| 12 Jun 2026 | Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05 (99237) | Par Health USA, LLC | Drug | Class II | 1 |
| 9 Jun 2026 | Al Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case (99208) | GREENWORLD FOOD EXPRESS (USA) LLC | Food | Class I | 1 |
| 5 Jun 2026 | Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816. NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet… (99136) | Inventia Healthcare Limited | Drug | Class II | 1 |
| 5 Jun 2026 | The Shadow Loose-Leaf Tea - Winter Spice Black Tea, net wt. 2oz (56 g). Product is packaged in cellophane bag within tubular container. UPC 00198168252543. Ingredients: Black Tea ( Keemun & Assam), Cinnamon, Holy Basil, Milky Oats, Licorice Root, Ashwagandha, Ginger. Produced By Wild Coast Brew, Myrtle Point, OR. | Wild Coast Brew LLC | Food | Class III | 3 |
| 4 Jun 2026 | Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10 | Breckenridge Pharmaceutical, Inc. | Drug | Class II | 2 |
| 4 Jun 2026 | Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059. | Haleon US Holdings LLC | Drug | Class I | 1 |
| 3 Jun 2026 | Primidone Tablets, USP, 50 mg, 100 Tablets per 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: 53746-544-01 | Amneal Pharmaceuticals, LLC | Drug | Class III | 1 |
| 3 Jun 2026 | MMB of Louisiana Pasteurized Donor Human Milk, Volume: 3 oz, Cal/Oz: 19, 0.9 g/dL Protein, packaged in a clear plastic bottle with white plastic cap (99155) | Mothers' Milk Bank of Louisiana at Ochsner Baptist | Food | Class III | 1 |
| 2 Jun 2026 | Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 5. | Dabur India Limited | Drug | Class II | 14 |
| 1 Jun 2026 | BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789. (99145) | BEEKEEPER'S NATURALS USA INC. | Drug | Class I | 1 |
| 1 Jun 2026 | Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30 | Ascend Laboratories, LLC | Drug | Class II | 1 |
| 1 Jun 2026 | Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31 | Sandoz Inc | Drug | Class III | 1 |
| 29 May 2026 | Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat,… | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 29 May 2026 | GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90. | Golden State Medical Supply Inc. | Drug | Class II | 1 |
| 28 May 2026 | KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, Issaquah, WA 98027, NDC 63981-171-80 | Guardian Drug Co. Inc. | Drug | Class II | 23 |
| 28 May 2026 | azuma foods TAKO WASABI Seasoned Octopus with Wasabi PERISHABLE/KEEP FROZEN PRODUCT OF JAPAN DISTRIBUTED BY: AZUMA FOODS INTERNATIONAL INC., U.S.A. HAYWARD, CA 94545 Retail: 3-50g PACKS NET WT. 5.3 OZ (150g) UPC: 745329900647 Foodservice: 2.2lbs UPC: 745329900746 | Azuma Foods International Inc USA | Food | Class I | 1 |
| 27 May 2026 | Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28 (99105) | Inter-Med Llc | Device | Class II | 1 |
| 27 May 2026 | Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03. | Ajanta Pharma USA Inc | Drug | Class II | 1 |
| 27 May 2026 | Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc.,… | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 27 May 2026 | Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46. | Lannett Company Inc. | Drug | Class II | 1 |
| 22 May 2026 | Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85. (99112) | Zep Inc | Drug | Class II | 1 |
| 22 May 2026 | Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-762-10 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 2 |
| 22 May 2026 | 001165: Standard Pasteurized Donor Human Milk; 100 mL bottles 001198: Pediatric Pasteurized Donor Human Milk; 200 mL bottles No UPC (99070) | University of California Health Milk Bank | Food | Class II | 1 |
