| 14 Feb 2024 | HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10 | HeartSine Technologies Ltd | Device | Class II | 1 |
| 13 Feb 2024 | Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6 | Amneal Pharmaceuticals of New York, LLC | Drug | Class II | 1 |
| 13 Feb 2024 | Gluten Free Bean and Cheese Burrito (5.5 oz), individual plastic overwrap, 12 retail units/case, frozen | AMY'S KITCHEN INC. | Food | Class II | 1 |
| 12 Feb 2024 | Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01 Event 93975 | Micro Labs Limited | Drug | Class II | 1 |
| 12 Feb 2024 | CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25. Event 94023 | MCKESSON CORPORATION | Drug | Class II | 1 |
| 9 Feb 2024 | Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1 | Apotex Corp. | Drug | Class II | 1 |
| 9 Feb 2024 | HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Drug | Class II | 1 |
| 9 Feb 2024 | Ham & Cotija Torta Sandwich on Telera Roll, 8.3 oz, plastic container, UPC 100001002017 Event 93989 | COMPASS GROUP USA, INC. | Food | Class I | 1 |
| 8 Feb 2024 | Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medical image data sets and treatment plans in radiation oncology. | PTW-FREIBURG | Device | Class II | 1 |
| 8 Feb 2024 | Chopped Salad Kit Southwest with condiments(toppings that include cheese), labeled salad bag (Green Cabbage, Green Leaf Lettuce, Kale, Red Cabbage, Carrots, Green Onions, Tortilla Strips, Cheddar Cheese, and Chipotle Ranch Dressing), Net Wt 13.4 oz, 6 bags per case. UPC 681131305129 | Fresh Express Incorpated | Food | Class I | 2 |
| 6 Feb 2024 | Azurion 3 with a Certeray generator -To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722221 (2) 722222 (3) 722280 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 3 |
| 6 Feb 2024 | Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 | Mallinckrodt Hospital Products Inc. | Drug | Class II | 2 |
| 6 Feb 2024 | Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, Nevada | Today The World | Drug | Class I | 3 |
| 5 Feb 2024 | Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals… | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 1 Feb 2024 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11 | Amerisource Health Services LLC | Drug | Class III | 1 |
| 1 Feb 2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41 Event 93868 | NATCO Pharma Limited | Drug | Class II | 1 |
| 1 Feb 2024 | TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3 Event 93928 | Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company | Drug | Class I | 1 |
| 1 Feb 2024 | Meta Psyllium Fiber Capsules packaged as 100 count or 160 count PET bottles - 12 bottles per case. | The Procter & Gamble Company | Food | Class II | 1 |
| 1 Feb 2024 | Dannon Plain Yogurt packaged in 32oz plastic carton with lid - 6 cartons per case | DANONE US LLC | Food | Class II | 1 |
| 1 Feb 2024 | Fresh Local , Country Corner Dairy, WHITE CHEDDAR CHEESE, INGREDIENTS: Pasteurized Milk, Salt , Rennet, Calcium Chloride, Cheese Culture, Contains Milk. Product comes in various sizes, 6 oz. up to 42 lbs. and is in vacuum sealed plastic packaging. | Country Corner Dairy, LLC | Food | Class II | 5 |
| 31 Jan 2024 | Hale and Hearty Soups; Tomato Basil and Rice; UPC 635508547872 Event 93910 | Hearty Acquisitions LLC | Food | Class I | 1 |
| 30 Jan 2024 | 1000000 White Flour UNBL EN MT delivered as bulk product in approximately 50,000 lbs trailers | Mennel Milling Company | Food | Class II | 26 |
| 26 Jan 2024 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel… | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 26 Jan 2024 | FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic. | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 25 Jan 2024 | IonoStar Plus, Catalog (REF) Numbers: a) 2540, b)2543, c) 2544, d) 2545, e) 2546, f) 2547, g) 2549; dental cement | Voco GmbH | Device | Class II | 2 |
| 25 Jan 2024 | Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11 | Amerisource Health Services LLC | Drug | Class II | 1 |
| 25 Jan 2024 | Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67 | Teva Pharmaceuticals USA, Inc | Drug | Class III | 2 |
