| 11 Jul 2023 | Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30. | Ascend Laboratories, LLC | Drug | Class II | 1 |
| 10 Jul 2023 | Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 10 Jul 2023 | Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon; e) 1 gallon; f) 5 gallon; g) 55 gallon;… (92634) | Tenn South Distillery LLC dba Big Machine Distillery | Drug | Class II | 1 |
| 10 Jul 2023 | SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10 | New England Life Care, Inc. dba Advanced Compounding Solutions | Drug | Class II | 4 |
| 10 Jul 2023 | 365 by Whole Foods Market Organic Asian Inspired Chopped Salad Kits 12 oz plastic bags 9 bags per case UPC: 9948246932 Item#: 9770522 (92684) | Braga Fresh Foods | Food | Class I | 1 |
| 8 Jul 2023 | Lipton Diet Green Tea Citrus, 24 pack of 16.9floz bottles. UPC # 0-12000-01722-3 | Pepsico Inc | Food | Class III | 1 |
| 7 Jul 2023 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01. | SterRx, LLC | Drug | Class II | 5 |
| 5 Jul 2023 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28 | Teva Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 5 Jul 2023 | Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class III | 1 |
| 5 Jul 2023 | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00 | B. Braun Medical Inc. | Drug | Class II | 1 |
| 3 Jul 2023 | Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43. | Accord Healthcare, Inc. | Drug | Class II | 2 |
| 1 Jul 2023 | Coca Cola Ultimate; packaged in 20oz PET bottles, 24 loose bottles per case *Product incorrectly labeled as Coca Cola Ultimate Zero Sugar (92652) | Coca Cola Bottling Group United | Food | Class II | 1 |
| 30 Jun 2023 | Phillips Butterscotch Cone Coating; packaged in 96fl oz metal cans, 6 cans per case | Lyons Magnus LLC | Food | Class II | 1 |
| 30 Jun 2023 | Fry Daddy's Original Party Mix 3.75oz and 12oz bags UPCs 860007991509 and 850047648006. 12 bags per wholesale case | Fry Daddy's Brand | Food | Class II | 10 |
| 27 Jun 2023 | Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60 | Cipla USA, Inc. | Drug | Class I | 1 |
| 27 Jun 2023 | Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 26 Jun 2023 | Digisonics OBView Versions 4.8.2 SP6 - 4.8.3, Ultrasound reporting software (92619) | Digisonics, Inc | Device | Class II | 1 |
| 26 Jun 2023 | Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08 | Strides Pharma Inc. | Drug | Class II | 1 |
| 26 Jun 2023 | Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited. | Preferred Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 26 Jun 2023 | Rose Street Patisserie Multi Grain Bread. Net Wt. 375 grams. 882 7th Street West, St. Paul, MN 55102 (92626) | Rose Street Bread Lab | Food | Class I | 1 |
| 23 Jun 2023 | PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10, (92582) | Vivus, Inc. | Drug | Class III | 1 |
| 23 Jun 2023 | Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2. | Amerisource Health Services LLC | Drug | Class II | 1 |
| 23 Jun 2023 | Cargill Trisodium Citrate Dihydrate packaged in 50 lb. paper bags and 2,000 lb. supersacks. Product item ids: 1. SKU 100002299, TSC DIHYD FN 50LB BG 6132-04-3 KH FC 2. SKU 100105400, TSC DIHYD FN 2000LB RED HNDL SS KH 3. SKU 100106066, TSC DIHYD FN 2000LB RED HNDL SS KH FCC 4. SKU 100105370, TSC DIHYD GNLR 50LB BG KH… | Cargill, Inc Corporate Headquarters | Food | Class II | 2 |
| 23 Jun 2023 | 1/2 gallon CN Smith brand Apple Cider; 1/2 gallon and 16 oz. Wilson Farms brand Apple Cider; 1 gallon, 1/2 gallon, and 16 oz. Carlson Orchards brand Apple Cider - all packaged in HDPE bottles and shipped in corrugated closed boxes. (92593) | Bevovations, LLC | Food | Class II | 1 |
| 22 Jun 2023 | Fromagerie Ottavi Tome Corse Sheep Milk Cheese (92592) | FMA International LLC | Food | Class I | 1 |
