III | 1 |
| 23 Jun 2020 | Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99. | VistaPharm, Inc. | Drug | Class III | 2 |
| 23 Jun 2020 | Blanxart 85% Nicaragua Organic Dark Chocolate Bar, packaged in paper packaging with internal foil wrapper. Net weight 4.4 oz (125 g). UPC 8 32924 00058 9. Product's label is read in parts: "***BLANXART 85% NICARAGUA ORGANIC DARK CHOCOLATE***Organic dark chocolate, Cocoa 85% minimum. Ingredients: cocoa, cane sugar,… | Power Selles Imports dba Culinary Collective | Food | Class II | 1 |
| 19 Jun 2020 | PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224) | Becton Dickinson & Company | Device | Class II | 12 |
| 19 Jun 2020 | 7-Select Yogurt Pretzels Naturally Flavored Vanilla Crunchy Pretzel Covered in a Vanilla Yogurt NET WT 5 OZ (142 g) UPC 5254856657 | Mount Franklin Foods LLC | Food | Class I | 1 |
| 19 Jun 2020 | Fresh Express Iceberg Garden / Lechuga Repollo 24 oz., UPC 071279104119, iceberg lettuce, carrots & red cabbage | Fresh Express Incorporated | Food | Class II | 92 |
| 18 Jun 2020 | Mueller Sports Medicine Hybrid Wraparound Knee Support, Qty: 1 unit per box Event 85884 | Mueller Sports Medicine, Inc | Device | Class II | 1 |
| 18 Jun 2020 | Simply Nature Sweet Potato Bites, 12oz retail boxes variety pack, Expiration date 4/9/2022. Lot code R20AJ-01A. Event 85936 | Name withheld | Food | Class II | 1 |
| 18 Jun 2020 | Coke Zero Sugar 20 oz UPC 049000040869 | Name withheld | Food | Class II | 4 |
| 18 Jun 2020 | Gordon Choice Imitation Crab Supreme Style, Net Wt 40 oz (2 lb 8 oz) Keep Frozen. UPC 93901-71212. For Distribution exclusively by Gordon Food Service Wyoming, MI 49509 | Trident Seafoods Corporation | Food | Class I | 1 |
| 18 Jun 2020 | Fresh Express Chopped Kit SOUTHWEST TOTAL NET WT. 11.5 oz (326g) plastic bag. FRESH EXPRESS INCORPORATED P.O. BOX 80599, SALINAS, CA 93912 UPC 0 71279 30602 5 | Fresh Express Incorpated | Food | Class I | 1 |
| 17 Jun 2020 | LoFric Origo, Nelaton, 16in, FR10 urinary catheters | Wellspect HealthCare (Division of DENTSPLY IH AB) | Device | Class II | 3 |
| 17 Jun 2020 | FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740 | FHC, Inc. | Device | Class II | 1 |
| 17 Jun 2020 | Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only After Dilution, Distributed by HF Acquisition Co, LLC, Mukilteo, WA 98275, NDC 63323-739-12 | HF Acquisition Co. LLC | Drug | Class III | 1 |
| 17 Jun 2020 | Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01 | Preferred Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 17 Jun 2020 | NORTH STAR TRADING COMPANY SWEET & SALTY CARAMEL TRAIL MIX NET WT 14OZ (396g) MANUFACTURED FOR YOUR MILITARY EXCHANGES BY FLAGSTONE FOODS, INC. SAINT PAUL, MN 55102 UPC 0 80948 63064 4 | Flagstone Foods LLC | Food | Class II | 1 |
| 17 Jun 2020 | Brill 30 lb. cases of 480 1.0 oz. chocolate chip with mini colored candy pieces frozen cookie dough, MDM # 10194626, Manufactured by Brill, Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM Event 85881 | Brill Inc | Food | Class II | 1 |
| 16 Jun 2020 | BodyGuard BodySet, REF: A120-160SAS | CME America, LLC | Device | Class I | 37 |
| 16 Jun 2020 | Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12. | Glaxosmithkline Consumer Healthcare Holdings | Drug | Class II | 2 |
| 16 Jun 2020 | Hill Country Fare Pink Lemon Drink 1 GAL CONT. NET. 3.78L Contains < 1% Juice UPC 4122005174 | Name withheld | Food | Class I | 4 |
| 15 Jun 2020 | POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 10859821006770 - Product Usage: Introducer with Extended Dwell Catheter is used to gain access to the vascular system to sample… Event 85808 | Access Scientific LLC | Device | Class III | 1 |
