| 16 Jan 2025 | Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90. | Appco Pharma LLC | Drug | Class III | 1 |
| 7 Jan 2025 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11 | Amerisource Health Services LLC | Drug | Class II | 1 |
| 31 Dec 2024 | The Granola Bar brand The OG Bar; 4 oz; Ingredients: Oats, brown sugar, honey, almonds, butter, olive oil, cashews, coconut flakes, chia seeds, vanilla extract, kosher salt; Contains: Tree nuts. Baked in a facility that also processes wheat, eggs, dairy, soy and nuts. Event 96111 | The Granola Bar | Food | Class II | 1 |
| 30 Dec 2024 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India Limited, Hyderabad- 500 081, India, Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Grand Cayman Islands, NDC 82009-117-10 | Granules Pharmaceuticals Inc. | Drug | Class II | 1 |
| 30 Dec 2024 | Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ | Rising Pharma Holding, Inc. | Drug | Class II | 3 |
| 27 Dec 2024 | Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10 | Eugia US LLC | Drug | Class II | 1 |
| 27 Dec 2024 | Marketside, BROCCOLI FLORETS, 12oz, BEST IF USED BY DEC 10 2024, PRODUCT OF USA, MEXICO Event 96081 | Braga Fresh Foods LLC | Food | Class I | 1 |
| 23 Dec 2024 | VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee,… | Percussionaire Corporation | Device | Class I | 1 |
| 23 Dec 2024 | First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6 Event 96052 | First Aid Beauty Ltd | Drug | Class II | 1 |
| 23 Dec 2024 | Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93 | Viatris Inc | Drug | Class II | 2 |
| 20 Dec 2024 | Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion procedures.… | Integrity Implants Inc. | Device | Class II | 1 |
| 20 Dec 2024 | Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403 | Randox Laboratories, Limited | Device | Class II | 2 |
| 20 Dec 2024 | Baxter Solution Set with Duo-Vent Spike, REF 2R8404 | Baxter Healthcare Corporation | Device | Class II | 3 |
| 20 Dec 2024 | Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002 | Baxter Healthcare Corporation | Device | Class I | 4 |
| 20 Dec 2024 | Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 20 Dec 2024 | Buttered Vegetables KEEP FROZEN NET WT 10.5 OZ (300g) INGREDIENTS: CARROTS, PEAS, CALIFLOWER, CORN, BUTTER, SUGAR, SALT, CORN STARCH, PARSLEY MAY CONTAIN WHEAT. DISTRIBUTED BY LIDL USA, LLC. 3500 S. CLARK STREET, ARLINGTON, VA 22202 UPC 4 056489 122876 | Lidl US TRADING | Food | Class II | 1 |
| 19 Dec 2024 | Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component | Ortho-Clinical Diagnostics, INc. | Device | Class II | 3 |
| 19 Dec 2024 | BD PCR Cartridges used with MAX System. Model Number: 437519 | Becton Dickinson & Co. | Device | Class II | 1 |
| 19 Dec 2024 | Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE Event 95954 | Name withheld | Device | Class II | 1 |
| 19 Dec 2024 | Bodor P and C series laser cutting machines Event 96035 | Jinan Bodor Cnc Machine Co Ltd | Device | Class II | 1 |
| 19 Dec 2024 | 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue. | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 19 Dec 2024 | 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 | Intuitive Surgical, Inc. | Device | Class II | 37 |
| 19 Dec 2024 | Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922, NDC 0054-0709-20 | West-Ward Columbus Inc | Drug | Class III | 1 |
| 19 Dec 2024 | ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, For IV or IM Use, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, This is a Compounded Drug. Hospital/Office Use Only. NDC 63037-137-25 | Hikma Injectables USA Inc | Drug | Class II | 2 |
| 19 Dec 2024 | River Valley Ranch & Kitchens Spinach Artichoke Dip Mix. net wt. 16 oz. (453g). UPC 6 92016-40021 1. Keep Refrigerated After Opening. 39900 60th Street, Burlington, WI 53105. Event 96045 | River Valley Ranch Ltd | Food | Class III | 1 |
