| 9 Nov 2023 | Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334. Event 93418 | Name withheld | Drug | Class II | 1 |
| 9 Nov 2023 | Jeni's Splendid Ice Cream: Buttercream Birthday Cake Ice Cream packaged in paperboard pint cups with heat seals and paper lids - 8 pints per case | Jeni's Splendid Ice Creams LLC | Food | Class II | 1 |
| 6 Nov 2023 | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1 | Taro Pharmaceuticals Inc. | Drug | Class III | 1 |
| 1 Nov 2023 | ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 5 |
| 31 Oct 2023 | Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Drug | Class I | 2 |
| 31 Oct 2023 | LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0087-1 | Cardinal Health Inc. | Drug | Class I | 6 |
| 31 Oct 2023 | Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case. | Abbott Laboratories | Food | Class II | 1 |
| 30 Oct 2023 | V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935 | Grato Holdings, Inc. | Drug | Class III | 1 |
| 29 Oct 2023 | WANABANA APPLE CINNAMON FRUIT PUREE, Net Weight: 2.50 oz (71g) Pouches, 15 poches per carton, 3-pack carton in one box. | WANABANA USA LLC | Food | Class I | 3 |
| 27 Oct 2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ, 08807, NDC# 65162-212-10 | Amneal Pharmaceuticals of New York, LLC | Drug | Class II | 1 |
| 27 Oct 2023 | Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141. | NCS Healthcare of Kentucky Inc | Drug | Class III | 2 |
| 27 Oct 2023 | Crush Orange Soda, 24 Pack. 24 - 12 oz. cans. Caffeine Free. Contains No Juice. UPC 0 78000-01309 2. Produced under the Authority of Dr Pepper/Seven Up, Inc., 6425 Hall of Fame Lane, Frisco, TX 75034 Event 93334 | Pepsi Beverages, LLC | Food | Class II | 1 |
| 26 Oct 2023 | Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08. | VistaPharm LLC | Drug | Class III | 1 |
| 23 Oct 2023 | stryker Sage PrimaFit External Urine Management System for the Female Anatomy | Sage Products Inc | Device | Class II | 1 |
| 23 Oct 2023 | Achieva 1.5T | Philips North America Llc | Device | Class II | 7 |
| 23 Oct 2023 | Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60. | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 23 Oct 2023 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, | Glenmark Pharmaceuticals Inc., USA | Drug | Class III | 1 |
| 23 Oct 2023 | Gills Onions 3 lb. bags, diced yellow onions | Gills Onions, LLC | Food | Class I | 73 |
| 20 Oct 2023 | Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle) Event 93278 | ITF PHARMA INC | Drug | Class II | 1 |
| 20 Oct 2023 | Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-879-01 | Glenmark Pharmaceuticals Inc., USA | Drug | Class III | 1 |
| 20 Oct 2023 | Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11 Event 93254 | Zyla Life Sciences US Inc. | Drug | Class III | 1 |
| 20 Oct 2023 | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4 | Omega & Delta Co., Inc. | Drug | Class II | 3 |
| 20 Oct 2023 | Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 2 |
| 20 Oct 2023 | Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30 | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 20 Oct 2023 | Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01 Event 93236 | Edenbridge Pharmaceuticals, LLC | Drug | Class III | 1 |
| 20 Oct 2023 | Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box *Sample Kits* | Nutricia North America | Food | Class II | 1 |
| 20 Oct 2023 | Qilu Enterprises brand enoki mushrooms packaged in a 7.05 ounce (200 gram) flexible plastic bag with UPC code 928918-610109. | UTOPIA FOODS INC | Food | Class I | 1 |
| 20 Oct 2023 | Item 19858, Amazon Fresh, Frosted Mini Brownie with yellow and purple icing with sprinkles, 12 count per pack, packaged in a plastic clear clamshell container, net wt. 14oz. Case UPC 1 08 42379 19858 5; Retail package UPC 8 42379 19858 8. Event 93287 | GIVE AND GO PREPARED FOODS CORP | Food | Class II | 1 |
| 19 Oct 2023 | Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators Event 93303 | Name withheld | Device | Class II | 1 |