| 25 Jan 2024 | Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562. Event 93880 | Name withheld | Drug | Class II | 1 |
| 25 Jan 2024 | Authentic Fresh to You Deluxe Triple Decker Club Net Wt. 8.8oz (254g). Product packaged in a plastic PET container. Event 93897 | MG Foods Middletown | Food | Class I | 1 |
| 25 Jan 2024 | Utz Wavy Originals Potato Chips, Net WT. 2.75 oz (78g), UPC 0-41780-19014-7. Event 93884 | UTZ QUALITY FOODS, LLC | Food | Class I | 1 |
| 23 Jan 2024 | Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20 | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 22 Jan 2024 | Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit)-A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. Product Code: 332079 | B. Braun Medical, Inc. | Device | Class II | 2 |
| 22 Jan 2024 | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1. | IntegraDose Compounding Services LLC | Drug | Class II | 1 |
| 22 Jan 2024 | Mighty Fine Chocolate Ice Cream Event 93895 | Byrne Dairy, Inc | Food | Class I | 1 |
| 19 Jan 2024 | GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes | W.L. Gore & Associates, Inc. | Device | Class II | 1 |
| 19 Jan 2024 | CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115 | Bestco LLC | Drug | Class II | 5 |
| 19 Jan 2024 | Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS | OMEZA LLC | Drug | Class II | 2 |
| 19 Jan 2024 | Al Amir Fresh Foods Classic Hummus Creamy Garbanzo, packaged in round plastic clear container, net wt. 8oz. There are 12 containers per case. UPC on 8oz container: 7 55134 12341 4. The recalled product label declares: Ingredients: Garbanzo Beans, Tahini Paste, Garlico (Fresh Garlic/Oil/Lemon/Salt), Natural Citric… | Lydia Pack 3 Inc | Food | Class I | 4 |
| 19 Jan 2024 | Bulk case of Fortune cookies, labeled as 6 lb (1.3 lb per bag/ 4 bags per case) | New World Company | Food | Class II | 3 |
| 18 Jan 2024 | Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01 | Name withheld | Drug | Class III | 2 |
| 18 Jan 2024 | Woodstock 5 Grain Cereal. Oats, Rye, Triticale, Barley, Golden Flax. Net Wt. 18.5 oz (1 lb 2.5 oz) 524g. UPC 0 42563-01772 9. Distributed by Woodstock, 313 Iron Horse Way, Providence, RI 02908. Packaged in a plant that also processes wheat. | UNFI General Corporate | Food | Class II | 1 |
| 17 Jan 2024 | Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01 Event 93839 | Henry Schein Inc. and Glove Club HSI Gloves Inc. | Drug | Class II | 1 |
| 17 Jan 2024 | MEXICAN STYLE QUINOA SALAD | Hans Kissle Company, LLC | Food | Class I | 1 |
| 16 Jan 2024 | W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue Model Number: 30061000 Event 93917 | W&H DENTALWERK BUERMOOS GMBH | Device | Class II | 1 |
| 16 Jan 2024 | Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine. | Maquet Medical Systems USA | Device | Class II | 2 |
| 16 Jan 2024 | Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI. | Olympus Corporation of the Americas | Device | Class II | 1 |
| 16 Jan 2024 | Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57 | Ascend Laboratories, LLC | Drug | Class II | 1 |
| 16 Jan 2024 | OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4. | Den-Mat Holdings, LLC | Drug | Class II | 2 |
| 16 Jan 2024 | Pan Fry Noodle Fresh Noodles, Alfred Louie, Inc. 24 Lb. cartons, Keep Refrigerated. Deep Fry Noodle Fresh Noodles, Alfred Louie, Inc. 40Lb cartons, Keep Refrigerated. Event 93836 | Alfred Louie Inc | Food | Class II | 1 |
| 15 Jan 2024 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01 | Amneal Pharmaceuticals of New York, LLC | Drug | Class II | 1 |
| 14 Jan 2024 | Notoginseng Formula Special Gout Granule; 100% Natural; 8 G x 10 PACKS; CITI TRADE INT'L LIMITED; ADDRESS: 3/FINTERNATIONAL PLAZA 20 SHEUNG YUET RD, KOWLOON BAY, KOWLOON; "Nourish and helps the kidney with detoxification. Effectively dissolves uric acid crystals in joints. Has a curative effect on a variety of… Event 93618 | 8TH AVE PHARMACY | Food | Class II | 1 |
| 12 Jan 2024 | 3M Specialty Blade Assembly, REF 9660,70-2011-8462-2, 7100213114, used with used with 3M Surgical Clipper Catalog Number 9661L | 3M Company - Health Care Business | Device | Class II | 2 |