| 21 Jun 2023 | Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10 (92564) | Individual firm, name withheld | Drug | Class II | 1 |
| 21 Jun 2023 | Trader Joe s Organic Tropical Fruit Blend Pineapple, Banana, Strawberry, Mango, SKU #051191, packaged in pillow bags. Each case consists of 24 bags and each bag is 16 oz. UPC on retail bag: 00511919 | Scenic Fruit Company, LLC | Food | Class I | 2 |
| 21 Jun 2023 | 1st phorm Level-1 Sustained Assimilation Protein. Chocolate Marshmallow. Protein Supplement. Item number 502396. Net Wt. 2.45 lbs (1.11kg) UPC 8 50036-64808 6. Manufactured & Designed Exclusively for 1st Phorm, 2091 Fenton Logistics Pk Blvd, Fenton, MO 63026 | International Food Companies DBA International Food Products | Food | Class II | 2 |
| 21 Jun 2023 | Mini Deviled Crabs, 1oz | SANTOS FROZEN FOODS | Food | Class I | 3 |
| 21 Jun 2023 | Private Selection 48oz Classic Fruit Medley, frozen product, 8/48 oz bags per case. UPC 0 11110 82026 6. Distributed by The Kroger Co. Cincinnati, OH | Townsend Farms Inc | Food | Class I | 4 |
| 21 Jun 2023 | Tampico brand Mango Punch; LESS THAN 1% JUICE; 1 GAL (3.78 L); INGREDIENTS: WATER, HIGH FRUCTOSE CORN SYRUP, LESS THAN 2% OF MANGO JUICE FROM CONCENTRATE, ORANGE JUICE FROM CONCENTRATE, TANGERINE JUICE FROM CONCENTRATE, ASCORBIC ACID (VITAMIN C), NATURAL AND ARTIFICIAL FLAVORS, POTASSIUM SORBATE (PRESERVATIVE), EDTA… (92589) | Garelick Farms LLC | Food | Class II | 1 |
| 19 Jun 2023 | GEM FLOW COUPLER Monitor, PN 5156-00000-011 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 16 Jun 2023 | NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010 | Cardinal Health 200, LLC | Device | Class II | 1 |
| 16 Jun 2023 | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152… | The Harvard Drug Group | Drug | Class II | 1 |
| 16 Jun 2023 | Tostitos Avocado Salsa Jar Dip 15 oz, UPC 2840005597 packaged in a clear glass jar | Frito-Lay, Inc. Headquarters | Food | Class I | 1 |
| 16 Jun 2023 | Romaine lettuce packed in bulk 45 pound mini-bins (92677) | C&E Farms, Inc. | Food | Class II | 1 |
| 16 Jun 2023 | Romaine lettuce, packaged into the following configurations and sizes: 1. Medium, Produce Code 720832, 6-2lb per shipping case. 2. Medium, Produce Code 720840, 10-2lb per shipping case. 3. 1.5XRandom, Produce Code 720625, 4-2.5lb bags per shipping case. 4. 1.5XRandom, Produce Code 720725, 4-2.5lb bags per shipping… | G.O. Corporation | Food | Class II | 3 |
| 16 Jun 2023 | Pineapple Chunks packaged under the following brand names and sizes. 1. 365 Whole Foods Market, Net Wt 16 oz (1 lb) 454g UPC 0 99482-40854 1. Keep Frozen. Distributed by: Whole Foods Market, Austin, TX 78703. 2. 365 Whole Foods Market, Net Wt 10 oz (284g) UPC 0 99482-49096 6. Keep Frozen. Distributed by: Whole Foods… | SunOpta Grains and Foods Inc. | Food | Class I | 16 |
| 15 Jun 2023 | SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 | Baxter Healthcare Corporation | Device | Class I | 2 |
| 15 Jun 2023 | Wegmans single serve snack tray (5.7oz) packaged in a clear square plastic packaging with fruit, almonds and cheese 6 trays per case | Stellex/CF Houston, LLC | Food | Class II | 2 |
| 14 Jun 2023 | Simplexa Direct Amplification Disc Kit, Rx Only, IVD The Simplexa Direct Amplification Disc Kit, REF: MOL1455 is 1 box containing 3 Direct Amplification Discs (DADs). Each box contains discs individually pouch-sealed and labeled with REF: MOL1452 | DiaSorin Molecular LLC | Device | Class II | 1 |
| 14 Jun 2023 | Impella 2.5 intravascular micro axial blood pump, Product Number 005042 | Abiomed, Inc. | Device | Class I | 6 |
| 14 Jun 2023 | Frozen Wild Alaska Smoked Salmon Spread packaged in 6 oz. (net weight) rigid plastic tubs. Product packed in 10 units per case. Product is labeled in part, "***KENAI*RED FISH COMPANY***WILD ALASKA SMOKED SALMON SPREAD KEEP FROZEN - STIR & REFRIGERATE AFTER OPENING Ingredients: Wild Alaska Smoked Salmon (Salmon, Brown… (92574) | Kenai Red Fish Company LLC | Food | Class III | 1 |