| 22 May 2026 | 1. TNVitamins Ultrapotent Complete Green Superfood Moringa Capsules (120 count) 2. Doctor s Pride Complete Green Superfood Ultra Potent Moringa 10,000 mg (120 capsules) (99072) | Total Nutrition Inc | Food | Class I | 1 |
| 21 May 2026 | BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional… (98855) | Individual firm, name withheld | Device | Class II | 1 |
| 21 May 2026 | MOSAIQ Oncology Information System | Elekta, Inc. | Device | Class II | 1 |
| 21 May 2026 | Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3. | Keystone Industries | Drug | Class II | 7 |
| 21 May 2026 | Fairhope Roasting Company Cold Brew Coffee Concentrate, packaged in 1-gallon plastic jugs, UPC 852236006062, for food service only (99056) | Fairhope Roasting Company | Food | Class II | 1 |
| 20 May 2026 | Birch Benders Sweet Potato Pancake and Waffle Mix 12oz bag, UPC 8 1000156076 8, 6 bags per case | Hometown Food Company | Food | Class I | 1 |
| 19 May 2026 | TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300. | Howmedica Osteonics Corp. | Device | Class II | 2 |
| 19 May 2026 | Medtronic O-arm O2 Imaging System. Model Number: BI70002000. (99041) | Medtronic Navigation, Inc.-Boxborough | Device | Class II | 1 |
| 19 May 2026 | ESTRELLA, Bebida de Parcha (Passion Fruit Drink), multiple sizes, 14 OZ.FL. (413 ML), 64 OZ.FL (1,920mL), 120 OZ.FL. (3.54LT.) 14 OZ.FL Plastic Bottles packed in cases of 25 bottles. KEEP REFRIGIRATED. (99037) | Refresqueria Estrella Inc. | Food | Class III | 1 |
| 19 May 2026 | Farm Rich Pizza Cheese Crunchers | Rich Products Corp | Food | Class II | 1 |
| 19 May 2026 | Individual Unit Label (both lid and front of cup): Whole Foods Market Kitchens Minestrone Soup, VEGETARIAN NET WT 24 OZ (1 Lb 8OZ) 680g. Case Label: Whole Foods Global Minestrone Soup 702505, KEEP REFRIGERATED, Distributed by Whole Foods Market Austin, TX 78703. Eight (8)/ 24 oz. Cups (Net Wt. 12 LBS)/case. (99038) | Kettle Cuisine, LLC | Food | Class I | 1 |
| 18 May 2026 | DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm) | DeRoyal Industries Inc | Device | Class II | 1 |
| 18 May 2026 | Philips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for MultiDiagnost Eleva; Model # 708034 for MultiDiagnost Eleva with Flat Detector; Model # 708036 for MultiDiagnost Eleva; Model # 708037 for MultiDiagnost Eleva with Flat Detector; Model # 708038 for MultiDiagnost Eleva with Flat Detector. | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 2 |
| 18 May 2026 | Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP. | Abiomed, Inc. | Device | Class I | 1 |
| 18 May 2026 | Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02 | Eugia US LLC | Drug | Class III | 1 |
| 18 May 2026 | PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10. | AbbVie Inc. | Drug | Class III | 1 |
| 18 May 2026 | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1. | IntegraDose Compounding Services LLC | Drug | Class II | 1 |
| 18 May 2026 | Legacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags | International Food Products Corporation | Food | Class II | 3 |
| 18 May 2026 | Raw Shelled Peanuts (Runner Type) 2,200 lb. Poly Tote Bags and 50kg Poly Bags (99057) | Wilco Peanut Co | Food | Class I | 1 |
| 15 May 2026 | HarmonyAIR A-Series Surgical Lighting System | Steris Corporation | Device | Class II | 1 |
| 15 May 2026 | HarmonyAIR A-Series Surgical Lighting System | Steris Corporation | Device | Class II | 2 |
| 15 May 2026 | VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04. | PAI Holdings LLC | Drug | Class II | 4 |
| 15 May 2026 | Great Value Hawaiian Roll 4pk, Item # F63384. Product is perishable dinner roll ready to eat, sold in a corrugated case of 18 packages (4.5oz net wt.) individually wrapped in laminated film. This product was never sold in stores and was never available for consumer purchase. All affected product remained at wholesale… (99020) | United States Bakery | Food | Class II | 1 |
