| 5 Feb 2021 | Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 62756-129-40 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class III | 1 |
| 5 Feb 2021 | Kowalski's Buffalo Cauliflower Bites with Kowalski's Steakhouse Blue Dressing. Net Wt. 22 oz (1 lb. 6 oz) 624 g. UPC 95631-89341. Keep Refrigerated. MFG BY: RDW Eagan, MN 55121 | Russ Davis Wholesale Inc | Food | Class II | 1 |
| 4 Feb 2021 | Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01 | Wilshire Pharmaceuticals Inc | Drug | Class II | 2 |
| 3 Feb 2021 | 20 Mile Black Cherry Organic Frozen Custard, Contents: One U.S. Pint, and 86 oz. Scoopers. UPC 50005-48807. Made by Barron County Organics, LLC, 10-Mile Organic and Local General Store, 796 29 3/4 Ave. Barronett, WI 54813. | Barron County Organics | Food | Class II | 17 |
| 3 Feb 2021 | The RETAIL package is black cardboard box and product is described as: Publix Parmesan-Crusted Wild Alaskan Salmon Fillets, Frozen, net wt. 12 oz. Each retail box has 2 individually vacuum-packaged portions of 5oz salmon with 1oz of glaze of soy sauce for each portion. The salmon and glaze are both in a vacuum-packed… | Ocean Beauty Seafoods LLC | Food | Class II | 1 |
| 2 Feb 2021 | Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC… | Apotex Corp. | Drug | Class I | 2 |
| 2 Feb 2021 | Sprout's Vanilla Flavored Yogurt Covered Cranberries UPC 646670463778 12 Ounce Stand-Up Pouch Bag Ambient Storage | Ohio Hickory Harvest Brand Products, Inc. | Food | Class I | 1 |
| 29 Jan 2021 | Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV- 2 in human venous whole blood, plasma from anticoagulated blood or serum. | Confirm Biosciences Inc | Device | Class II | 2 |
| 29 Jan 2021 | Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01. (87256) | Akebia Therapeutics dba Keryx Biopharmaceutials, Inc | Drug | Class III | 1 |
| 29 Jan 2021 | BUFFALO STYLE CHICKEN Sliders NET WT. 5OZ (141g) Ingredients: Tuna Salad*** CONTAINS: EGG, FISH (TUNA), MILK, WHEAT Distributed By Renaissance Food Group, LLC 4322 Moreland Ave. Conley, GA 30288 UPC 8 26766 15590 3 | Renaissance Food Group, LLC | Food | Class II | 1 |
| 28 Jan 2021 | Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30) | Accord Healthcare, Inc. | Drug | Class III | 1 |
| 28 Jan 2021 | think! Protein + Fiber Oatmeal, Farmer's Market Berry Crumble bowl 1.76 oz. individual unit UPC 753656711836 also sold in retail 6 pack with UPC 753656712338 (87240) | Glanbia Performance Nutrition (Manufacturing), Inc | Food | Class II | 1 |
| 28 Jan 2021 | Happy Belly Mayo Light Mayonnaise 30 FL OZ Plastic Jar Item B08B6T9RC6 | Treehouse Foods | Food | Class II | 1 |
| 28 Jan 2021 | Dole Endless Summer Salad Kit; 13 oz. bag UPC: 0-71430-01073-0 Contains Milk, Wheat Distributed by Dole Fresh Vegetables, Inc., Monterey, CA 93940 Contains Swiss cheese, Sunflower seeds, romaine lettuce, red cabbage, summer vinaigrette, herbs & spices, artisan croutons, carrots. | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 27 Jan 2021 | Nongshim brand Shin Ramyun; Sold in the following packaging configurations: 4.2 oz, individual bags UPC 031146150601 16 count box (16 x 4.2 oz. pkgs.) UPC 031146022854 10 count box (10 x 4.2 oz. pkgs.) UPC 00031146023981 (87242) | Nongshim America, Inc. | Food | Class II | 1 |
| 26 Jan 2021 | Maine Grains Inc. brand Organic Yellow Peas sold between 10/17/2019 and 11/1/2020; product was packaged in 25lb bulk bags, 12 x 1lb cases; and clear cellophane 1lb bags sold online and labelled as "Crop Rotation Organic Yellow Peas" (87225) | Maine Grains, Inc | Food | Class I | 1 |
