| 14 Dec 2020 | Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF) Part Number: 823073 | Integra LifeSciences Corp. | Device | Class II | 2 |
| 14 Dec 2020 | Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40 | CIPLA | Drug | Class II | 1 |
| 14 Dec 2020 | Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232 Event 86982 | SCA Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 11 Dec 2020 | Outshine Fruit & Cream Bars - Creamy Pineapple Coconut 6 fruit and dairy bars, 14.7 fl. oz. UPC: 41548 91817 4 Distributed by Nestle Dreyers Ice Cream, Oakland, CA Event 86983 | Dreyers Grand Ice Cream, Inc. | Food | Class II | 1 |
| 10 Dec 2020 | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 9 Dec 2020 | Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01 Event 86955 | Akebia Therapeutics dba Keryx Biopharmaceutials, Inc | Drug | Class II | 1 |
| 9 Dec 2020 | Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a) 106-count bottle, b)120-count bottle, Rx only, Manufactured for: Biogen Inc., Cambridge, MA 02142, NDC 64406-020-01 Event 86945 | Biogen MA Inc. | Drug | Class II | 1 |
| 9 Dec 2020 | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053 | Morton Grove Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 8 Dec 2020 | Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC… | Shilpa Medicare Limited | Drug | Class II | 6 |
| 7 Dec 2020 | Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17 | Hikma Pharmaceuticals USA Inc. | Drug | Class II | 1 |
| 7 Dec 2020 | Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01. | AVKARE Inc. | Drug | Class I | 2 |
| 5 Dec 2020 | Holiday Cookie Platter packaged in plastic container 20 OZ (1.25 LB) 567g. UPC 41415 88690 Event 86938 | George DeLallo Co. Inc. New Stanton Warehouse and Production | Food | Class I | 1 |
| 4 Dec 2020 | Market of Choice brand Sour Cherry Baked Brie is wrapped in a plastic shrink wrap and has a white adhesive store label. UPC 0 217241 414996. The label is read in parts: "***SOUR CHERRY BAKED BRIE*** Puff Pastry (wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), malted barley flour,… | Market of Choice Inc | Food | Class I | 1 |
| 3 Dec 2020 | Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets (10x10 unit dose) blister pack, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 NDC 68382-771-77 | Zydus Pharmaceuticals (USA) Inc | Drug | Class II | 2 |
| 3 Dec 2020 | HOUSE RECIPE HONEY MUSTARD DRESSING & DIP NET WT 1 OZ.(28g) cup CONTAINS: EGGS DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077 UPC 0 73473 05797 8 | Treehouse Foods | Food | Class I | 1 |
| 2 Dec 2020 | MicroScan Pos MIC Panel Type 34 - Product Usage: For the determination of antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic cocci and listeria monocytogenes. | Beckman Coulter Inc. | Device | Class II | 1 |
| 2 Dec 2020 | CANYON BAKEHOUSE GLUTEN FREE BAGELS EVERYTHING NET WT. 14 OZ (396g) Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00221 8 | Flowers Foods (Corporate Offices) | Food | Class II | 2 |
| 1 Dec 2020 | Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422 | Biomet, Inc. | Device | Class II | 1 |
| 1 Dec 2020 | True Goodness by Meijer Organic Green Peas Frozen 10 Oz plastic bag UPC 7-08820-73708-2, 12 bags per case-pack Event 86966 | Meijer Distribution | Food | Class III | 1 |
| 1 Dec 2020 | CACAO MARKET MARIE BELLE NEW YORK; Dark Chocolate Pearls; Ingredients: Cocoa bean, sugar, biscuit cereals (wheat flour, sugar, wheat malt, wheat starch, raising agent: E500ii, palm oil, salt, vanilla flavoring 17%, cocoa butter, emulsifier (soy lecithin), natural vanilla extract; This product may contain traces of… | Maribel's Sweets, Inc. | Food | Class I | 1 |