| 13 Jun 2023 | Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. | Wright Medical Technology, Inc. | Device | Class II | 1 |
| 13 Jun 2023 | Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN… (92514) | Individual firm, name withheld | Device | Class II | 1 |
| 13 Jun 2023 | Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE… | K.C. Pharmaceuticals, Inc | Drug | Class II | 2 |
| 13 Jun 2023 | Tony Charchere's Ranch Salad Dressing packaged in 12oz PET bottle - 6 bottles per case (92611) | SCREAMING EAGLE CO PACK LLC | Food | Class III | 1 |
| 12 Jun 2023 | da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12 | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 12 Jun 2023 | Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac). | Abbott | Device | Class I | 1 |
| 12 Jun 2023 | AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101 | Tornier, Inc | Device | Class II | 2 |
| 12 Jun 2023 | Oxylog 3000 Plus emergency and transport ventilator | Draeger Medical, Inc. | Device | Class I | 1 |
| 12 Jun 2023 | Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03 | Ferring Pharmaceuticals Inc | Drug | Class II | 1 |
| 12 Jun 2023 | Martinelli's Gold Medal 100% Apple Juice 10 oz. glass bottles, 24 units per case Apple shaped glass bottles Shelf stable UPC: 041244000098 (92526) | Individual firm, name withheld | Food | Class II | 1 |
| 12 Jun 2023 | Gelato Boy Chocolate Chunk Gelato, frozen dessert, 24 month shelf life, paper cup and lid. 14 FL OZ, UPC: 853457008002, distributed by Gelato Boy, 5401 Western Ave., Boulder, CO 80301 (92528) | Individual firm, name withheld | Food | Class III | 1 |
| 12 Jun 2023 | Havasu Beetroot Powder, 11.5 oz. (92507) | Supplement Manufacturing Partner, Inc. | Food | Class II | 1 |
| 9 Jun 2023 | Pearl Milling Company Self-Rising Yellow Corn Meal Mix Net Wt 80 oz (5 lb) UPC 3000057380 packaged in paper bag with printed label | PepsiCo Beverages & Foods | Food | Class II | 2 |
| 9 Jun 2023 | Sun Wave Brand Jelly Cup (Assorted Flavors); Made in Taiwan; Item Number 12151; UPC 715685121512; Net Weight 35.27 oz. (1000 g) Sun Wave Brand Jelly Cup (Assorted Flavors); Made in Taiwan; Item Number 12143; UPC 715685121437; Net Weight 52.91 oz. (1500 g) | Richin Trading Inc | Food | Class I | 3 |
| 8 Jun 2023 | BD Synapsys Informatics Solution, Catalog Number 444150 | Becton Dickinson & Co. | Device | Class II | 1 |
| 8 Jun 2023 | Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60 | Olympus Corporation of the Americas | Device | Class I | 7 |
| 8 Jun 2023 | Churritos Corn Flour sticks, shelf stable, 6 months shelf life, packed in a rectangular shape clear polypropylene bag with net wt.11 oz (311.845g.), UPC# 6-0972233599-7. Product labeled in part, "***BOTANAS MICHOACANS CHURRITOS CORN FLOUR STICKS***Best By:***Ingredients: Corn Flour, wheat flour (niacin, reduced iron,… (92517) | Individual firm, name withheld | Food | Class II | 1 |
| 8 Jun 2023 | Fresh To You Chicken Filet Sandwich. MGF0635. Net Wt. 8oz. Perishable - Keep Refrigerated. Manufactured By MG Foods, Oak Creek, WI 53154 (92513) | Compass USA | Food | Class II | 1 |
| 7 Jun 2023 | Great Value Sliced Strawberries. Item # 107356. Frozen, packaged flexible plastic bags. Net wt. 4 lbs (64oz). UPC on retail bag: 0 78742 25387 9. A total of 6 sellable units (4lbs. each) are placed into a case for distribution to retailer. DISTRIBUTED BY: Walmart Inc. Bentonville, AR. | Oregon Potato Company | Food | Class I | 5 |
| 6 Jun 2023 | OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck Model Number: NL5000 | NeuroLogica Corporation | Device | Class II | 1 |
| 6 Jun 2023 | Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation (92413) | Individual firm, name withheld | Device | Class II | 1 |
