| 15 Sep 2021 | Kroger Kale Bag 16oz plastic bag 8 packages per case | The Kroger Co | Food | Class I | 1 |
| 14 Sep 2021 | Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30 | Direct Rx | Drug | Class II | 1 |
| 13 Sep 2021 | Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93 (88609) | Viatris | Drug | Class III | 1 |
| 10 Sep 2021 | 1. Dickies Seafood Cooked & Spiced Shrimp (12 oz) UPC 5240700804 Sell by 9/8/2021 & 9/12/2021. Labeled containers 2. Dickies Seafood Cooked & Spiced Shrimp (2.25 LB) UPC 5240700806 Sell by9/8/2021 & 9/12/2021.Labeled containers 3. Dickies Seafood Cooked & Spiced Shrimp (5 LB) Sell by 9/8/2021.Sold in bags over the… (88643) | SSPI Mid-Atlantic, Inc | Food | Class II | 1 |
| 9 Sep 2021 | Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-45, UPC 0 11110 37049 | Vi-Jon, Inc. | Drug | Class II | 1 |
| 9 Sep 2021 | Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99 | Aurobindo Pharma USA Inc. | Drug | Class II | 1 |
| 9 Sep 2021 | Daniele - PLAIN BULK (28 LB.); Plain Breadsticks; Case Pack 4/7lb bags; Item #1383; PLAIN: UNBLEACHED ENRICHED WHEAT FLOUR (CONTAINS MALTED BARLEY FLOUR, NIACIN, REDUCED IRON, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID), SOYBEAL OIL, YEAST, SALT, CORN AND MALT SYRUP.; CONTAINS: Wheat (88657) | JAG SPECIALTY FOODS, LLC | Food | Class II | 1 |
| 8 Sep 2021 | Banquet Cut European Style Cold Smoked Salmon, Item Number 2-92845, brand Gerard and Dominique Seafoods, packaged in pouch, net wt. per pouch is random, frozen, UPC of pouch: 2 92845 00250 3. The storage/thawing instructions on the pouch is read in parts: "***KEEP FROZEN UNTIL USED. THAW UNDER REFRIGERATION AT OR… | Seabear Company | Food | Class II | 1 |
| 7 Sep 2021 | Oatmeal Cranberry Cookie, packed in closed bags, 12oz net wt. The label of affected product is read in parts: "***Oatmeal Cranberry Cookie*** Ingredients: Oats, dried cranberries, Shepherds Grain Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine, mononitrate, riboflavin, folic acid), naturally… | Baker's Corner Bakery | Food | Class II | 6 |
| 3 Sep 2021 | Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21 | Meitheal Pharmaceuticals Inc | Drug | Class III | 1 |
| 3 Sep 2021 | AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17 | ICU Medical Inc | Drug | Class I | 1 |
| 3 Sep 2021 | Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16 | Morton Grove Pharmaceuticals, Inc. | Drug | Class II | 3 |
| 3 Sep 2021 | Whole Foods Market - Vegan Croissant 4 Count CONTAINS WHEAT, SOY May contain other allergens due to shared production areas, NET WT 0lb 11oz (312g) PLU 69435 packaged in clear plastic container | Whole Foods Market Brand 365, Llc | Food | Class I | 1 |
| 1 Sep 2021 | Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747 | Monarch PCM, LLC | Drug | Class III | 2 |
| 1 Sep 2021 | Trader Joe's Nuts Raw California Walnut Baking Pieces NET WT. 16 OZ (1 LB) 454g SKU# 51934-89685 UPC 0051 9342 Contains Walnuts Dist & Sold Exclusive By: Trader Joe's, Monrovia, CA 91016 (88614) | Andersen & Sons Shelling, Inc. | Food | Class II | 1 |
| 1 Sep 2021 | $7 Crab Cake Meal packaged in a 3 compartment plastic container. 14oz, UPC 2 07879400700 8. Refrigerated product. | Weis Markets, Inc., Ice Cream Division | Food | Class I | 1 |
| 31 Aug 2021 | Carrot cake (no brand), 6 inch and 8 inch sizes, on plastic base, with clear plastic dome. UPC code: 8 13749 01001 4 6-inch cake 8 50024 83623 5 8-inch cake (88605) | The Baking Institute Baking Co. | Food | Class II | 1 |
| 30 Aug 2021 | Banoful Top Orange Biscuit (88580) | KBF INC | Food | Class I | 1 |
| 27 Aug 2021 | 10 ga ARS Decompression Needle, Part Number ZZ-0298 | North American Rescue LLC. | Device | Class II | 1 |