| 25 Jan 2021 | Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01 | Nostrum Laboratories Inc | Drug | Class II | 1 |
| 25 Jan 2021 | O Organics Plant Based Mushroom and Veggie Organic Burger Patties, 10 oz Package of 4/ 2.5oz patties packaged in cardboard box (87227) | Goodman Food Products Texas Inc | Food | Class II | 1 |
| 25 Jan 2021 | "Wildtree***Leslies Chili Blend***Organic & Gluten Free***Net Wt. 3.7 oz. ***Distributed by: Wildtree" | Wildtree Inc. | Food | Class II | 2 |
| 22 Jan 2021 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88 | Ascend Laboratories LLC | Drug | Class II | 2 |
| 22 Jan 2021 | Butter Flavored Popcorn Artificially Flavored 8oz. UPC:7017306021 | Bickel's Snack Foods Inc | Food | Class II | 1 |
| 22 Jan 2021 | Reese Bearnaise Sauce packaged in glass jars 7.5 oz UPC: 7067060109 | World Finer Foods, Inc. | Food | Class II | 2 |
| 21 Jan 2021 | Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 21 Jan 2021 | Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic ointment jar, Rx Only, Stanley Specialty Pharmacy 3120 Latrobe Dr. Suite 200 Charlotte, NC 28211 (87255) | Stanley Specialty Pharmacy Compounding and Wellness Center | Drug | Class II | 1 |
| 21 Jan 2021 | Door County Coffee & Tea Co. French Vanilla Flavored Cappuccino. 10 Single Serve cups .51 oz (14g)/EA. Net Wt. 5.1 oz. (144g) (87206) | Door County Coffee & Tea Co., Inc. | Food | Class II | 1 |
| 21 Jan 2021 | RUFFLES "PARTY SIZE" ORIGINAL POTATO CHIPS 13 1/2 oz. UPC 028400034005 packaged in flexible bags | Frito-Lay, Inc. Headquarters | Food | Class I | 1 |
| 19 Jan 2021 | AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC. (87300) | Sky Medical Supplies and Equipments LLC | Device | Class II | 1 |
| 18 Jan 2021 | Blueberry Blizzard Coffee Cake, Item 259, Net Wt. 24 oz. | Nueske Applewood Smoked Meat, Inc | Food | Class II | 2 |
| 18 Jan 2021 | Amy's Soups made with organic Lentils - Golden Lentil - Indian Dal. Net Wt. 14.4 oz (408g) Ready to serve - do not add water Ingredient: Filtered water, Organic Yellow Split Peas, Organic Red Lentils, Organic Carrots, Organic Tomato Puree, Organic Extra Virgin Olive Oil, Shallots, Organic Garlic, Sea Salt, Organic… | Amys Kitchen Inc | Food | Class II | 1 |
| 17 Jan 2021 | HIland 1% Lowfat Chocolate Milk Half Pint UPC: 72060-00156-3 packaged in a paper carton 50 cartons per case | Hiland Dairy Foods Company, LLC | Food | Class II | 1 |
| 15 Jan 2021 | Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation. | Biomet, Inc. | Device | Class II | 1 |
| 15 Jan 2021 | SARS-CoV-2 Antigen Test | Qiagen Sciences LLC | Device | Class II | 1 |
| 15 Jan 2021 | Good & Gather Four Cheese Gnocchi, Net Wt. 16 oz. (454g), Keep Frozen. Needs to be Fully Cooked. UPC 0 85239-10366 1 Product of Italy. Dist by Target Corporation, Minneapolis, MN 55403 (87190) | EMILIA FOODS SRL | Food | Class II | 1 |
| 15 Jan 2021 | "Lake Champlain Chocolates ***NET WT. 9 oz. (255 g)***a sensational best-of valentines collection***"UPC: 76993385787 https://www.lakechamplainchocolates.com/galentines-gift-box GALENTINE SELECTION 15PC BOX 9oz | Champlain Chocolate Company | Food | Class II | 14 |
| 14 Jan 2021 | Butternut Veggie Spirals Tray, Keep Refrigerated, NET WT 9.5oz (269g) | Individual firm, name withheld | Food | Class II | 5 |
| 14 Jan 2021 | Samyang Buldak Extremely Spicy Hot Chicken Flavor Sauce Hot Chili Sauce Net Wt. 200 g (7.05 oz) Product of Korea UPC: 8 801073 411395 Ingredients: Water, Artificial chicken flavor powder (artificial flavor, dextrin, sugar, red pepper powder, yeast powder, chili pepper powder, modified potato starch, egg, curry powder… | Samyang Foods Co Ltd | Food | Class II | 3 |