| 18 Dec 2024 | Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty. Event 96030 | Name withheld | Device | Class II | 1 |
| 18 Dec 2024 | Monitoring Service Application (MSA). Software to process, analyze, display, and report cardiac events in ECG data received from compatible devices. Event 95837 | Braemar Manufacturing, LLC | Device | Class I | 1 |
| 18 Dec 2024 | EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703 | Encore Medical, LP | Device | Class II | 1 |
| 18 Dec 2024 | Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories. | Olympus Corporation of the Americas | Device | Class I | 1 |
| 18 Dec 2024 | GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING | Device | Class II | 13 |
| 18 Dec 2024 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma… | Eugia US LLC | Drug | Class II | 1 |
| 18 Dec 2024 | Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15. | AvKARE | Drug | Class III | 2 |
| 18 Dec 2024 | Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC 70010-001-03 | Granules Pharmaceuticals Inc. | Drug | Class II | 1 |
| 18 Dec 2024 | Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134 | Alcon Research LLC | Drug | Class I | 1 |
| 18 Dec 2024 | Wicklow Gold Cheddar Nettle & Chive Cheese, 5.2 oz., plastic cryo-vac , 8 packages per case | Abbey Specialty Foods | Food | Class I | 2 |
| 17 Dec 2024 | glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC: 60687-480-21, Unit Dose NDC: 60687-480-11 | Amerisource Health Services LLC | Drug | Class II | 1 |
| 17 Dec 2024 | Orgain 30g Plant Protein, Complete Protein Powder, 6g Prebiotic +Fiber, 9g EAAS+BCAAs, 1gSugar, Chocolate Flavor; NET WT 32.1 OZ (2.01 LB) 912g; Nutritional Facts: Serving size 2 scoops, UPC: 8 51770 00760 3; QUESTIONS ABOUT ORGAIN PRODUCTS? 888-881-GAIN(4246) Lot# 4172-02-P Event 96021 | Orgain, LLC | Food | Class I | 1 |
| 16 Dec 2024 | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus. | Integra LifeSciences Corp. | Device | Class II | 3 |
| 16 Dec 2024 | LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct. | Olympus Corporation of the Americas | Device | Class II | 1 |
| 16 Dec 2024 | Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221; 5)… | MEDLINE INDUSTRIES, LP - Northfield | Device | Class I | 2 |
| 16 Dec 2024 | FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7 Event 95994 | SHOPPERS- PLAZA | Drug | Class I | 1 |
| 16 Dec 2024 | Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ 08873, NDC 70069-716-01 | SOMERSET THERAPEUTICS LLC | Drug | Class III | 1 |
| 16 Dec 2024 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05 | FDC Limited | Drug | Class II | 1 |
| 16 Dec 2024 | Pinsarella Roman Pizza, POL127-24, UPC 6 08539 14655 0 -Oval, 12x7/ 7.0 Oz, Parbaked, 6 units per bag, 24 units per box., UPC 1 98715 69442 0 - Oval, 14x9/ 10.6 Oz, Parbaked, 6 units per bag, 24 units per box., UPC 6 08539 33371 4 - Round, 8" / 5.0 Oz, Parbaked, 6 units per bag, 36 units per box., Good Until: 12… Event 96007 | Pinsarella Food LLC | Food | Class I | 1 |
| 13 Dec 2024 | Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected. Component: No | Trinity Sterile, Inc. | Device | Class II | 5 |
| 13 Dec 2024 | Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. | Hologic, Inc. | Device | Class II | 1 |
| 13 Dec 2024 | Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-21 | Amerisource Health Services LLC | Drug | Class II | 1 |
| 13 Dec 2024 | Mr. Bing brand Sriracha Chili Sauce; 9 oz and 18 oz, in clear PET bottle with green cap; UPC 850044819072 and UPC 850044819058 Event 95992 | Name withheld | Food | Class II | 1 |
| 13 Dec 2024 | Horizon Organic Aseptic Plain Whole Milk 8OZ 12 Pack. Refrigerate after opening. With the following UPC: 3663207113 (12 pack); 3663207127 (single unit). Distributed by: Danone US, LLC Broomfield, CO 80021. HOD (Horizon Organic Dairy) #: 140236 | Horizon Organic Dairy, LLC | Food | Class II | 1 |