| 27 Aug 2021 | Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32 | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 8 |
| 27 Aug 2021 | Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711 | DuPont Nutrition USA, Inc | Drug | Class I | 1 |
| 26 Aug 2021 | Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP Stamford, CT 06901-3431 NDC 67618-153-01, NDC 67618-153-03 (88539) | AVRIO HEALTH L.P | Drug | Class II | 1 |
| 25 Aug 2021 | Trader Joe's Super Spinach Salad with Quinoa, carrots, cranberries, chickpeas, edamame, pumpkin seeds and a carrot ginger miso dressing. Net Wt. 10 oz. (284 g) Dressing and seeds/nuts are packed in separate clear pouches and visible to consumer. Contains: Soy UPC: 096155 SKU: 96155 Dist & Sold exclusively by Trader… | World Class Distribution, Inc. | Food | Class II | 1 |
| 25 Aug 2021 | Roasted Red Pepper 12" Supreme Flour Wraps, Tortilleria Sonora, Inc. (88592) | Individual firm, name withheld | Food | Class II | 1 |
| 24 Aug 2021 | DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only | Medtronic Perfusion Systems | Device | Class II | 2 |
| 23 Aug 2021 | Jimbo's BLOODY MARY MIX; 2.5OZ MAKES ABOUT 45 SERVINGS; Ingredients: Horseradish Powder, Parsley, Worcestershire Powder, Cayenne Pepper, Lemon Peel, Black Pepper, Celery Seed Powder, Lemon Juice Crystals, Sea Salt; Hand made in a facility that contains wheat, dairy, eggs and nuts; New England Cupboard 30 Liberty… (88555) | Jimbo's Kitchen | Food | Class II | 1 |
| 23 Aug 2021 | Loki Fish Wild Keta Salmon Lox, packaged in a 4 oz. plastic pouch, sliced on a coated board, 24 packages to a case. UPC 92103 00111. The label is read in parts: LOKI FISH *** WILD KETA LOX *** Ingredients: Wild Keta salmon, honey, salt and spices *** PRODUCT OF USA *** KEEP REFRIGERATED BELOW 38F… (88554) | Loki Fish Company - Office | Food | Class I | 1 |
| 23 Aug 2021 | 1. "***JOY***Tamarind Chutney***NET WT 8 OZ (228g)***06.19 BEST BY 093022***INGREDIENTS: TAMARIND TOMATOES, SALT, SPICES, SUGAR, STABILIZERS (GUAR, TRAGAGANTH AND XANTHAN), CITIRC ACID, SODIUM BENZOATE AS PRESERVATIVE.***Distributed by: Joy Gourmet Foods LLC.***48-80 Maspeth Ave., Maspeth, NY 11378***Tel: (718)… | Joy Gourmet Foods LLC. | Food | Class I | 4 |
| 20 Aug 2021 | LiquaSonic Ultrasound Gel 250mL, Model No. 001205 | Athena Medical Products Inc | Device | Class I | 2 |
| 20 Aug 2021 | Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged | Greiner Bio-One North America, Inc. | Device | Class II | 1 |
| 20 Aug 2021 | SARS-CoV-2 Process Control (Pellet) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. | Microbiologics Inc | Device | Class II | 1 |
| 20 Aug 2021 | SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use as an external, non-viable control material to evaluate the performance of nucleic acid tests that detect SARS-CoV-2 virus. | Microbiologics Inc | Device | Class II | 1 |
| 20 Aug 2021 | Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90 | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 19 Aug 2021 | Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01 (88506) | Rhodes Pharmaceuticals, L.P. | Drug | Class II | 1 |
| 19 Aug 2021 | Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 | Eli Lilly & Company | Drug | Class II | 1 |
| 19 Aug 2021 | Strawberry Yogurt Granola Parfait packaged in clear plastic cups and labeled in the following ways: 1) Go Fresh Market Strawberry Granola Yogurt, Net wt. 6.5 oz (184 g), UPC 7 58870 32670 5, Distributed by Produce Innovation, Norwalk, IA; 2) HWY 28 Farms, Strawberry Yogurt Parfait, Net wt. 6.5 oz (184 g), UPC 7 58870… | Loffredo Fresh Gardens Inc. DBA Produce Innovations | Food | Class II | 3 |