| 15 May 2026 | DRAGONFLY Thai Ginger Powder Net Weight: 4.37 oz (125 g) PRODUCT OF THAILAND Packed for: U.S. Trading Company Hayward, CA 94545-1130 UPC: 721557533567 (99017) | U.S. Tov, Inc. dba U.S. Trading Company | Food | Class II | 1 |
| 14 May 2026 | Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product… | Abiomed, Inc. | Device | Class I | 1 |
| 14 May 2026 | ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy | ConMed Corporation | Device | Class II | 11 |
| 14 May 2026 | Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton) | Fresenius Kabi USA, LLC | Drug | Class III | 1 |
| 14 May 2026 | Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. (98972) | AVEVA Drug Delivery Systems, Inc. | Drug | Class III | 1 |
| 14 May 2026 | Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc. | Asclemed USA Inc. | Drug | Class II | 1 |
| 14 May 2026 | Salt (99009) | United Salt Corp | Food | Class III | 1 |
| 14 May 2026 | Enoki Mushroom, Net Weight 150g; Product of Korea; Distributed by IQ Produce UPC: 8809316 814286 (99001) | IQ PRODUCE, LLC | Food | Class I | 1 |
| 13 May 2026 | Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor | Individual firm, name withheld | Device | Class II | 2 |
| 13 May 2026 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide… | Thoratec LLC | Device | Class II | 3 |
| 13 May 2026 | Nutrisystem, Chocolate Cheesecake, 2 oz (57g) packages, Flow Wrapped, 48 units per case, Keep frozen (99218) | Nutrisystem Inc | Food | Class II | 1 |
| 13 May 2026 | Hellas Meze Golden Smoked Whole Herring (98989) | Terra Medi LLC | Food | Class I | 1 |
| 12 May 2026 | Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software | Abbott Medical | Device | Class II | 1 |
| 12 May 2026 | Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure. | Boston Scientific Corporation | Device | Class II | 1 |
| 12 May 2026 | Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G; | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 12 May 2026 | Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1. (98976) | Spectra Medical Devices, Llc | Drug | Class II | 1 |
| 12 May 2026 | DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class I | 1 |
| 12 May 2026 | STRAUS FAMILY CREAMERY Vanilla Bean ORGANIC SUPER PREMIUM ICE CREAM ONE PINT (473mL) Produced and Distributed by Straus Family Creamery, Petaluma, CA 94952 UPC: 784830100306 | Individual firm, name withheld | Food | Class II | 5 |
| 12 May 2026 | Adndale Magnesium Glycinate Gummies 400 mg. Plastic bottle containing 90 gummies. Net weight: 11.36 ounces. Serving size: 2 gummies. UPC: 860008784551 Firm name and address listed on label: Dkiru Ltd, Keepers Cottage, 3 Dublin Rd, Leixlip, Co. Kildare W23 H3C4, Ireland (98984) | Dkiru LLC | Food | Class II | 1 |
| 11 May 2026 | NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090 T50 SN020… | In2bones USA, LLC | Device | Class II | 1 |
| 11 May 2026 | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the… | Inspire Medical Systems Inc. | Device | Class II | 2 |
| 11 May 2026 | HH Fresh Trading Corp. (branded) ENOKI MUSHROOM; Premium Quality; Net WT/ Poids Net 150g(5.29oz) Distributed by HH Fresh Trading Exported by JIA YANG INTERNATIONAL ENTERPRISES CO., LTD. Produced by Green Farm (Taiwan) UPC: 4711498860002 (98993) | HH FRESH TRADING CORP | Food | Class I | 1 |
| 8 May 2026 | Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C | AMD Medicom Inc. | Device | Class II | 2 |
| 8 May 2026 | Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator) Product identifiers: 2082663-001, 2082663-002, M1241424 Product impacted only if service blender M1091607-R was installed during the last Preventative Maintenance | Datex-Ohmeda Inc | Device | Class I | 3 |
