| 17 May 2024 | Product is MACARONI Salad, but the bottom container is mislabeled with the ingredients statement for COLESLAW. Product is refrigerated and packaged in a clear square container with 3 applied labels with a clear lid. Net Wt: 32oz. (2lbs) 907 g. There are 6 packages per case. Distributed and Sold by Aldi, Batavia, IL. | Reser's Fine Foods, Inc. | Food | Class II | 1 |
| 14 May 2024 | niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10 | American Regent, Inc. | Drug | Class II | 1 |
| 13 May 2024 | Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01 | American Regent, Inc. | Drug | Class II | 1 |
| 10 May 2024 | Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03 | Preferred Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 10 May 2024 | Price Chopper Fat Free Cottage Cheese with Pineapple Added 16oz plastic tub. (94616) | Individual firm, name withheld | Food | Class II | 1 |
| 8 May 2024 | Amyloid Complete (94596) | FoodScience, LLC | Food | Class II | 1 |
| 7 May 2024 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44 | MACLEODS PHARMA USA, INC | Drug | Class II | 1 |
| 3 May 2024 | Brand Name: Cerene Cryotherapy Device Product Name: DEVICE, THERMAL ABLATION, ENDOMETRIAL Model/Catalog Number: FGS-7000 Product Description: The Cerene Cryotherapy Device is an endometrial ablation device that uses nitrous oxide (N2O) to freeze and ablate the endometrium to reduce future menstrual bleeding. The… (94506) | Channel Medsystems, Inc. | Device | Class II | 1 |
| 3 May 2024 | Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343 | Philips North America Llc | Device | Class II | 30 |
| 3 May 2024 | chuao CHOCOLATIER potato chip mini chocolate bar, 0.39oz/11g (94572) | Kairo's Group, Inc. dba Chuao Chocolatier | Food | Class III | 1 |
| 3 May 2024 | Savor brand Spicy MANGO slices; net weight 8.0 oz. (227 grams) (94569) | Savor Fine Foods | Food | Class II | 1 |
| 2 May 2024 | TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762 | RemedyRepack Inc. | Drug | Class II | 1 |
| 1 May 2024 | CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Cherry Flavor, 10 fl. oz bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10. | Pharma Nobis LLC | Drug | Class II | 2 |
| 1 May 2024 | Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01 (94535) | Individual firm, name withheld | Drug | Class III | 1 |
| 30 Apr 2024 | Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05 | Hikma Injectables USA Inc | Drug | Class III | 1 |
| 30 Apr 2024 | Marketside Brioche Rolls, Authentic French Recipe, Net Wt. (.88 OZ (280g) (94666) | BAKERLY BARN LLC | Food | Class II | 1 |
| 29 Apr 2024 | Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), 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 | 3 |
| 29 Apr 2024 | Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25 | Hikma Injectables USA Inc | Drug | Class I | 1 |
| 27 Apr 2024 | Sysco Classic Riced Cauliflower packed in a 4lb plastic bag (6 units of 4 lb. per carton box). (94530) | CN Frozen Foods, INC | Food | Class II | 1 |
| 26 Apr 2024 | traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00 | Rubicon Research Private Limited | Drug | Class II | 1 |
| 26 Apr 2024 | YoCrunch¿ Vanilla Lowfat Yogurt with M&Ms 18 6oz cups per case | DANONE US LLC | Food | Class II | 1 |
| 25 Apr 2024 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ | FDC Limited | Drug | Class II | 1 |
| 25 Apr 2024 | MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10 | Sagent Pharmaceuticals | Drug | Class II | 1 |
| 25 Apr 2024 | Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77 | Viatris Inc | Drug | Class III | 1 |
| 25 Apr 2024 | Wegman's Half Loaf Garlic Bread | Wegmans Food Markets, Inc. | Food | Class II | 1 |
| 24 Apr 2024 | Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06 | Acella Pharmaceuticals, LLC | Drug | Class III | 1 |
| 24 Apr 2024 | Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04 | Lupin Pharmaceuticals Inc. | Drug | Class II | 2 |
