| 13 Jun 2023 | Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13 | AVKARE LLC | Drug | Class III | 1 |
| 12 Jun 2023 | Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30 (92458) | Amring Pharmaceuticals Inc | Drug | Class III | 1 |
| 6 Jun 2023 | GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3 | HF Acquisition Co LLC | Drug | Class III | 1 |
| 1 Jun 2023 | Julian's Recipe Original Cauli-Wafels, 7.41 oz. | Julian's Recipe, LLC | Food | Class II | 3 |
| 31 May 2023 | ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08 | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories | Drug | Class I | 1 |
| 30 May 2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10. | Amneal Pharmaceuticals of New York, LLC | Drug | Class II | 1 |
| 27 May 2023 | Recalled product has the carton labeled as Tillamook 1.5 QT CHOCOLATE PEANUT BUTTER Ice Cream, frozen, 1.5 Qt. and has the correct lid labeled as Tillamook WAFFLE CONE SWIRL ICE CREAM. The carton label is read Tillamook CHOCOLATE PEANUT BUTTER ICE CREAM, KEEP FROZEN ***allergen advisory "Made on equipment that makes… (92427) | Tillamook County Creamery Association | Food | Class II | 1 |
| 25 May 2023 | Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle). | Golden State Medical Supply Inc. | Drug | Class II | 1 |
| 25 May 2023 | Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05 | Viatris Inc | Drug | Class II | 1 |
| 25 May 2023 | Fresh Organic Freezer Strawberries Mexico with calyx (caps) removed, net wt. 18 lbs., packaged in a T60-800 Polyethylene Homopolymer picking tray. Product is imported and distributed in fresh condition by Cascade International Foods. (92442) | Cascade International Foods, Inc | Food | Class I | 1 |
| 25 May 2023 | Wegmans Penne Rigate Mozzarella Salad Net Wt 30 OZ (1 LB 14 OZ) 850 g. Packaged in a plastic container. | ASK Foods Inc | Food | Class II | 1 |
| 25 May 2023 | enterade Advanced Oncology Formula; Original Vanilla Flavor; Medical Food; Helps manage and maintain GI function; 8 FL OZ (237 mL); Recommended Use: Use as directed by your doctor, enterade is a medical food for patients under the supervision of a physician; Refrigerate after opening; Ingredients: Water, amino acid… (92408) | ENTRINSIC HEALTH SOLUTION INC | Food | Class II | 1 |
| 24 May 2023 | Tastykake Chocolate Kandy Kakes NET WT 8 OZ (227g) 6-1.3 OZ (38g) PKGS TASTY BAKING COMPANY, PHILADELPHIA, PA 19112 UPC 0 25600 00225 4 | Flowers Foods (Corporate Offices) | Food | Class I | 1 |
| 24 May 2023 | Texas Pete BUFFALO Wing Sauce 12 FL OZ - 355 mL TW GARNER FOOD CO. WINSTON-SALEM, NC 27105 UPC 0 75500 10011 6 (92400) | T.W. GARNER FOOD CO | Food | Class II | 1 |
| 23 May 2023 | BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish | Young Dental Manufacturing I, LLC | Device | Class II | 1 |
| 23 May 2023 | Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10 | Fresenius Medical Care Holdings, Inc. | Drug | Class II | 1 |
| 22 May 2023 | Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663; | Wilson-Cook Medical Inc. | Device | Class II | 2 |
| 22 May 2023 | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25 (92374) | New England Life Care, Inc. dba Advanced Compounding Solutions | Drug | Class III | 1 |
| 22 May 2023 | Van Leeuwen brand BROWN SUGAR CHUNK WITH COOKIE DOUGH & BROWNIES FENCH ICE CREAM; 14 FL OZ (414 ML); ingredients: cream, milk, dark brown sugar, cane sugar, egg yolks, wheat flour, unbleached flour (wheat flour, malted barley flour), water, cocoa processed with alkali, canola oil, coconut oil, invert sugar, eggs, egg… (92392) | Van Leeuwen Ice Cream LLC | Food | Class I | 1 |
| 19 May 2023 | ARROW Endurance Extended Dwell Peripheral Catheter System | ARROW INTERNATIONAL Inc. | Device | Class I | 1 |
| 19 May 2023 | Miyako Select Shredded Crab Meat Keep Refrigerated #1485 Ingredients: Fish Protein (Pollock, Threadfin Bream and/or Flying Fish), Water, Potato Starch, Modified Food Starch, Contains less than 2% of the following: Sugar, Salt, Sorbitol, Carrageenan, Natural and Artificial Flavors (Hydrolyzed Soy Protein, Qab… | Aquamar Inc | Food | Class I | 3 |
| 19 May 2023 | Frederik's by Meijer Dark Chocolate Almonds, 12oz stand-up pouch, UPC 7-08820-68730-1 | Meijer Inc | Food | Class I | 2 |
| 19 May 2023 | Organic Pineapple Chunks, Item 4510-000, packed in 30 lb. poly-lined boxes. | SunOpta Grains and Foods Inc. | Food | Class I | 1 |