| 18 Aug 2021 | CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures. | In2bones USA, LLC | Device | Class II | 1 |
| 18 Aug 2021 | Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FP2 in Somatom systems: SOMATOM go.Up - Model 11061620 SOMATOM go.Up - Model 11061628 SOMATOM go.All - Model 11061630 SOMATOM go.Top - Model 11061640 SOMATOM X.cite - Model 11330001 Computed… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 18 Aug 2021 | Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy (88515) | Prescription Labs Inc dba Greenpark | Drug | Class II | 1 |
| 18 Aug 2021 | X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 13682 41232 2 (88530) | Phe Inc | Drug | Class I | 1 |
| 18 Aug 2021 | Albanese World's Best Mini Gummi Butterflies 7.5oz UPC 634418523525 | Albanese Confectionery Group, Inc. | Food | Class II | 1 |
| 18 Aug 2021 | Rocky Top Farms Cherry Butter sold in 1 gallon food service and 10oz retail sizes. 10 oz retail units may be sold individually and as multi-pack and variety packs online. (88582) | Individual firm, name withheld | Food | Class II | 1 |
| 17 Aug 2021 | EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 | Olympus Corporation of the Americas | Device | Class II | 1 |
| 17 Aug 2021 | Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01 | RemedyRepack Inc. | Drug | Class II | 1 |
| 16 Aug 2021 | syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180 | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 13 Aug 2021 | Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of… | Quidel Corporation | Device | Class II | 1 |
| 13 Aug 2021 | The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent… | Philips North America Llc | Device | Class II | 3 |
| 13 Aug 2021 | Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4 | SigmaPharm Laboratories LLC | Drug | Class II | 1 |
| 13 Aug 2021 | Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701 | Akorn, Inc. | Drug | Class II | 1 |
| 13 Aug 2021 | Chantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets. | Pfizer Inc. | Drug | Class II | 4 |
| 13 Aug 2021 | Hostess Soft White Hamburger Buns, Net Wt. 12 OZ, UPC 888109110987 | Hostess Brands, LLC | Food | Class II | 2 |
| 13 Aug 2021 | DAIYA CHEESE VEGAN CHEDDAR STYLE SLICE 8/7.8oz Plastic bag MANUFACDTURED BY: DAIYA FOODS INC., BURNABY, BC CANADA VSA 4R4 PRODUCT OF CANADA KEEP REFRIGERATED UPC 3 08 71459 00022 1 | Sysco Atlanta, LLC | Food | Class II | 12 |
| 13 Aug 2021 | 12 PC Shrimp Tempura Kabuki Roll [BR] UPC: 81244803670 Products were sold from Genji Sushi counters inside Whole Foods Market stores | Individual firm, name withheld | Food | Class II | 25 |
| 12 Aug 2021 | EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is intended to be used as an accessory to… (88584) | AMTEC SALES Inc | Device | Class I | 1 |
| 12 Aug 2021 | Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.INNHERB.com. Konzon NDC 51367-008-10 (88371) | ANHUI WELCOME FOREIGN TRADE CO.,LTD. | Drug | Class II | 1 |
| 11 Aug 2021 | McKesson Lap Sponge, X-Ray Detectable 12"x 12", 5/pack, Sterile McKesson Part # 16-2112121 | Cypress Medical Products LLC | Device | Class II | 1 |
| 11 Aug 2021 | Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396 | Philips North America Llc | Device | Class II | 12 |
| 11 Aug 2021 | Naproxen Sodum Tablets USP 220 mg, (Caplet), Manufactured by: Granules India Limited, Sy.No. 160/A, 161/E, 162, &174/A, Gagillapur Village, Dundigal-Gandimalsamma Monday, Medchai-Maikhajgir District - 500043, Telangana, INDIA. NDC 62207-762-36 (88475) | Granules USA, Inc. | Drug | Class II | 1 |
| 11 Aug 2021 | Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108 (88467) | Ebay Seller - John Nguyen | Drug | Class I | 1 |