| 12 Dec 2024 | DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr) | Medtronic Perfusion Systems | Device | Class II | 3 |
| 12 Dec 2024 | Impella RP with SmartAssist; Product Number: 0046-0035; | Abiomed, Inc. | Device | Class I | 2 |
| 12 Dec 2024 | ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331) | Boston Scientific Corporation | Device | Class I | 6 |
| 12 Dec 2024 | FORCE FOREVER 400mg Tablets, Huesos y articulaciones sin dolor, SUPLEMENTO ALIMENTICIO, 60-count bottles Event 96001 | GNMart LLC | Drug | Class I | 1 |
| 12 Dec 2024 | Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma, Inc., 373 RT US 46 W Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8022-01. | Akron Pharma, Inc. | Drug | Class III | 7 |
| 12 Dec 2024 | Nhan Sam Tuyet Lien Truy Phong Hoan, Capsules, 30-Count Bottles, Manufactured by Yee Hong Pharmaceuticals, SDN, Penang, Malasia. Event 95980 | Buy-Herbal | Drug | Class I | 1 |
| 12 Dec 2024 | Cucumbers, Wholesale Produce Supply, 752 Kasota Circle, Minneapolis, MN 554145. Product of Mexico. Cucumbers sold in the following pack sizes: 1. 5 lb. pack 2. 6 ct individual items per case. 3. 12 ct individual items per case. 4. 24 ct individual items per case. 5. 36 ct individual items per case. Event 96040 | WHOLESALE PRODUCE SUPPLY LLC DBA | Food | Class I | 1 |
| 11 Dec 2024 | nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System Event 95991 | Nuwellis Inc | Device | Class I | 1 |
| 11 Dec 2024 | chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01 | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 2 |
| 11 Dec 2024 | Great Value, Chicken Broth, 48 oz. , Aseptic paper cartons, 6 retail units per case, 120 cases/pallet . Event 96023 | TREE HOUSE FOODS INC | Food | Class II | 1 |
| 11 Dec 2024 | Daily Veggies Enoki Mushroom, 200g Product of Korea UPC Codes: 8809159458890 | New Age International, Inc. | Food | Class I | 1 |
| 11 Dec 2024 | Connie's Classic Thin Crust Cheese Pizza, Chicago's Finest. Net Wt 20.36 oz. (1lb 4.36 oz) 577g. UPC 0 75706-19104 8. Keep Refrigerated. Distributed by: Palermo Villa, nc. Milwaukee, WI 53208. Event 95968 | Palermo Villa, Inc | Food | Class II | 1 |
| 11 Dec 2024 | WELLSLEY FARM VANILLA NON-FAT GREEK YOGURT; 40 oz; UPC 888670048078 | Name withheld | Food | Class II | 2 |
| 10 Dec 2024 | Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842 | Mercury Enterprises, Inc. dba Mercury Medical | Device | Class I | 1 |
| 10 Dec 2024 | EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706 | Encore Medical, LP | Device | Class II | 1 |
| 10 Dec 2024 | Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W050080090, Size: 5MM X… | ev3 Inc | Device | Class II | 1 |
| 10 Dec 2024 | Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges. Event 96022 | Biocartis Nv | Device | Class II | 1 |
| 10 Dec 2024 | Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack | VIONA PHARMACEUTICALS INC | Drug | Class II | 2 |
| 10 Dec 2024 | 235214 Baker's Source Traditional Cornbread Mix Complete, 5 LB Bags, 30 LB Cases Foodservice Use, Human Consumption & mix with water and bake Shelf Stable Dry Mix, 1 Year Shelf Life Event 95965 | C.H. Guenther & Son, Inc. | Food | Class I | 1 |
| 10 Dec 2024 | Gardner's Candies Cappuccino Meltaway Bar 1.25 oz. (35g), Item Number: 15207/online website item number is 0015207, sold individually and; also as part of Gardner's Meltaway Treat Box 6 oz, Item Number: 50135 or online website item number is 0050135 Event 95972 | GARDNER'S CANDIES , INC | Food | Class I | 1 |
| 10 Dec 2024 | Yu Yee, Five Spice Powder,1.76oz | Summit Import Corporation | Food | Class II | 1 |
| 10 Dec 2024 | Chow Ciao Whole Grain Breaded Broccoli Nuggets - 30 lbs. Event 95931 | Better Brands Inc. | Food | Class II | 1 |