| 12 Jan 2024 | Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30 | Golden State Medical Supply Inc. | Drug | Class II | 1 |
| 12 Jan 2024 | Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801. | Neptune Resources, LLC | Drug | Class I | 3 |
| 12 Jan 2024 | 5 oz 2pk Chocolate Croissant, bakery box with clear top (UPC 7789050655) and Chocolate Croissant 2 oz, bakery box with clear top (UPC 7789048398) | Wegmans Food Markets, Inc. | Food | Class II | 5 |
| 11 Jan 2024 | Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx. | Brasseler USA I Lp | Device | Class II | 1 |
| 11 Jan 2024 | Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11 | Amerisource Health Services LLC | Drug | Class II | 1 |
| 11 Jan 2024 | Rizo Bros Cotija (Grated) 8 oz. UPC 72724200043 7 oz. UPC 7-27242-14022-5 Tio Francisco, Casa Cardenas 9 oz. UPC 7-27242-00022-2 & 8-11371-27109-4 Rizo Bros Cotija 8 oz. UPC 7-27242-00043-7 Tio Francisco Cotija 14 oz. 7-27242-00517-3 Food City Cotija 16 oz. Tio Francisco Cotija (Grated) 20 oz. UPC 7-27242-00056-7 Tio… | Rizo Lopez Foods, Inc. dba Don Francisco Cheese | Food | Class I | 14 |
| 11 Jan 2024 | RESER'S POTATOE POTATOES MASHED RED SKN 4/5# SUPC/ITEM # 3264 | Name withheld | Food | Class II | 36 |
| 10 Jan 2024 | Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44 | MEDLINE INDUSTRIES, LP - Northfield | Drug | Class II | 1 |
| 10 Jan 2024 | Protocol for Life Balance, Phosphatidyl Serine 300mg softgels, 50 count bottle, UPC 707359123922. NOW Foods, Phosphatidyl Serine 300mg softgels, 50 count bottle, UPC 733739023926. | Now Foods | Food | Class III | 1 |
| 10 Jan 2024 | Makana Brownie Assortment Box Golden Macadamia Nut Brownie Milk Chocolate Covered Macadamia Nut Brownie Dark Chocolate Covered Macadamia Nut Brownie Made in Hawaii by Big Island Candies, Inc. Hilo Flagship Retail Gift Shop and Factory Big Island of Hawaii Ala Moana Center Street Level 1 Center Court… Event 93815 | Big Island Candies, Inc. | Food | Class I | 1 |
| 8 Jan 2024 | Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. | Microbiologics Inc | Device | Class II | 1 |
| 8 Jan 2024 | BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit. | Maquet Medical Systems USA | Device | Class II | 2 |
| 8 Jan 2024 | Sensi Disc Amoxicillin with Clavulanic Acid 20/10 g, Catalog No. 231628 and 231629. These discs are used for semi-quantitative in vitro susceptibility testing | Becton Dickinson & Co. | Device | Class II | 30 |
| 8 Jan 2024 | Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30 | Teva Pharmaceuticals USA, Inc | Drug | Class II | 1 |
| 8 Jan 2024 | the original BENNY T'S VESTA DRY HOT SAUCE GHOST NET WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99498 0 (Habanero & Bhut Jolokia (aka Ghost)) | Benny Ts Vesta Inc dba Vesta Firey Gourmet Toppings | Food | Class II | 5 |
| 5 Jan 2024 | OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite Event 93791 | IMPULSE DYNAMICS (USA) INC | Device | Class II | 1 |
| 5 Jan 2024 | Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06 | Lupin Pharmaceuticals Inc. | Drug | Class II | 2 |
| 4 Jan 2024 | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03 | Azurity Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 4 Jan 2024 | Dragonfly Jelly Bar Handbag 11.64oz, 17.63oz UPC Code 721557357156, 721557357163 Dragonfly Jelly Bar Backpack 7.93oz, 28.22oz UPC Code 721557357170, 721557357187 | U.S. Tov, Inc. | Food | Class I | 1 |
| 3 Jan 2024 | Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296. | Philips North America | Device | Class II | 12 |
| 3 Jan 2024 | The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the two viruses. | Quidel Corporation | Device | Class II | 1 |
| 3 Jan 2024 | Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images. | FUJIFILM Healthcare Americas Corporation | Device | Class II | 2 |
| 3 Jan 2024 | Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed… | BALT USA, LLC | Device | Class II | 2 |
| 3 Jan 2024 | 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platforms for supporting… | Thoratec Corp. | Device | Class I | 1 |