| 19 Oct 2023 | Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01 | Zydus Pharmaceuticals (USA) Inc | Drug | Class II | 3 |
| 19 Oct 2023 | Strong Iodine Solution U.S.P. (Lugol's Solution) (Iodine 5%), 14 mL Glass Dropper bottle in box, RX only, Safecor Health, LLC, Woburn, MA 01801. NDC# 48433-230-15 | Safecor Health, LLC | Drug | Class II | 1 |
| 19 Oct 2023 | Mini Fruit Jelly Cups; Assorted Flavor; UPC: 4 714379 320985, Net Wt. 52.9 oz | Tiffany Food Corp. | Food | Class I | 3 |
| 19 Oct 2023 | Nature's Path Organic Pumpkin Spice Waffles, 7 oz., UPC 0 5844959077 4 | Nature'S Path Foods Inc | Food | Class II | 2 |
| 19 Oct 2023 | Kroger Collard Greens packaged in plastic 16oz bag - 8 bags per case | The Kroger Co | Food | Class I | 1 |
| 18 Oct 2023 | KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack) | Microbiologics Inc | Device | Class II | 2 |
| 18 Oct 2023 | Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03 | Integrity Bio-Chemicals LLC | Drug | Class II | 3 |
| 18 Oct 2023 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences,… | Exela Pharma Sciences LLC | Drug | Class I | 3 |
| 18 Oct 2023 | HEB Central Market Blueberry Buckwheat Gluten Free Waffle, 8.25oz, UPC 004122025365 Giant Eagle Blueberry Gluten Free Waffle, 11.3oz, UPC 030034944940 Topco Full Circle Market Gluten Free Waffles - Blueberry, 11.3oz, UPC 036800486980 | Treehouse Foods | Food | Class III | 1 |
| 18 Oct 2023 | Asenzya Hot & Spicy Cajun Style Seasoning, Item 121331. Net Wt 15 lbs. Distributed by: Asenzya 7616 South Sixth Street, Oak Creek, WI 53154. Event 93321 | Asenzya Inc. | Food | Class II | 1 |
| 17 Oct 2023 | FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB ports. The BioFire FilmArray Torch (BioFire Torch) is an automated in vitro diagnostic (IVD) device intended for use with FDA-cleared or approved IVD BioFire FilmArray Panels.… | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 17 Oct 2023 | Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11 | AbbVie Inc. | Drug | Class III | 1 |
| 17 Oct 2023 | Wegman's Organics Sweet Kale Chopped Salad Kit, 8oz. Event 93164 | Braga Fresh Foods | Food | Class I | 1 |
| 17 Oct 2023 | HEB Kale Greens, Net Wt. 32oz | Safeway Fresh Foods LLC | Food | Class I | 3 |
| 13 Oct 2023 | AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation | Avanos Medical, Inc. | Device | Class II | 1 |
| 13 Oct 2023 | Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty | Corin Ltd | Device | Class II | 2 |
| 13 Oct 2023 | Novum IQ Syringe infusion system, Product Code 40800BAXUS | Baxter Healthcare Corporation | Device | Class I | 1 |
| 13 Oct 2023 | Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10. Event 93225 | Name withheld | Drug | Class II | 1 |
| 13 Oct 2023 | JayRobb Vanilla Flavored Egg White Protein Powder. Net Weight 24 oz (1.5 lbs) 680g Dietary Supplement. UPC 6 03907-00462 3 Event 93235 | Select Custom Solutions, LLC | Food | Class II | 1 |
| 12 Oct 2023 | Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software. | CHANGE HEALTHCARE CANADA COMPANY | Device | Class II | 1 |
| 12 Oct 2023 | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6 | Medtronic Inc | Device | Class II | 3 |
| 12 Oct 2023 | Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder) | Maquet Medical Systems USA | Device | Class II | 1 |
| 12 Oct 2023 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number XT160 | Olympus Corporation of the Americas | Device | Class I | 6 |
| 11 Oct 2023 | BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump Infusion Set Vented syringe adapter Smallbore Tubing, Catalog # 10010483; BD AlarisTM Pump Infusion Set 1.2 Micron Filter Low Sorbing Tubing (PE Lined) SmartSiteTM Y-site, Catalog # 10010453; BD AlarisTM Pump Infusion Set 0.2 Micron Filter Low… | Becton Dickinson & Company | Device | Class II | 3 |
| 11 Oct 2023 | VariSoft infusion set, Model Number 1002827 | Unomedical A/S | Device | Class I | 3 |
