| 15 Oct 2024 | OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc., Fairfield, NJ 07004, NDC 71399-0039-06. | Akron Pharma, Inc. | Drug | Class II | 1 |
| 10 Oct 2024 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05. | Breckenridge Pharmaceutical, Inc | Drug | Class II | 1 |
| 8 Oct 2024 | AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg, (95520) | Individual firm, name withheld | Drug | Class II | 1 |
| 3 Oct 2024 | Happy Moose Juice Tropical Roots packaged in a plastic 12 fl. oz. bottle. Ingredients: Mandarin Orange, Organic Carrot Juice, Organic Pineapple Juice, Lemon Juice, and Organic Turmeric Juice. UPC 860012096503 | Youngstown Grape Distributors, Inc. | Food | Class II | 5 |
| 3 Oct 2024 | Chois Kimchi Company Gluten Free Gochujang Red Chili Paste, packaged 16oz plastic pouch with spout, keep refrigerated. UP 8 58878 00330 8. Made By Chois Kimchi, LLC Portland, OR 97230. (95492) | Choi's Kimchi LLC | Food | Class I | 1 |
| 1 Oct 2024 | Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord Healthcare Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad 382 213, India. Mfg. Lic. No.: G/28/1336, NDC 16729-288-38 | ACCORD HEALTHCARE, INC. | Drug | Class II | 1 |
| 30 Sep 2024 | Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc.,… | Glenmark Pharmaceuticals Inc., USA | Drug | Class III | 1 |
| 30 Sep 2024 | El Gallo Azul Cock Brand Queso Procesado/Processed Cheese 300g packaged in a metal can (95463) | Yucatan Products dba Lorena Sandoval | Food | Class II | 1 |
| 30 Sep 2024 | Hungarian Mushroom Soup sold at PCC Community Market as: (1) Sold in grab and go plastic retail container, net wt. 24 oz. UPC 20452200000. (2) Sold hot in self-serve soup bar. (3) Sometimes used as a sauce for Hungarian Meatballs served in some stores self-serve hot bar. (95469) | Puget Consumers Co-Op | Food | Class II | 1 |
| 28 Sep 2024 | King Harvest Spinach Hummus, perishable and refrigerated, packed in plastic tubs with tamper evident lids. Net wt. 10oz. Dist. Exclusively by Pacific Coast Fresh Co Portland, Oregon. UPC 0 25726 31108 7. | Pacific Coast Fresh CO | Food | Class II | 1 |
| 27 Sep 2024 | Lunds & Byerlys lone star dip. Net Wt 12 oz. (340.5g) UPC 0 18169-74197 9. Produced by Lunds & Byerlys, Edina, MN 55424. (95474) | Lund Food Holdings Inc | Food | Class II | 1 |
| 26 Sep 2024 | Horizon Organic Ultra Pasteurized Heavy Whipping Cream, refrigerated, One Pint (473ml), UPC 7 42365 21685 5. There are 12 cartons per case. Distributed by: Horizon Organic Dairy, LLC (Horizon) Broomfield, CO 80021.UPC: 742365216855 | Horizon Organic Dairy, LLC | Food | Class II | 1 |
| 26 Sep 2024 | Great Value Diced Peaches, Mandarin Segments, & Cherry Mixed Fruits Variety Pack, 4 oz, 12 Pack | Walmart Inc | Food | Class III | 2 |
| 25 Sep 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58 | Fresenius Kabi Compounding, LLC | Drug | Class II | 10 |
| 24 Sep 2024 | Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. (95489) | Individual firm, name withheld | Device | Class II | 1 |
| 24 Sep 2024 | medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2 | Smiths Medical ASD, Inc. | Device | Class II | 24 |
| 24 Sep 2024 | Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27. | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 24 Sep 2024 | Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01. (95418) | Nivagen Pharmaceuticals Inc | Drug | Class II | 1 |
| 24 Sep 2024 | Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. | VIONA PHARMACEUTICALS INC | Drug | Class II | 1 |
| 24 Sep 2024 | Grabeez The Big Cheese SNACK MIX Net Wt. 3.25 oz (92g) Ingredients: Peanuts***Cheese Pretzel Gems***Vegetable Shortening***Snackin' Mix***Cheez-It Crackers***Cheese Wicks***Contains Milk, Peanuts, Soy, Wheat and Sesame. Truly Good Foods, Charlotte, NC 28273 | Tropical Nut & Fruit Company | Food | Class II | 1 |
| 23 Sep 2024 | Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61 | Advanced Accelerator Applications USA, Inc. | Drug | Class II | 1 |