| 9 Dec 2024 | VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting. | Maquet Cardiovascular, LLC | Device | Class I | 2 |
| 9 Dec 2024 | JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L Event 95818 | JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD | Device | Class I | 1 |
| 9 Dec 2024 | BORSARI Food Company Incorporated; BLOODY MARY MIX ; 32 FL. OZ; INGREDIENTS: Tomato juice, corn syrup, non-fat milk solids, orange juice, lemon juice, lime juice, cayenne pepper, vinegar, salt, garlic powder, Worcestershire sauce, prepared horseradish, maltic acid, sodium and potassium benzoate, yellow 5 & 6; UPC:… Event 95945 | Borsari Food Company Inc | Food | Class II | 1 |
| 6 Dec 2024 | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 | Fresenius Kabi USA, LLC | Device | Class I | 1 |
| 6 Dec 2024 | Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB | GE Medical Systems, LLC | Device | Class II | 1 |
| 6 Dec 2024 | Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04 | Amerisource Health Services LLC | Drug | Class II | 4 |
| 6 Dec 2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. | Breckenridge Pharmaceutical, Inc | Drug | Class II | 2 |
| 6 Dec 2024 | Cal Yee's Dark Chocolate Almonds (8-oz plastic bag) | Cal Yee Farm LLC | Food | Class I | 11 |
| 6 Dec 2024 | Cascade Raw Cheddar GTIN #90854115003059 packed in an approximately 6 lb quarter wheels vacuum sealed. All quarter wheels are variable weight sold by the pound and each vacuum sealed package contains 1 quarter wheel. Event 95941 | Heber Valley Artisan Cheese, LLC. | Food | Class I | 1 |
| 6 Dec 2024 | Sprout Gyro Family Kit, net wt. 1.750 lb (794 g), food, perishable, plastic tray, 28oz, U UPC 20594800000. | Sprouts Farmers Market | Food | Class I | 1 |
| 6 Dec 2024 | Beef & Lamb Gyro Sandwich Express Meal Kit. Net wt. 31.8oz. UPC 0 13454 38313 1. Each kit contains 6 Pitas, Gyro Meat, Tzatziki Sauce 3oz. cups, Fire Feta Sauce, Feta Cheese Crumbles. Packaged in clear plastic clamshell. Distributed by Fresh Creative Foods, Vista CA. | Reser's Fine Foods, Inc. | Food | Class I | 3 |
| 5 Dec 2024 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed cardiac glycoside… | Name withheld | Device | Class II | 2 |
| 5 Dec 2024 | Dialyzer Optiflux 160NRe | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 5 Dec 2024 | LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as… | Waldemar Link GmbH & Co. KG (Mfg Site) | Device | Class II | 1 |
| 4 Dec 2024 | DULoxetine DR USP, 30 mg, 90-count bottle, Rx Only, Packaged by: PD Rx Pharmaceuticals Inc, Oklahoma City, OK 73127, NDC: 43063-877-90 | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 4 Dec 2024 | Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15. | AvKARE | Drug | Class II | 1 |
| 4 Dec 2024 | ZOE brand Daily 30+ Prebiotic blend; Dietary Supplement; 500g resealable pouch Event 95916 | Zoe US, Inc. | Food | Class II | 1 |
| 3 Dec 2024 | 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES) | Stryker Corporation | Device | Class II | 1 |
| 3 Dec 2024 | The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks. | Qualigen Inc | Device | Class III | 1 |
| 3 Dec 2024 | ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning | Name withheld | Device | Class II | 30 |
| 3 Dec 2024 | MN Milk Bank for Babies Pasteurize Donor Human Milk. Volume: 4 fl. oz. / 120 ml. Milk Type: 20 kcal/oz. 1.0 g/dL Total Protein. MN Milk Bank for Babies, Roseville, MN 55113 Event 95915 | Minnesota Milk Bank for Babies | Food | Class II | 1 |
| 3 Dec 2024 | Wegmans Jalapeno Baked Cheese Puffs, Jalapeno flavored, 10oz, (283 g), SKU #6877 | Herr Foods Inc | Food | Class II | 1 |
| 2 Dec 2024 | Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846 | MICROVENTION INC. | Device | Class II | 1 |
| 2 Dec 2024 | MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002. Event 95887 | Moximed, Inc. | Device | Class II | 1 |