| 3 Jan 2024 | Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 2 Jan 2024 | 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier | Zimmer Surgical Inc | Device | Class II | 1 |
| 2 Jan 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028;… | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 2 |
| 2 Jan 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 722022; Allura Xper… | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 2 |
| 2 Jan 2024 | Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006… | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 1 |
| 2 Jan 2024 | Vandevi Compounded Asafoetida 50 gm, 100 gms 200 gm, 500 gm, 1 kg. Packaged in yellow plastic bottles with plastic shrink wrap blue/yellow labels. Event 93776 | KINJIN FOOD PRIVATE LIMITED | Food | Class II | 1 |
| 29 Dec 2023 | EVair air compressor, model numbers: M1230849 and M1230847 | Datex-Ohmeda, Inc. | Device | Class I | 3 |
| 29 Dec 2023 | MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM"; | Aesculap Inc | Device | Class II | 2 |
| 29 Dec 2023 | 202225 SALMON BAKKA FROST FILLET 6/7KG FR FRO F LB 202002 SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB 202012 SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB 202022 SALMON BAKKAFROST FAROE ISLANDS 7/8KG FR FRO F LB 202032 SALMON BAKKAFROST FAROE ISLANDS 8/9KG FR FRO F LB SAL005 SALMON BAKKAFROST SCOTTISH FLT… | Ocean Group Inc. | Food | Class I | 2 |
| 28 Dec 2023 | Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE | Cardinal Health 200, LLC | Device | Class I | 13 |
| 28 Dec 2023 | Samsung Digital Diagnostic Mobile X-ray System, Model GM85. | NeuroLogica Corporation | Device | Class II | 1 |
| 28 Dec 2023 | AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile. Event 93848 | MRP, LLC dba Aquabiliti | Device | Class II | 1 |
| 28 Dec 2023 | Bubble Sensor (REF: 70105.5720) | Maquet Medical Systems USA | Device | Class II | 1 |
| 28 Dec 2023 | FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-072-41. | Denver Solutions, LLC DBA Leiters Health | Drug | Class I | 6 |
| 27 Dec 2023 | Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 -… | Abiomed, Inc. | Device | Class I | 1 |
| 27 Dec 2023 | Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6)… | Abiomed, Inc. | Device | Class II | 1 |
| 26 Dec 2023 | Senographe Pristina | GE Medical Systems, SCS | Device | Class II | 1 |
| 26 Dec 2023 | GE Healthcare neonatal incubator, models: a) Care Plus, b) Care Plus 1000, c) Care Plus 2000, d) Care Plus 3000, e) Care Plus 4000, Plus 4000 | Wipro GE Healthcare Private Ltd. | Device | Class I | 6 |
| 22 Dec 2023 | Baxter Exactamix Pro 1200, REF EXM12DY | Baxter Healthcare Corporation | Device | Class I | 2 |
| 22 Dec 2023 | GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis Event 93727 | GE HEALTHCARE AUSTRIA GMBH & CO | Device | Class II | 1 |
| 22 Dec 2023 | AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (bone void filler) | Musculoskeletal Transplant Foundation, Inc. | Device | Class II | 2 |
| 22 Dec 2023 | Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO | Windstone Medical Packaging, Inc. | Device | Class I | 4 |
| 22 Dec 2023 | HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty | Howmedica Osteonics Corp. | Device | Class II | 2 |
| 22 Dec 2023 | Melissa's Hot Kimchi Pickled Napa Cabbage NET WT. 14 oz (397g) Ingredients: Napa Cabbage, Radish, Water, Garlic, Red Pepper, Organic Sugar Cane, Sea Salt, Calcium Lactate, Ginger, Onion, Sorbitol, and Xanthan Gum. Produce on equipment that also processes products containing fish. Distributed By: World Variety… | World Variety Produce Inc dba Melissa's | Food | Class I | 1 |
| 22 Dec 2023 | Solgar, Triple Strength, Shellfish -Free, Glucosamine Chondroitin MSM, 120 Tablets per bottle. Glass Bottle, 12 per Case, Store at room temperature . Product Number -1319 Event 93707 | Nestle Product Technology Center - Nestle Health Science | Food | Class III | 1 |
| 21 Dec 2023 | HENRY SCHEIN CRITERION EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) | AMD Medicom Inc. | Device | Class II | 3 |