| 23 Sep 2024 | Sour Charlie bread, #2092, bag of 6 rolls (net wt. 7oz), 48 mini loaves per case. UPC code 0076011611894. Product was packaged bulk in a clear plastic bag inside a cardboard box and was not sold to consumers. Product was not labeled with a best by/exp date but recalling firm sells as "fresh" and estimates loaves will… (95425) | Salt City Baking Company, LLC | Food | Class II | 1 |
| 19 Sep 2024 | AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode | Ad-Tech Medical Instrument Corporation | Device | Class II | 3 |
| 19 Sep 2024 | Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633 | Baxter Healthcare Corporation | Device | Class II | 9 |
| 19 Sep 2024 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2 | Gilead Sciences, Inc. | Drug | Class I | 1 |
| 19 Sep 2024 | Lactaid Lactose Reduced milk 1. 96 oz Lactaid Whole Milk 2. 96 oz Lactaid 2% Milk 3. 96oz Lactaid 1% Milk 4. 96oz Lactaid Fat Free Milk (1607) 5. 96oz Lactaid 2% Calcium Enriched Milk (15567) | HP Hood LLC | Food | Class I | 1 |
| 18 Sep 2024 | A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the… (95416) | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. | Device | Class II | 1 |
| 18 Sep 2024 | Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia. (95391) | 123Herbals | Drug | Class I | 1 |
| 18 Sep 2024 | EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1 (95390) | EnviroServe Chemicals Inc. | Drug | Class II | 1 |
| 17 Sep 2024 | Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods. | Mckesson Medical-Surgical Inc. Corporate Office | Device | Class II | 1 |
| 17 Sep 2024 | Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87. | Bionpharma Inc. | Drug | Class I | 1 |
| 16 Sep 2024 | The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deployment of the graft material out of the Graft Tube and adjacent to where the implant is to be placed, as supported… (95341) | Spineology, Inc. | Device | Class II | 1 |
| 16 Sep 2024 | Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve. | Cook Incorporated | Device | Class II | 1 |
| 16 Sep 2024 | Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043, | AbbVie Inc. | Drug | Class II | 2 |
| 16 Sep 2024 | Rum Raisin Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen | Today's Frozen Desserts, Inc. | Food | Class II | 5 |
| 14 Sep 2024 | Mini Raspberry Lemon Coffee Cake, net wt. 13.5oz. UPC 8 57297 00745 4. Made with Gluten-Free Ingredients in a Gluten-Friendly Bakery. Macrina Bakery - Kent, WA. Ingredients: CANE SUGAR, GREEK YOGURT (GRADE A PASTEURIZED CULTURED MILK, CREAM, NONFAT MILK), EGGS, RASPBERRIES, BROWN RICE FLOUR, UNSALTED BUTTER (CREAM… (95381) | Mac & Co | Food | Class II | 1 |
| 13 Sep 2024 | Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z | Zyno Medical LLC | Device | Class I | 1 |
| 13 Sep 2024 | MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535) | Integra LifeSciences Corp. | Device | Class II | 1 |
| 13 Sep 2024 | EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy. Model/Catalog Number: BD-410X-1055 | Olympus Corporation of the Americas | Device | Class II | 1 |
| 13 Sep 2024 | S'mores Bites, 1 yummy pound, Distributed by Nuts.com, Cranford, NJ, 07016 (95403) | Individual firm, name withheld | Food | Class I | 1 |
| 13 Sep 2024 | Enjoy Premium Taro Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags | KTM Services, Inc. | Food | Class I | 2 |
| 12 Sep 2024 | Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3) BT-20-0002AP, 4) BT-20-0007, 5) BT-20-0011, and 6) RMS010118CP | Baxter Healthcare Corporation | Device | Class I | 1 |
| 12 Sep 2024 | BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150 | Becton Dickinson & Co. | Device | Class II | 1 |
| 11 Sep 2024 | LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01 (95344) | Waldemar Link GmbH & Co. KG (Corp. Hq.) | Device | Class II | 1 |
| 11 Sep 2024 | SynchroMed II Infusion Pump. Product Number: 8637-20 (95419) | Individual firm, name withheld | Device | Class II | 1 |