| 13 Jan 2021 | Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set) (87094) | BEMER INT. AG | Device | Class II | 1 |
| 11 Jan 2021 | LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests. It comprises a portable LumiraDx Instrument… | LumiraDx | Device | Class II | 1 |
| 11 Jan 2021 | Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24048 DELTA RGL PL 0.5, 24053 - CHAMBER 24053 DELTA, 24147 - VALVE 24147 DELTA SML PL0.5, 25121-1 - ASSY 25121-1 DELTA SML SNAP PERIT 120, 25121-5 - ASSY 25121-5 DELTA SML SNAP P-CATH 120, 25131-1 - DELTA… | Individual firm, name withheld | Device | Class II | 3 |
| 11 Jan 2021 | Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial 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 III | 1 |
| 10 Jan 2021 | Lancaster Butternut Squash Noodles 12 oz.(340g); UPC 8 13055 01749 3, 8 13055 01864 3 | Lancaster Foods LLC | Food | Class II | 8 |
| 8 Jan 2021 | Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 8 Jan 2021 | 13C-Spirulina Gastric Emptying Breath Test (GEBT) - Product Usage: intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastroparesis. (87186) | Cairn Diagnostics | Device | Class II | 1 |
| 8 Jan 2021 | Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 NDC 51672-4001-1 | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class II | 1 |
| 7 Jan 2021 | BioGX SARS-CoV-2 Reagents for BD MAX System Catalog number (REF) 444213. In vitro diagnostic. SARS-CoV-2 Reagents is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal… | Becton Dickinson & Co. | Device | Class II | 1 |
| 7 Jan 2021 | Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K | Cardinal Health 200, LLC | Device | Class II | 6 |
| 7 Jan 2021 | Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and… | Cardinal Health 200, LLC | Device | Class II | 13 |
| 7 Jan 2021 | Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05 | Bausch Health Companies, Inc. | Drug | Class III | 2 |
| 6 Jan 2021 | 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materials. catalog number 03157334001 . in vitro diagnostic use. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 6 Jan 2021 | Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A | Arrow International Inc | Device | Class II | 1 |
| 6 Jan 2021 | Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ Fabricado por: De La Cruz Products, A Division of DLC Laboratories, Inc. Paramount, CA 9023 USA; UPC 024286150426 (87257) | DLC Laboratories, Inc | Drug | Class II | 1 |
| 6 Jan 2021 | "LAVVA Blueberry Dairy Free Pili Nut Yogurt. NO SUGAR ADDED. NET WT 5.3OZ (150g) ***KEEP REFRIGERATED***DISTRIBUTED BY EVR FOODS INC. NEW YORK, NY 10010" (87096) | EVR FOODS INC | Food | Class II | 1 |
| 5 Jan 2021 | Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only. | Helena Laboratories, Corp. | Device | Class II | 1 |
| 5 Jan 2021 | Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. The RT-PCR test runs on a Franklin Real-Time PCR Thermocycler Device (Reference/Catalog Number 1000003,1000018) with the Software Controller… | Biomeme, Inc. | Device | Class III | 1 |
| 5 Jan 2021 | Weis Quality Cookies and Cream Ice Cream (48oz). Packaged in a squround paper container with a UPC of 041497-01253. | Weis Markets, Inc., Ice Cream Division | Food | Class II | 4 |
| 5 Jan 2021 | Dole Chopped Kit Sesame Asian Salad & Topping Net Wt: 9.5 oz (269 g) Dressing Net: 2.5 FL oz (72 mL) Total Net Wt. 12.25 oz (347 g) UPC 0-71430-00035-9 | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 4 Jan 2021 | Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837 | Cook Inc. | Device | Class II | 1 |