| 24 Apr 2024 | Haloperidol decanoate Injection 50mg/mL, packaged in a) 1 mL Single-Dose Vials (NDC 70069-381-01) and b) 10 1mL Single-Dose Vials (NDC 70069-381-10), Rx only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India. | SOMERSET THERAPEUTICS LLC | Drug | Class II | 1 |
| 24 Apr 2024 | Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. | Aurobindo Pharma USA Inc. | Drug | Class II | 2 |
| 24 Apr 2024 | Queso de mano, Fresh soft white cheese, NET WT 24 oz.(640g), Keep Refrigerated, plastic container, packed 12 plastic containers of 24 oz per case (94505) | Tama Corporation | Food | Class I | 1 |
| 23 Apr 2024 | IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 23 Apr 2024 | SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979. | Ethicon, Inc. | Device | Class II | 1 |
| 23 Apr 2024 | Cascade IOMAX Cortical Module, REF: 190296-200 (94504) | Cadwell Industries Inc | Device | Class II | 1 |
| 23 Apr 2024 | EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-dose Pre-filled Syringe, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591, NDC 61755-005-01 | Regeneron Pharmaceuticals Inc | Drug | Class II | 1 |
| 23 Apr 2024 | Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net Wt 45g, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-804-90 | EPI Health, LLC | Drug | Class II | 3 |
| 22 Apr 2024 | Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116 | Philips North America Llc | Device | Class II | 2 |
| 22 Apr 2024 | Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class III | 1 |
| 22 Apr 2024 | Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, distributed by VSD Productions Inc., Las Vegas, NV. (94455) | Stop Clopez Corp | Drug | Class I | 1 |
| 19 Apr 2024 | Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x. | Philips North America Llc | Device | Class II | 1 |
| 19 Apr 2024 | GloStrips, Fluorescein Sodium Ophthalmic Strips USP (0.6 mg Fluorescein), Rx Only, a) 100 strips per carton, NDC 51801-003-40; b) 300 strips per carton, NDC 51801-003-50, Nomax, Inc., St. Louis, MO 63123. | Nomax Inc | Drug | Class II | 4 |
| 19 Apr 2024 | Amphotericin B Liposome for Injection, 50mg vials, 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 62756-233-01 | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 18 Apr 2024 | Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump (94491) | OptumHealth Care Solutions LLC | Device | Class I | 1 |
| 18 Apr 2024 | Longreen Corporation 4 in1 Reishi Coffee, 18.2 grams/sachet, 10 sachets/box | BF Suma Pharmaceuticals, Inc. | Food | Class II | 3 |
| 18 Apr 2024 | Mucci Food Products, Ltd. Tiramisu Italian Dessert, 2, 4.25 lb trays per case (94488) | Mucci Food Products, Ltd. DBA Mama Mucci's Pasta | Food | Class II | 1 |
| 18 Apr 2024 | Sammy's Milk GOAT MILK TODDLER FORMULA, 25.68 oz (78g) pouch | Graceleigh, Inc. dba Sammy's Milk | Food | Class I | 2 |
| 17 Apr 2024 | Yamaha Surface Mounter YR series, YS series, i-Pulse series, Sigma series, S series, M series. Affected models: YSM10, YSM20R(SV)-1, YSM20R(SV)-2, YSM20R-1, YSM20R-2, YSM20-1, YSM20-2, YSM20W-2, YRM20-1, YRM20-2, SIGMA-G5S2, S20, M20 ***Updated as of 6/10/2024*** Surface Mounter model S10, YC8. Component Dispenser… | YAMAHA MOTOR CORPORATION | Device | Class II | 2 |
| 17 Apr 2024 | Blood Pump Rotor, Model Number: F40015481 Rev A | Fresenius Medical Care Holdings, Inc. | Device | Class II | 5 |
| 17 Apr 2024 | Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND | Integra LifeSciences Corp. | Device | Class II | 1 |
| 17 Apr 2024 | CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic. | Cardinal Health 200, LLC | Device | Class II | 1 |
| 17 Apr 2024 | Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system | NRT X-RAY A/S | Device | Class II | 1 |
| 17 Apr 2024 | Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies. | LeMaitre Vascular, Inc. | Device | Class II | 1 |
| 17 Apr 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01. | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 17 Apr 2024 | Java Wafer - Mocha Hazelnut [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)] | Individual firm, name withheld | Food | Class II | 5 |