| 11 Aug 2021 | Wavy Lay s Original Potato Chips UPC 0 28400 04380 9 packaged in flexible bag | Frito-Lay, Inc. Headquarters | Food | Class I | 1 |
| 11 Aug 2021 | Gordon Choice Deli Style Tuna Salad, Refrigerated, 4 Lb. retail unit, 2 4 Lb. retail units per wholesale case. Wholesale case labeled as Deli Style Tuna Salad The recalled product contains tuna salad, but it has two labels. The bottom container states Deli Style Chicken Salad, while the top lid label states Deli… (88500) | RMH Foods | Food | Class II | 1 |
| 10 Aug 2021 | TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420578 | DePuy Orthopaedics, Inc. | Device | Class II | 7 |
| 10 Aug 2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01 | SterRx, LLC | Drug | Class I | 2 |
| 10 Aug 2021 | Wegmans Sunflower Crunch Chopped Salad Kit: Includes Green Cabbage, Green Leaf Lettuce, Sunflower Seeds, Red Cabbage, Carrot, Kale, Uncured Bacon, Green Onion with Wegmans Organic Coleslaw dressing. Washed and ready to eat. Salad and toppings: Net Wt 10.1 oz. (286 g) Dressing: Net 2.58 Fl Oz. (76 mL) Total Net Wt… | Taylor Farms Retail, Inc. | Food | Class II | 1 |
| 10 Aug 2021 | Crunchmaster Multi Grain Baked Gluten-Free Crackers 5-Seed Sesame, Amaranth, Flax, Chia & Quinoa 20 oz. UPC Code: 8-79890-00220-9 (88487) | TH Foods Inc | Food | Class II | 1 |
| 9 Aug 2021 | Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators. | Ad-Tech Medical Instrument Corporation | Device | Class II | 3 |
| 9 Aug 2021 | DuoDERM CGF Dressing 10x10CM (1x5PK) (ICC 187660) DuoDERM Extra Thin Dressing 15X15CM (1X10PK) (ICC 187957) DuoDERM Extra Thin Dressing 10X10CM (1X10PK) (ICC 187955) | ConvaTec, Inc | Device | Class II | 1 |
| 9 Aug 2021 | Marketside Chocolate Candy Cookie Cake, 24 oz. 12 x 12 black tray with clear lid. (88468) | Jimmy's Cookies, LLC | Food | Class I | 1 |
| 7 Aug 2021 | Flourless Chocolate Torte, 14 oz., in recyclable plastic circular container with black base and clear lid, Gem City Fine Foods, 3403 S 1400 W, Suite C, West Valley City, UT 84119. There are 4/cs. UPC 855026001186. Store Frozen or Thawed in Fridge. | Gem City Fine Foods, LLC | Food | Class II | 2 |
| 6 Aug 2021 | NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 | Smiths Medical ASD Inc. | Device | Class I | 2 |
| 6 Aug 2021 | Medtronic HVAD Pump Implant Kits | Heartware, Inc. | Device | Class II | 1 |
| 6 Aug 2021 | Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including mammograms) and data from various imaging sources. | GE Healthcare, LLC | Device | Class II | 2 |
| 6 Aug 2021 | EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: EPIQ 5 - 795120 EPIQ 5C - 795205 EPIQ 5G - 795204 EPIQ 7 - 795117 EPIQ 7C - 795201 EPIQ 7G - 795200 EPIQ CVxi -795232 EPIQ CVx - 795231 | Philips Ultrasound Inc | Device | Class II | 2 |
| 6 Aug 2021 | Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC… | The Harvard Drug Group | Drug | Class II | 1 |
| 6 Aug 2021 | Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01 | XELLIA PHARMACEUTICALS USA, LLC | Drug | Class II | 2 |
| 6 Aug 2021 | Fermentation Derived Pepsin Product packaging: 5 individual LDPE bags with a net weight of 5kg each and 2.5kg sample bags packaged in 25 kg HDPE Drums (88459) | Ingredion | Food | Class II | 1 |
| 5 Aug 2021 | Bone Marrow Transplantation biopsy needle | M.D.L. S.r.l. | Device | Class II | 5 |
| 5 Aug 2021 | AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia. (88462) | Armstrong Medical Services Limited | Device | Class I | 1 |
| 5 Aug 2021 | Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341 | Beckman Coulter Inc. | Device | Class II | 1 |