| 6 Jun 2023 | Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, REF 981023322, spinal implant | Medtronic Sofamor Danek USA Inc | Device | Class II | 7 |
| 5 Jun 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US… | Datascope Corp. | Device | Class I | 2 |
| 5 Jun 2023 | Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. | Exactech, Inc. | Device | Class II | 2 |
| 5 Jun 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US… | Datascope Corp. | Device | Class I | 2 |
| 5 Jun 2023 | Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 | Luminex Corporation | Device | Class II | 2 |
| 5 Jun 2023 | Perifix¿ / Epidural anesthesia kit (10 count carton) | B. Braun Medical, Inc. | Device | Class II | 2 |
| 5 Jun 2023 | Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02 | Homeocare Laboratories, Inc. | Drug | Class II | 11 |
| 5 Jun 2023 | Organic Daybreak Blend Brand Name: Wawona Frozen Foods 4 lb. plastic bags - 10 bags per case Keep Frozen Item# 684779 UPC: 0 34742 07244 5 Sold by Costco (92465) | Wawona Frozen Foods Inc. | Food | Class I | 1 |
| 2 Jun 2023 | Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly | Beckman Coulter Biomedical GmbH | Device | Class II | 2 |
| 2 Jun 2023 | Regal Gourmet Snacks Milk Chocolate Raisins 16oz. clear plastic tub, UPC 028744201002 (92488) | Regal Health Food International, Inc. | Food | Class I | 1 |
| 1 Jun 2023 | MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery | Megadyne Medical Products, Inc. | Device | Class I | 8 |
| 1 Jun 2023 | Maggi Masala ae Magic, 6 grams, Packaged in plastic sachets. 1920 sachets per case. | Amin Trading Agency LLC | Food | Class II | 3 |
| 1 Jun 2023 | Fanta Orange 12pk (12, 12 oz. cans) Wrap UPC 0 4900003073 0 (92492) | Great Lakes Coca-Cola Distribution LLC | Food | Class II | 1 |
| 31 May 2023 | COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells | Beckman Coulter, Inc. | Device | Class II | 1 |
| 31 May 2023 | REF: 218-1604, 1.6mm x 4mm Profile Zero Auto-Drive Screw, Rx Only, Sterile | Osteomed, LLC | Device | Class II | 2 |
| 31 May 2023 | Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use. | Remel, Inc | Device | Class II | 1 |
| 31 May 2023 | UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diagnostic and therapeutic treatments of temporary to short-term duration, especially in ophthalmology Art.no. / REF no.: 15000004 Art.no. / REF no.: 15000006 (92534) | UFSK - International OSYS Gmbh | Device | Class II | 1 |
| 30 May 2023 | REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R | Individual firm, name withheld | Device | Class II | 2 |
| 30 May 2023 | Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK,… | DeRoyal Industries Inc | Device | Class II | 5 |
| 30 May 2023 | GE Healthcare Vivid S60, ultrasound device | Individual firm, name withheld | Device | Class II | 4 |
| 30 May 2023 | Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 26 May 2023 | Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 | Abiomed, Inc. | Device | Class II | 1 |
| 26 May 2023 | 1. VIT-RA-TOX Calphonite #38, 15 Fl. oz. (444 ml) in an amber glass bottle; 2. Sonne's Calphonite #2, 15 Fl. oz. (444 ml) in an amber glass bottle | Anatox Inc | Food | Class III | 2 |
| 26 May 2023 | Rudolphs OnYums Onion Flavored Snack Rings 3 oz. UPC 0-24622-57106-9 packaged in metallized film bags, 15 bags per case (92426) | Rudolph Foods Company | Food | Class II | 1 |
| 26 May 2023 | A20180 BATTER MIX X4 50.00 BAG | Newly Weds Foods, Inc. | Food | Class I | 196 |
| 25 May 2023 | Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use | Philips Respironics, Inc. | Device | Class II | 1 |
| 25 May 2023 | Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T13664 - T14045. (92447) | QUIDEL CARDIOVASCULAR INC | Device | Class I | 1 |
| 25 May 2023 | Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor | TELEFLEX LLC | Device | Class II | 3 |