| 11 Sep 2024 | First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80 (95422) | Zhejiang Jingwei Pharmaceutical Co., Ltd. | Drug | Class II | 1 |
| 11 Sep 2024 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06 | Mckesson Medical-Surgical Inc. Corporate Office | Drug | Class II | 1 |
| 11 Sep 2024 | Item FLD4006, Potato Salad, distributed in plastic clamshell containers, net wt. 0.56lb. The H-Mart label declares: Potato, Mayonnaise, Sugar, Vegetable. | Lemonland Food Corp | Food | Class I | 13 |
| 10 Sep 2024 | Minute Maid Zero Sugar Lemonade 12 cans carton UPC 0 25000 12115 9 CANNED UNDER THE AUTHORITY OF THE COCA-COLA COMPANY, ATLANTA, GA (95317) | COCA COLA Consolidated LLC | Food | Class II | 1 |
| 9 Sep 2024 | iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 | Atrium Medical Corporation | Device | Class II | 1 |
| 9 Sep 2024 | Sqwincher Electrolyte Beverage Mix, Orange powder pack, Net Wt 47.66 oz (3lb) 1.35 kg: UPC 7588008834 / 16 per case / 5 gal yield item number 159016404 | Kent Precision Foods Group, Inc. | Food | Class II | 2 |
| 9 Sep 2024 | 7-Eleven Fudge Brownie with Chocolate Chip, 3.5 oz. UPC: 05254856392 (95327) | Innovation Bakers, LLC | Food | Class I | 1 |
| 9 Sep 2024 | Bacalaitos Criollos, CODFISH FRYING MIX, 7 oz., packaged in a plastic bag, 24 packages (units) per cases of 7 onz. (95310) | Avole, Inc. | Food | Class II | 1 |
| 6 Sep 2024 | Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application. | Boston Scientific Corporation | Device | Class II | 1 |
| 6 Sep 2024 | Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.1.000, 8.3.2.000, 8.4.0.000, 8.4.1.000… | Agfa Healthcare NV | Device | Class II | 1 |
| 6 Sep 2024 | Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component. | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION | Device | Class II | 1 |
| 6 Sep 2024 | Flavor#115 Electrolytes, Net Contents 3.78L, #740-0115, GTIN barcode 00850010449043. Product is packaged as a Bag In Box (BIB) single unit for use in Bevi Smart Water Cooler machines dispensing flavored waters. (95347) | Hydration Labs Inc. dba Bevi | Food | Class II | 1 |
| 6 Sep 2024 | Gorilla Mind Rauwolscine Dietary Supplement, Suppress Appetite, Increased Fat Loss, Increased Energy, dosage 3mg, 90 capsules per bottle, UPC 8 50017 02016 0. Product is manufactured for Gorilla Mind LLC 7154 W. State Street, STE 138, Boise, ID. Product label declares "***Supplement Facts: Rauwolscine Extract***Other… (95313) | Gorilla Mind LLC | Food | Class I | 1 |
| 5 Sep 2024 | NxTAG Respiratory Pathogen Panel, REF: I051C0447 | Luminex Molecular Diagnostics Inc | Device | Class II | 2 |
| 5 Sep 2024 | 1.2mm Cross Cut Fissure - Intended for use in the cutting, drilling, reaming, decorticating, shaping and smoothing of bone, bone cement and teeth in a variety of surgical procedures including but not limited to dental, ENT (ear, nose and throat), neuro, spine and endoscopic applications Catalog Number: 5820-066-012 | Stryker Corporation | Device | Class II | 1 |
| 5 Sep 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes intravascular ultrasound… | Boston Scientific Corporation | Device | Class II | 22 |
| 5 Sep 2024 | Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1. (95304) | Empower Pharmacy | Drug | Class II | 1 |
| 5 Sep 2024 | Whole cantaloupe, brand name Kandy, packed in a corrugated box, 9 count (95309) | Eagle Produce LLC, dba Martori Farms | Food | Class I | 1 |
| 4 Sep 2024 | Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200 | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 4 Sep 2024 | Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples | LEICA BIOSYSTEMS NUSSLOCH GMBH | Device | Class II | 6 |
| 4 Sep 2024 | bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option. | B-K Medical A/S | Device | Class II | 1 |
| 4 Sep 2024 | Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 33 |
| 3 Sep 2024 | GE Heathcare Giraffe OmniBed; neo natal incubator | DATEX--OHMEDA, INC. | Device | Class I | 2 |
