| 16 Apr 2021 | Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8 | Noven Pharmaceuticals Inc | Drug | Class II | 2 |
| 14 Apr 2021 | Freshness Guaranteed Macaroni Salad Amish, item # 579284, refrigerated, packaged in a clear cup with clear snap on lid, net wt. 32 oz. UPC 0 78742 13235 8. Each master case containing 6/32 oz. packages. Distributed by: Walmart Inc, Bentonville, AR. The CORRECT label is read in parts: "***FRESHNESS GUARANTEED MACACONI… | Reser's Fine Foods, Inc. | Food | Class II | 1 |
| 13 Apr 2021 | Mountain West Mothers' Milk Bank - Pasteurized Donor Human Milk, 3 fluid ounce BPA free plastic bottles, embossed with "Donor Human Milk" and graduation marks on the front side Unique identifier label which includes distributing Milk Bank Code (MWMMB), Batch ID, Unique Bottle number, Expiration Date, QR Code, Total… (87740) | Mountain West Mothers' Milk Bank Inc. | Food | Class II | 1 |
| 13 Apr 2021 | Trader Joe's Restaurant Style White Corn Tortilla Chips; Net Wt. 9 oz. (255g) | Snak King Corporation | Food | Class II | 1 |
| 12 Apr 2021 | Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178 | Edge Pharma, LLC | Drug | Class II | 1 |
| 9 Apr 2021 | Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60 | Teligent Pharma, Inc. | Drug | Class II | 1 |
| 8 Apr 2021 | J-Basket Premium Korean Seaweed Snack - Wasabi flavor on outer wrap for 3 inner packages Inner packages labeled J-Basket Premium Seaweed Snack - Original. Net Wt 0.52 oz. (15g) 3-0.17 oz. (5g) packs Distributed by JFC International Inc., Los Angeles, CA 90040 Wasabi outer package UPC 0 11152 29507 7 Ingredients:… | J F C International Inc | Food | Class II | 1 |
| 7 Apr 2021 | Snowville Creamery Whipping Cream 64oz Paperboard Carton Sold as individual Units (87688) | Snowville Creamery, LLC | Food | Class II | 1 |
| 7 Apr 2021 | Thai Home brand Green Curry Paste packaged in glass jars. Net weight 6.5 oz (180g). Refrigerate after opening. UPC 8616080004023. Manufactured by: Jansala & Foods LLC 1620 SE 3rd Ave Portland, OR 97214 jansalafoods@gmail.com Distributed by: Earthly Gourmet 2143 SE Lafayette St Portland, OR 97202… | Jansala & Foods LLC | Food | Class III | 6 |
| 2 Apr 2021 | Starwest Botanicals Item#: 209617-34, Item# 209617-31 Wood Betony Herb C/S Organic Stackys Officinalis Origin: Croatia Daily serving size: Pour 8-12 oz of boiling water (212F) over 1 tsp. of tea. Steep 3-4 minutes. Net. weight: 4 oz. (113.4g) Lot#: P92769, Net weight: 1 lb (453.6) Lot# P92770 7 67963 12755 6, 7 67963… | Starwest Botanicals, Inc | Food | Class II | 1 |
| 1 Apr 2021 | DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite. | Stryker Leibinger GmbH & Co. KG | Device | Class II | 1 |
| 1 Apr 2021 | Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30. | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 31 Mar 2021 | ELI 280 Electrocardiograph, with AM12M Acquisition Module accessory. Impacted software version of the AM12M is version 1.5.1 - Product Usage: indicated for use on adult and pediatric populations. | Welch Allyn Inc Mortara | Device | Class II | 4 |
| 31 Mar 2021 | LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling. | Smiths Medical ASD Inc. | Device | Class II | 12 |
| 31 Mar 2021 | Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0 | Apotex Corp. | Drug | Class II | 1 |
| 31 Mar 2021 | Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 fl. oz., 473 mL bottles Rx Only, Manufactured by: Mikart, LLC, Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 10631-206-02. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 30 Mar 2021 | Motha Jelly Crystals - Mixed Fruit Flavoured Jelly, Net Wt. 100g, | USA LANKA INC | Food | Class II | 5 |
| 29 Mar 2021 | Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14. | Teligent Pharma, Inc. | Drug | Class III | 1 |
| 29 Mar 2021 | Lite'n Foamy Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Contents: 18 oz/ 532 ml per foam pump container, For Institutional and Industrial Use Only, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA. UPC 7 53727 26288 5 SKU# 333806 NDC: 64009-331-82 | Spartan Chemical Co Inc | Drug | Class I | 6 |