| 25 May 2023 | Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050 | TELEFLEX LLC | Device | Class I | 123 |
| 25 May 2023 | Cricket Creek Farm brand Sophelise cheese | Cricket Creek Farm LLC | Food | Class I | 4 |
| 24 May 2023 | Power-PRO 2- A powered ambulance cot that consists of a platform, including a mattress, mounted on a wheeled, retractable X-frame that is designed to support and transport a maximum weight of 700 lb (318 kg). Model Number: 6507 | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 24 May 2023 | RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a specific DNA sequence on a chromosome. | Cytocell Ltd. | Device | Class II | 2 |
| 23 May 2023 | wDR 2.2 Mobile Digital Diagnostic X-Ray System | SEDECAL SA | Device | Class II | 1 |
| 23 May 2023 | SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3… | TEI Biosciences, Inc. | Device | Class II | 17 |
| 23 May 2023 | Soft Cream Spread, Net Wt 16oz (1lb) (92424) | Central America Products Corporation | Food | Class II | 1 |
| 22 May 2023 | BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, 111-194, 111-195, 111-196, 111-197, 111-198; BD Pyxis CII Safe, Software: V8, 111-199-01, 111-200-01, 111-201-01, 111-202-01, 111-203-01, 111-204-01, 111-205-01,… | CareFusion 303, Inc. | Device | Class II | 1 |
| 22 May 2023 | Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS | Covidien, LLC | Device | Class II | 1 |
| 19 May 2023 | NexGen Precoat Stemmed Tibial Plate Size 5 | Zimmer, Inc. | Device | Class II | 1 |
| 19 May 2023 | DigitalDiagnost C90, Model No. 712034 and 712035 | Philips North America Llc | Device | Class II | 1 |
| 19 May 2023 | Contour¿ next GEN Blood Glucose Monitoring System (92536) | Ascensia Diabetes Care US, Inc. | Device | Class II | 1 |
| 19 May 2023 | Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed | Baxter Healthcare Corporation | Device | Class II | 2 |
| 19 May 2023 | Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476, g. M1235957, h. M1149051, i. M1146098; Labeled as the following: GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, GIRAFFE OMNIBED, GIRAFFE OMNIBED CS1, OMNI G… | DATEX--OHMEDA, INC. | Device | Class II | 3 |
| 19 May 2023 | TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs | GE Healthcare Finland Oy | Device | Class I | 9 |
| 19 May 2023 | Springworks Organic single cut green leaf lettuce, 4 oz. (92378) | Springworks Farm Inc. | Food | Class II | 1 |
| 18 May 2023 | Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610 | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 18 May 2023 | Allen Advance Chest Support with Pad | Baxter Healthcare Corporation | Device | Class II | 1 |
| 18 May 2023 | MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 7 |
| 18 May 2023 | Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 52 |
| 18 May 2023 | Mott s no sugar added applesauce 6 pack 3.9 oz (111g) Containers 23.4 oz (666g). Individual units are packaged in plastic cups and placed in a cardboard sleeve of 6 sups with 12 sleeves to a case. Retail unit UPC is 14800000078 . Case label UPC is 10014800000075 (92384) | MOTTS LLP | Food | Class II | 1 |
| 17 May 2023 | Access Hybritech p2PSA reagent, REF B03704 and REF A49752. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 16 May 2023 | Aeris Balloon Dilation Catheter (92558) | Bryan Medical Inc | Device | Class II | 1 |
| 16 May 2023 | Aptio Automation Storage and Retrieval Module (SRM) | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 16 May 2023 | Cinnamon Sticky Buns With Nuts 6 Count Net WT 2 LB 1 OZ (935g). Packaged as a singe pack or 6 pack. Packaged in a plastic container. (92356) | Individual firm, name withheld | Food | Class II | 1 |
| 15 May 2023 | Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device. (92448) | DRE Medical Group Inc | Device | Class II | 1 |