| 30 Nov 2020 | CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN | Advanced Nutriceuticals, LLC | Drug | Class II | 17 |
| 30 Nov 2020 | Tomato Paste in a 6 oz.(170g) metal can Cases size varies - 12, 24 or 28 count. Packaged under brand names of: Happy Harvest, Kroger, Signature Select, Food Club, Members Mark, Great Value, Essential Everyday, Summer is Inside, Harmons, Pastene, Avenue A. | Pacific Coast Producers | Food | Class II | 2 |
| 27 Nov 2020 | Organic Basil,15 bags, Net. Wt.15Lbs case. Event 86877 | Vallarta Organics LLC | Food | Class II | 1 |
| 26 Nov 2020 | 1. Fresh Attitude Baby Spinach, 11 oz. 2. Fresh Attitude Baby Spinach, 5 oz. Event 86876 | Veg Pro International Inc | Food | Class I | 1 |
| 25 Nov 2020 | 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790, 110009794, 110009796, 110009798, 110009800 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones. | Biomet, Inc. | Device | Class II | 16 |
| 25 Nov 2020 | Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01 | Torrent Pharma Inc | Drug | Class I | 1 |
| 25 Nov 2020 | +Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% Alcohol Antiseptic, packaged in bottles of a) 33.8 Oz (1000mL) Barcode: GOOD-GEL-04062020L; b) 127.8 oz (3780mL) Barcode 0723707893163, Distributed by: PS Promotional Services LLC Allen Street #406 Dallas, Texas 75204 Produced By: Simex… | Simex Logistics SA de CV | Drug | Class II | 5 |
| 24 Nov 2020 | Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G56229 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. | Cook Inc. | Device | Class I | 21 |
| 24 Nov 2020 | Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15. | Ascend Laboratories LLC | Drug | Class II | 1 |
| 24 Nov 2020 | Provolini Antipasta Net Wt. 7 oz (198g) UPC 0-72368-39343-8 Event 86881 | George DeLallo Co. Inc. New Stanton Warehouse and Production | Food | Class II | 1 |
| 24 Nov 2020 | Hy-Vee, Short Cuts, Grill Ready Veggie Mix sold by weight in approximate 1 lb containers, Distributed by Hy-Vee Inc, West Des Moines, IA UPC 272104 XXXXXX | Hy-Vee Stores Inc | Food | Class I | 2 |
| 23 Nov 2020 | ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the quantitative determination of gamma-glutamyl transferase in human serum and plasma. Siemens Material Number (SMN): ADVIA Chemistry: 10309495 (20 mL) 10316298 (70 mL) | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 23 Nov 2020 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the controlled administration of fluids. | Baxter Healthcare Corporation | Device | Class II | 4 |
| 23 Nov 2020 | APEX Compounding System Control Panel Module, REF: 601224, Product Code AX1000 - Product Usage: intended for intravascular administration to a patient. | B Braun Medical, Inc. | Device | Class II | 3 |
| 23 Nov 2020 | Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. | GE Healthcare, LLC | Device | Class II | 2 |
| 23 Nov 2020 | Organic fresh cut basil packaged in plastic clamshell containers The Fresh Market Organic Basil NET WT 0.5oz (14g), UPC:7-37094-23027-2 Good & Gather organic basil NET WT 0.5oz (14.17g), UPC:0-85239-12215-0 Naturally Better Organic Fresh Cut Basil 0.5oz (14g), UPC:6-07880-20230-4 Naturally Better Organic Fresh Cut… | Shenandoah Growers, Inc. | Food | Class II | 1 |
| 23 Nov 2020 | Prairie Farms 1% Lowfat Chocolate Milk, 1 gallon, UPC 72730-26126 | PRAIRIE FARMS | Food | Class I | 2 |
| 23 Nov 2020 | Whole Foods Market Popcorn Chicken Shaker with Sweet Chili Variable weight sold by lb. Packed For Whole Foods Market | Whole Foods Market | Food | Class I | 1 |