| 26 Mar 2021 | The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system containing saline. The system is made out of silicone and consists of 4 main components: a pump, two cylinders, a fluid reservoir and kink-resistant tubing that is used to connect the pump to the cylinders and fluid reservoir. By pumping the… | Boston Scientific Corporation | Device | Class II | 1 |
| 26 Mar 2021 | Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only, Manufactured for: Lupin Pharmaceutical, Inc., Baltimore, MD 21202; Manufactured by: Lupin… | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 26 Mar 2021 | Sabra Dipping Co, Classic Hummus ,10oz. PET cup, sealed with lid, 12 ct. Manufacturing Codes 300067. Expiration date 4/26/21 | Sabra Dipping Company, LLC | Food | Class I | 1 |
| 26 Mar 2021 | HARRIS TEETER FRESH FOODS MARKET 3 Layer COOKIES & CREME CAKE NET WT 48 OZ (3 LB) 1.36kg packages PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 UPC: 0 72036 95224 0 (87629) | Individual firm, name withheld | Food | Class I | 1 |
| 25 Mar 2021 | cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190 | Roche Molecular Systems, Inc. | Device | Class II | 2 |
| 25 Mar 2021 | RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613) | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 25 Mar 2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx 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 62756-142-02. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class III | 1 |
| 25 Mar 2021 | Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080 (87608) | Cosette Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 25 Mar 2021 | Dawn Food Products, 7 2 Layer Vanilla Bean Waterfall Cake, 35 oz., cake is placed on a cardboard plate which is then placed on a plastic plate and closed in a plastic dome, 6 cakes per case , Keep frozen for storage. Store refrigerated or ambient for sale and use. | RISE BAKING COMPANY | Food | Class I | 2 |
| 24 Mar 2021 | Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions) | Pacific Medical Group Inc. | Device | Class I | 1 |
| 24 Mar 2021 | Drop Arm Versamode" (87606) | Gf Health Products | Device | Class II | 1 |
| 24 Mar 2021 | BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213 | Becton Dickinson & Co. | Device | Class II | 1 |
| 24 Mar 2021 | Trident Seafoods Pacific Salmon Burgers (# 414469), frozen. Costco item #502497. Each retail bag contains of 12/4oz. pieces. Retail bag net wt. 48 oz (3 lb or 1.36 kg). Retail bag UPC 0 28029 14469 7. Each Master case contains of 12/3 lbs. packages. The MASTER CASE label is read in part: "***PACIFIC SALMON BURGERS… | Trident Seafoods Corporation | Food | Class II | 1 |
| 23 Mar 2021 | Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and… | Covidien Llc | Device | Class II | 1 |
| 23 Mar 2021 | SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA | Sunstar Americas, Inc. | Device | Class II | 1 |
| 23 Mar 2021 | Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066,… | Philips North America, LLC | Device | Class II | 1 |
| 22 Mar 2021 | Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-10 | Macleods Pharma Usa Inc | Drug | Class III | 1 |
| 22 Mar 2021 | Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk, Inc., Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-3204-90 (Pen), NDC 0169-3204-97 (Kit) | Novo Nordisk Inc | Drug | Class I | 13 |
| 22 Mar 2021 | Bobo's Maple Pecan Oat Bars, 3 oz., UPC 8 2926200021 0, Best By 7/30/21 or 7/31/21. | Simply Delicious Inc. | Food | Class I | 1 |
| 22 Mar 2021 | La Fe Brand Frozen Peppers and Onions 16 oz bags. (87573) | Grace Kennedy Foods USA LLC | Food | Class II | 1 |
| 22 Mar 2021 | Crimson Snapper Fillet, Natural Cut CO Treated, Net WT 10 LBS, Size 10/12 oz (87571) | Sea World, LLC | Food | Class III | 1 |
| 22 Mar 2021 | Land O Lakes Queso Bravo White Cheese Dip with Jalapeno and Red Peppers. Net Wt 5 lbs. (2.26kg), UPC 34500-48238. Shipping Case: 6 - 5 lb Pouches. Net Wt. 20.00 Lbs. (13.60 kg) Item Code 48238000034500 | Land O'Lakes, Inc. | Food | Class II | 1 |