| 12 Jun 2020 | Software 1898072 IPC upgrade v 2.7.3.0 - Product Usage: The IPC system is indicated for the incision/cutting removal, drilling and sawing of soft and hard tissue and bone in surgical procedures. | Medtronic Xomed, Inc. | Device | Class II | 1 |
| 12 Jun 2020 | Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05 | Aurobindo Pharma USA Inc. | Drug | Class II | 1 |
| 12 Jun 2020 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61 | The Harvard Drug Group | Drug | Class II | 1 |
| 12 Jun 2020 | Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665 | Beaming White Llc | Drug | Class II | 3 |
| 12 Jun 2020 | NOW Real Food Raw Macadamia Nuts Unsalted 8 oz retail bag UPC 733739071194 Item number 7119 | NOW Health Group Inc. | Food | Class I | 1 |
| 11 Jun 2020 | PORT-A-CATH II POWER P.A.C. Low Profile" system. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 11 Jun 2020 | Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07) | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 11 Jun 2020 | Anti-Viral Immune Enhance "Corona Virus (COVID-19) " "Influenza (H1N1)" "Bronchitis" "Common Cold" 60 Capsules, Dietary Supplement, Manufactured by: Golden Nutrition Event 85860 | GOLDEN NUTRITION INC | Food | Class II | 1 |
| 11 Jun 2020 | Similac Pro-Advance Infant Formula with Iron, Milk-Based, Ready to Feed, 32 FL OZ (1 QT) Event 85855 | Abbott Nutrition, Division of Abbott Laboratories | Food | Class III | 1 |
| 11 Jun 2020 | Xi Zhi Liang Fruit Jelly Cups; 21.1oz (600g); packaged in pink, yellow, and blue plastic backpacks with numerous individual plastic jelly cups inside each backpack and a toy car in a pouch on the front of the plastic backpack; the product contains konjac powder | Rong Shing Trading NY Inc | Food | Class I | 1 |
| 10 Jun 2020 | Leksell Vantage Stereotactic System, UDI/GTIN 7340048304887 | Elekta Instrument AB | Device | Class II | 1 |
| 10 Jun 2020 | Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery. | NuVasive Inc | Device | Class II | 1 |
| 10 Jun 2020 | PERMA-HAND/MERSILK SILK BLU and VIRGIN SILK BLU, Product Codes EH7457G EH7983G FV768 FV769 FV7771 U7058 U7059 W1782 W1784 W1819 W1820 W818 W819 W870 | Ethicon, Inc. | Device | Class II | 1 |
| 10 Jun 2020 | Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-30 | Crown Laboratories | Drug | Class II | 2 |
| 10 Jun 2020 | Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30. | Alembic Pharmaceuticals Limited | Drug | Class II | 1 |
| 10 Jun 2020 | Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC carton: 60687-374-01, NDC unit dose: 60687-374-11 | American Health Packaging | Drug | Class III | 1 |
| 9 Jun 2020 | enVista one-piece hydrophobic acrylic toric intraocular lens, Bausch and Lomb - Product Usage: is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision. | Bausch & Lomb Surgical, Inc. | Device | Class II | 1 |
| 9 Jun 2020 | Expansion Control Overlay, Item No. 1004EC - Product Usage: The EHOB WAFFLE Overlay is more than a support surface, assisting in lateral transfers, boosts and turns to protect patients throughout the hospital journey. Through immersion and envelopment, the WAFFLE Overlay is designed to offload the patient and relieve… | EHOB, Inc. | Device | Class II | 1 |
| 9 Jun 2020 | Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle, This is a compounded drug not for resale, Store at room temperature, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419. | MasterPharm LLC | Drug | Class I | 1 |
| 8 Jun 2020 | Lokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V Kombi; 30005 LokomatPro L6.2 120V PE; 30683 LokomatPro L6.2 110V FD PE; 30684 LokomatPro L6.2 110V FD Kombi; 32001 LokomatPro L6.2 110V FD AD Product Usage: The intended use of the Lokomat is to support treadmill training to treat… Event 85857 | Hocoma AG | Device | Class II | 1 |