| 21 Dec 2023 | Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT | Covidien LP | Device | Class II | 2 |
| 21 Dec 2023 | Article No. NA6050411, Valiant PhD No. 1 Econo | Ivoclar Vivadent, Inc. | Device | Class II | 1 |
| 21 Dec 2023 | FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56 Event 93810 | G & H Wire Company | Device | Class II | 1 |
| 21 Dec 2023 | MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 7 |
| 21 Dec 2023 | TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 | MICROVENTION INC. | Device | Class II | 1 |
| 21 Dec 2023 | Popcorn Pre-Pop in 8oz Polypropylene bag packaged 20 bags to a case Event 93769 | County Fair Foods, Inc. | Food | Class II | 1 |
| 20 Dec 2023 | These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES: a) MSC351400AN/Z (7 X 8 , 150 ct canister), b) MSC351410AN/Z (6 x 5 , 150ct canister), c) MSC3560012… | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 20 Dec 2023 | Barco MDSC-8527 NXF, Part Number K9352421 Event 93712 | Name withheld | Device | Class II | 1 |
| 20 Dec 2023 | global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer. | CooperSurgical, Inc. | Device | Class II | 1 |
| 20 Dec 2023 | Fat Choy Kee Dried Longan Event 93750 | HY SUCCESS INC. | Food | Class I | 1 |
| 20 Dec 2023 | Shennongyuan Dried Longan packaged in a silver metal box bulk 18kgs Event 93677 | J T Trading Inc. | Food | Class I | 1 |
| 19 Dec 2023 | Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T | OriGen Biomedical, Inc. | Device | Class II | 1 |
| 19 Dec 2023 | EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510. | Boston Scientific Corporation | Device | Class II | 1 |
| 19 Dec 2023 | smiths medical Medfusion Model 4000 syringe pump | Smiths Medical ASD Inc. | Device | Class I | 1 |
| 19 Dec 2023 | smiths medical Medfusion Model 3500 Syringe pump | Smiths Medical ASD Inc. | Device | Class I | 1 |
| 18 Dec 2023 | Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25 | Vortex Surgical Inc. | Device | Class II | 1 |
| 18 Dec 2023 | PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423. | Angiodynamics, Inc. | Device | Class II | 1 |
| 18 Dec 2023 | Aldi Choceur Burnt Caramel Chocolate Bars, Net Wt. 1.75oz. UPC 4099100202809 Event 93685 | Astor Chocolate Corp. | Food | Class II | 1 |
| 15 Dec 2023 | ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110 | Philips North America | Device | Class II | 2 |
| 15 Dec 2023 | ESG PK CUTTING FORCEPS, 5MM, 33CM | Olympus Corporation of the Americas | Device | Class II | 1 |
| 15 Dec 2023 | ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 | Globus Medical, Inc. | Device | Class II | 1 |
| 15 Dec 2023 | Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 15 Dec 2023 | BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 453560279811 453560279801; 4x4 digit format 2170-3000A 2170-3001A 2170-3002A 2170-3003A | Philips North America | Device | Class I | 3 |
| 15 Dec 2023 | Mint Dark Chocolate bar, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box. | Font Group of America Corp. | Food | Class II | 6 |
| 14 Dec 2023 | FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit) | BioFire Diagnostics, LLC | Device | Class II | 2 |
| 13 Dec 2023 | Spectral CT on Rails: Software Version 5.1.0.X, model 728334. | PHILIPS MEDICAL SYSTEMS | Device | Class II | 2 |
| 13 Dec 2023 | Ito-Shoten Seasoned Mushroom 200g/7.06 oz. Product of Japan Distributed by Mitsuwa Corporation Torrance, CA 90501 Event 93859 | Mitsuwa Corporation | Food | Class II | 1 |
| 12 Dec 2023 | Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 722078, 722223; Azurion… | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 1 |
| 12 Dec 2023 | Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 | Steris Corporation | Device | Class II | 2 |
| 12 Dec 2023 | Tasty Snacks Plum Queen Dried Plums Net Weight 200G (7OZ) Packaged in cans. 30 cans per case. | Win Luck Trading Inc | Food | Class II | 1 |
| 11 Dec 2023 | Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044 | Olympus Corporation of the Americas | Device | Class II | 1 |
| 11 Dec 2023 | ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 11 Dec 2023 | Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S | Globus Medical, Inc. | Device | Class II | 3 |