| 2 Dec 2024 | Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24. | Coloplast Manufacturing US, LLC | Device | Class II | 2 |
| 2 Dec 2024 | VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 | Accriva Diagnostics, Inc. | Device | Class II | 1 |
| 2 Dec 2024 | McKesson Cardiology Hemo software | A L I Technologies Ltd | Device | Class II | 3 |
| 2 Dec 2024 | Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA | RemedyRepack Inc. | Drug | Class II | 1 |
| 2 Dec 2024 | Cucumber Coins (sliced cucumbers); 1.25-oz, 2-oz, 2.16-oz, 2.25-oz, 2.6-oz, 3-oz, 4-oz Brand: Snack Buddies | First Quality Produce | Food | Class I | 4 |
| 2 Dec 2024 | Grecian Delight Tzatziki sauce, 3.75 lb. tub, UPC 07365000286, SKU SAL028, 4 tubs per case. Sysco Classic Tzatziki sauce, 3.75 lb. tub, UPC 074865886277, SKU SAL9669136, 4 tubs per case. | Grecian Delight/Kronos | Food | Class I | 3 |
| 1 Dec 2024 | Whole and Cut Cucumbers packaged in the following sizes: 1. Peak Cucumber Item 08027, 24 count. Product of Mexico. 2. Peak Cucumber Item 08009, 5 LB. Product of Mexico. 3. Cucumber Super Select Item 22200, 24 count. Product of Mexico. 4. Cucumber Item 22201, 5 lb. Product of Mexico. 5. Cucumber Super Select Item… | RUSS DAVIS WHOLESALE | Food | Class I | 5 |
| 29 Nov 2024 | Esteem Synergy Stomahesive Skin Barrier, part of Esteem synergy, which is a two-piece ostomy system consisting of an adhesive skin barrier and an adhesive pouch: ESTEEM SYN FLX WHT16/35MM PRECUT(1X10), REF: 405473; ESTEEM SYN FLX WHT35/35MM PRECUT(1X10), REF: 405479 | ConvaTec, Inc | Device | Class II | 1 |
| 29 Nov 2024 | Cucumber Diced Greek Cut (1/8"x1/8"x1"), 360# Drum with poly liner item C0376, 30# Box with poly liner item C0369. Cucumber Diced Regular Cut (1/8"x1/8"x1/4"), 300# Drum with poly liner item C0390, 30# Box with poly line C0383 Event 95923 | E-Z SPUDS INC | Food | Class I | 1 |
| 29 Nov 2024 | Olympia Foods Grecian Dip Tzatziki sauce, item 100, 4 lb. tubs, UPC 10045059001001, 4 tubs per case; item 104, 32lbs pail, UPC 00045059001042 Event 95925 | Olympia Foods | Food | Class I | 1 |
| 29 Nov 2024 | DELI FRESH VEGETABLE TRAY MED, 4 lb., packaged in a plastic container with a plastic lid, UPC 11110-99274 | The Kroger Co | Food | Class I | 4 |
| 29 Nov 2024 | whole fresh American cucumbers packaged in bulk cardboard containers labeled with the "Pamela" brand, a generic white box with a sticker that provides the implicated grower's name, "Agrotato, S.A. de C.V.," or a clear PamPak branded bag of 6 individual cucumbers with the UPC 8 2540107010 6 " Pamela (Bulk Pack 24ct,… Event 95873 | BALOIAN FARMS | Food | Class I | 1 |
| 27 Nov 2024 | Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators | 3B Medical, Inc. | Device | Class II | 1 |
| 27 Nov 2024 | OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. | IsoTis OrthoBiologics, Inc. | Device | Class II | 1 |
| 27 Nov 2024 | OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100. | IsoTis OrthoBiologics, Inc. | Device | Class II | 1 |
| 27 Nov 2024 | Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube. | Trokamed GmbH | Device | Class I | 4 |
| 27 Nov 2024 | 14019 Cucumber Select 6 CT, 01034 Cucumber Select 5# packaged in polybags Dairyland Produce, LLC Event 95905 | HARDIES FRESH FOODS | Food | Class I | 1 |
| 27 Nov 2024 | Product is a whole, fresh cucumber with no individual packaging, labeling, PLU, or other identifying information. Cucumber weight and size varies. Type of master packaging: 1.PACKAGED IN BULK IN 1 1/9 BUSHEL CARDBOARD BOXES WITH THE DELTA FRESH LABEL; OR 2.PACKAGED IN BULK IN 1 1/9 BUSHEL GENERIC WHITE CARDBOARD… Event 95872 | Delta Fresh LLC. | Food | Class I | 1 |
| 27 Nov 2024 | Texas Harvest Product: 01035 Cucumber Sliced 5# 5-pound trays with sealed film Event 95901 | Dairyland Produce, LLC | Food | Class I | 1 |