| 8 Jun 2020 | Accurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005 GTIN /UPN: 20763000153551 - Product Usage: (sterile, single-use) comprises an electrically insulated shaft, an active electrode for RF energy delivery, a hub with a female slip luer fitting, and a stylet with a color-coded cap to… | Medtronic Sofamor Danek USA Inc | Device | Class II | 6 |
| 8 Jun 2020 | Philips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3 Patient Monitor (Model No. 867030) or a lntelliVue MMX Multi-Measurement Module (Model No. 867036) | Philips North America, LLC | Device | Class II | 1 |
| 8 Jun 2020 | ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by… | KCI USA, INC. | Device | Class II | 1 |
| 5 Jun 2020 | ADVIA Chemistry Calibrator | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 5 Jun 2020 | GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to work with video endoscopes, in conjunction… | Verathon, Inc. | Device | Class I | 1 |
| 5 Jun 2020 | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction. | OrthoPediatrics Corp | Device | Class II | 2 |
| 5 Jun 2020 | metFORMIN HCL ER 500 mg, a) 30 tablets (NDC 72789-009-30); b) 60 tablets (NDC 72789-009-60); c) 90 tablets (NDC 72789-009-90); d) 180 tablets (NDC 72789-009-93); e) 100 tablets (NDC 49483-0623-01) bottles, Rx only PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127 | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 5 Jun 2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg Rx Only 100 Tablets bottles, Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No, L-82, L-83, Verna Intl. Estate, Verna, Goa-403 722, India NDC 49483-623-01 Event 85818 | Marksans Pharma Limited | Drug | Class II | 1 |
| 5 Jun 2020 | Stumptown Cold Brew Coffee and Chocolate with Oatmilk. Product is TetraPak Prisma Pak aseptic packaging. Keep refrigerated. Net 11 fl. oz (325 mL). UPC on the single unit is 8 55186 00688 5. Event 85817 | Stumptown Coffee Corp | Food | Class II | 1 |
| 4 Jun 2020 | Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems… | Cardinal Health 200, LLC | Device | Class II | 2 |
| 4 Jun 2020 | Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. | Boston Scientific Corporation | Device | Class II | 10 |
| 4 Jun 2020 | CareLink SmartSync Device Manager, Model Number 24970A | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 9 |
| 4 Jun 2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01 | SOMERSET THERAPEUTICS LLC | Drug | Class III | 3 |
| 3 Jun 2020 | DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23 Event 85894 | Dufner Instrumente GmbH | Device | Class II | 1 |
| 3 Jun 2020 | MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run. | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 3 Jun 2020 | HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam. | Coltene Whaledent Inc | Device | Class II | 4 |
| 3 Jun 2020 | COOPERSURGICAL Os FinderTM Cervical Dilator, Taper: 2.0 mm to 4.0 mm OD Length: 21.5 cm Box of 50 Part Number: 1176 | CooperSurgical, Inc. | Device | Class II | 1 |
| 3 Jun 2020 | Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc), 14.4 FL OZ. (426 mL), A.P. Deauville LLC New Brunswick, NJ 08901, NDC 42913-020-00, UPC 815195014097 Event 85806 | A.P. Deauville, LLC | Drug | Class II | 1 |
| 3 Jun 2020 | Walker Emulsions Hand Sanitizer (60%), Non-Sterile Solution, Alcohol Antiseptic 60%, 1 Gallon, Topical Solution, Walker Emulsions Inc., 4401 SE Johnson Creek Blvd., Portland, OR 97222, NDC 74940-0415-1 | WALKER EMULSIONS INC | Drug | Class II | 2 |
| 3 Jun 2020 | TOUFAYAN BAKERIES SMART POCKETS EVERYTHING 6 COUNT NET WT 7.4 OZ. (210 g), UPC 0 7312400792 7. 12 packages per case. Product expiration date or shelf life date is not added to package by firm but may be added by retail store. According to the recalling firm, shelf life is approximately 14 days but can be extended… Event 85819 | Toufayan Bakery, Inc. | Food | Class II | 1 |