| 20 Mar 2021 | Taste of Inspirations Garlic Parmesan Wing Sauce (87560) | Schlotterbeck & Foss, LLC | Food | Class I | 1 |
| 20 Mar 2021 | 365 Whole Foods Market Farm Raised Cooked Shrimp 2 lbs/Ready- to - Serve Tail-On/Peeled & Deveined/41-55 Shrimp/lb NET WT 32 OZ (2 LB) 907g packaged in clear plastic bag (87589) | Avanti Frozen Foods Private Limited | Food | Class III | 1 |
| 19 Mar 2021 | Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608 (87548) | Asclemed USA Inc. dba Enovachem Pharmaceuticals | Drug | Class III | 1 |
| 19 Mar 2021 | Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5 | X-Gen Pharmaceuticals Inc. | Drug | Class II | 1 |
| 19 Mar 2021 | Oreo 3-Milk Cake (Oreo Tres Leches Cake). Cake net wt. 2.80 lbs. (1.27kg). Cake is packaged in rigid plastic dome, individually labeled, and sold in grab and go retail refrigerated display case. (87574) | Surtidoras Bakery Inc | Food | Class I | 1 |
| 19 Mar 2021 | AMPI Buttermilk Powder, formula 219. 25 KG Net (55.12 Lbs Net). Distributed by: Associated Milk Producers, Inc., New Ulm, Minnesota 56073. Packaged in Kraft Paper Poly-lined bags. (87582) | AMPI | Food | Class II | 1 |
| 18 Mar 2021 | Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42 | Washington Homeopathic Products, Inc. | Drug | Class III | 3 |
| 18 Mar 2021 | Anand Far Far (Garlic Sandige) Net Weight 7 oz./200 g package ingredients: rice, wheat flour, garlic, red chilli, refined palm oil and salt. UPC 8 78776 00232 6 Product of India Imported and Distributed by Babco Foods International, LLC, Bridgewater, NJ (87628) | Babco Foods International, LLC | Food | Class II | 1 |
| 18 Mar 2021 | Glutenull Goji Berries & Chocolate Cookies, packaged in a clear plastic clamshell container, net wt. 11 oz. (320g). UPC 628451529132. The label also states "Non-GMO * Gluten Free Certified * Vegan * GluteNull Bakery Port Coquitlam, BC V3C 6P8 ***". (87675) | Amra Services Ltd. | Food | Class I | 1 |
| 17 Mar 2021 | CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524 | Integra LifeSciences Corp. | Device | Class II | 1 |
| 17 Mar 2021 | BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora of bacteria and fungi. Catalog Number: 221558 | Becton Dickinson & Co. | Device | Class II | 2 |
| 17 Mar 2021 | Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or… | Medtronic Sofamor Danek USA, Inc | Device | Class II | 2 |
| 17 Mar 2021 | Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30 | Alembic Pharmaceuticals Limited | Drug | Class I | 1 |
| 17 Mar 2021 | Real Alkalized Water, packed in 16.9 oz., 1 Liter, 1.5 Liter, 1-Gallon and 5-Gallon plastic bottles. Drinkrealwater.com | Real Water, Inc. | Food | Class I | 2 |
| 17 Mar 2021 | Blanxart Milk Chocolate with Hazelnuts Cacao 33% Min. Net wt.7 oz. Product is packaged with paper and internal foil wrapper. UPC 6 66785 20322 9. The label is read in parts: "***BLANXART Milk Chocolate with Hazelnuts CACAO 33% *** BB Chocolate Grup, S.A Tambor del Bruc 13 08970 Sant Joan Despi Barcelona, Spain ***… | Power Selles Imports dba Culinary Collective | Food | Class II | 1 |
| 16 Mar 2021 | VIDAS¿ CMV IgM 30 Tests | Biomerieux Inc | Device | Class II | 1 |
| 16 Mar 2021 | Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033 | K2M, Inc | Device | Class II | 1 |
| 16 Mar 2021 | El Sembrador Peas and Carrots, poly bags, 12/16 oz | Bonduelle USA Inc. | Food | Class II | 2 |
| 15 Mar 2021 | Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range. | Medline Industries Inc | Device | Class II | 1 |
| 15 Mar 2021 | Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 15 Mar 2021 | The Toasted Oat Bakehouse Blueberry Cobbler Soft Granola (6 -10 oz pouches per case); and Soft Granola Crumble Bars Blueberry Cobbler (5 - 28.3g bars per pack/6 packs per case) | The Toasted Oat | Food | Class II | 4 |
| 15 Mar 2021 | Nuts.com brand Diced Dried Figs packaged in 1lb stand up gusset pouches. (87532) | Individual firm, name withheld | Food | Class I | 1 |