| 21 Nov 2020 | Dole" Organic Romaine Hearts 3pk Organic Biologique) (UPC 0-71430-90061-1), Wild Harvest Organic Romaine Hearts, Net Wt 12 oz. (UPC 7-11535-50201-2), | Dole Fresh Vegetables Inc | Food | Class I | 1 |
| 20 Nov 2020 | HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 2 |
| 20 Nov 2020 | Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 20 Nov 2020 | Haag Streit Surgical Floor stands FS 2-11 (Ref no. 615H511) and FS 2-15 (Ref no. 615H515) in combination with the operating microscopes HS Hi-R NEO 900 (Ref no. 657 820) and HS Hi-R NEO 900A (Ref no. 657 821), with software REF 615 588 versions 2.0 to 3.3 - Product Usage: use in ophthalmology and in other disciplines… | Haag-Streit USA Inc | Device | Class II | 1 |
| 20 Nov 2020 | Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90 Event 86867 | Novocol Pharmaceutical of Canada, Inc. | Drug | Class III | 1 |
| 20 Nov 2020 | Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205 | SCA Pharmaceuticals | Drug | Class III | 1 |
| 20 Nov 2020 | Good & Gather Banana Chocolate Chip Date & Nut Bars, UPC 0 85239-04216 8. 5-1.6 oz (45g) Bars. Net Wt. 8oz (225g). DIST BY: Target Corporation, Minneapolis, MN 55403. Event 86815 | Riverside Natural Foods, Ltd. | Food | Class II | 1 |
| 20 Nov 2020 | YAGUMO AMANATTO GIFT BOX 6P 6/19.01 OZ JAN Code: 49 03089 39050 4 Imported by JFC International Inc. Los Angeles, CA 90040 | J F C International Inc | Food | Class II | 1 |
| 20 Nov 2020 | Chef Mitch Maier's Black Garlic BBQ Sauce. Net Wt. 19 oz. (538g). UPC 8 60248-00251 4. | Out of the Kitchen, LLC | Food | Class II | 3 |
| 19 Nov 2020 | Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy. Event 86907 | Name withheld | Device | Class II | 1 |
| 19 Nov 2020 | DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S | Synthes (USA) Products LLC | Device | Class II | 17 |
| 19 Nov 2020 | CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1 | US Pharmaceuticals Inc. | Drug | Class II | 1 |
| 18 Nov 2020 | IceFORCE" 2.1 CX 90¿ Cryoablation Needle | Boston Scientific Corporation | Device | Class II | 37 |
| 18 Nov 2020 | BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm) REF 305106 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampoules and parts of the body below the surface of the skin. | Becton Dickinson & Company | Device | Class II | 1 |
| 18 Nov 2020 | Philips IntelliVue X2 Multi measurement Server: M3002A (865039) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital… | Philips North America Llc | Device | Class II | 2 |
| 18 Nov 2020 | Bransist Safire, Digital Angiography System containing a MS-200 Ceiling Suspended C-arm Support - Product Usage: designed to provide fluoroscopic images of the patient during diagnostic surgical and interventional angiography and cardiology procedures. | Shimadzu Medical Systems | Device | Class II | 3 |
| 18 Nov 2020 | Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04 | The Harvard Drug Group | Drug | Class II | 1 |
| 18 Nov 2020 | Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manufactured by: Fusion Health and Vitality, LLC. 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004. Event 86834 | Fusion Health and Vitality LLC | Drug | Class II | 1 |
| 18 Nov 2020 | Golden Boy brand Custard muffin Original; 7.76 ounce, rigid clear plastic packages | Hong Thai Foods Corp | Food | Class I | 2 |
| 17 Nov 2020 | Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft). | Remote Diagnostic Technologies Ltd. | Device | Class II | 1 |
| 17 Nov 2020 | Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 17 Nov 2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05 | Fresenius Kabi USA, LLC | Drug | Class I | 1 |