| 19 May 2023 | Onion Powder Premium, 44.9 and 50 lb. fiber bags sold as bulk ingredient (92405) | Olam Food Ingredients | Food | Class I | 1 |
| 19 May 2023 | Bacaolinita Liquid Dietary Supplement With vitamins A and D + B12 8 fl. oz (236 mL) UPC 841548000028 packaged in a bottle inside a cardboard box (92385) | Procaps S.A. de C.V. | Food | Class II | 1 |
| 18 May 2023 | HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840 | Maquet Medical Systems USA | Device | Class II | 10 |
| 18 May 2023 | QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388 | Maquet Medical Systems USA | Device | Class II | 8 |
| 18 May 2023 | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 | Aurolife Pharma, LLC | Drug | Class III | 1 |
| 18 May 2023 | Chili Cacahuate Japones, net weight 5 oz (127g), packaged in a soft teal colored plastic pouch with the UPC code 7 09972 80082 2. There are 6 pouches per case. Werner Gourmet Meat Snacks Inc. Tillamook, OR 97141. The label declares: INGREDIENTS: CHILI, RICE FLOUR, WHEAT FLOUR , SUGAR , LEAVENING ***, SALT, SOYSAUCE… | Werner Gourmet Meat Snacks, Inc. | Food | Class II | 1 |
| 18 May 2023 | EARTH KRATOM TRAINWRECK 150 CAPSULES (UPC: 908193737324) (50 UNITS/CASE) and 300 CAPSULES (UPC: 005821990011) (25 UNITS/CASE). DISTRIBUTED BY FIRE WHOLESALE. Ingredients: Mitragyna speciosa leaf, purified water, vegetable magnesium stearate, and gelatin capsules. | Fire Distributors Plus LLC | Food | Class II | 2 |
| 17 May 2023 | TYR Anamix Early Years infant formula Net Wt. 14.1 oz (400g) UPC: 749735002186 Product is a powder packed metal cans. 6 cans per case. | Nutricia North America | Food | Class II | 1 |
| 17 May 2023 | Hu Vanilla Crunch Dark Chocolate bar | HU PRODUCTS | Food | Class II | 1 |
| 16 May 2023 | HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech | Heartware, Inc. | Device | Class II | 1 |
| 16 May 2023 | Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C] | Draeger Medical Systems, Inc. | Device | Class II | 1 |
| 16 May 2023 | Fresh location Apple Cranberry Walnut Salad, 7.5oz clear plastic container, UPC 8 55110 00815 2 | The H.T. Hackney Company | Food | Class II | 5 |
| 16 May 2023 | Nature's Energy Children's Chewable Colostrum Berry, 180 count, UPC 804879183945 GTIN 860008676979 | Individual firm, name withheld | Food | Class II | 3 |
| 16 May 2023 | Wegmans Italian Classics Diavolo Pasta Sauce 24 OZ (92354) | LiDestri Foods, Inc. | Food | Class I | 1 |
| 15 May 2023 | Brat Roll Frozen Dough Product Code 18429 UPC: 00078296184292. Individual unit wt 2.50 oz. Packaged in a cardboard box. 180 pieces per case. (92364) | Gonnella Frozen Products, LLC | Food | Class I | 1 |
| 12 May 2023 | Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020 | Ossur H / F | Device | Class II | 1 |
| 12 May 2023 | Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual | Boston Scientific Neuromodulation Corporation | Device | Class II | 1 |
| 12 May 2023 | ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded by: Empower Pharmacy, 5980 W Sam Houston Pkwy N Ste 300 Houston, TX 77041, NDC 72627-2405-1 (92367) | Empower Clinic Services LLC dba Empower Pharmacy | Drug | Class II | 1 |
| 11 May 2023 | Living Nutz Nut & Seed Butter Raw Sprouted & Stoneground; 8 oz., 12 oz. or 64 oz. (92319) | Living Nutz Living Organic Foods | Food | Class I | 1 |
| 10 May 2023 | Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20 (92275) | BearCare, Inc. | Device | Class I | 1 |
| 10 May 2023 | ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class I | 120 |
| 9 May 2023 | HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), Rx Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0600-2 | SSM Health Care St. Louis DBA SSM St. Clare Health Center | Drug | Class II | 1 |
| 9 May 2023 | Black Fungus Golden Koi 2.5 oz packages 100 bags per case UPC: 81005681145 Product of China (92332) | AH USA Group Inc | Food | Class I | 1 |
| 8 May 2023 | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 | Remote Diagnostic Technologies Ltd. | Device | Class II | 1 |
| 8 May 2023 | Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 | Galt Medical Corporation | Device | Class II | 2 |
| 8 May 2023 | simply to go Strawberry Yogurt Parfaits, 8.53oz, UPC 477088125794; packaged in plastic cups | Sodexo Operations, LLC | Food | Class II | 2 |