| 11 Mar 2021 | Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur. | Arthrex, Inc. | Device | Class II | 1 |
| 11 Mar 2021 | Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102). (87580) | Individual firm, name withheld | Device | Class II | 1 |
| 11 Mar 2021 | Disposable Sampling Tube, REF VSM01, Contents: Transport Media - 50, Nasal Swab - 50, Package Insert - 1, IVD, CE | Krishe Inc | Device | Class II | 4 |
| 11 Mar 2021 | ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc.… | Ferring Pharmaceuticals Inc | Drug | Class II | 2 |
| 11 Mar 2021 | Whole Foods Market Cranberry Biscotti PLU 41712 packaged in a clear plastic clam shell container | Whole Foods Market | Food | Class I | 1 |
| 10 Mar 2021 | Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 10 Mar 2021 | Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as the growth medium for antimicrobial disk diffusion tests with Haemophilus species. | Remel Inc | Device | Class II | 2 |
| 10 Mar 2021 | AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters. | Oscor, Inc. | Device | Class II | 1 |
| 10 Mar 2021 | Tippin's Country Gravy, Net Wt 16 OZ, Keep Refrigerated, Tippin's Gourmet Pies LLC, Kansas City, KS UPC 6 80816 12023 1 packaged in plastic cups (87506) | Tippins | Food | Class II | 1 |
| 9 Mar 2021 | A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only. (87569) | Individual firm, name withheld | Device | Class II | 1 |
| 9 Mar 2021 | Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01. | Cardinal Health Inc. | Drug | Class III | 1 |
| 8 Mar 2021 | Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-EU-001 (sold in European Regions only) - Product Usage: intended for bone biopsy of the vertebral body and bone lesions. | Arrow International Inc | Device | Class II | 1 |
| 8 Mar 2021 | BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias. | BIOTRONIK Inc | Device | Class II | 25 |
| 8 Mar 2021 | Yellowfin Tuna portions Frozen IVP-CO Treated, Net WT 20 LBS, Size 1 LB. (87678) | QUIRCH FOODS | Food | Class II | 1 |
| 8 Mar 2021 | Live Better vegan vitamin d-3 by CVS Health, 50 mcg (2000 IU), 40 tablets in blue PET jar, Distributed by: CVS Pharmacy, Inc. one CVS Drive, Woonsocket, RI 02895, UPC 0 50428 62499 9 | New Generation Wellness Inc. | Food | Class III | 2 |
| 8 Mar 2021 | Kareem Chef Halva 1lb and 2lb sizes in plastic tub | KAREEM MART INC | Food | Class I | 3 |
| 5 Mar 2021 | Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S | Centinel Spine, Inc. | Device | Class II | 1 |
| 5 Mar 2021 | Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-K3834CG1L Specialty Triathlon TS Trial Cutting… | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 5 Mar 2021 | ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 20 |
| 5 Mar 2021 | MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton. | Boston Scientific Corporation | Device | Class II | 2 |
| 5 Mar 2021 | Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094 | Covidien | Device | Class II | 1 |
| 4 Mar 2021 | Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 4 Mar 2021 | Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT | Covidien, LP | Device | Class II | 3 |
| 4 Mar 2021 | Regard, Item Number 830067009, custom cardiovascular procedure kit | ROi CPS LLC | Device | Class II | 1 |
| 3 Mar 2021 | BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439. | CareFusion 303, Inc. | Device | Class I | 1 |
| 3 Mar 2021 | Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardiopulmonary bypass (CPB) procedures. | Medtronic Perfusion Systems | Device | Class I | 1 |
| 2 Mar 2021 | Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor. | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 2 Mar 2021 | Synapse PACS - Radiological Image Processing System - Product Usage: intended for use, as a web based application, on an off-the-shelf PC meeting or exceeding minimum specifications and networked with FUJIFILM Synapse PACS Software (Server). | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 2 Mar 2021 | Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** For Emergency Use Authorization Only, Box Label - FaStep Rapid Diagnostic Test *** COVID-19 IgG/IgM Rapid Test Device… (87541) | AZURE BIOTECH INC | Device | Class II | 1 |