| 17 Nov 2020 | REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX 75149. NDC 66977-107-03 Event 86767 | MPM Medical LLC | Drug | Class I | 1 |
| 17 Nov 2020 | DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05 | Fresenius Kabi USA, LLC | Drug | Class III | 1 |
| 17 Nov 2020 | ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30 | Golden State Medical Supply Inc. | Drug | Class II | 1 |
| 17 Nov 2020 | Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden Event 86805 | BASF Corporation | Drug | Class II | 1 |
| 17 Nov 2020 | CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03 | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class II | 10 |
| 17 Nov 2020 | Victoria Taylor Seasonings Sicilian Seasoning/Assaisonement Sicilien; Italian style seasoning blend; 2.5oz; packaged in a glass jar. Canadian product only. | Victoria Gourmet, Inc. | Food | Class II | 1 |
| 17 Nov 2020 | PHARMORIGINS CORE with Natural Orange Flavor NATURAL ENERGY and IMMUNE HEALTH Dietary Supplement 30 Servings (45g) Supplement Facts***Hordenine HCL*** Manufactured by: Fusion Health Vitality, LLC 1360 Union Hill Road, Suite 11B Alpharetta, GA 30004 888.964.5327 UPC 7 28028 21054 5 Event 86773 | Fusion Health and Vitality LLC | Food | Class II | 1 |
| 16 Nov 2020 | Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused. | Covidien Llc | Device | Class II | 1 |
| 16 Nov 2020 | Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16 | Galt Medical Corporation | Device | Class II | 1 |
| 16 Nov 2020 | FRESH EXPRESS KIT CAESAR SUPREME, Romaine Lettuce, Creamy Caesar Dressing, Italian Artisan Cheeses, Savory Garlic Croutons, Total Net WT. 10.5oz (298g) | Fresh Express Incorpated | Food | Class I | 1 |
| 14 Nov 2020 | Presidents Choice Coleslaw 14 oz. plastic bag UPC:0-6038322267-3 | Dole Fresh Vegetables Inc | Food | Class III | 1 |
| 13 Nov 2020 | Randox Mg R1 - Product Usage: For the quantitative in vitro determination of Magnesium in serum, plasma and urine Catalogue Number: MG3880 | Randox Laboratories Ltd. | Device | Class II | 2 |
| 13 Nov 2020 | Synergy raw kombucha - Multi-Green; 16 fl. oz. (473 mL) UPC 7 22430 14016 2 GT's Living Foods LLC Beverly Hills, CA Event 86715 | GT's Living Foods | Food | Class II | 1 |
| 13 Nov 2020 | Minute Maid STRAWBERRY LEMONADE FLAVORED WITH OTHER NATURAL FLAVORS 59 FL OZ (1.8 QT) 1.75 L PRODUCED FOR THE COCA-COLA COMPANY ATLANTA, GA Unit UPC 0 25000 01970 8 Case UPC 000-25000-04812-8 | The Coca-Cola Company | Food | Class II | 2 |
| 13 Nov 2020 | On the Go Sweet & Salty Trail Mix | Kanan Enterprises Inc. | Food | Class I | 1 |
| 13 Nov 2020 | Sysco Arrezzio 3/8" Petite Diced Tomatoes in Tomato Puree, #7807458, each metal can has the net weight of 6.38 lbs. (2.89 kg). UPC 7 34730 21799 4. The label is read in parts: "***Arrezzio Petite Diced Tomatoes in Tomato Puree *** INGREDIENTS: Vined-Ripened Tomatoes, Salt, Citric Acid, and Calcium Chloride ***… Event 86768 | The Neil Jones Food Company | Food | Class II | 1 |
| 12 Nov 2020 | Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100 | ConMed Corporation | Device | Class II | 2 |
| 12 Nov 2020 | Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Event 86755 | Biocomposites, Ltd. | Device | Class II | 1 |
| 12 Nov 2020 | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode. | LivaNova USA Inc | Device | Class II | 1 |
| 12 Nov 2020 | Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport. Event 86756 | Hill-Rom Manufacturing, Inc. | Device | Class II | 1 |
| 12 Nov 2020 | Tucson Tamale Blue Corn & Veggie Tamales (2 Pack), 11 OZ (312g), plastic bag, UPC 8 53437 00234, Keep Frozen, 6 packs/box (case) | Tucson Tamale Wholesale Company, LLC | Food | Class II | 2 |