| 16 Apr 2024 | Stryker Blueprint Software, Catalog #BPUE001. (94444) | Individual firm, name withheld | Device | Class II | 1 |
| 16 Apr 2024 | Bulk flour tortillas sold to food service. 20ct 6in flour. 12 packages of 20ct per case. Packed in clear plastic bag and cardboard box. (94449) | La Original Tortilla Co., Inc. | Food | Class II | 1 |
| 16 Apr 2024 | Infinite Herbs Organic Basil packed in a clear 2.5 oz, 2.0 oz, and 4 oz PET clamshell container. | Infinite Herbs, LLC | Food | Class I | 1 |
| 16 Apr 2024 | Martinelli's Gold Medal Apple Juice From U.S. Grown Fresh Apples 1 Liter (33.8 fl oz.) No Additives of Any Kind UPC 0 00 41244 00102 6 | S Martinelli & Company | Food | Class II | 1 |
| 15 Apr 2024 | Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143 | Philips North America Llc | Device | Class II | 2 |
| 15 Apr 2024 | CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. | Maquet Medical Systems USA | Device | Class II | 1 |
| 12 Apr 2024 | APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system. (94445) | Medartis Inc. | Device | Class II | 1 |
| 12 Apr 2024 | Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01 (94355) | Dercher Enterprises, Inc., DBA Gordon Laboratories | Drug | Class II | 1 |
| 12 Apr 2024 | DB Yummers Sweet & Smokey Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 74872001101. | Individual firm, name withheld | Food | Class II | 3 |
| 12 Apr 2024 | 1. Country Club, Price Chopper, Good & Gather, Hiland, Belfonte, Great Value, Hen House Vitamin D Whole Milk, 1 gallon. 2. Country Club, Price Chopper, Good & Gather, Best Choice, Good Nature Family Farms Vitamin D Whole Milk, Half Gallon. 3. Belfonte, Hiland Vitamin D Whole Milk, Quart | Hiland Dairy Foods Company, LLC | Food | Class III | 1 |
| 11 Apr 2024 | Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24 | FUJIFILM Healthcare Americas Corporation | Device | Class II | 1 |
| 11 Apr 2024 | Roly Poly Bakery brand MULTIGRAIN bread; INGREDIENTS: Whole Wheat Flour, High Gluten Flour, Ryechops, Sesame, Caraway, Brownflex, Soybean, Pearl Wheat, Sunflower, Salt, Water. (94406) | Roly-Poly Bakery | Food | Class I | 1 |
| 10 Apr 2024 | Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01 | Imprimis NJOF, LLC | Drug | Class III | 1 |
| 10 Apr 2024 | Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ 07852, NDC 71384-340-08 | Imprimis NJOF, LLC | Drug | Class II | 1 |
| 9 Apr 2024 | Spectrum IQ Infusion pump, Product Code 357009 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 9 Apr 2024 | VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589 | QUIDELORTHO | Device | Class II | 2 |
| 9 Apr 2024 | The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT | Individual firm, name withheld | Device | Class II | 2 |
| 9 Apr 2024 | Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13 | Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. | Drug | Class III | 4 |
| 9 Apr 2024 | King Kullen Broccoli Cutlets with Breadcrumbs and Parmesan; 20oz; oven safe tin package with a clear dome top marked with a UPC Code 0 8531610145 0 (94403) | Gracie's Kitchens Inc. | Food | Class I | 1 |
| 8 Apr 2024 | HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P | HeartSine Technologies Ltd | Device | Class II | 1 |
| 8 Apr 2024 | Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure… | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 8 Apr 2024 | Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only. Used in breath analysis for metabolic… (94256) | Vyaire Medical, Inc. | Device | Class I | 1 |
| 8 Apr 2024 | Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30. | Individual firm, name withheld | Drug | Class I | 2 |
| 8 Apr 2024 | D-LO's Delightful Gourmet Cheesecake, Pistachio, 142g single serve UPC 8 60007 40398 9, and 678g six serving UPC 8 60007 40395 8, both serving sizes in clear plastic container with hinged lid (94497) | Individual firm, name withheld | Food | Class I | 1 |