| 8 May 2026 | Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 00884450529645 00884450529690 00884450529744 REF: MSWSTDS35150… | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 8 May 2026 | Lunds & Byerly's Curry Powder Sweet (98965) | J and J Bunting, Inc | Food | Class II | 1 |
| 8 May 2026 | Fly By Jing (branded) Creamy Sesame Noodles; 3.8 oz packets. Sold in single and 4 packs. Single UPC: 8-50052-23988-6 4 pack UPC: 8-50052-23991-6 (98961) | Fly By Jing Inc. | Food | Class II | 1 |
| 7 May 2026 | Atlan A350. Model Number: 8211500. anesthesia workstation | Draeger, Inc. | Device | Class I | 2 |
| 7 May 2026 | Bicarby Dialysate; Model number: RFP-400-G; | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 7 May 2026 | Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 6 May 2026 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Fresenius Kabi USA, LLC | Device | Class I | 1 |
| 6 May 2026 | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | Fresenius Kabi USA, LLC | Device | Class I | 1 |
| 6 May 2026 | Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System | Stryker Corporation | Device | Class II | 1 |
| 6 May 2026 | Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333867); 25GA. PENCAN SPINAL BUP. TRAY W/DURAPREP (333862); GOVP24BK 24G PENCAN TRAY W/ BUP & DEXTROS (332607); P24BK 24G PENCAN TRAY W/BUP & DEXTROSE (333868); P25BKAY PENCAN SPINAL TRAY (333865); P27BK… | B Braun Medical Inc | Device | Class I | 3 |
| 6 May 2026 | NEURO NOURISH dietary supplement; 6-IN-1 PREBIOTIC, PROBIOTIC, VITAMIN, MINERAL, FATTY ACID, AND ANTIOXIDANT NUTRITIONAL SUPPLEMENT TO SUPPORT DRAIN AND GUT HEALTH NET WT. 5.9 OZ; UPC: 310M5951601 (99116) | SENSORY SUPPLEMENT LLC | Food | Class II | 1 |
| 6 May 2026 | 1) Cheese Sauce Mix, 25.5 oz., packaged in a sealed poly bag and packed 12 bags per case, UPC 0399549125016 2) Cheese Sauce Mix, 25 lb., packaged in a tied poly bag and packed 1 bag per case, UPC 0039954924308 3) Creamier Cheese Sauce Mix, 25 lb., packaged in a tied poly bag and packed 2 bags per case, UPC… | The Coffee Connexion Co., Inc | Food | Class I | 4 |
| 6 May 2026 | CANNOLI SICILIANI intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging: box, Net wt. 240g 8.47 oz UPC: 8056093851380 firm name & address listed on label: MID DOLCIARIA SRL VIA CASALINI, 8 -95032 - BELPASSO (CT) | MID DOLCIARIA SRL | Food | Class II | 2 |
| 6 May 2026 | UPC 22655200000 CAKE CARROT 8IN 2-Layer UPC 27813200000 CAKE CARROT 8IN 2-Layer These are Albertson's store-made items and sold by unit at point of sale with grocery store's scale labels. | Albertsons Companies LLC | Food | Class II | 121 |
| 5 May 2026 | Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30. | Ascend Laboratories, LLC | Drug | Class II | 1 |
| 5 May 2026 | 72% CACAO CHOCOLATE WITH DATE SUGAR WAFERS Ingredients: Cacao Beans, Organic Date Powder, Organic Cocoa Powder Net Wt 25lb (11.3kg) Made in the USA GUITTARD CHOCOLATE COMPANY Burlingame, CA 94010 Item: 0568C25 UPC: 00071818367654 (98949) | Guittard Chocolate Company | Food | Class I | 1 |
| 5 May 2026 | Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Waukesha, WI 53166. | Legacy Bakehouse LLC | Food | Class I | 3 |
| 5 May 2026 | My Wife's Slaw, packaged in 8 oz. and 16 oz. glass mason jars with metal lids/bands, MyWifeslaw.web.app, Zanesville, Ohio. Ingredients: Cabbage, Sugar, Vinegar, Mustard, Carrots, Onion, Bell Pepper, Salt, Black Pepper, Cayenne Pepper. | Individual firm, name withheld | Food | Class II | 2 |
| 4 May 2026 | Pediatric care bed; Product Designation: KayserBett IDA; (98820) | KAYSERBETTEN GMBH & CO. KG | Device | Class I | 1 |
| 4 May 2026 | SD LTM 64 PLUS, EEG Amplifier/recorder, Model/Catalog Number: SD LTM 64 PLUS, Software Version: firmware 2021.02, 2022.01 or 2022.02 (98924) | Individual firm, name withheld | Device | Class II | 1 |