| 2 Mar 2021 | BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behring Coagulation System is an instrument intended to perform quantitative assays of a specific parameters in plasma. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 2 Mar 2021 | Wilton Rainbow Chip Crunch Sprinkles, 5.25 oz (148g) clear plastic bottle, SKU 710-5364 UPC 070896453648 | Wilton Industries Inc | Food | Class I | 6 |
| 2 Mar 2021 | FRESH TO YOU Club on Toast, Net Wt. 10.3oz (292g), MG Foods Charlotte, NC 28208, UPC MGF0930 | Canteen Inc. dba MG Foods, Inc. | Food | Class I | 31 |
| 27 Feb 2021 | B&G Sweet Heat Pepper Dip, Ready To Eat, Refrigerated, packaged in 10 oz, semi-rigid plastic container. UPC 7 42832 07566 4. Product label is read in parts: "***SWEET HEAT PEPPER DIP ***Ingredients: Cream Cheese, Sour Cream, Jalapenos, Sugar, Apple Cider Vinegar, Granulated Garlic, Cayenne Pepper, Turmeric, Celery… (87477) | B&G Sweet Heat Peppers | Food | Class II | 1 |
| 26 Feb 2021 | Panther Fusion Tube Tray, REF PRD-04000, PN: FA-15004, Cont. 18 Tube Trays - Product Usage: an ancillary consumable to the Panther Fusion System that is used to contain the PCR and RT-PCR steps of the assay processing. | Hologic, Inc | Device | Class II | 1 |
| 26 Feb 2021 | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP,… | Heartware, Inc. | Device | Class I | 1 |
| 26 Feb 2021 | Stryker, REF PC9001, PINPOINT Video Processor/Illuminator, Rx Only CE 0197, MD Medical Device, UDI: (01) 00858701006049 - Product Usage: used with both the SPY-PHI and PINPOINT systems, the intended use for both imaging systems are being documented here. | Stryker Corporation | Device | Class II | 1 |
| 26 Feb 2021 | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR,… | Heartware, Inc. | Device | Class II | 1 |
| 26 Feb 2021 | Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR,… | Heartware, Inc. | Device | Class II | 1 |
| 26 Feb 2021 | Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR | Heartware, Inc. | Device | Class I | 6 |
| 26 Feb 2021 | CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measurement and monitoring of gastric reflux in adults and children from 4 years of age. | Covidien Llc | Device | Class II | 2 |
| 26 Feb 2021 | Quaker Rice Crisps Sweet Barbecue Flavor, 3.03 oz. bag, UPC 0 30000 31984 0 | THE QUAKER OATS COMPANY | Food | Class II | 1 |
| 26 Feb 2021 | Haug Fresh Taco Tray, Net Wt. 29 oz. (823g), UPC 6 10014 16416 4; Net Wt. 16 oz (454g), UPC 6 10014 16383 9; Net Wt. 16 oz (454g), UPC 6 10014 16415 7, 2/16 oz packages per unit. Packed & Distributed by J&J Distributing, 653 Rice St. St. Paul, MN 55103. | J & J Distributing Company | Food | Class II | 10 |
| 25 Feb 2021 | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part | Tenacore LLC | Device | Class I | 2 |
| 25 Feb 2021 | Amicus MNC Apheresis Kit - Double Needle - Product Usage: intended for use in the collection of blood components and mononuclear cells. | Fenwal Inc | Device | Class II | 3 |
| 25 Feb 2021 | BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1 | Biocare Medical, LLC | Device | Class II | 1 |
| 24 Feb 2021 | Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures. | Arthrex, Inc. | Device | Class II | 1 |
| 23 Feb 2021 | Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l | Trinity Sterile, Inc. | Device | Class II | 1 |
| 22 Feb 2021 | Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for… | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 2 |
| 22 Feb 2021 | ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or… | DePuy Orthopaedics, Inc. | Device | Class II | 3 |
| 22 Feb 2021 | EPIX Therapeutics DiamondTemp Unidirectional Small Curve Ablation Catheter, 7.5 French Size(2.48 mm), Connector Type: ODU 19 PIN, REF CEDT100S, SterileEO, UDI 00812499030198 | EPIX THERAPEUTICS, INC | Device | Class II | 6 |
| 18 Feb 2021 | ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 18 Feb 2021 | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery -warmed… | Smisson-Cartledge Biomedical, LLC | Device | Class I | 3 |