| 8 Apr 2024 | Kowalski Simply Sides - Jack's Potato Salad, 16oz. plastic tub, UPC: 754721282701. 6 retail tubs per wholesale case. (94387) | Home Style Foods, Inc. | Food | Class II | 1 |
| 8 Apr 2024 | Ready Meals Teriyaki Salmon W Rice 13.5OZ TRAY BLK&GOLD ALUM 22OZ with Plastic Lid #81061425 UPC: 002113010092 Sell Thru 04/12/24 LOT TFSW095A | Taylor Farms Southwest, Inc | Food | Class II | 1 |
| 5 Apr 2024 | IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434 | IVOCLAR VIVADENT AG | Device | Class II | 6 |
| 5 Apr 2024 | Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115 | Randox Laboratories Ltd. | Device | Class III | 1 |
| 5 Apr 2024 | WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device. | Wishbone Medical, Inc. | Device | Class II | 1 |
| 5 Apr 2024 | Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No | Jiangsu Shenli Medical Production Co., Ltd. | Device | Class II | 88 |
| 5 Apr 2024 | International Bread Pita Chips Retail Clamshell Container: 10oz., Bulk bag: 10lbs. UPC: Plain Baked Pita Chips: 6 81942 22110 6 | INTERNATIONAL PITA BREAD, INC. | Food | Class II | 2 |
| 5 Apr 2024 | Blues Hog Sweet & Savory Seasoning, 6.25oz plastic bottle, 12 bottles per case (94379) | Baron Spices Inc | Food | Class III | 1 |
| 5 Apr 2024 | Bottle is labeled as Johnny's Parmesan Garlic Seasoning, 5oz (141g), packaged in poly bottle with green spice cap, UPC 0 70381 10060 6. Distributed by Johnny s Fine Foods Inc. 319 E. 25th St. Tacoma, WA 98421. Label declares: CONTAINS: MILK. MANUFACTURED IN A FACILITY THAT ALSO PROCESSESS PROUCT CONTAINING WHEAT,… (94383) | OS Holding Inc | Food | Class II | 1 |
| 4 Apr 2024 | 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation… | Stryker Leibinger GmbH & Co. KG | Device | Class II | 1 |
| 4 Apr 2024 | Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ketones, Ascorbic Acid, Glucose, pH, Specific Gravity and Leucocytes in Urine by the Dip and Read Technique. (94454) | Macherey Nagel Gmbh & Co. Kg | Device | Class II | 1 |
| 3 Apr 2024 | InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity. | Olympus Corporation of the Americas | Device | Class II | 1 |
| 3 Apr 2024 | The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. Device dimensions and configuration are shown on the product label. A… (94347) | Individual firm, name withheld | Device | Class II | 1 |
| 3 Apr 2024 | Bizcocho de Boda Puertorrique¿o Naked "Puerto Rican wedding cake naked", packaged in aluminum mold/plastic showcase, 24 Pack per case of 10 oz / 6 pack per case of 32 oz/ 4 pack per case of 51.2 oz, Net Wt. 10 oz UPC 851249003075, 32 oz. UPC 851249003112 and 52.2 oz UPC 85124900313. (94361) | Individual firm, name withheld | Food | Class II | 1 |
| 2 Apr 2024 | Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US | Fisher & Paykel Healthcare, Ltd. | Device | Class II | 1 |
| 2 Apr 2024 | Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) (94394) | Andover Healthcare Inc. | Device | Class II | 1 |
| 1 Apr 2024 | OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124 | Philips Respironics, Inc. | Device | Class I | 1 |
| 1 Apr 2024 | LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000 (94389) | Individual firm, name withheld | Device | Class II | 1 |
| 1 Apr 2024 | EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 | Cook Medical Incorporated | Device | Class II | 2 |
| 29 Mar 2024 | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614 | Stryker Leibinger GmbH & Co. KG | Device | Class II | 1 |
| 29 Mar 2024 | The Oncology Essentials Package of the Spectral CT imaging system. | Philips North America Llc | Device | Class II | 1 |
| 29 Mar 2024 | Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face Protection, Inc., 825 East Highway 151, Platteville, WI 53818. NDC: 0498-0631-37 (94345) | HONEYWELL INC | Drug | Class II | 1 |
| 29 Mar 2024 | Sensible Portions brand Garden Veggie Straws Sea Salt. 1 oz bag UPC:2951530057 Packaged in a 30 CT Variety Pack that contains Sea Salt, Cheddar Cheese, and Zesty Ranch in plastic bags. (15 sea salt, 10 ranch, 5 cheddar cheese) UPC: 29515-32543 (94353) | THE HAIN CELESTIAL GROUP INC | Food | Class I | 1 |