| 5 Aug 2021 | Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device | C.R. Bard Inc | Device | Class II | 21 |
| 5 Aug 2021 | Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH Schiffgraben 23, 38690 Gosfar, Germany Distributed by Hikma USA Inc. Berkeley Heights, NJ 07922, NDC 0143-9240-01 | Hikma Pharmaceuticals USA Inc. | Drug | Class III | 1 |
| 4 Aug 2021 | smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 4 Aug 2021 | Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices. | Cardinal Health | Device | Class I | 3 |
| 4 Aug 2021 | cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190 | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 4 Aug 2021 | Ultrasound Gel labeled under the following brand names: MediChoice Ultrasound Gel, Athena Liquasonic Ultrasound Gel, Eco-Med EcoGel Ultrasound Gel, MAC Medical Supply Ultrasound Gel, Eco-Med EcoGel 200 Blue High Velocity Ultrasound Gel, Eco-Med EcoGel 200 Multi-Purpose Ultrasound Gel, and Eco-Med EcoGel 200… (88483) | Mac Medical Supply Co Inc | Device | Class I | 1 |
| 4 Aug 2021 | Raw Shelled Peanuts, Skins Removed, Split Nut Blanched Runner Peanuts, Net. Wt. 2000# Olam Edible Nuts - Blakely, GA (88221) | Individual firm, name withheld | Food | Class II | 1 |
| 3 Aug 2021 | Verigene EP Amplification Reagent Kit Test | Luminex Corporation | Device | Class II | 1 |
| 3 Aug 2021 | Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to… | Olympus Corporation of the Americas | Device | Class II | 1 |
| 3 Aug 2021 | Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50. | Teligent Pharma, Inc. | Drug | Class I | 1 |
| 2 Aug 2021 | Steripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be used for the access of a specimen from Catheter Port to BD Vacutainer¿ Blood Collection or Urine Collection Tubes. (88338) | Magnolia Medical Technologies, Inc. | Device | Class II | 1 |
| 2 Aug 2021 | BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES, REF: 20019E | CAREFUSION | Device | Class II | 15 |
| 2 Aug 2021 | Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35 | Akorn, Inc. | Drug | Class II | 1 |
| 2 Aug 2021 | Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh, INDIA NDC 33342-060-15 | Macleods Pharma Usa Inc | Drug | Class II | 1 |
| 2 Aug 2021 | Golden Natural Product Inc. brand Dried Apricot Subkhon with Bone, Net Wt. 16 oz (1 lb) 454 g; and Golden Natural Product Inc. brand Dried Apricot Subkhon Jumbo, Net Wt. 16 oz (1 lb) 454 g Manufactured and Packed by: Gardencells LLC, Urgut, Samarkand region Republic of Uzbekistan; Distributed in USA by: GOLDEN… (88380) | Golden Natural Products | Food | Class I | 1 |
| 30 Jul 2021 | Arjo Disposable Repositioning Sling, Model AHD001 (88403) | Getinge Dominican Republic SA | Device | Class II | 1 |
| 30 Jul 2021 | Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body or extremities Model Number: 781315 | Philips North America Llc | Device | Class II | 7 |
| 30 Jul 2021 | BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 | Leica Microsystems, Inc. | Device | Class II | 1 |
| 30 Jul 2021 | Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630 | Paragon 28, Inc. | Device | Class II | 1 |
| 30 Jul 2021 | FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01 (88489) | Custopharm, Inc. | Drug | Class II | 1 |
| 29 Jul 2021 | ECHELON MRI System | Hitachi Healthcare Americas Corporation | Device | Class II | 3 |
| 29 Jul 2021 | Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04 | The Harvard Drug Group | Drug | Class II | 1 |
| 29 Jul 2021 | Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14. | Teligent Pharma, Inc. | Drug | Class III | 1 |
| 29 Jul 2021 | Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59 | Teligent Pharma, Inc. | Drug | Class II | 1 |