| 5 May 2023 | bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator | Vyaire Medical | Device | Class II | 2 |
| 5 May 2023 | Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy | Elekta, Inc. | Device | Class II | 1 |
| 5 May 2023 | Multigrain Spicy Salmon Avocado Roll, net wt. 7 oz., Ready to Eat, perishable and refrigerated product. UPC 8 51016 00244 7. Manufactured by Origami Catering 828 N Killingsworth St., Portland, OR 97217. The Ingredients statement is read in part: Multigrain Sushi Rice ***, Salmon (fish), Avocado, ***Mayonnaise… (92291) | Origami Catering, LLC | Food | Class II | 1 |
| 5 May 2023 | Jost Chemical Magnesium Citrate Tribasic Hydrate, USP, Powder, Net Wt 110 lb/ 50 kg packaged in bulk lined fiber drums | Jost Chemical Co | Food | Class III | 1 |
| 5 May 2023 | a.) BEAN SPROUTS, 10 LBS, PRODUCT OF USA; CHANG FARM; SO.DEERFIELD, MA; KEEP REFRIGERATED; package in plastic bags b.) Nature's Wonder brand Premium BEAN SPROUTS; ALL NATURAL AND READY TO COOK; NET WT 12 oz (340 g); REFRIGERATE | Chang & Son Enterprises, Inc. | Food | Class I | 2 |
| 4 May 2023 | Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX | Datascope Corp. | Device | Class III | 1 |
| 4 May 2023 | Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A | Olympus Corporation of the Americas | Device | Class II | 4 |
| 3 May 2023 | NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device | NOXBOX LTD | Device | Class I | 1 |
| 3 May 2023 | Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 3 May 2023 | MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 3 May 2023 | The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery system that is advanced under… | Bolton Medical Inc. | Device | Class II | 1 |
| 3 May 2023 | Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83. | SUN PHARMACEUTICAL INDUSTRIES INC | Drug | Class II | 1 |
| 3 May 2023 | Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807. | Denison Pharmaceuticals, LLC | Drug | Class II | 4 |
| 2 May 2023 | V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS). | SenTec AG | Device | Class II | 1 |
| 2 May 2023 | Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers: a) REF 1-10003-100 (SIZE 1 Right Medial); b) REF 1-10003-110 (SIZE 1 Left Medial); c) REF 1-10003-200 (SIZE 2-Right Medial); d) REF 1-10003-210 (SIZE 2-Left Medial); e) REF 1-10003-300 (SIZE 3- Right Medial); f) REF… | Smith & Nephew, Inc. | Device | Class II | 4 |
| 2 May 2023 | Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics | Helena Laboratories, Corp. | Device | Class II | 1 |
| 1 May 2023 | BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088 | Becton Dickinson & Co. | Device | Class II | 1 |
| 1 May 2023 | Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B, LD2110X23B, and VT2110X24B | Philips Respironics, Inc. | Device | Class I | 4 |
| 28 Apr 2023 | Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation | TELEFLEX LLC | Device | Class II | 1 |
| 28 Apr 2023 | QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 | Qiagen Sciences LLC | Device | Class II | 1 |
| 27 Apr 2023 | Intelli-C, Right side suspended Tabletop, REF: 03400000 | NRT X-RAY A/S | Device | Class II | 2 |
| 26 Apr 2023 | Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles, and C) 15 mL bottles, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs | Akorn, Inc. | Drug | Class II | 86 |
| 26 Apr 2023 | TURKEY AND HAVARTI Sandwich NET WT. 8.55OZ (242g) CONTAINS MILK, SOY, WHEAT MAY CONTAIN EGG Distributed By Rennaissance Food Group, LLC 4322 Moreland Ave Conley, GA UPC 8 26766 15584 2 (92198) | GARDEN HIGHWAY ATLANTA | Food | Class II | 1 |
| 26 Apr 2023 | Trader Joes Instant Cold Brew Coffee, 3.5 oz.(99g), 24 jars per case. (92326) | Regal Trading, Inc. | Food | Class II | 1 |
| 25 Apr 2023 | LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13 | Linkbio Corp. | Device | Class II | 1 |
| 25 Apr 2023 | SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB | LumiraDx | Device | Class II | 1 |
| 24 Apr 2023 | AVNS ambIT System - PIB/PCA W 2.5in Cath, Product Code: 220509 | Avanos Medical, Inc. | Device | Class II | 5 |
| 24 Apr 2023 | Alinity i Anti-TPO Reagent Kit, List Number 09P3521 (92271) | Abbott Ireland Limited | Device | Class III | 1 |