| 11 Nov 2020 | Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000 | Integra LifeSciences Corp. | Device | Class II | 1 |
| 11 Nov 2020 | (1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right port, 4-liter Reservoir, XC modified to Advance Catalog Number: 3CX*FX25REC CAPIOX FX25 Advance Oxygenator with… | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 11 Nov 2020 | RayStation 4, 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, including all service packs. RayStation 10A and RayPlan 10A are also affected, but not the 10A service pack. (Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0) | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 11 Nov 2020 | ELI 380 Electrocardiograph - Product Usage: intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. | WELCH ALLYN, INC/MORTARA | Device | Class II | 1 |
| 11 Nov 2020 | Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30 Event 86708 | InvaTech Pharma Solutions, LLC | Drug | Class III | 1 |
| 10 Nov 2020 | AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075 | Applied Medical Technology Inc | Device | Class III | 1 |
| 10 Nov 2020 | CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the… | CryoLife, Inc. | Device | Class II | 2 |
| 10 Nov 2020 | PROKERA, non-sterile - Product Usage: Biologic corneal bandage. | TissueTech, Inc. | Device | Class II | 3 |
| 10 Nov 2020 | Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Srikakulam, India - 532 409, Manufactured for: Eywa Pharma Inc. 2 Research Way, Floor 3 Princeton, NJ 08540, NDC 71930-063-52 Event 86740 | EYWA PHARMA INC | Drug | Class II | 1 |
| 10 Nov 2020 | HQO High Quality Organics Organic Thyme Leaves, Whole Net Weight 30 lbs., 500 lbs. High Quality Organics 1201 Moya Boulevard Reno, Nevada 89506 Certified Organic by QAI Event 86743 | High Quality Organics | Food | Class I | 1 |
| 9 Nov 2020 | Shimadzu Mobile X-Ray System, MobileDaRt Evolution (MX8 Version), with adjustable handle option, Made in Japan - Product Usage: The device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. | Shimadzu Medical Systems | Device | Class II | 1 |
| 9 Nov 2020 | K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM. | Helena Laboratories, Corp. | Device | Class II | 1 |
| 9 Nov 2020 | Canon Aquilion Prime SP, Multislice Helical CT Scanner, TSX-303B/8L - Product Usage: intended to acquire and display cross-sectional volumes of the whole body, including the head. | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 7 Nov 2020 | MX60ET (enhanced enVista Toric) enVista One-Piece Hydrophobic Acrylic Toric Model MX60ET - Product Usage: The lens is intended for placement in the capsular bag. | Bausch & Lomb Surgical, Inc. | Device | Class II | 1 |
| 6 Nov 2020 | Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 6 Nov 2020 | Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using the latest programming technology and is easy to install and to use. | Spacelabs Healthcare, Ltd. | Device | Class II | 1 |
| 6 Nov 2020 | clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30 | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 6 Nov 2020 | Tanimura & Antle brand Romaine lettuce. 1 head 12,15,018 and 24 case Product of USA UPC: 2-27918 20314-9 Tanimura & Antle, Salinas, CA Event 86720 | Name withheld | Food | Class I | 1 |
| 6 Nov 2020 | Green Raisins 200 grams (7 oz.) Packaged in plastic bags. Bar Code:992203621 Event 86724 | Singh Trading Inc. DBA Roshni Foods | Food | Class II | 1 |
| 6 Nov 2020 | Quantum Health branded Elderberry liquid herbal extract dietary supplement is packaged in 2oz glass bottle, 12 bottles/case. Product is shelf stable with net wt. 2 fl oz/59 mL. UPC code: 0 46985 01625 4 Product is distributed by Quantum, Inc., Eugene, OR. Event 86726 | Quantum Inc | Food | Class I | 1 |