| 29 Jul 2021 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01 | Teva Pharmaceuticals USA | Drug | Class II | 3 |
| 29 Jul 2021 | Salted Caramel, brand Full Tilt Ice Cream, packaged in 16oz pre-packed pints and 3 gallon tubs. UPC on pint container only: 00856962005009. | Full Tilt Ice Cream, LLC | Food | Class II | 13 |
| 28 Jul 2021 | Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001 | Roche Diabetes Care, Inc. | Device | Class II | 4 |
| 27 Jul 2021 | Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002 (88399) | Clarus Medical, Llc | Device | Class II | 1 |
| 27 Jul 2021 | CareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of SARS-CoV-2 Antigen Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within five days… | Versea Diagnostics LLC | Device | Class II | 4 |
| 27 Jul 2021 | Cahill Cheddar with Porter PLU 93579 packaged in clear plastic | Whole Foods Market | Food | Class I | 2 |
| 26 Jul 2021 | Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10 | Elekta Inc | Device | Class II | 1 |
| 26 Jul 2021 | Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01 | Abbott Laboratories | Device | Class II | 1 |
| 26 Jul 2021 | Cahills Ireland Whiskey Cheese - 5lb. Waxed Deli Wheel | CAHILLS FARM CHEESE LIMITED | Food | Class I | 5 |
| 23 Jul 2021 | AUGMENT Injectable Kit, 3cc, Model K30003010, Lot 1706343 (88395) | BioMimetic Therapeutics, LLC | Device | Class II | 1 |
| 23 Jul 2021 | MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selected blood vessel in the peripheral,… | Mivi Neuroscience Inc | Device | Class II | 2 |
| 23 Jul 2021 | Merge Hemo, Software packages 10.2, 10.3, and 10.4 | Merge Healthcare, Inc. | Device | Class II | 1 |
| 23 Jul 2021 | Jessie Sterile Arm Suspension Kit, Product Code 711300, (previous product code 100401), Sample Kit S711300 | Aspen Surgical Products, Inc. | Device | Class II | 3 |
| 23 Jul 2021 | PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1, | Professional Disposables International, Inc | Drug | Class II | 7 |
| 22 Jul 2021 | BD" Mouse IgG2a Isotype Control APC X39 ASR | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 1 |
| 22 Jul 2021 | Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d) 115307 (M 150 SET) e) 115309 (ST 100 SET) f) 955467 (M 150 SET) g) 955468 (ST 100 SET) h) 955595 (M 100 SET) i) 955596 (ST 150 SET) Used with Prismaflex or PrisMax control units for continuous fluid… | Baxter Healthcare Corporation | Device | Class II | 2 |
| 22 Jul 2021 | Hiland 100% Pure Apple Juice From Concentrate No Sugar Added Pasteurized 4 FL OZ (118 mL) packaged in paper cartons 75 cartons per case | Hiland Dairy Foods Company LLC | Food | Class II | 1 |
| 21 Jul 2021 | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145 | Cardiovascular Systems Inc | Device | Class II | 2 |
| 21 Jul 2021 | Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB | Cordis Corporation | Device | Class I | 5 |
| 20 Jul 2021 | Nihon Kohden NKV-550 Ventilator, REF: NKV-550-U, CE 0344, UDI: (01) 00843685100012 The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. (88411) | NIHON KOHDEN ORANGEMED, INC | Device | Class II | 1 |
| 20 Jul 2021 | Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000 | Welch Allyn Inc | Device | Class II | 1 |
| 20 Jul 2021 | Solero Generator Refurbished US PG, Item No. H78712740000USD0, Catalog No. 12740000USD | Angiodynamics, Inc. | Device | Class II | 4 |
| 20 Jul 2021 | HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20 | Ethicon Endo-Surgery Inc | Device | Class II | 2 |
| 20 Jul 2021 | Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030 (88303) | HIS ENTERPRISE INC | Drug | Class II | 1 |