| 3 Sep 2024 | Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: (1) 782117 (2) 782143 | Philips North America Llc | Device | Class II | 13 |
| 3 Sep 2024 | (1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp with 1.13cm Bell and Insert, Reorder #230CR, Sterile; (4) Centurion CirClamp with 1.45cm Bell and Insert, Reorder #245CR, Sterile; (5) Centurion CirClamp with 1.1cm Bell,… | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 3 Sep 2024 | Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12. | Ascend Laboratories, LLC | Drug | Class II | 1 |
| 3 Sep 2024 | Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Champlain, NY USA 12919, Made in Canada, NDC 67226-2232-6. SKU 10-160-ZZ-80059-R (95339) | Vivier Pharma, Inc. | Drug | Class II | 1 |
| 3 Sep 2024 | Blue Tape Sriracha sauce is refrigerated condiment, packaged in a 10.5oz clear squeeze bottle, sold individually. Ingredients: Chilies, Garlic, Capsicum, Sugar, Salt, White Wine Vinegar. There is no company address on the label and no UPC code. (95298) | Individual firm, name withheld | Food | Class II | 1 |
| 30 Aug 2024 | Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system. | Fresenius Kabi USA, LLC | Device | Class I | 1 |
| 30 Aug 2024 | Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support. | Mercury Enterprises, Inc. dba Mercury Medical | Device | Class I | 1 |
| 30 Aug 2024 | Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery (95322) | Individual firm, name withheld | Device | Class II | 1 |
| 30 Aug 2024 | The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s)… (95314) | Individual firm, name withheld | Device | Class II | 1 |
| 30 Aug 2024 | IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066) | Philips North America | Device | Class II | 1 |
| 30 Aug 2024 | Monarch Inflation Device 30 atm/bar REF IN2130 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and… | Merit Medical Systems, Inc. | Device | Class II | 6 |
| 30 Aug 2024 | MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 3 |
| 30 Aug 2024 | Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22. | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 29 Aug 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿¿¿¿¿¿ 2089507-149; j)¿¿¿¿¿¿ 2089507-153; k)¿¿¿¿¿… | GE Healthcare | Device | Class II | 1 |
| 29 Aug 2024 | Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding. | Wilson-Cook Medical Inc. | Device | Class II | 1 |
| 29 Aug 2024 | Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty | Tornier, Inc | Device | Class II | 1 |
| 29 Aug 2024 | Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA (95172) | Microcare Medical | Device | Class II | 1 |
| 29 Aug 2024 | BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons. | CooperVision, Inc. | Device | Class II | 2 |
| 29 Aug 2024 | Shiso Katsuo Ninniku (Pink Pickled Garlic), Net WT 5.2 OZ (147g). Products of China; Imported By Niitakaya U.S.A. Inc., Motebello, CA 90640 ITEM No. 3700 | Niitakaya USA Inc | Food | Class II | 2 |
| 29 Aug 2024 | KARA BOONDHI INGREDIENTS: Gram flour, Edible beg oil (Refined Palmolein Oil), Chilly powder, Curry leaf, pepper, Asafoetida, Corn Flour, Urid dhall, Black salt. Natural Antioxidant (Mixed Tocopherol INS 305) ALLERGEN INFORMATION: Made in a FActory that Process Peanuts, Tree nuts, Soy, Milk, Wheat Sesame and Jaggery… | Grace Imports, Inc | Food | Class II | 3 |
| 28 Aug 2024 | Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 28 Aug 2024 | The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the… | Beckman Coulter, Inc. | Device | Class II | 1 |
| 28 Aug 2024 | MEDLINE HEART CABG CDS, REF CDS983376R | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 6 |
| 28 Aug 2024 | BIG BOTTOM MILK COMPANY, CHOCOLATE MILK GRADE A, 1 US Gallon (3.79 liters), Big Bottom Milk Company 221 Hogan Rd, Forest City, NC, Expiration Date 09/09/2024 UPC code 8 50061 50604 7 | Big Bottom Milk Company | Food | Class II | 3 |