| 11 Dec 2023 | Flow-i C20 Anesthesia System, model 6677200 | Getinge Usa Sales Inc | Device | Class II | 5 |
| 8 Dec 2023 | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 1 |
| 8 Dec 2023 | Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator | Olympus Corporation of the Americas | Device | Class II | 1 |
| 8 Dec 2023 | Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12) | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 1 |
| 7 Dec 2023 | Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C) | Name withheld | Device | Class II | 2 |
| 6 Dec 2023 | Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm | Stryker, Inc. | Device | Class II | 2 |
| 6 Dec 2023 | Milk N Cookies Keto Brick / 1 Brick, 145g 5.1 oz Event 93564 | Savage Sports LLC | Food | Class III | 1 |
| 4 Dec 2023 | Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve Sterile Saline 8 Fr/Ch (2.67 mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile… | Cardinal Health 200, LLC | Device | Class I | 10 |
| 1 Dec 2023 | SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026 | Howmedica Osteonics Corp. | Device | Class II | 58 |
| 29 Nov 2023 | RX Series Copper (Cu) Assay Ref. Number CU2340 | Randox Laboratories Ltd. | Device | Class II | 1 |
| 29 Nov 2023 | Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L | American Contract Systems, Inc. | Device | Class II | 18 |
| 28 Nov 2023 | Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures, non-unions or osteotomies. | TriMed Inc. | Device | Class II | 1 |
| 28 Nov 2023 | Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length. | XTANT Medical Holdings, Inc | Device | Class II | 1 |
| 28 Nov 2023 | Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053 | AtriCure, Inc. | Device | Class II | 2 |
| 27 Nov 2023 | Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154 | Mirion Technologies (Capintec), Inc. | Device | Class II | 1 |
| 21 Nov 2023 | Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410 | Beckman Coulter, Inc. | Device | Class II | 2 |
| 20 Nov 2023 | NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL | THOR Photomedicine Ltd | Device | Class II | 1 |
| 17 Nov 2023 | Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL) Event 93544 | Draegerwerk Ag & Co. Kgaa | Device | Class II | 1 |
| 16 Nov 2023 | AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia repair procedures Model ABSTACK30 | Covidien LP | Device | Class II | 1 |
| 15 Nov 2023 | The device is an X-ray system that is capable of radiographic and fluoroscopic studies and is used in an interventional setting. The system consists of a C-arm which is equipped with an X-ray tube, beam limiter and X-ray receptor, X-ray controller, computers with system and processing software, and a patient… | Canon Medical System, USA, INC. | Device | Class II | 2 |
| 15 Nov 2023 | Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3 | Medtronic MiniMed, Inc. | Device | Class II | 1 |
| 13 Nov 2023 | CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. | Kilitch Healthcare India Limited | Drug | Class I | 22 |
| 10 Nov 2023 | EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-0880 | Olympus Corporation of the Americas | Device | Class II | 12 |
| 2 Nov 2023 | Sperm separation media are used to separate motile sperm from other constituents of semen. | Fujifilm Irvine Scientific, Inc. | Device | Class II | 1 |
| 29 Aug 2023 | Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide. | CooperSurgical, Inc. | Device | Class II | 1 |
| 8 Aug 2023 | Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 Event 93729 | Name withheld | Device | Class II | 1 |
| 11 Feb 2022 | CombiDiagnost R90 1.0 (709030) | PHILIPS MEDICAL SYSTEMS | Device | Class II | 2 |
| 6 Jan 2022 | Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system | Philips North America | Device | Class II | 3 |
| 14 Oct 2021 | MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007 | SEDECAL SA | Device | Class II | 1 |
| 1 Mar 2021 | Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular) | Abiomed, Inc. | Device | Class II | 1 |