| 4 May 2026 | MEDLINE Urethral Catheter, Red Rubber Latex, Medline Product Number/SKU (REF), French sizes: 1. DYND13508 - 08 Fr; 2. DYND13510 - 10 Fr; 3. DYND13512 - 12 Fr; 4. DYND13514 - 14 Fr; 5. DYND13515 - 15 Fr; 6. DYND13516 - 16 Fr; 7. DYND13518 - 18 Fr; 8. DYND13520 - 20 Fr; 9. DYND13522 - 22 Fr; 10. DYND13614 - 14 Fr; 11.… | Medline Industries, LP | Device | Class II | 30 |
| 4 May 2026 | White Cheddar Seasoning packed in the following sizes and configurations: 1. Net Wt. 1.2 oz (34g) Distributed by: Fireworks Popcorn, Division of Jonco Industries, Milwaukee, WI 53218. Sold in a Fireworks Popcorn, Natural American Popcorn Popping & Toppings gift set. Contains: 3 popcorns & 3 popcorns seasonings. 2.… (98973) | Jonco Industries | Food | Class I | 1 |
| 4 May 2026 | Market of Choice Vegan Kale Caesar Salad, Net Wt. 9.5oz. Finished product is pre-packaged into a clear flexible plastic clamshell container. Label has UPC 0 210126 01099 3. Market Central Kitchen 1150 Owen Loop S. Eugene, OR 97402 The Za'atar spice, which contains Sesame Seeds, is mixed with chickpeas and packaged… | Market of Choice Inc | Food | Class II | 1 |
| 1 May 2026 | DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. | Philips North America Llc | Device | Class II | 1 |
| 1 May 2026 | Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models | GE Medical Systems, LLC | Device | Class II | 3 |
| 1 May 2026 | Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830 | INSPIREMD Inc | Device | Class II | 6 |
| 1 May 2026 | a2 Platinum Premium infant formula Milk-based Powder with Iron 31.7oz (900g) Intended use: infant formula (0 12 months). Condition: shelf stable product Type of packaging: metal tin with plastic dust cap. Net weight: 31.7oz (900gm). UPC: 813267020335. Firm name listed on label: The a2 Milk Company. 4909 Pearl East… (98887) | The a2 Milk Company | Food | Class I | 1 |
| 1 May 2026 | SECOND NATURE KETO CRUNCH SMART MIX, 10-ounce retail-sized plastic pouch, UPC 077034013405, 6-10oz units per case. (98889) | SECOND NATURE BRAND | Food | Class II | 1 |
| 1 May 2026 | #007560 Fiery Hot Seasoning (Reduced Salt), Net Wt: 25 lbs. JCB Flavors, 1224 Clark Street, Watertown, WI 53094 | JCB Flavors, LLC | Food | Class I | 10 |
| 30 Apr 2026 | Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064, 722222), Azurion 5 M12 (722227), Azurion 5 M20 (722228), Azurion 7 B12 (722067, 722225), Azurion 7 B20 (722068, 722226), Azurion 7 M12 (722078, 722223), Azurion 7 M20 (722079, 722224). | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 2 |
| 30 Apr 2026 | Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear implant designed to provide useful hearing to individuals with severe-to-profound hearing loss. It… | Advanced Bionics, LLC | Device | Class II | 1 |
| 30 Apr 2026 | directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2 | Accriva Diagnostics, Inc. | Device | Class II | 1 |
| 30 Apr 2026 | TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00; | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. | Device | Class II | 3 |
| 30 Apr 2026 | BD Pyxis MedStation 4000 REF: 303 Medication cabinet | CareFusion 303, Inc. | Device | Class II | 8 |
| 30 Apr 2026 | Halyard, Pain Pack. Kit Code: AMPK48-01. | AVID Medical, Inc. | Device | Class II | 4 |
| 30 Apr 2026 | Brand Name: CORFLO Product Name: CORFLO* Safety PEG Kit Model/Catalog Number: 30-4320 | Avanos Medical, Inc. | Device | Class II | 20 |
| 30 Apr 2026 | Malazi 100% PURE SUDANESE SESAME Tahina G.W.: 1K.g UPC 6 224011 088244 Produced by: AL-MALAZ COMPANY FOR TRADE AND INDUSTRY Piece No. 110-250 acres area Badr City - Egypt (98923) | Nassar Investment Company LLC | Food | Class I | 1 |
| 29 Apr 2026 | Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 | Boston Scientific Neuromodulation Corporation | Device | Class II | 1 |