| 27 Aug 2024 | Whole Grains Bakery labeled "Poppy Seed Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC "7 13583 05 103 0" | The Posh Bakery, Inc. | Food | Class I | 9 |
| 26 Aug 2024 | Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID | Nova Ortho-Med Inc | Device | Class II | 3 |
| 26 Aug 2024 | FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer | Qualigen Inc | Device | Class II | 1 |
| 26 Aug 2024 | Dry Dates, 50 lb. bag (95413) | BlueStar Direct LLC | Food | Class II | 1 |
| 26 Aug 2024 | M&P Food Products Cheese & Cherry Blintzes; Hand Made Russian Style; 6 Classic; NET WT. 14 OZ. (396g); KEEP FROZEN; INGREDIENTS: Flour, low fat milk; eggs, margarine; sugar, salt; FILLING INGREDIENTS: Farmer Cheese, cherries; Cheese & Cherry Blintzes Net Wt. 14 OZ. (396g) UPC: 707163303257 | M & P Food Productions, Ltd. | Food | Class II | 9 |
| 23 Aug 2024 | AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. (95274) | Individual firm, name withheld | Device | Class II | 1 |
| 23 Aug 2024 | BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution. | Young Dental Manufacturing I, LLC | Device | Class II | 1 |
| 23 Aug 2024 | 54th St Blackened Sauce, 9lb bags - 4 bags per case. (95237) | La Fontanella Food Products LLC | Food | Class II | 1 |
| 22 Aug 2024 | StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 22 Aug 2024 | Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart. The Healgen Series Reagent Strips for… (95248) | Healgen Scientific Llc | Device | Class II | 1 |
| 22 Aug 2024 | KINOVA Jaco assistive robot. Model Numbers: PJ 0000 0001, PJ 0000 0012, PJ 0090 0001, PJ 0090 0006, KR MJ2 0001. Jaco replaces the function of the upper limb on one side of the body. (95065) | Kinova Inc | Device | Class I | 1 |
| 22 Aug 2024 | Marionberry Scones, bulk packaged in cake boxes with parchment paper, unwrapped. Products are not individual labeled and are held in bulk for retail sale. Each location has a notebook with all the ingredients used in the scones. | Skagit River Bakery & Cafe | Food | Class II | 2 |
| 21 Aug 2024 | ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test) | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 21 Aug 2024 | Percussionaire, Inc., REF: P5-TEE, Qty: 1, Rx Only. IPV (Intrapulmonary Percussive Ventilation) therapy In-Line Valve | Percussionaire Corporation | Device | Class I | 2 |
| 21 Aug 2024 | Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1. | CHANGE HEALTHCARE CANADA COMPANY | Device | Class II | 3 |
| 21 Aug 2024 | Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045 | XTANT Medical Holdings, Inc | Device | Class II | 1 |
| 21 Aug 2024 | Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100 | Olympus Corporation of the Americas | Device | Class II | 1 |
| 21 Aug 2024 | Vanta Implantable Neurostimulator (INS), Model 977006 (95281) | Individual firm, name withheld | Device | Class II | 1 |
| 21 Aug 2024 | Heart of the Earth (HOTE) 100% Pure Ceremonial Cacao Pre-Ground Paste. Net Wt. 16oz (454g). Packaged in Kraft paper heat sealed stand-up pouch bags with inner plastic liner with SKU PC-GRUCCP-1LB. Product of Guatemala. Distributed Soul Lift Cacao of Portland, Oregon. The product is 100% pure cacao (chocolate) which… (95213) | Inner Waymark LLC | Food | Class II | 1 |
| 20 Aug 2024 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 | Ossur H / F | Device | Class II | 1 |
| 20 Aug 2024 | Grade A Brown Chicken Eggs, in shell, Bulk 15 dozen. For Foodservice. Keep Refrigerated. Sold with the following brands: 1. Milo's Poultry Farms, N 3873 Valley Road, Bonduel, WI 54107. Organic Eggs from Free Range Hens. 2. M&E Family Farms, Eggs from Free Range Hens. N 3873 Valley Road, Bonduel, WI 54107. EXPANDED… (95203) | Milo's Poultry Farms, LLC | Food | Class I | 1 |
| 19 Aug 2024 | Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI UPGRADE KIT, 3DIMENSIONS 2.3.0.3 SYSTEM… | Hologic Inc | Device | Class II | 1 |
| 19 Aug 2024 | Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C | Merit Medical Systems, Inc. | Device | Class II | 10 |