| 11 Oct 2023 | Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6, AF5140MB-F, AF1140MB-T, AF1140MB-PW,… | SunMed Holdings, LLC | Device | Class II | 9 |
| 10 Oct 2023 | Stewarts Chocolate Chip Cookies; 6 oz package; packaged in a flexible plastic clamshell type package Event 93198 | The Cookie Factory LLC | Food | Class II | 1 |
| 9 Oct 2023 | Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234) | Philips Ultrasound, Inc. | Device | Class II | 2 |
| 9 Oct 2023 | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | Philips North America | Device | Class II | 1 |
| 9 Oct 2023 | Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400 | Biomet, Inc. | Device | Class II | 19 |
| 9 Oct 2023 | Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy. | Philips North America Llc | Device | Class II | 3 |
| 9 Oct 2023 | Spectral CT on Rails, Software Version 5.1.0, Model Number 728334 | Philips North America | Device | Class II | 1 |
| 9 Oct 2023 | Frozen and fresh RTE Lobster meat (1 lb. packages to 12 lb. case) 1. Greenhead Lobster HPP Fresh Cooked Claw and Knuckle Meat GHL-CKF - Fresh - 1 lb. oxygen permeable bag, master cased in a 12 lbs. Styrofoam box 2. Greenhead Lobster Fresh Cooked Claw and Knuckle Meat GHL-CKF -CK (2 lb) Fresh Cooked Meat - Non HPP - 2… Event 93193 | Greenhead Lobster Products LLC | Food | Class I | 1 |
| 9 Oct 2023 | Stabilyze Sugar Stable Dark Chocolate Peanut Butter, 50g (1.76 oz), sold individual package or box. Each package has UPC 0 16073 00213 1. There are 12 packages per display box (box UPC 0 16073 00223 0). The label allergens contains statement declares Milk, Peanut, Tree Nuts (Almond, Cashew, Coconut, Hazelnut). | Betty Lou's Inc | Food | Class II | 1 |
| 6 Oct 2023 | ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003 | LEONI CIA CABLE SYSTEMS | Device | Class II | 2 |
| 6 Oct 2023 | CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles | Young Dental Manufacturing I, LLC | Device | Class II | 1 |
| 6 Oct 2023 | Hinterland Dairy Farmstead Cheese Happy Jack Monterey Jack Cheese, packaged in bulk and 8oz packages. | Hinterland Dairy Inc | Food | Class II | 4 |
| 5 Oct 2023 | Mobilett Mira wireless (VA20) mobile x-ray system(s) | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 5 Oct 2023 | Favorite Day Bakery demi French bread. Net Wt. 8 oz (227g) UPC 0 85239-13232 6. Distributed by Target Corporation, Minneapolis, MN 55403. Event 93177 | Rise Baking Company, LLC dba The New French Bakery Inc. | Food | Class II | 1 |
| 4 Oct 2023 | HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A000052, P7501A000053, P7501A000054, P7501A000055, P7501A001851, P7501A001972, P7501A001973, and P7501A001974 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 4 Oct 2023 | CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery pressure and heart rate. | St. Jude Medical | Device | Class II | 1 |
| 4 Oct 2023 | CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 | Name withheld | Device | Class II | 10 |
| 4 Oct 2023 | BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems. | Philips North America | Device | Class II | 6 |
| 4 Oct 2023 | Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79 | MEDLINE INDUSTRIES, LP - Northfield | Drug | Class II | 1 |
| 4 Oct 2023 | Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06 Units per mL), Rx only, Leiter Compounding Health, 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-157-70 | Denver Solutions, LLC DBA Leiters Health | Drug | Class III | 3 |
| 4 Oct 2023 | Guilt Free No Sugar Added Ice Cream Homemade Vanilla 1.5qts Event 93186 | TH Searcy LLC | Food | Class I | 1 |
| 3 Oct 2023 | Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503) | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 2 Oct 2023 | Coapt Dome Electrode, Gen2 system, cutaneous electrode Event 93137 | Coapt LLC | Device | Class II | 1 |
| 2 Oct 2023 | Coapt ControlSeal Electrode, cutaneous EMG Electrode Event 93138 | Coapt LLC | Device | Class II | 1 |
| 2 Oct 2023 | EVIS EXERA III Gastrointestinal Videoscope | Olympus Corporation of the Americas | Device | Class II | 1 |