| 4 Jan 2021 | B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs. | Aomori Olympus Co., Ltd. | Device | Class II | 111 |
| 4 Jan 2021 | Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12 | Ethicon, Inc. | Device | Class II | 1 |
| 30 Dec 2020 | Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems. | Baxter Healthcare Corporation | Device | Class II | 6 |
| 30 Dec 2020 | Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01 | AuroMedics Pharma LLC | Drug | Class II | 1 |
| 29 Dec 2020 | REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile | Allergan PLC | Device | Class II | 1 |
| 29 Dec 2020 | Tegral Satin EC CL Vegan Cake packaged in 50lbs bags (87071) | Puratos Corporation | Food | Class II | 1 |
| 29 Dec 2020 | AK 10 5/8" Par Baked Stuffed Crust, frozen Pizza Crust, Item 1115660, Case Count / Unit Weight, 283 Count / 21.5 oz. Keep Frozen at 0 to -10F. Alive & Kickin' Pizza Crust, Green Bay, WI 54313 USA | Port City Bakery, Inc | Food | Class II | 4 |
| 28 Dec 2020 | Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field. (87009) | Mar-Med Co | Device | Class II | 1 |
| 28 Dec 2020 | FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 28 Dec 2020 | Pisiva Pea Protein 80% 20 kg (44 lbs) packaged in poly lined kraft paper bags. (87167) | Hill Pharma Inc | Food | Class I | 1 |
| 24 Dec 2020 | Philips EPIQ Diagnostic Ultrasound System, Models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, EPIQ 7W, EPIQ CVx & EPIQ CVxi - Product Usage: the systems can assist the interventionist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray… | Philips Ultrasound Inc | Device | Class II | 1 |
| 23 Dec 2020 | Valkyrie LTOWB Collection (P/N 80-820, NSN 6515016862423). Blood collection convenience kit. The Valkyrie LTOWB Collection Set includes the items needed to allow for pre-screening to identify Low Titer Type O Donors as well as collect the blood from the donor. | Combat Medical Systems, LLC | Device | Class I | 5 |
| 23 Dec 2020 | BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 | Becton Dickinson & Company | Device | Class II | 1 |
| 23 Dec 2020 | Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. | Draegar Medical Systems, Inc. | Device | Class II | 1 |
| 23 Dec 2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047. | Fresenius Kabi USA, LLC | Drug | Class I | 1 |
| 23 Dec 2020 | IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottles, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, Made in China, ALSO distributed with Custom front labels as follows a) Sadie G. Mays Health & Rehabilitation Center, b) Pacers logo, c) northwood CHURCH, d) ROGERTHEROOFER.com… | Shane Erickson Inc | Drug | Class II | 3 |
| 22 Dec 2020 | Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists of two probes (71kb and 131kb) that are situated distal (telomeric) to the CRLF2 gene | Cytocell Ltd. | Device | Class II | 1 |
| 22 Dec 2020 | Wako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C or L-Type LDL-C for the determination of high density lipoprotein cholesterol (HDL-C) or low density lipoprotein cholesterol (LDL-C) in serum or plasma. | Fujifilm Medical Systems U.S.A., Inc. | Device | Class III | 1 |
| 22 Dec 2020 | Vegan Chocolate Cake, 25 oz., packaged in plastic base/cake dome, UPC 855026001421, Gem City Fine Foods, www.gemcityfinefoods.com. Keep Frozen. | Gem City Fine Foods, LLC | Food | Class II | 1 |
| 21 Dec 2020 | Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the… | Baxter Healthcare Corporation | Device | Class II | 1 |