| 16 Aug 2024 | Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure. | Windstone Medical Packaging, Inc. | Device | Class II | 5 |
| 15 Aug 2024 | Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190 | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 15 Aug 2024 | ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11653093, with software. | Siemens Medical Solutions USA, Inc. | Device | Class II | 3 |
| 14 Aug 2024 | 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R | 3M Company - Health Care Business | Device | Class II | 1 |
| 14 Aug 2024 | Montreal Fudge brand Chocolate Fudge with Nuts; 5.6oz (95196) | Individual firm, name withheld | Food | Class II | 1 |
| 13 Aug 2024 | Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS | Olympus Corporation of the Americas | Device | Class II | 2 |
| 12 Aug 2024 | Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) | Merit Medical Systems, Inc. | Device | Class II | 2 |
| 12 Aug 2024 | BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed. | Becton, Dickinson and Company, BD Bio Sciences | Device | Class II | 1 |
| 9 Aug 2024 | STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia. Synchronized cardioversion is indicated for… | Physio-Control, Inc. | Device | Class II | 1 |
| 9 Aug 2024 | GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to… | Wipro GE Healthcare Private Ltd. | Device | Class II | 2 |
| 8 Aug 2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. | Datascope Corp. | Device | Class I | 2 |
| 8 Aug 2024 | eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal (95241) | T.G. Eakin Limited | Device | Class III | 1 |
| 8 Aug 2024 | CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons. | Datascope Corp. | Device | Class I | 2 |
| 8 Aug 2024 | DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere, | Alcon Research LLC | Device | Class II | 1 |
| 7 Aug 2024 | MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063 | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 7 Aug 2024 | PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. | Fisher & Paykel Healthcare, Ltd. | Device | Class II | 1 |
| 7 Aug 2024 | Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24667 | Cook Biotech, Inc. | Device | Class II | 12 |
| 7 Aug 2024 | PACEMAKER PACK, SLCV01J; Medical convenience kit | American Contract Systems, Inc. | Device | Class II | 19 |
| 5 Aug 2024 | The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning phase, the desired… (95194) | QUANTUM SURGICAL SAS | Device | Class II | 1 |
| 5 Aug 2024 | GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system. | GE Healthcare | Device | Class II | 1 |
| 2 Aug 2024 | BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 2 Aug 2024 | Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB. | AURIS HEALTH INC | Device | Class II | 2 |
| 1 Aug 2024 | Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute or chronic care facility. | Outset Medical, Inc. | Device | Class II | 1 |
| 1 Aug 2024 | BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 443624 | Becton Dickinson & Co. | Device | Class II | 2 |
| 1 Aug 2024 | WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN):… | Boston Scientific Corporation | Device | Class II | 31 |
| 31 Jul 2024 | MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851 | Medtronic MiniMed, Inc. | Device | Class I | 3 |
| 31 Jul 2024 | Silver-Plated Copper Sims Uterine Sound, Part Number 64-600 | CooperSurgical, Inc. | Device | Class II | 2 |
| 31 Jul 2024 | Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system. | Inspire Medical Systems Inc. | Device | Class II | 2 |
| 31 Jul 2024 | IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry. | Beckman Coulter Inc. | Device | Class II | 1 |
| 26 Jul 2024 | Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide,… | ARROW INTERNATIONAL Inc. | Device | Class II | 1 |
| 24 Jul 2024 | Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right. | TMJ Solutions Inc | Device | Class II | 1 |