| 2 Oct 2023 | The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The… | Carestream Health, Inc. | Device | Class II | 1 |
| 2 Oct 2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24 | Pfizer Inc. | Drug | Class I | 3 |
| 29 Sep 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004 | Instrumentation Laboratory | Device | Class II | 3 |
| 29 Sep 2023 | IRON assay, Reference Numbers 6K95-41 and 6K95-30 | Sentinel CH SpA | Device | Class II | 2 |
| 29 Sep 2023 | LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051 | Physio-Control, Inc. | Device | Class II | 10 |
| 29 Sep 2023 | DJO EMPOWR Knee Punch Handle, REF: 801-05-040 | Encore Medical, LP | Device | Class II | 1 |
| 29 Sep 2023 | ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA | Biomic Sciences, LLC dba ION Intelligence of Nature | Drug | Class I | 3 |
| 29 Sep 2023 | FreshPoint Bix Produce Company, Cantaloupe. Item # 03143. 3 melons per bag. | Bix Produce Company LLC | Food | Class I | 1 |
| 28 Sep 2023 | Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator | Abbott | Device | Class II | 1 |
| 28 Sep 2023 | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 | Covidien | Device | Class I | 1 |
| 28 Sep 2023 | Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pre-filled applicator, packaged in 1 prefilled applicator per carton, Rx Only, Manufactured By Padagis, Yeruham, Israel; Distributed By: Padagis, Allegan, MI 49010. NDC: 45802-396-01 | Padagis US LLC | Drug | Class II | 1 |
| 28 Sep 2023 | Organic Protein & 50 Superfoods Protein Powder with Probiotic - Chocolate flavor Event 93145 | Orgain | Food | Class I | 1 |
| 28 Sep 2023 | ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104. Event 93210 | ActiPharma, Inc. | Food | Class III | 1 |
| 27 Sep 2023 | EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0. | Boston Scientific Corporation | Device | Class II | 2 |
| 27 Sep 2023 | JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee prosthesis | Smith & Nephew, Inc. | Device | Class II | 2 |
| 27 Sep 2023 | StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The StealthStation FlexENT System, with StealthStation ENT software, is… | Medtronic Navigation, Inc. | Device | Class I | 1 |
| 27 Sep 2023 | UNICORN Ice-cream base, natural flavors, Artificial Flavoring, Artificial color. DISTRIBUTED BY PARADISE FLAVORS LLC. 4 oz. Packaged in plastic pouch. Frozen. | Paradise Flavors LLC | Food | Class I | 39 |
| 27 Sep 2023 | Edible Cookie Dough Chocolate Chip packaged in 6 oz plastic cups lot # 3240 Event 93142 | Cookies-n-Milk Incorporated | Food | Class I | 1 |
| 26 Sep 2023 | Grafton DBM Crunch, Model Numbers: T44115, Demineralized Bone Matrix | Medtronic Sofamor Danek USA Inc | Device | Class II | 7 |
| 26 Sep 2023 | Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter | Cordis US Corp | Device | Class I | 1 |
| 26 Sep 2023 | FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids between large volume parenteral solution containers. | B. Braun Medical, Inc. | Device | Class II | 9 |
| 25 Sep 2023 | Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033,… | Aizu Olympus Co., Ltd. | Device | Class II | 22 |
| 25 Sep 2023 | RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component. | Encore Medical, LP | Device | Class II | 2 |
| 25 Sep 2023 | Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm | Securitas Healthcare LLC | Device | Class II | 3 |
| 25 Sep 2023 | Penzeys Brady Street Cheese Sprinkle. Item 20756. net wt 2.2 oz (62g). Penzeys Spices, Wauwatosa, WI 53222. Event 93126 | Penzeys, Ltd. | Food | Class II | 1 |
| 22 Sep 2023 | DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100 | Musculoskeletal Transplant Foundation, Inc. | Device | Class II | 1 |
| 22 Sep 2023 | Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25 | West-Ward Columbus Inc | Drug | Class III | 1 |