| 15 May 2023 | NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800 | NeuMoDx Molecular Inc | Device | Class III | 1 |
| 12 May 2023 | Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 12 May 2023 | TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926 | Full Vision Inc | Device | Class II | 7 |
| 10 May 2023 | PushTracker E2 component utilized with the SmartDrive MX2+ Power Assist Device (Part Numbers: MX2-32K, MX2-32P, MX2-32PK, MX2-33D, MX2-33P, MX2-33PK, MX2-33S, MX2-150, MX2-167, MX2-32D); a wearable watch that communicates with a SmartDrive Power Assist Device via the SmartDrive MX2+ Application | Permobil | Device | Class II | 2 |
| 8 May 2023 | VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM. Product Code:… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 4 May 2023 | Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640 | Randox Laboratories Ltd. | Device | Class III | 2 |
| 4 May 2023 | BETTA LINK SR KNOTLESS IMPLANT KIT-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:110045154 | T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. | Device | Class II | 6 |
| 3 May 2023 | Gose con Sandia, Sour Ale with watermelon, limes and sea salt, 12 oz. Can 6 pk. (72 oz. total) Can UPC 7 96363 00495 2, Carton UPC 7 96363 00495 2 (6 cans per carton, 4 cartons per case) (92281) | Avery Brewing Company | Food | Class II | 1 |
| 2 May 2023 | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14 | Hologic, Inc | Device | Class II | 1 |
| 2 May 2023 | LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE; | Implant Direct Sybron Manufacturing LLC | Device | Class II | 1 |
| 1 May 2023 | EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 14553901 | Phadia US Inc | Device | Class II | 2 |
| 1 May 2023 | Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20. (92565) | Glenmark Therapeutics, Inc. | Drug | Class II | 1 |
| 26 Apr 2023 | MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched device designed to fit the patients anatomy to transfer a patient-specific pre-operative plan to the OR. Ref: KNM-ZB02-00-01 (92621) | Individual firm, name withheld | Device | Class II | 1 |
| 26 Apr 2023 | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P | HeartSine Technologies Ltd | Device | Class II | 1 |
| 13 Apr 2023 | 1. Hy-Vee Salt & Vinegar Braided Pretzels, 10 oz poly bags, UPC: UPC: 75450-27706, 12 pack; 2. Dakota Style Salt & Vinegar Pretzel Kravings, 4.5 oz poly bags, UPC: 84872-60030, 6 pack; 3. Dakota Style Salt & Vinegar Pretzel Kravings, 10 oz poly bags, UPC 84872-60018, 12 pack, 4 pack, and 6 pack; 4. Four Brothers Salt… | Dakota Style, Inc | Food | Class I | 4 |
| 16 Mar 2023 | Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G (92532) | Ellex Medical Pty Ltd. | Device | Class II | 1 |
| 27 Feb 2023 | RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief. (92389) | Appliedvr | Device | Class II | 1 |
| 15 Feb 2023 | KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver | Pro-Dex Inc | Device | Class II | 1 |
| 9 Feb 2023 | Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons (NDC 72288-847-47 and 72288-847-37), Distributed By: Amazon.com Services LLC., 410 Terry Avenue N., Seattle, WA 98109. | L. Perrigo Company | Drug | Class II | 13 |
| 30 Jan 2023 | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15. | Global Pharma Healthcare Private Limited | Drug | Class I | 4 |
| 23 Dec 2022 | LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11 | Waldemar Link GmbH & Co. KG (Mfg Site) | Device | Class II | 2 |
| 18 Mar 2021 | LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right | Waldemar Link GmbH & Co. KG (Mfg Site) | Device | Class II | 4 |
| 22 Jan 2021 | Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1, 10A, 10A SP1 and 10B. Software versions: 8.1, 9.0, 9.1, 9.2, 10.0, 10.1. (92441) | RaySearch America Inc | Device | Class II | 1 |