| 27 Nov 2024 | An Pan bun is a sweet roll filled with sweet red bean paste, stamped with black sesame seeds on top. Product is packaged in clear polypropylene bag, heat sealed with white labels on front and back. Net wt. 2.9pz. UPC 854077007055. The affected label states "**INGREDIENTS: Azuki Filling (Sugar, water, red beans,… Event 95885 | Name withheld | Food | Class III | 1 |
| 27 Nov 2024 | a.) King Kullen brand Vegetable Platter; UPC 85316-10005; 44oz plastic container b.) Wild by Nature brand Vegetable Platter; UPC 85316-10005; 44 oz plastic container | Gracie's Kitchens Inc. | Food | Class II | 34 |
| 26 Nov 2024 | AMT Mini Enteral Extension Set, 12" Right Angle Feeding Set with Y-Port. Model/Catalog Number: E6-1222 | Applied Medical Technology Inc | Device | Class II | 1 |
| 26 Nov 2024 | 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus Self Etching Primer is an orthodontic all-in-one etchant and primer that is used in the bonding process of orthodontic appliances to teeth. Event 95841 | 3M Unitek Corporation | Device | Class II | 1 |
| 26 Nov 2024 | Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972 | Beckman Coulter, Inc. | Device | Class II | 1 |
| 26 Nov 2024 | Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack Component: N/A | O&M HALYARD, INC. | Device | Class II | 1 |
| 26 Nov 2024 | Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitrile) Copper (I) tetratluoroborate - 1 mg; Stannous Chloride Dihydrate - 0.D75 mg; L-Cysteine Hydrochloride Monohydrate - 1 mg; Sodium… Event 95839 | Curium US, LLC | Drug | Class II | 1 |
| 26 Nov 2024 | Raw cucumbers packaged in cardboard boxes or plastic boxes (RPC) with "SunFed", "Vegetables", or "Agrotato" labeling. 1 1/9 BU CAS Super Slicer Cucumber/10814780010749 1 1/9 BU CAS Select Slicer Cucumber/10814780010756 1 1/9 BU CAS Large Slicer Cucumber/10814780010763 1 1/9 BU CAS Small Slicer Cucumber/10814780010770… Event 95850 | SunFed Produce, Inc. | Food | Class I | 1 |
| 26 Nov 2024 | Kirkland Signature ORGANIC EGGS PASTURE-RAISED 24 EGGS, GRADE A LARGE, NET WEIGHT 48OZ (3 LB) 1.36 kg, UPC 0 96619 10680 6, DISTRIBUTED BY: COSTCO WHOLESALE CORPORATION 730 LAKE DRIVE, ISSAQUAH, WA 98027 Event 95844 | Handsome Brook Farms, LLC | Food | Class I | 1 |
| 25 Nov 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000687 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended… | Olympus Corporation of the Americas | Device | Class II | 11 |
| 25 Nov 2024 | AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100 | Angiodynamics, Inc. | Device | Class II | 1 |
| 25 Nov 2024 | Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide monitoring system with patient data. | Spacelabs Healthcare, Inc. | Device | Class II | 1 |
| 25 Nov 2024 | GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3) A0659MB | GE Medical Systems, LLC | Device | Class II | 3 |
| 25 Nov 2024 | Xhibit Telemetry Receiver, Model 96280, with Service Manual. Intended to provide monitoring system with patient data. | Spacelabs Healthcare, Inc. | Device | Class II | 1 |
| 24 Nov 2024 | Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2; | Adept Medical Ltd | Device | Class II | 8 |
| 22 Nov 2024 | Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 | Nipro Renal Soultions USA, Corporation | Device | Class II | 1 |
| 22 Nov 2024 | Clarity Precision Grip Attachments, for use in orthodontic treatment. Part numbers/SKUs: 359-830 359-831 359-832 359-833 359-834 359-835 359-836 359-837 | 3M Company - Health Care Business | Device | Class II | 1 |
| 22 Nov 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 8 |
| 22 Nov 2024 | Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile. | Cook Biotech, Inc. | Device | Class II | 3 |
| 22 Nov 2024 | Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubilant Draximage Inc., dba Jubilant Radiopharma, Kirkland , Quebec, H9H, 4J$, Canada, NDC# 65174-179-05. Event 95836 | Jubilant Draximage Inc., dba Jubilant Radiopharma | Drug | Class II | 1 |