| 29 Apr 2026 | Boston Scientific CSK Electrodes: REF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm) REF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm); REF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm); REF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M… | Boston Scientific Neuromodulation Corporation | Device | Class II | 2 |
| 29 Apr 2026 | Plum Solo Precision IV Pump, 40001-0401 | ICU Medical, Inc. | Device | Class II | 3 |
| 29 Apr 2026 | Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray… | Mozarc Medical US LLC | Device | Class II | 1 |
| 27 Apr 2026 | Aligned Medical AMS16835 Fluids Kit RX | Windstone Medical Packaging, Inc. | Device | Class II | 1 |
| 27 Apr 2026 | PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 (98959) | Oculus Technologies of Mexico, S.A. de C.V. | Device | Class II | 1 |
| 27 Apr 2026 | BD¿Spinal Tray with BD¿Quincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405609. | Becton Dickinson & Company | Device | Class I | 10 |
| 27 Apr 2026 | Medline EBSI Kit EBSI1534 | Medline Industries, LP | Device | Class II | 34 |
| 27 Apr 2026 | cafe nouria blueberry muffin NET WT. 6 OZ (170g) UPC: 811070033986 (98857) | The Brownie Baker Inc. | Food | Class II | 1 |
| 24 Apr 2026 | EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01 (98797) | BERLIN HEART GMBH | Device | Class II | 1 |
| 24 Apr 2026 | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 24 Apr 2026 | Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation (98952) | Medartis AG | Device | Class II | 1 |
| 24 Apr 2026 | Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648; | Bayer Medical Care, Inc. | Device | Class II | 1 |
| 24 Apr 2026 | GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | GE Medical Systems Information Technologies Inc | Device | Class II | 6 |
| 24 Apr 2026 | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3 | Devicor Medical Products Inc | Device | Class II | 1 |
| 24 Apr 2026 | CASE v7.0 Cardiac Testing System Model no. 3031234-001 Product Code SU3 | GE Medical Systems Information Technologies Inc | Device | Class II | 1 |
| 23 Apr 2026 | Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly; IN-10600 , Tracker B; IN-16400, Tracker A; IN-16100, Tracker C; IN-28050, Tracker E | Kico Knee Innovation Company | Device | Class II | 2 |
| 23 Apr 2026 | Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife (98911) | SSC- Surgical Specialties Corporation | Device | Class II | 1 |
| 23 Apr 2026 | Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042 | Covidien LLC | Device | Class II | 3 |
| 22 Apr 2026 | RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-N4-36-109-36U 28-N4-36-154-32U… | Bolton Medical Inc. | Device | Class I | 1 |
| 22 Apr 2026 | Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 21 Apr 2026 | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph | GE Medical Systems China Co., Ltd. | Device | Class II | 1 |
| 21 Apr 2026 | PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCU | ARROW INTERNATIONAL, LLC | Device | Class I | 35 |
| 21 Apr 2026 | (BULK) SPL-BEV Banana CWT (Banana Smoothie); Super Sack Tote Item# 355-0099 (98841) | Honeyville, Inc | Food | Class I | 1 |
| 20 Apr 2026 | Automated Impella Controller (AIC); Product Code: 0042-0000-US; | Abiomed, Inc. | Device | Class I | 1 |
| 20 Apr 2026 | Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 /… | Shimadzu Medical Systems | Device | Class II | 1 |
| 20 Apr 2026 | Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation… (99007) | Staar Surgical AG | Device | Class II | 1 |
| 20 Apr 2026 | Allia IGS 3 Pulse angiographic X-ray system | GE Medical Systems, LLC | Device | Class II | 5 |