| 16 Jul 2021 | Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILE, Rx only, UDI: (01) 00884838023758 for use with defibrillator | Philips North America LLC | Device | Class II | 1 |
| 16 Jul 2021 | Assist and Amend Advanced Digestive Enzyme Formula, Dietary Supplement, 60 capsules per bottle, Manufactured for and distributed by New Dawn Nutrition Omaha, NE (88332) | New Dawn Nutrition, Inc. | Food | Class II | 1 |
| 15 Jul 2021 | Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. | Beckman Coulter Inc. | Device | Class II | 1 |
| 15 Jul 2021 | BrightFarms Sunny Crunch; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm | Bright Farms | Food | Class I | 10 |
| 14 Jul 2021 | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet… | Pentax of America Inc | Device | Class II | 2 |
| 13 Jul 2021 | Pipeline Flex Embolization Device | Micro Therapeutics Inc, | Device | Class I | 2 |
| 12 Jul 2021 | ACUSON Juniper Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 12 Jul 2021 | Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489 | W. L. Gore & Associates Inc. | Device | Class II | 1 |
| 12 Jul 2021 | QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by Native Promotional Products, Tulsa, OK NDC 74447-010 (88275) | NATIVE PROMOTIONS, INC | Drug | Class II | 1 |
| 9 Jul 2021 | COPAN FLOQSwabs, STERILE.EO, for drawing clinical samples. CE0123, for the following reference numbers REF:501CS01, Minitip, sterile Single Wrapped, Molded bp 80mm; REF: 20226, P/N 501CS01Q100, Minitip, Sterile, Single Wrapped, bp 60MM, BUNDLES OF 20 pcs; REF: 501CS01.Q20, P/N 1127700, Minitip Applicator Sterile Ind.… (88437) | Individual firm, name withheld | Device | Class II | 1 |
| 9 Jul 2021 | AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System. (88337) | PROCEPT BIOROBOTICS CORPORATION | Device | Class II | 1 |
| 8 Jul 2021 | Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma. | Argon Medical Devices, Inc | Device | Class II | 1 |
| 6 Jul 2021 | Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial determination of cancer antigen CA 27.29 in human serum and plasma (EDTA) using the Atellica IM Analyzer. SMN: 10995478 | Siemens Healthcare Diagnostics, Inc | Device | Class II | 3 |
| 5 Jul 2021 | CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2 (88397) | Zeltiq Aesthetics, Inc | Device | Class II | 1 |
| 2 Jul 2021 | The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app. (88389) | Hero Health | Device | Class II | 1 |
| 2 Jul 2021 | Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21. | KVK-Tech, Inc. | Drug | Class I | 1 |
| 1 Jul 2021 | Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic… (88450) | Individual firm, name withheld | Device | Class II | 1 |
| 1 Jul 2021 | ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080 | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 30 Jun 2021 | Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 30 Jun 2021 | MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS | Promise Pharmacy, LLC | Drug | Class II | 1 |
| 29 Jun 2021 | Vascular Table without Fowler (USV1) and Ultrasound Vascular Table with Fowler (USV2). Intended Use: Vascular Ultrasound examination table Catalog Number: 66783 and 64219 | Oakworks Inc | Device | Class II | 1 |
| 28 Jun 2021 | AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000 | Encore Medical, LP | Device | Class II | 1 |
| 28 Jun 2021 | MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 (88396) | MY01, INC. | Device | Class II | 1 |
| 25 Jun 2021 | KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005 | Straumann USA LLC | Device | Class II | 1 |