| 6 Nov 2020 | HomeChef Meal kit:One-Sheet Pretzel-Crusted Chicken with roasted broccoli and honey mustard..31.0 OZ (1 LB 15 OZ) 879g | The Kroger Co | Food | Class II | 3 |
| 5 Nov 2020 | RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates. | Medline Industries Inc | Device | Class II | 1 |
| 5 Nov 2020 | ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021 Event 86798 | VEO DIAGNOSTICS, LLC | Device | Class II | 1 |
| 5 Nov 2020 | Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60 | Teligent Pharma, Inc. | Drug | Class III | 1 |
| 4 Nov 2020 | Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from the screw head. Catalog number: 5101-90195 | K2M, Inc | Device | Class II | 1 |
| 3 Nov 2020 | Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque. | K2M, Inc | Device | Class II | 1 |
| 3 Nov 2020 | Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s mydriatic and non-mydriatic ophthalmic cameras. Event 86737 | Kowa Optimed Inc | Device | Class II | 1 |
| 3 Nov 2020 | STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-Water-/Suction-/ Biopsy-Valve) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229 | GA HEALTH COMPANY LIMITED | Device | Class II | 11 |
| 3 Nov 2020 | EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit… | Boston Scientific Corporation | Device | Class II | 1 |
| 3 Nov 2020 | Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59 | Teligent Pharma, Inc. | Drug | Class III | 1 |
| 2 Nov 2020 | 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder. | Chromsystems Instruments & Chemicals GmbH | Device | Class II | 4 |
| 30 Oct 2020 | Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5 | Invacare Corporation | Device | Class II | 1 |
| 29 Oct 2020 | PryTime Medical - ER-Reboa Plus Catheter, Ref: ER7232PLUS, Guidewire Free, Compatabel with 7Fr introducer Sheaths, Arterial Line, Rx Only, UDI: (01) 0 0850001 10505 7 - Product Usage: intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of… Event 86797 | Prytime Medical Devices, Inc. | Device | Class II | 1 |
| 29 Oct 2020 | 6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels. | Chromsystems Instruments & Chemicals GmbH | Device | Class II | 3 |
| 28 Oct 2020 | Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15 | Lohxa LLC | Drug | Class I | 1 |
| 28 Oct 2020 | Lemonade 1/2 gallon glass bottle. UPC:7525200265. "10% Real Juice Lemonade" | Homestead Creamery, Inc. | Food | Class II | 1 |
| 27 Oct 2020 | MAC VU360, Electrocardiograph | GE Healthcare, LLC | Device | Class II | 1 |
| 27 Oct 2020 | MANI TROCAR KIT 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery, Ref: MTK 23S | Mani, Inc. - Kiyohara Facility | Device | Class II | 2 |
| 27 Oct 2020 | Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 52376-021-02; b) 4 fl oz (118 mL) NDC 52376-021-04, Sunstar Americas, Inc. | Sunstar Americas, Inc. | Drug | Class I | 1 |
| 27 Oct 2020 | Pacific Jade Indian Curry Sauce Starter With Fenugreek and Cardamom, wholesale case with 2, 39 oz. plastic tubs, case UPC 50758108742487 Event 86676 | CELTRADE CANADA | Food | Class II | 1 |
| 27 Oct 2020 | Natural Grocers, Elderberries Whole Organic, 4 oz. (113g), plastic bag, UPC 0-0082-00304-3 Event 86678 | Vitamin Cottage Natural Foods Market, Inc DBA Natural Grocers | Food | Class II | 1 |
| 27 Oct 2020 | Macaroni & Cheese, chef s case; Macaroni & Cheese, packaged in clear plastic container; Macaroni & Cheese, online and catering product code begins with 286501, 263608, 114449, or 109866 | Whole Foods Market | Food | Class I | 7 |