| 28 Mar 2024 | NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System. | Zimmer, Inc. | Device | Class II | 1 |
| 28 Mar 2024 | RayStation 7.0.0.19. Radiation Therapy Treatment Planning System. | RAYSEARCH LABORATORIES AB | Device | Class II | 12 |
| 28 Mar 2024 | Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator (94338) | Individual firm, name withheld | Device | Class II | 1 |
| 28 Mar 2024 | Geissler's Supermarket Philadelphia Avo or Cucumber Classic Roll (sushi roll) Ingredients read in part: "***INGREDIENTS: SMOKED SALMON, CREAM CHEESE, AVOCADO, CUCUMBER, RICE. NORI. WHITE STEAMEDRICE. VINEGAR. SUGAR. SALT. LEMON. MIRIN.WASABI. GINGER. WATER, SOYSAUCE (WHEAT, SOYBEANS, ALCOHOL)***MADE IN A FACILITY… | Geissler's Supermarket | Food | Class I | 6 |
| 27 Mar 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D | Cardinal Health 200, LLC | Device | Class II | 5 |
| 26 Mar 2024 | BiPAP V30 Auto Ventilator, Part Number 1111178 | Philips Respironics, Inc. | Device | Class I | 3 |
| 26 Mar 2024 | Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. | Medtronic Navigation, Inc. | Device | Class I | 1 |
| 26 Mar 2024 | Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300,… | Cipla USA, Inc. | Drug | Class II | 1 |
| 26 Mar 2024 | 5 lb.Food Club All Purpose Flour Best if Used by 03/08/2025 (94301) | Shawnee Milling Company | Food | Class II | 1 |
| 25 Mar 2024 | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component | Ossur H / F | Device | Class II | 4 |
| 25 Mar 2024 | Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater, NJ 08807, NDC # 69238-1605-2. | Amneal Pharmaceuticals of New York, LLC | Drug | Class II | 1 |
| 23 Mar 2024 | 5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters. | Philips Ultrasound, Inc. | Device | Class II | 1 |
| 23 Mar 2024 | Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in (a) 8.5 fl oz (251 mL) plastic bottle UPC 0 82252 03120 9 (b) 2.2 fl oz (65 mL) plastic bottle, UPC 0 82252 34030 1 , Manufactured in Aruba by Aruba Aloe Balm Inc., Pitastraat 115, Aruba, Dutch Caribbean. | Aruba Aloe Balm N.V. | Drug | Class I | 2 |
| 22 Mar 2024 | Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT Corporation) 120V Uninterruptable Power Supply Model: SCL500RM1U 2. APC (Schneider Electric IT Corporation) 230V Uninterruptable Power Supply Model: SCL500RMI1U | Philips North America Llc | Device | Class II | 1 |
| 22 Mar 2024 | Redux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme. | Parker Laboratories, Inc. | Device | Class II | 1 |
| 22 Mar 2024 | Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 1067716 | EBI, LLC | Device | Class II | 4 |
| 22 Mar 2024 | 12 oz Aluminum cans of root beer packaged 12 cans per carton. 2/12pks per case | Pepsico Inc. | Food | Class III | 1 |
| 21 Mar 2024 | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter | Boston Scientific Corporation | Device | Class I | 48 |
| 21 Mar 2024 | Goya Red Kidney Beans, Net Wt.15.5oz.(439g), metal (tin) cans, 24 cans/15.5 oz. per case | Tradewind Foods de Puerto Rico Inc. | Food | Class II | 1 |
| 21 Mar 2024 | Amy's Kitchen Enchilada Verde Whole Meal 10 oz. 12 pk Item # 000085 | AMY'S KITCHEN INC. | Food | Class II | 1 |
| 20 Mar 2024 | Alinity m System, Part Number: 08N53-002 | Abbott Molecular, Inc. | Device | Class II | 1 |
| 20 Mar 2024 | 3M Durapore Surgical Tape, Catalog Number 1538-118 | 3M Company - Health Care Business | Device | Class II | 1 |
| 20 Mar 2024 | Baxter Spectrum IQ Infusion Pump, Product Code 3570009 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 20 Mar 2024 | ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 47-2357-017-04 | Zimmer, Inc. | Device | Class II | 21 |
| 20 Mar 2024 | Belgian Yummies Homemade Ice Cream Strawberry Gelato. Packaged in 5 Liter gray carapina liner. | Individual firm, name withheld | Food | Class I | 9 |