| 22 Apr 2023 | Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only | Merit Medical Systems, Inc. | Device | Class II | 13 |
| 21 Apr 2023 | Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B. | MEDLINE INDUSTRIES, LP - Northfield | Device | Class II | 1 |
| 21 Apr 2023 | Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053 | Masimo Corporation | Device | Class II | 4 |
| 21 Apr 2023 | Vital Proteins Collagen Peptides, retail 24oz plastic canister, UPC 8 57273 00866 6; 6 retail units per wholesale case (92242) | Individual firm, name withheld | Food | Class II | 1 |
| 20 Apr 2023 | Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 51818 | C.R. Bard Inc | Device | Class II | 4 |
| 20 Apr 2023 | G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC… | Novis PR, LLC dba Kramer Novis | Drug | Class I | 1 |
| 17 Apr 2023 | Total Knee Pack, REF CETJ130, medical convenience kits | American Contract Systems, Inc. | Device | Class III | 1 |
| 17 Apr 2023 | Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV… | DeRoyal Industries Inc | Device | Class II | 2 |
| 14 Apr 2023 | VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data Release Versions (DRVs) 6215 through 6223. In vitro diagnostic -VITROS Chemistry Products Calibrator Kit 11 is used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT… | Ortho-Clinical Diagnostics, Inc. | Device | Class II | 1 |
| 14 Apr 2023 | RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A0026577 | Mechatronics USA | Device | Class III | 2 |
| 13 Apr 2023 | TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E | Howmedica Osteonics Corp. | Device | Class II | 2 |
| 13 Apr 2023 | DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724 | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 5 |
| 11 Apr 2023 | StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems | Medtronic Navigation, Inc. | Device | Class I | 1 |
| 11 Apr 2023 | StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems | Medtronic Navigation, Inc. | Device | Class I | 1 |
| 10 Apr 2023 | TETAS Mireya, SABOR Galleta Maria | DIBE LLC | Food | Class I | 5 |
| 7 Apr 2023 | Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4 (92187) | Cytrellis Biosystems, Inc. | Device | Class II | 1 |
| 6 Apr 2023 | Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil. | Elekta, Inc. | Device | Class II | 1 |
| 6 Apr 2023 | Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39501A2; Wire Tray f. Cleaning, 487 x 125 x… (92244) | Individual firm, name withheld | Device | Class II | 1 |
| 6 Apr 2023 | Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery | Cardinal Health 200, LLC | Device | Class II | 1 |
| 5 Apr 2023 | NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software | Illumina, Inc. | Device | Class II | 2 |
| 5 Apr 2023 | KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A (92182) | Individual firm, name withheld | Device | Class II | 1 |
| 30 Mar 2023 | Eye and Ear Dropper, Product Code 67082 | Apothecary Products, LLC | Device | Class II | 2 |
| 27 Mar 2023 | Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01 | Jarman's Midwest Cleaning Systems, Inc. | Drug | Class I | 3 |
| 21 Mar 2023 | Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1) Azurion 3M12: 722063, 722221; (2) Azurion 3M15: 722064, 722222; (3) Azurion SM12: 722227; (4) Azurion SM20: 722228; (5) Azurion 7B12/12: 722067, 722225; (6) Azurion 7820/15: 722068, 722226; (7) Azurion… | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | Device | Class II | 1 |
| 6 Mar 2023 | EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359 | Philips North America Llc | Device | Class II | 2 |
| 18 Nov 2022 | The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patients age,… (92205) | BioReference Health, LLC | Device | Class II | 1 |
| 21 Jul 2021 | CS¿9600¿is¿an¿extraoral¿system¿intended¿to¿produce¿two-dimensional¿and¿three-dimensional¿digital¿X-ray¿images¿of¿the¿dento-maxilofacial,¿ENT¿(Ear,¿Nose¿and¿Throat),¿cervical¿spine¿and¿wrist¿regions¿at¿the¿direction¿of¿healthcare¿professionals¿as¿diagnostic¿support¿for¿pediatric¿and¿adult¿patients.¿ (92206) | Trophy SAS | Device | Class II | 1 |
| 3 Mar 2021 | p-Chip Wand Reader (92483) | p-Chip Corporation | Device | Class II | 1 |
| 23 Jul 2019 | 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805 | New Standard Device Inc | Device | Class II | 1 |