| 2 Jun 2020 | Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only | Baxter Healthcare Corporation | Device | Class II | 1 |
| 2 Jun 2020 | Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair. | Cook Inc. | Device | Class II | 1 |
| 2 Jun 2020 | EasyDiagnost Eleva DRF, model no. 706050 - Product Usage: X-ray system, diagnostic, general-purpose. | Philips North America, LLC | Device | Class II | 1 |
| 2 Jun 2020 | Metformin Hydrochloride Extended - Release Tablets, USP, 500 mg, a) 100 (NDC 62037-571-01) and b) 1,000 (NDC 62037-571-10) count bottles, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ | Teva Pharmaceuticals USA | Drug | Class II | 2 |
| 29 May 2020 | RUSCH LASERTUBE (Rubber), RES 102004, Sizes: a) I.D. mm 4,0, Product Code 102004-000040 b) I.D. mm 5,0, Product Code 102004-000050 c) I.D. mm 6,0, Product Code 102004-000060 d) I.D. mm 7,0, Product Code 102004-000070 e) I.D. mm 8,0, Product Code 102004-000080 Product Usage: Tracheal intubation during laser surgery in… | TELEFLEX MEDICAL INC | Device | Class II | 1 |
| 29 May 2020 | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, Rx Only, 100 count bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-01 | Amneal Pharmaceuticals of New York, LLC | Drug | Class II | 12 |
| 28 May 2020 | Thora-Para 5 Fr Non-Valved Catheter Drainage Tray | Carefusion 2200 Inc | Device | Class II | 14 |
| 27 May 2020 | RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11416778 | Siemens Healthcare Diagnostics Inc | Device | Class II | 1 |
| 27 May 2020 | Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm Product Code: 58216 27US | Name withheld | Device | Class II | 6 |
| 27 May 2020 | Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 blister cards containing 15 tablets each (30 tablets), Rx Only, Distributed by Wyeth Pharmaceuticals LLC A subsidiary of Pfizer In Philadelphia, PA 19101 Made in Ireland, NDC 00008-1123-12 | Pfizer Inc. | Drug | Class III | 1 |
| 26 May 2020 | RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2 | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 26 May 2020 | ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM Event 85841 | U&I CORP. | Device | Class II | 1 |
| 26 May 2020 | Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module is optional and… | Radiometer Medical ApS | Device | Class II | 2 |
| 26 May 2020 | Pediatric Adjustable Flange Tracheostomy Tube Cuffless | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 23 May 2020 | Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and… | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 1 |
| 22 May 2020 | AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 | Tosoh Bioscience Inc | Device | Class II | 1 |
| 22 May 2020 | Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as interface to the FUJIFILM Synapse PACS Software (Server) | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 22 May 2020 | TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to… | Abbott | Device | Class II | 1 |
| 21 May 2020 | VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collected by the wireless remote monitoring system in healthcare settings. This is a secondary, adjunct patient monitor and is not intended to replace existing… Event 85802 | Vitalconnect Inc. | Device | Class II | 1 |
| 20 May 2020 | VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979 | Ortho Clinical Diagnostics | Device | Class II | 5 |
| 20 May 2020 | Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2, Product Code IAP-0400 | Arrow International Inc | Device | Class I | 10 |
| 19 May 2020 | Isolation Droplet Bundle Kit | ROi CPS LLC | Device | Class II | 2 |
| 19 May 2020 | Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01 Event 85742 | Flexion Therapeutics, Inc. | Drug | Class III | 1 |