| 19 Mar 2024 | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only | TriMed Inc. | Device | Class II | 2 |
| 19 Mar 2024 | Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80220; c) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 82020; d) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number… | Medtronic Perfusion Systems | Device | Class II | 13 |
| 19 Mar 2024 | Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 | Pyramids Wholesale Inc. | Drug | Class I | 11 |
| 18 Mar 2024 | LightStrike Blackout Curtains, Part numbers; 610-00008, 610-00009, 610-00019, 610-00020, and 610-00024, used with the LightStrike Germ-Zapping Robots Models: PXUV4D, PXUV5D, LSMUV6-FT, or LSMUV6-SL, for whole room microbial reduction. (94258) | XENEX Disinfection Services Inc. | Device | Class II | 1 |
| 18 Mar 2024 | GE Healthcare Innova IGS 5, computed tomography x-ray system | GE Medical Systems, SCS | Device | Class II | 7 |
| 18 Mar 2024 | DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015 | Angiodynamics, Inc. | Device | Class II | 15 |
| 18 Mar 2024 | FRENCH S CRISPY FRIED ONIONS ORIG 16/6 OZ, Case Pack - 16/6 OZ, | McCormick & Company, Inc.- Consumer Product Division | Food | Class II | 2 |
| 15 Mar 2024 | Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannulas. These Custom Paks are surgical procedure packs used by ophthalmic surgeons in a variety of ophthalmic surgeries. The Custom Pak is a collection of various ophthalmic surgical instruments and necessary materials.… | Alcon Research, LLC | Device | Class II | 1 |
| 15 Mar 2024 | Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery | Baxter Healthcare Corporation | Device | Class II | 1 |
| 15 Mar 2024 | Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm (Symmetrical Tip, Heparin Coating, Silver Ion Sleeve and Tal VenaTrac Stylet- Intended for acute and chronic hemodialysis, apheresis, and infusion. Model Number (CFN): 8888119369P | Covidien LP | Device | Class II | 2 |
| 15 Mar 2024 | PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA¿ TL system is intended to provide immobilization and stabilization of spinal segments in… | SPINEART SA | Device | Class II | 1 |
| 14 Mar 2024 | Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY | Merit Medical Systems, Inc. | Device | Class II | 2 |
| 14 Mar 2024 | VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF 421982; c) AST-GN99, REF 423102; d) AST-N390, REF 423340; e) AST-N391, REF 423341; f) AST-N392, REF 423342; g) AST-N395, REF 423491; h) AST-N401, REF 423643; i) AST-N402, REF 423644; j)… | Biomerieux Inc | Device | Class I | 1 |
| 14 Mar 2024 | Johnson & Johnson VISION Reusable LAMINAR High Flow Irrigation Sleeve and Test Chamber 21 Gauge REF OPOHF21L The irrigation sleeve is a device intended to direct irrigation solution across the shaft of a phacoemulsification tip, allowing the solution to enter the eye during ocular surgery. | Johnson & Johnson Surgical Vision, Inc. | Device | Class II | 1 |
| 14 Mar 2024 | Keller Funnel 2, REF: HA-001, STERILEEO, Rx Only, | Allergan Sales, LLC | Device | Class II | 1 |
| 13 Mar 2024 | Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer… | Biomet, Inc. | Device | Class II | 1 |
| 13 Mar 2024 | Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW… | Electro Medical Systems SA | Device | Class II | 3 |
| 13 Mar 2024 | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker… | Hologic, Inc | Device | Class I | 1 |
| 12 Mar 2024 | namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT,… | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 2 |
| 12 Mar 2024 | Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule dietary supplement, Folate 1667mcg DFE, 5000mcg Folic Acid, 120 capsules per package, UPC 8 12325 02354 7. Manufactured exclusively by: Kirkman, Lake Oswego, OR 9703, (94230) | HTO Nevada Inc DBA Kirkman | Food | Class III | 1 |