| 21 Nov 2024 | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads. | Abbott Medical | Device | Class II | 1 |
| 21 Nov 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B | Name withheld | Device | Class II | 4 |
| 21 Nov 2024 | Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X. | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 18 |
| 20 Nov 2024 | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing. | Nova Biomedical Corporation | Device | Class I | 3 |
| 19 Nov 2024 | SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field. Event 95889 | Med Michigan Holding Llc | Device | Class II | 1 |
| 19 Nov 2024 | VACUETTE SAFELINK, REF: 450210 Event 95748 | Greiner Bio-One GmbH | Device | Class II | 1 |
| 19 Nov 2024 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX | Baxter Healthcare Corporation | Device | Class II | 2 |
| 18 Nov 2024 | Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma. | Beckman Coulter, Inc. | Device | Class II | 1 |
| 18 Nov 2024 | EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional… Event 95902 | Elucent Medical Inc | Device | Class II | 1 |
| 18 Nov 2024 | Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992 | GE Medical Systems, LLC | Device | Class II | 5 |
| 18 Nov 2024 | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters). | Endo USA, Inc. | Drug | Class I | 4 |
| 16 Nov 2024 | --- Organic Baby Carrots --- Organic Baby Peeled Carrots 12/12oz Steam-to-Serve; Organic Baby Peel Carrot12/12oz Steam-to-Serve RPC --- Brand --- Cal-Organic; Marketside | Grimmway Enterprises, Inc. dba Grimmway Farms | Food | Class I | 5 |
| 14 Nov 2024 | UMARY ACID HYALURONIC, 850 MG CAPLETS, 30-count bottle, UPC7502265120323 Event 95777 | MXBBB | Drug | Class II | 1 |
| 13 Nov 2024 | Brand Name: Alcon Product Name: Monarch III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch III D delivery cartridge Lens Guide, Intraocular Component: N/A | Alcon Research LLC | Device | Class II | 1 |
| 13 Nov 2024 | Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3 Event 95655 | Brands International Corporation | Drug | Class II | 1 |
| 12 Nov 2024 | Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158; | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 12 Nov 2024 | STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695 | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 7 |
| 12 Nov 2024 | Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile. Event 95832 | Aerin Medical, Inc. | Device | Class II | 1 |
| 8 Nov 2024 | O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117 | O&M HALYARD, INC. | Device | Class II | 2 |
| 8 Nov 2024 | Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400 | Hologic, Inc. | Device | Class II | 1 |
| 8 Nov 2024 | Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912; 6) KIT,ORP PLASTIC FLAP,Catalog Number… | Cardinal Health 200, LLC | Device | Class II | 10 |
| 6 Nov 2024 | Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system measures changes… | St. Jude Medical | Device | Class II | 1 |
| 6 Nov 2024 | 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon. | Abbott Vascular Inc | Device | Class II | 4 |
| 6 Nov 2024 | MAJOR NEURO PACK-LF Convenience kit, SKU DYNJ0578916X. Convenience kits used for various procedures. | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 10 |
| 5 Nov 2024 | NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX Event 95971 | NOA Medical Industries Inc | Device | Class II | 1 |
| 5 Nov 2024 | El Gallo Jalapeño Queso salsa Event 95717 | Las Delicias Distributors, LLC | Food | Class II | 1 |
| 4 Nov 2024 | BYTE Aligner System REF PRS-0063 BYTE All-Day Aligner System BYTE AT-Night Aligner System A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct… Event 95745 | Straight Smile, LLC | Device | Class II | 1 |