| 18 Feb 2021 | Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc.,… | Zydus Pharmaceuticals (USA) Inc | Drug | Class I | 2 |
| 18 Feb 2021 | UnTortillas Grain Free * 3 g of non-fibre carbs * 210g 6 tortillas per bag, 8 packages per case. UPC# 40628250179024 packaged in flexible plastic (87478) | BakeryWorks LLC | Food | Class II | 1 |
| 16 Feb 2021 | EXTREME H2O 59% (hioxifilcon A) spherical soft contact lens for daily wear - Product Usage: indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does… (87421) | Individual firm, name withheld | Device | Class II | 1 |
| 16 Feb 2021 | MedSchenker Smart Transport Medium (STM) System: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL - MULTIPURPOSE CULTURE MEDIUM - Product Usage: intended for the collection and transport of clinical specimens containing viruses, from the collection site to the testing laboratory. I (87575) | Vectornate USA Inc | Device | Class II | 1 |
| 12 Feb 2021 | NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm,¿ +0mm; Packaged End Cap 8.5/10.7mm,¿ +5mm; Packaged End Cap 8.5/10.7mm,¿ +10mm; Packaged End Cap 8.5/10.7mm,¿ +15mm; Packaged End Cap 8.5/10.7mm,¿… | Nuvasive Specialized Orthopedics Inc | Device | Class II | 3 |
| 12 Feb 2021 | PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones. | Nuvasive Specialized Orthopedics Inc | Device | Class II | 3 |
| 11 Feb 2021 | Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters, surgical drains, and tubes from sizes 5-40 French. (87351) | Hollister Incorporated | Device | Class II | 1 |
| 8 Feb 2021 | SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult (87432) | Sharp Medical Products | Device | Class II | 1 |
| 4 Feb 2021 | Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 4 Feb 2021 | KeVita Cucumber Rosemary (primary package), 15.2 oz., glass bottles, 6 packages per case, refrigerated storage (87510) | Tropicana Products, Inc. | Food | Class II | 1 |
| 3 Feb 2021 | Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset. | LumiraDx | Device | Class II | 1 |
| 3 Feb 2021 | Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S DR, Evera XT VR, Evera S VR and Evera MRI S VR models; 2) Visia family: Visia AF ICD, Visia AF S ICD, Visia AF MRI ICD, and Visia AF MRI S ICD models. Implantable Cardioverter Defibrillators (ICDs)… | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class I | 2 |
| 2 Feb 2021 | Alcon Custom Ophthalmic Surgical Procedure Packs | Alcon Research, LLC | Device | Class II | 1 |
| 1 Feb 2021 | Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1 | Kimberly-Clark Corporation | Drug | Class II | 1 |
| 28 Jan 2021 | Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free… | OriGen Biomedical, Inc. | Device | Class III | 1 |
| 19 Jan 2021 | Enteral Infusion Pump | Cardinal Health 200, LLC | Device | Class II | 1 |
| 19 Jan 2021 | Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for… | Stryker Sustainability Solutions | Device | Class II | 1 |
| 17 Jan 2021 | Roasted Salted In shell Pistachios 3 lb. bag, 25 lb cartons, 30 lb. cartons, 50 lb. sacks, 2,000 lb. sacks, 2,200 lb sacks Packed by horizon Nut Company Tulare, CA 93274 Product of U.S.A. (87243) | Horizon Nut Company, LLC | Food | Class III | 1 |
| 11 Jan 2021 | Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only. | C.R. Bard, Inc. | Device | Class II | 1 |
| 23 Dec 2020 | At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801) | Tenderneeds Fertility LLC | Device | Class II | 10 |
| 22 Dec 2020 | The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains… (87505) | Individual firm, name withheld | Device | Class II | 1 |
| 23 Nov 2020 | LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia… | Diasorin Inc. | Device | Class II | 1 |
| 23 Oct 2020 | VGlove NITRILE *** Protect Your Life 100 Patient examination gloves (87447) | HUBO INTERNATIONAL INC | Device | Class II | 1 |
| 4 Sep 2019 | MicroScan WalkAway-40 plus Instrument | Beckman Coulter Inc. | Device | Class II | 4 |