| 24 Jun 2021 | cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 21 Jun 2021 | Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, Manual; Serial Numbers: 10001-SC1-20 to 10483-SC1-20; 10001-SC1-21 to 10224-SC1-21; 10231-SC1-21 to 10456-SC1-21; 10481-SC1-21 to 10570-SC1-21. Model Number: CHAIR-0-SC2-030; Advance Chair, 100mm (4in) Castors, Std… (88441) | Accora Inc | Device | Class II | 1 |
| 14 Jun 2021 | Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation | Ion Beam Applications S.A. | Device | Class II | 1 |
| 9 Jun 2021 | Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general open surgical procedures when used in conjunction with the Gyrus ACMI G400 workstation Ref: 970010PC | Olympus Corporation of the Americas | Device | Class II | 1 |
| 8 Jun 2021 | Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188 | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 28 May 2021 | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x 19 cm, Item Code 8888541019 | Covidien, LP | Device | Class II | 18 |
| 25 May 2021 | Vita Aid Keto-Elemental Nutrition (Chocolate), VA-958. The product is a powder, packaged in an aluminum bag , with a net weight of 315g. | Naturo Aid Pharmaceutical Inc. | Food | Class II | 5 |
| 13 May 2021 | Purim Health Products: EpiGenius Kids Creamy Chocolate; 630 Grams, individually packed pouches. Daily Superfoods. This high protein, whole-food blend is an excellent source of vitamins A, C, D and E and contains superfruits and superveggies, along with healthy fat, fiber and probiotics. UPC: 7 64934 04600 7… | Organic By Nature, Inc. | Food | Class I | 1 |
| 12 May 2021 | Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25 | American Health Packaging | Drug | Class III | 1 |
| 12 May 2021 | MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL, Manufactured by Grupo V-Klean S.A. de C.V, Calle Alborada 124, Parques del Pedregal, Tlalpan, 14250 Ciudad de Mexico, CDMX, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made in Mexico UPC: 6 76753… | Global Sanitizers LLC | Drug | Class I | 6 |
| 26 Apr 2021 | NES Reprocessed Visions PV .035 IVUS Catheter, Sterile. For use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a crosssectional image of such vessels. NES Ref. No. R-88901 (88345) | Northeast Scientific Inc. | Device | Class II | 1 |
| 19 Mar 2021 | Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F MENISCAL COMP.T5 RM/LM 7MM NL475 UNIVATION F… | Aesculap Implant Systems LLC | Device | Class II | 8 |
| 17 Mar 2021 | Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10 | SIGHT DIAGNOSTICS LTD | Device | Class II | 1 |
| 10 Mar 2021 | CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 87806 10004 2, NDC 76305-300-02; c) 6 OZ (170 g) tube, UPC 6 87806 10006 2, NDC 76305-300-03; d) 8 OZ (226.8g) jar, UPC 6 87806 10008 2, NDC 76305-300-04; e) 16 OZ… | China Gel Inc | Drug | Class II | 3 |
| 4 Mar 2021 | Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function | Arjohuntleigh Magog, Inc. | Device | Class II | 1 |
| 1 Mar 2021 | Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue" (88206) | Cellex | Device | Class II | 1 |
| 5 Oct 2020 | EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 (88478) | Thera Test Laboratories, Inc. | Device | Class II | 1 |
| 2 Sep 2020 | HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131 | Charles Paint Research Inc | Drug | Class II | 2 |
| 14 Aug 2020 | Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO. | Grupo Asimex de Mexico SA de CV | Drug | Class I | 2 |
| 30 Jul 2020 | EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 (88477) | Thera Test Laboratories, Inc. | Device | Class II | 1 |
| 22 Jul 2020 | CombiDiagnost R90 Software Version R1.0 and R1.1 | Philips Medical Systems Gmbh, DMC | Device | Class II | 1 |