| 22 Sep 2023 | Whole cantaloupe, Brand name Kandy 11 count carton, 8 count carton, 9 count carton, 15 count carton d. Container description; Red Corrugated Paper Carton or Black Plastic RPC. Event 93121 | Eagle Produce LLC, dba Martori Farms | Food | Class I | 1 |
| 21 Sep 2023 | TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005 | Acclarent, Inc. | Device | Class II | 1 |
| 21 Sep 2023 | Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit | ROi CPS LLC | Device | Class II | 1 |
| 21 Sep 2023 | Atrium Advanta V12 Covered Stent System, 10mm x 59mm x 80cm (OUS)-Indicated for restoring and improving the patency of the iliac andrenal arteries. Renal approval includes 5mm, 6mm and 7mm diameter Advanta V12 covered stent sizes. In Canada, the Advanta V12 Covered Stent indication excludes renal arteries. REF: 85361 | Atrium Medical Corporation | Device | Class II | 1 |
| 21 Sep 2023 | CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system | Philips North America Llc | Device | Class II | 10 |
| 21 Sep 2023 | 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System | B. Braun Medical, Inc. | Device | Class I | 2 |
| 21 Sep 2023 | Kula Can Pina Colada + KRATOM SELTZER, 12 oz (355ML) DIETARY SUPPLEMENT Event 93157 | Kula Brands LLC | Food | Class I | 1 |
| 20 Sep 2023 | Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack | Cardinal Health 200, LLC | Device | Class I | 6 |
| 20 Sep 2023 | ORALE! CAMARON MOLIDO, GROUND SHRIMP, NET WT. 2 OZ. 57 g (in paper cartons) (12 packages per case of 2 oz each), PACKED & DISTRIBUTED BY: LISY CORP., INGREDIENTS: Precooked Shrimp and Salt., UPC: 096786202233. | EL Chilar-HF, LLC | Food | Class III | 4 |
| 19 Sep 2023 | Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on outer label, inner label and IFU, outer box artwork for Vasoview Hemopro 2 (HP2). | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 19 Sep 2023 | LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood. | Magellan Diagnostics, Inc. | Device | Class II | 1 |
| 18 Sep 2023 | Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured | Nova Biomedical Corporation | Device | Class II | 2 |
| 18 Sep 2023 | IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System. | Ion Beam Applications S.A. | Device | Class II | 1 |
| 18 Sep 2023 | Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI W/S; (7)2050-000… | Atrium Medical Corporation | Device | Class II | 3 |
| 15 Sep 2023 | Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system Event 93129 | Asensus Surgical Inc | Device | Class I | 1 |
| 15 Sep 2023 | BD Alaris PCU REF 8015 | CareFusion 303, Inc. | Device | Class I | 3 |
| 14 Sep 2023 | Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System | GE Healthcare | Device | Class II | 3 |
| 13 Sep 2023 | Astral 100 and Astral 150 ventilators | ResMed Ltd. | Device | Class I | 1 |
| 13 Sep 2023 | Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 13 Sep 2023 | BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid. | Breg Inc | Device | Class II | 1 |
| 13 Sep 2023 | Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access. | Stryker Corporation | Device | Class II | 1 |
| 12 Sep 2023 | RayCare 5B and 6A including service packs- An oncology information system used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care Product name (build number): (1)RayCare 5B SP1 (5.1.1.60246); (2)RayCare 5B SP3 (5.1.3.60023); (3) RayCare 6A… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 12 Sep 2023 | Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200 | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 12 Sep 2023 | VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge) | Ortho-Clinical Diagnostics, INc. | Device | Class II | 1 |
| 12 Sep 2023 | Fine Sconehenge Baking Company, Chocolate Chip Scone, individually sealed plastic bag | The Kitchen Garden Co, LLC | Food | Class I | 5 |
| 11 Sep 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005 | Stryker Corporation | Device | Class II | 19 |
| 8 Sep 2023 | Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 | Omega Medical Imaging, Inc. | Device | Class II | 1 |