| 1 Nov 2024 | FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended for in vitro diagnostic for the following: " Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. " It is… | Becton, Dickinson and Company, BD Bio Sciences | Device | Class II | 5 |
| 1 Nov 2024 | Napoleonas Torte packaged under the following sizes: 1. Small, Net Wt 1.25 lbs. (sub ingredients contain wheat, yellow #5 and #6, and sulfites not declared on final product label) 2. Medium, Net Wt 2.75 lbs. (sub ingredients contain yellow #5 and #6 not declared on final product label) 3. Large, Net Wt 6 lbs (sub… | Lithuanian Bakery, Inc. | Food | Class I | 2 |
| 29 Oct 2024 | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No | SEASPINE ORTHOPEDICS CORPORATION | Device | Class II | 2 |
| 28 Oct 2024 | Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. | Noah Medical | Device | Class II | 1 |
| 22 Oct 2024 | Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from the Opthalmic surgical site. Model Number: Q604206 | Carwild Corporation | Device | Class II | 3 |
| 22 Oct 2024 | KIRKLAND Signature Smoked Salmon NET WT 340 g (12 oz) MUST KEEP REFRIGERATED. INGREDIENTS: Atlantic Salmon (Salmo Salar), Salt, and Natural Hardwood Smoke. Color Added. Distributed by: Costco Wholesale Corporation P.O. Box 34535 Seattle, WA 98124-1535 UPC 0 96619 25697 6 Event 95612 | Acme Smoked Fish Corp. | Food | Class I | 1 |
| 16 Oct 2024 | Smaxel Fractional CO2 Laser, a Class IV medical laser system. Event 96034 | IDS LTD | Device | Class II | 1 |
| 16 Oct 2024 | Member's Mark Hatch Chile Chicken Enchiladas, ready to cook, perishable, packaging type: aluminum/black oven-safe tray Net wt. variable - average 1.52 lbs. UPC 00226529000004, UPC 00409802813793 Event 95669 | Sam'S Club | Food | Class II | 1 |
| 7 Oct 2024 | DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 | DRG International, Inc. | Device | Class II | 1 |
| 5 Oct 2024 | CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Electronics System (PES) REF CM1100 Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Which interfaces with CardioMEMSTM HF System Patient Electronics System (PES) and CardioMEMSTM HF System Hospital Electronics System (HES)).… | St. Jude Medical | Device | Class II | 2 |
| 2 Oct 2024 | TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis. Event 95732 | Name withheld | Device | Class II | 1 |
| 1 Sep 2024 | Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N Event 95983 | SIN SISTEMA DE IMPLANTE NACIONAL S.A | Device | Class II | 1 |
| 28 Jun 2023 | The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT)/Otology/Neurotology/ Otorhinolaryngology, orthopedic, and general surgical applications including maxillofacial… | Stryker Corporation | Device | Class II | 1 |
| 28 Jun 2023 | stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery | Stryker Corporation | Device | Class II | 2 |
| 5 Apr 2023 | BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352 | CareFusion 303, Inc. | Device | Class II | 1 |
| 14 Feb 2023 | BD Pyxis MedStation ES (Med ES Main), REF 323 | CareFusion 303, Inc. | Device | Class II | 6 |
| 3 Aug 2022 | Eclectic Herb Vitamin Herb Blend vita biotic dietary supplement, 750mg, 150 capsules per plastic bottle, UPC 0 23363 52002 2. Eclectic Institute, Inc. 755 NE 6th Street Gresham, OR 97030. The affected label declared "Oregon Grape 190mg ***Oregon Grape 97mg***Cayenne Root (Allium sativum) 195mg ***Ginger Fruit… Event 96000 | Eclectic Institute Inc | Food | Class III | 1 |
| 14 Mar 2022 | Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses. | Augustine Temperature Management, LLC | Device | Class II | 5 |
| 21 Jun 2021 | muRata Vios Monitoring System Model 2050; bedside cardiac monitor, including cardiotachometer and alarm rate | Murata Vios, Inc. | Device | Class II | 1 |