| 18 May 2020 | CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-046050 2042084-001-208621 2042084-001-045915 2042084-001-215164 2042084-001-078474 2042084-001-053034 2042084-001-215165… | GE Healthcare, LLC | Device | Class II | 1 |
| 15 May 2020 | MEVION S250i, MEVION S250; Proton Radiation Treatment System | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 15 May 2020 | Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only. | Siemens Healthcare Diagnostics Inc. | Device | Class II | 2 |
| 15 May 2020 | DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type… Event 85685 | Mediana Co., Ltd. | Device | Class II | 1 |
| 15 May 2020 | (1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 11313246 (2) CentraLink Data Management System software version 16.0.3 Siemens Material Number (SMN): 11314337 Product Usage: are clinical laboratory information modules which consolidate test orders and test results, provide… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 15 May 2020 | 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. | TeDan Surgical Innovations LLC | Device | Class II | 7 |
| 14 May 2020 | DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. | Neocis Inc. | Device | Class II | 3 |
| 14 May 2020 | Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the components necessary to successfully obtain an open patient airway with an Ambu King LTS-D" Supraglottic Airway. Event 85832 | Bound Tree Medical | Device | Class II | 1 |
| 14 May 2020 | Aminature L-Cysteine HCl Anhydrous 100 mesh 25KG DRUM Event 85939 | Cj Haide (Ningbo) Biotech Co., Ltd | Food | Class II | 1 |
| 14 May 2020 | "Radhuni Curry Powder, 400 grams (14.11 oz.)***Ingredients: Coriander, Tumeric, Chili, Bitsalt, Aniseed, Sodium Chloride, Garlic, Cumin, Bay leaf, Ginger, Cinnamon, Clove, Cardamon***Product of Bangladesh***Imported by New Hoque & Sons Inc., NY USA***" Event 85710 | New Hoque & Sons, Inc. | Food | Class I | 1 |
| 12 May 2020 | MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection and differentiation of HSV-1 and HSV-2 present in cerebrospinal fluid (CSF), or cutaneous and mucocutaneous lesion swabs from patients with… | DiaSorin Molecular LLC | Device | Class II | 3 |
| 12 May 2020 | Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591 | XTANT Medical | Device | Class II | 1 |
| 11 May 2020 | ABL80-FLEX-393-839 Box Label, REF 393-839, IVD, CE, UDI: 05700693938394 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting. | Radiometer Medical ApS | Device | Class II | 2 |
| 11 May 2020 | Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial | BIOTA Biosciences LLC | Drug | Class II | 5 |
| 8 May 2020 | uCT 760 System, Computed Tomography X-ray System | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 1 |
| 8 May 2020 | Merge Healthcare Merge Application Server Software Release and Merge Healthcare Merge Cardio Workstation Software Release - Product Usage: VERICIS is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images,… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 8 May 2020 | uCT 530 Computed Tomography X-Ray System | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 1 |
| 7 May 2020 | Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 24 Apr 2020 | Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153 | LivaNova USA Inc. | Device | Class II | 22 |
| 23 Apr 2020 | R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride solution 50 mL in 60 mL Syringe, Compounded by QuVa 519 Bloombury, NJ 08804, NDC 70092143350 | QuVa Pharma, Inc. | Drug | Class III | 1 |
| 22 Apr 2020 | Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes. Event 85655 | LABORIE MEDICAL TECHNOLOGIES, CANADA ULC | Device | Class II | 1 |
| 20 Apr 2020 | Oscar 2, Model 250 System | Suntech Medical, Inc. | Device | Class II | 1 |