| 21 Dec 2020 | Getinge CM320 Series Washer Disinfector - Product Usage: A multi chamber washer disinfector intended for washing, disinfecting and drying of surgical instruments, containers, operating theatre shoes and operating theatre accessories normally used in hospitals and central disinfection facilities. The disinfected items… | Getinge Group Logistics America, LLC | Device | Class II | 1 |
| 21 Dec 2020 | Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 Manufactured: 2020-10-29 Expires: 2020-12-28 Container Type: 15x100mm plate, 18 ml | Hardy Diagnostics | Device | Class II | 1 |
| 21 Dec 2020 | SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128 | OMNIlife science Inc. | Device | Class II | 3 |
| 21 Dec 2020 | PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to… | Nihon Kohden America Inc | Device | Class II | 1 |
| 18 Dec 2020 | Liko Multirall 200 overhead lift- overhead lift is a general-purpose lift with the intended use in healthcare, intensive care and rehabilitation. Affected devices: Liko Multirall 200 (product number 3130001) Universal SlingBar 450 R2R (product number 3156095) Universal SlingBar 350 R2R (product number 3156094)… | Hill-Rom, Inc. | Device | Class I | 1 |
| 18 Dec 2020 | VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 18 Dec 2020 | Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information. | Topcon Medical Systems, Inc. | Device | Class II | 1 |
| 18 Dec 2020 | ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing. (87048) | Alung Technologies Inc | Device | Class II | 1 |
| 17 Dec 2020 | System, X-Ray, Tomography, Computed: Revolution Apex, Revolution CT with Apex Edition | GE Healthcare, LLC | Device | Class II | 2 |
| 17 Dec 2020 | Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid Concentrate for Bicarbonate Hemodialyis Part Number: 08-3251-9 | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 17 Dec 2020 | O H Danish Bakery Almond Danish Kringle, UPC 67209-00006. Net Weight: 24 oz. (1 lb. 8 oz) 680.3 grams (87008) | O & H DANISH BAKERY | Food | Class II | 1 |
| 16 Dec 2020 | Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ 7 DIAGNOSTIC… | Philips Ultrasound Inc | Device | Class II | 1 |
| 15 Dec 2020 | WAHL 4212 HEATED MASSAGER, SKU F800000004212 - Product Usage: intended to relieve minor muscle aches and pains. (87229) | Wahl Clipper Corp | Device | Class II | 1 |
| 14 Dec 2020 | EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01 | Phadia US Inc | Device | Class II | 1 |
| 14 Dec 2020 | PRYTIME MEDICAL REBOA Catheter Introducer Kit, REF: KT1835C, Contents: Needle, 18 GA x 7 CM ECHOGENIC, STERILE, 1 EA, SYRINGE, 30CC, STERILE 1 EA, INTRODUCER SHEATH KIT, 7 FR W/.035 SHORT GUIDEWIRE, STERILE 1 EA., PREFILLED, STERILE FIELD SALINE SYRINGE, 10 ML, 4 EA, CLAMP, 5 FR, STERILE, 1 EA, SCALPEL, #11SS,… (87099) | Prytime Medical Devices, Inc. | Device | Class II | 1 |
| 14 Dec 2020 | Neuroreader Medical Image Processing Software - Product Usage: intended to automate the current manual process of identifying, labeling, and quantifying the volume of segmentable brain structures identified on MR images. (86995) | Individual firm, name withheld | Device | Class II | 1 |
| 14 Dec 2020 | Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System | K2M, Inc | Device | Class II | 1 |
| 11 Dec 2020 | FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product Usage: intended for use as a web based application on an off-the shelf PC which meets or exceeds minimum specifications and is networked with a FUJIFILM Synapse PACS server. | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 11 Dec 2020 | therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121 | Qiagen Sciences LLC | Device | Class II | 1 |