| 8 Sep 2023 | Centricity Universal Viewer Workflow Manager, Image processing radiological system | GE Healthcare | Device | Class II | 2 |
| 7 Sep 2023 | Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 7 Sep 2023 | Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR | Alcon Research, LLC | Device | Class II | 1 |
| 6 Sep 2023 | Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1 | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 6 Sep 2023 | AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted… Event 93206 | Name withheld | Device | Class II | 1 |
| 6 Sep 2023 | RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX4040 | Randox Laboratories Ltd. | Device | Class II | 5 |
| 1 Sep 2023 | Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked Event 93203 | Convergent Dental | Device | Class II | 1 |
| 1 Sep 2023 | General Pack, REF BBGP31C | American Contract Systems, Inc. | Device | Class II | 12 |
| 31 Aug 2023 | Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP Event 93179 | Pulmonx, Corp. | Device | Class II | 1 |
| 24 Aug 2023 | AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 | MICROVENTION INC. | Device | Class II | 1 |
| 22 Aug 2023 | Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 18 Aug 2023 | OPMI LUMERA 300, REF 6137 Event 93146 | Carl Zeiss Suzhou Co., Ltd. | Device | Class II | 1 |
| 17 Aug 2023 | SOZO Bilateral Arm L-Dex Software Event 92943 | Impedimed Limited | Device | Class II | 1 |
| 10 Aug 2023 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only | Covidien | Device | Class II | 2 |
| 1 Aug 2023 | SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO Event 92930 | SynCardia Systems LLC | Device | Class II | 1 |
| 25 Jul 2023 | The Sausage Maker Instacure #1 Event 92770 | The Sausage Maker, Inc. | Food | Class III | 1 |
| 20 Jul 2023 | Cosmedent FlexiCup Composite Finishing & Polishing System, Six Pack, Autoclavable Aluminum Oxide Polishing Instrument, Medium (Blue), REF #403-101, Rx. Event 92812 | Cosmedent, Inc. | Device | Class II | 1 |
| 18 Jul 2023 | Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental | Preat Corp | Device | Class II | 3 |
| 14 Jul 2023 | Q2 Multiport Extension set, REF: 9520, Rx Only Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps. | Quest Medical, Inc. | Device | Class II | 1 |
| 13 Jul 2023 | Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue EM2-BB-S; (5) Milan Black EM2-MB-S Event 93215 | EMPATICA SRL | Device | Class II | 1 |
| 22 May 2023 | One Step Pregnancy Test REF 100-01 | Universal Meditech Inc. | Device | Class II | 27 |
| 24 Apr 2023 | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only | Cepheid | Device | Class II | 2 |
| 29 Mar 2023 | Full Spectrum Cold Pressed Hemp Oil Gummies, Fruit Punch, 1.41 oz (4-count) and 8oz (15-count). | Tay's Sales and Distribution | Food | Class II | 5 |
| 28 Feb 2023 | Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 | Omega Medical Imaging, Inc. | Device | Class II | 1 |
| 2 Dec 2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3 | GlaxoSmithKline Consumer Healthcare Holdings LLC | Drug | Class II | 7 |
| 27 May 2022 | LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. Event 93170 | Name withheld | Device | Class II | 1 |
| 9 Nov 2021 | Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use, Rx Only, 1mL Single Dose Vial, (supplied in packages of 5 vials) Distributed by Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC: 42023-179-05 | PAR Sterile Products LLC | Drug | Class II | 1 |
| 5 Oct 2021 | Takumi brand frozen tuna ground meat, raw but ready to eat, vacuum packaged units in fiber boxes, net wt. 11 lbs. per box. individual units were sold by weight at the point of sale. Product of Fiji, and imported by Tokai Denpun USA INC. Bellevue, WA. Vacuum package label is read in parts: Product of Fiji - Frozen… Event 93190 | Tokai Denpun USA Inc | Food | Class II | 1 |
| 14 Sep 2020 | Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators. | Percussionaire Corporation | Device | Class II | 1 |