| 6 Apr 2020 | ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos… | Skeletal Kinetics, Llc | Device | Class II | 45 |
| 20 Mar 2020 | Utak NR Trace Elements Serum Control, 5 ml, REF 66816. The responsible firm on the label is UTAK LABORATORIES, INC., Valencia, CA. Control for in vitro diagnostics. Event 85660 | Utak Laboratories Inc | Device | Class III | 1 |
| 27 Feb 2020 | uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. | Shanghai United Imaging Healthcare Co., Ltd. | Device | Class II | 1 |
| 26 Feb 2020 | The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel. | Capso Vision, Inc. | Device | Class II | 1 |
| 23 Jan 2020 | DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to deliver the energy to the surgical site to ablate unwanted material. The optical conduit is used in conjunction with… | Ra Medical Systems, Inc. | Device | Class II | 1 |
| 17 Jan 2020 | Ameritus Medical Products ENFit Polyurethane and Silicone Feeding Tubes. Sterile and single use only. Catalog number ENF-40P-50 (4 fr. 50 cm ENFit Enteral Feeding Tube). | Kentec Medical, Inc | Device | Class II | 7 |
| 26 Dec 2019 | Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12 | Akorn, Inc. | Drug | Class III | 1 |
| 18 Dec 2019 | Elekta Unity, Image-Guided Radiation Therapy System | Elekta, Inc. | Device | Class II | 1 |
| 2 Dec 2019 | BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, abdominal masses, etc. | Argon Medical Devices, Inc | Device | Class II | 1 |
| 22 Nov 2019 | LOCATOR OVERDENTURE IMPLANT SYSTEM STERILE R Rx Only QTY 1 . Event 85369 | Zest Anchors LLC | Device | Class II | 1 |
| 18 Nov 2019 | LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case | LivaNova USA Inc. | Device | Class III | 1 |
| 15 Nov 2019 | Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05 | Rising Pharmaceuticals, Inc. | Drug | Class III | 2 |
| 4 Nov 2019 | Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for interventional procedures, such as invasive cardiology, interventional radiology, and interventional neuroradiology. | Shimadzu Medical Systems | Device | Class II | 1 |
| 23 Sep 2019 | TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement… Event 85392 | Tomtec Imaging Systems Gmbh | Device | Class II | 1 |
| 12 Sep 2019 | CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA. Event 85367 | Codan US Corporation | Device | Class II | 1 |
| 26 Aug 2019 | Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993 | LivaNova Deutschland GmbH | Device | Class II | 2 |
| 21 Aug 2019 | CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307. | CTL Medical Corporation | Device | Class II | 4 |
| 6 Aug 2019 | BodyGuardian Heart Remote Monitoring Kit, consisting of two BG Heart monitors, either Models BC-1001-A or BC1001-D, and a cell phone, either Models BP1008 or BP10014, that is paired to both of the monitors. Event 85233 | Preventice Services, LLC | Device | Class II | 1 |
| 1 Jun 2019 | Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin Tubes (BD Vacutainer-BD Codes 367884 & 367960; Centurion code 45177 (VACUTAINER GREEN TOP) and 84815 (VACUTAINER 3ML LT. GREEN). Centurion Kit Code: IV8860 | Centurion Medical Products Corporation | Device | Class II | 1 |
| 2 Apr 2019 | Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484 | Ortho Organizers, Inc. | Device | Class II | 2 |
| 29 Mar 2019 | Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300,… Event 85111 | PROVIDENCE MEDICAL TECHNOLOGIES | Device | Class II | 1 |
| 15 Jan 2019 | Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only. | Westmed, Inc. | Device | Class II | 3 |
| 8 Aug 2018 | Extra corporeal circuit with bio-active surface. | Medtronic Perfusion Systems | Device | Class II | 1 |
| 25 Jun 2018 | This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a… | DJO, LLC | Device | Class II | 1 |