| 12 Mar 2024 | Organic Yogi Echinacea Immune Support, Caffeine Herbal Supplement, Serving Size 1 tea bag, 16 tea bags per pack, 4 packs per box. UPC on box: 0 76950 45010 3. CASE GTIN: 60076950450105. East West Tea Company, LLC Eugene, OR Yogi Echinacea Immune Support, Caffeine Herbal Supplement, 16 tea bags per pack, 6 Packs per… (94438) | East West Tea Company, LLC | Food | Class III | 1 |
| 11 Mar 2024 | OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use. Uses the method of freezing point depression to measure osmolality of serum, plasma, and urine. Model/Catalog Number: OsmoPRO MAX Software Version: 1.5.0.0 (94330) | Advanced Instruments, LLC | Device | Class II | 1 |
| 9 Mar 2024 | Galaxy System REF GAL-001 (specifically GAL-019, Wired Controller) The Galaxy System and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. | Noah Medical | Device | Class II | 1 |
| 8 Mar 2024 | Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature. | ROUTE 92 MEDICAL INC | Device | Class I | 5 |
| 7 Mar 2024 | POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Model/Catalog Number: PS-0523CJDA | Olympus Corporation of the Americas | Device | Class II | 3 |
| 7 Mar 2024 | INNOMED CUP REMOVAL STARTER INSTRUMENT, REF 520054, Hip cutter blade cup (94337) | Innomed, Inc. | Device | Class II | 1 |
| 6 Mar 2024 | Supreme Tradition brand and Marcum brand ground cinnamon. Packaged in 1.5 oz and 2.25 oz clear plastics jars | Colonna Brothers Inc. | Food | Class II | 1 |
| 5 Mar 2024 | QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests | Quidel Corporation | Device | Class II | 2 |
| 5 Mar 2024 | Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests. | Randox Laboratories Ltd. | Device | Class II | 1 |
| 5 Mar 2024 | t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology | Tandem Diabetes Care, Inc. | Device | Class I | 1 |
| 4 Mar 2024 | IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions. | Ion Beam Applications S.A. | Device | Class II | 1 |
| 4 Mar 2024 | Fiji Natural Artesian Water 500 mL (24 pack) Case UPC Code: 6 32565 00004 3 Bottle UPC Code: 6 32565 00001 2 (94172) | Natural Waters of Viti Limited | Food | Class III | 1 |
| 1 Mar 2024 | Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly | Thoratec Corp. | Device | Class I | 2 |
| 1 Mar 2024 | Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170 | Alere San Diego, Inc. | Device | Class II | 1 |
| 28 Feb 2024 | Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems. | SEASPINE ORTHOPEDICS CORPORATION | Device | Class II | 1 |
| 27 Feb 2024 | TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-44B | Howmedica Osteonics Corp. | Device | Class II | 12 |
| 23 Feb 2024 | ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C | Siemens Medical Solutions USA, Inc. | Device | Class II | 3 |
| 15 Feb 2024 | Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha… | SEASPINE ORTHOPEDICS CORPORATION | Device | Class II | 1 |
| 12 Feb 2024 | ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card. (94339) | FA Online Inc | Drug | Class I | 1 |
| 10 Feb 2024 | Jalapenos packed in 6lb 10oz cans. 6 cans per case (94471) | M-C McLANE INTERNATIONAL | Food | Class II | 1 |
| 5 Feb 2024 | Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO | Abbott Medical | Device | Class II | 1 |
| 25 Jan 2024 | Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk fibers, for use in soft tissue approximation and/or ligation. | Covidien, LP | Device | Class II | 1 |
| 22 Jan 2024 | Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1, model numbers: a. SM-20HF-Batt; b. SM-32HF-Batt; c. SM-40HF-Batt; d. SM-50HF-Batt; e. SM-40-HF-B-D-VIR; f. SM-20HF-B-D-KM (AeroDR X30); g. SM-32-HF-B-D-KM (AeroDR X30); h. SM-40HF-B-D-KM (AeroDR X30); i. SM-50HF-B-D-KM (AeroDR X30); j.… | SEDECAL SA | Device | Class II | 1 |
| 9 Jan 2024 | Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC | Covidien | Device | Class II | 2 |
| 20 Nov 2023 | Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) | LEICA BIOSYSTEMS NUSSLOCH GMBH | Device | Class II | 1 |
| 14 Mar 2023 | ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of degenerative disc disease (94279) | Advanced Research Medical, LLC | Device | Class II | 1 |