| 24 Jul 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 16 Fr/Ch (5.3 mm) x 48… | Cardinal Health 200, LLC | Device | Class II | 2 |
| 23 Jul 2024 | Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 | Individual firm, name withheld | Device | Class II | 8 |
| 18 Jul 2024 | prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5 | Centinel Spine, Inc. | Device | Class II | 2 |
| 18 Jul 2024 | smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080; f)… | Smiths Medical ASD Inc. | Device | Class II | 5 |
| 16 Jul 2024 | Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device. | Beckman Coulter, Inc. | Device | Class III | 1 |
| 15 Jul 2024 | Collagen Joint Support with Black Currant LOT#: Q241851; 14 Stick Pack 3.92 oz (95443) | Quantum Fulfillment and Support, LLC | Food | Class II | 1 |
| 12 Jul 2024 | Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia. | Datex-Ohmeda, Inc. | Device | Class I | 11 |
| 12 Jul 2024 | Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A. | Supercore Products Group Inc. | Drug | Class I | 2 |
| 2 Jul 2024 | BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X,… | Argon Medical Devices, Inc | Device | Class II | 1 |
| 26 Jun 2024 | DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01 | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD | Device | Class II | 3 |
| 26 Jun 2024 | CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 | Smiths Medical ASD Inc. | Device | Class II | 9 |
| 26 Jun 2024 | Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dalayurevda.com, Made in India, UPC: 042535355019 (94893) | Guru Inc. | Drug | Class II | 1 |
| 18 Jun 2024 | Principal Display: SureLife Foods PALEO BARS, Net Wt. 14 oz. (392 g.)- 14 ct. individually wrapped bars (28 g. each) Certified Gluten Free, Certified Paleo Loaed with: Almonds, Honey, Shredded Coconut, Pumpkin Seeds, Brazil Nuts, Chia Seeds & More! Back Display: Ingredients: Whole Almonds, Honey, Shredded Coconut,… | Best Express Foods, Inc. | Food | Class II | 1 |
| 31 May 2024 | paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N | Smiths Medical ASD Inc. | Device | Class I | 2 |
| 24 May 2024 | Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC) (95392) | CUE HEALTH INC | Device | Class II | 1 |
| 15 May 2024 | Gelato ice cream packaged in Compostable Tubs which are labeled in part Vaschetta Accoppiata Compostabile . The gelato is packaged in four (4) sizes of Compostable Tubs: COMPOSTABLE YETI TUB 350 GR/ 500 CC (M) (16.90 fl. oz.) COMPOSTABLE YETI TUB 500 Gr/750 CC (25.36 fl. oz.) (L) COMPOSTABLE YETI TUB 750 Gr/1000 CC… (95037) | ALCAS USA CORP. | Food | Class III | 1 |
| 18 Apr 2024 | Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 16 Feb 2024 | Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A | CooperSurgical, Inc. | Device | Class II | 3 |
| 15 Feb 2024 | DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126 | Philips North America Llc | Device | Class II | 1 |
| 9 Jan 2024 | Custodiol HTK Solution, 500ml bottle. 10 per carton. (95182) | Individual firm, name withheld | Device | Class II | 1 |
| 23 Nov 2023 | The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled. | FUJIFILM Healthcare Americas Corporation | Device | Class II | 1 |
| 14 Sep 2023 | EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation | Olympus Corporation of the Americas | Device | Class II | 1 |
| 14 Jun 2023 | IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need… | Philips North America Llc | Device | Class II | 1 |
| 19 Apr 2023 | Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1 | Philips North America | Device | Class II | 1 |
| 13 Mar 2023 | Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00 | Spectrum Medical Ltd. | Device | Class II | 1 |
| 18 Jan 2023 | IntelliVue G7m Anesthesia Gas Module, Product Number 866173 | Philips North America | Device | Class II | 1 |
| 27 Jul 2022 | Diasol Acid Concentrate REF G100325-10Dex 100 | Diasol, Inc | Device | Class II | 1 |