| 10 Dec 2020 | SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor… | SenTec AG | Device | Class II | 1 |
| 10 Dec 2020 | GE Healthcare Precision 600FP, Classical R&F (radiographic and fluoroscopic) System - Product Usage: Intended for use by a qualified/trained doctor or technologist on both adult and pediatric subjects taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen,… | GE Healthcare, LLC | Device | Class II | 1 |
| 10 Dec 2020 | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO, | Argon Medical Devices, Inc | Device | Class II | 6 |
| 9 Dec 2020 | BD Stimex Insulated Needle 22G x 2.13in ( 50 units/cs.) Indicated for administration of medications to affect anesthesia or analgesia to a specific anatomical location (region). Catalog No. 404204 | Becton Dickinson & Company | Device | Class II | 2 |
| 9 Dec 2020 | Covidien CV-9590 Velosorb Fast Braided Fast absorbable Suture 14 Metric 36" 90 cm, GS-24 Taper 1/2 40 mm, undyed, UDI: 10884521151307 | Riverpoint Medical, LLC | Device | Class II | 1 |
| 8 Dec 2020 | ProxiDiagnost N90 Image-intensified fluoroscopic x-ray system (87039) | PHILIPS HOME HEALTHCARE SOLUTION | Device | Class II | 1 |
| 7 Dec 2020 | IOLMaster 700 | Carl Zeiss Meditec AG | Device | Class II | 1 |
| 2 Dec 2020 | 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or… | ICU Medical, Inc. | Device | Class II | 4 |
| 2 Dec 2020 | EMBLEM S-ICD Model A209 | Boston Scientific Corporation | Device | Class I | 2 |
| 2 Dec 2020 | EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209 | Boston Scientific Corporation | Device | Class II | 2 |
| 19 Nov 2020 | Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU | Heartware, Inc. | Device | Class I | 1 |
| 18 Nov 2020 | Optilite Freelite Mx Kappa Free Kit REF LK016.M.OPT.A | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 15 Nov 2020 | Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR) | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 3 |
| 2 Nov 2020 | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | Respironics California, LLC | Device | Class II | 16 |
| 30 Oct 2020 | Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. | Respironics California, LLC | Device | Class II | 17 |
| 30 Oct 2020 | DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS) | Neocis, Inc. | Device | Class II | 1 |
| 6 Oct 2020 | Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceiling lift or passive floor lift. | Arjohuntleigh Magog, Inc. | Device | Class II | 1 |
| 4 Sep 2020 | B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular. (86443) | Braxton Medical Corporation | Device | Class II | 1 |
| 20 Jul 2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (250 mL) bottle, Made in Mexico, Liq-E, S.A. DE C.V., Puerto Tampico No. 345 Col. La Fe San Nicolas de Los Garza, Nuevo Leon, Mexico. C.P. 66477. UPC # 7 501799 115621 | Liq-E S.A. De C.V. | Drug | Class I | 4 |
| 27 Mar 2020 | Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, Size 9F (3.2mm), Length 90 cm, Sterile EO, Rx Only, Quantity 1, UDI: 07613327376067 | Stryker Sustainability Solutions | Device | Class II | 1 |
| 5 Mar 2020 | TRx4851A 2.4 GHz IntelliVue Tele TRX, Model Number 862231; Includes Service Numbers 453564052401, 453564052411, 453564052441, 453564052451, 453564166851, 453564166861 | Philips North America, LLC | Device | Class II | 2 |
| 16 Aug 2019 | REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE (84217) | Enztec Limited | Device | Class II | 1 |