| 16 Apr 2026 | Brand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays. | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 15 Apr 2026 | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071; | Covidien, LP | Device | Class II | 1 |
| 15 Apr 2026 | Fresh Roast Systems ColorTrack. Model Name: ColorTrack. Model Number: BENCH R-100 (99111) | Fresh Roast Systems Inc | Device | Class II | 1 |
| 15 Apr 2026 | COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock… | Covidien LLC | Device | Class II | 1 |
| 13 Apr 2026 | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl) | O&M HALYARD INC | Device | Class II | 1 |
| 13 Apr 2026 | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip… | HF Acquisition Co LLC | Device | Class II | 2 |
| 10 Apr 2026 | Medline medical convenience kit labeled as EYE TRAY-LF, Medline Kit SKU DYNJ21627P | Medline Industries, LP | Device | Class II | 1 |
| 10 Apr 2026 | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: 1) ANESTHESIA TRAY, Medline SKU DYNJRA1355A; 2) SPINAL ANESTHESIA TRAY, Medline SKU DYNJRA2151. | Medline Industries, LP | Device | Class I | 7 |
| 3 Apr 2026 | TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis (98773) | Grace Medical, Inc. | Device | Class II | 1 |
| 3 Apr 2026 | Brazo Gitano [image] Caramel Sweet Roll The Original, Net Wt. 24 oz, packaged in a rigid plastic clamshell container with a transparent dome lid and tray base, one unit per container. KEEP REFRIGERATED. UPC 882479852232 | Galaxy RG Corp | Food | Class II | 23 |
| 2 Apr 2026 | Wawa Iced Tea Lemon 16 oz Pint, Plastic bottle | Wawa Beverage Company | Food | Class I | 4 |
| 24 Mar 2026 | Hintermann Series Talar Implant, Left, Size 2 REF 302112 (98987) | DT MedTech, LLC | Device | Class II | 1 |
| 23 Mar 2026 | Park St. Deli Macaroni & Cheese, NET WT 20 OZ (1 LB 4 OZ) 567g, product packed in plastic tub and placed into paperboard sleeve. 9/20 oz packages per case. (98714) | BEF Foods, Inc | Food | Class II | 1 |
| 16 Mar 2026 | TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816 | Smith & Nephew, Inc. | Device | Class II | 1 |
| 12 Mar 2026 | Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml container. Packed in single serving, 3 units/pack, and 10 units per pack. Single UPC: 49873-916-11 3pack UPC: 49873-916-15 10pack UPC: 49873-916-07 | Sato Pharmaceutical Inc. | Food | Class III | 1 |
| 9 Mar 2026 | ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 25 Feb 2026 | WeiKFiELD Custard Powder Kesar Pista, Net Wt. 300g (10.6 OZ.), Poly Jar , 24 units per outer case. (98850) | Weikfield Foods Pvt. Ltd. | Food | Class III | 1 |
| 4 Feb 2026 | The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. | Fresenius Kabi USA, LLC | Device | Class II | 1 |
| 30 Jan 2026 | Taro Cakes UPC CODE #652565100055 (98369) | E & S Grocery & Bakery Inc. | Food | Class I | 1 |
| 29 Jan 2026 | Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No | B Braun Medical Inc | Device | Class II | 8 |
| 15 Dec 2025 | Betaine Anhydrous, 2055kg, material packed in foil bags inside 15kg cardboard box Label reads in part as "***BETAINE ANHYDROUS 98%***Distributed by Creative Compounds, LLC Scott City, Missouri USA 63780***" (99015) | Creative Compounds, LLC | Food | Class II | 1 |
| 11 Dec 2025 | NexxZr T Multi A3.5 W98-16mm, REF: 745451 (98823) | Sagemax Bioceramics, Inc. | Device | Class II | 1 |
| 10 Dec 2025 | Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4 | Daavlin Distributing Company | Device | Class II | 1 |
| 23 Sep 2025 | iLet Bionic Pancreas, REF: BB1001 | Beta Bionics, Inc. | Device | Class II | 1 |
| 12 Feb 2025 | Mito Red Light, Super Mobile (98999) | MITO RED LIGHT INC | Device | Class II | 1 |
| 7 Dec 2023 | Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 8 |
| 17 Jan 2011 | Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella… | Abiomed, Inc. | Device | Class I | 1 |