| 26 Oct 2020 | Dole Brands, Savory Spinach Dijon, 4.9 oz, Event 86673 | Sunnyside Farms | Food | Class II | 1 |
| 23 Oct 2020 | Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents | Hardy Diagnostics | Device | Class II | 1 |
| 23 Oct 2020 | BD Ultra-Fine Pen Needles 32G x 4mm (5/32' )-intended for parenteral administration of a drug from a cartridge contained in a drug pen injector Catalog Number: 320122 | Becton Dickinson & Company | Device | Class II | 1 |
| 23 Oct 2020 | The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2… | Biomeme, Inc. | Device | Class II | 1 |
| 23 Oct 2020 | Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-23 TAV EVOLUT R CE… | Name withheld | Device | Class II | 3 |
| 23 Oct 2020 | PROCEED Surgical Mesh Hernia Mesh Oval, 15 cm x 20 cm | Ethicon, Inc. | Device | Class II | 1 |
| 23 Oct 2020 | Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis. | Coloplast Manufacturing US, LLC | Device | Class II | 1 |
| 23 Oct 2020 | Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to navigate the Ion Fully Articulating Catheter within the lung to a planned path in order to sample a target. User Manual: ION Endoluminal System, System, Instruments, and Accessories User Manual, PN 553990-05 REV. A 2019.12 | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 23 Oct 2020 | Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01 | Heritage Pharmaceuticals Inc | Drug | Class III | 1 |
| 21 Oct 2020 | Chef Myron's Eurasian Fusion Sauce, 64 FL OZ (1.89 L), Item # 400023288, 4 bottles/case. | JMH International, LLC | Food | Class III | 8 |
| 20 Oct 2020 | ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision… | Viewray, Inc. | Device | Class II | 2 |
| 19 Oct 2020 | Geistlich Bio-Oss Pen 0.25-1mm 0.25g - Product Usage: natural bone mineral for filling of bone defects in maxillofacial surgery, implantology, and periodontology. Product Number: 20115 | Geistlich Pharma North America, Inc. | Device | Class II | 3 |
| 19 Oct 2020 | MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation | Mevion Medical Systems, Inc. | Device | Class II | 1 |
| 16 Oct 2020 | DABRA Laser (RA-308 Excimer Laser) Intended Use: For use in ablating a channel in occlusive peripheral vascular disease. Indications: For crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. | Ra Medical Systems, Inc. | Device | Class II | 1 |
| 16 Oct 2020 | CORFLO NG/NI Pediatric Neonatal Feeding Tube w/ Anti-IV Connector | Avanos Medical, Inc. | Device | Class II | 1 |
| 16 Oct 2020 | Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract. | Olympus Corporation of the Americas | Device | Class II | 10 |
| 13 Oct 2020 | Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested. | Luminex Corporation | Device | Class II | 2 |
| 12 Oct 2020 | Cardioblate CryoFlex, Surgical Ablation Probe, Model Number 60SF2, PROBE 60SF2 CRYOFLEX 10CM 26L - Product Usage: is a single use, disposable cryoprobe that is designed for use with the CryoFlex Surgical Ablation System. The probe has an integrated thermocouple for monitoring temperature at its ablation segment. | MEDTRONIC ATS MEDICAL, INC. | Device | Class II | 4 |
| 12 Oct 2020 | Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits. | ROi CPS LLC | Device | Class II | 1 |
| 9 Oct 2020 | Luminesse ML PMMA, 98x20mm, REF: 5336-B1 - Product Usage: used as a milling blank in the fabrication of provisional crowns and bridges. All blanks are solely used by a Trained Dental Technician or on the order of a dental professional. Event 86614 | Talladium Inc | Device | Class III | 1 |
| 8 Oct 2020 | InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01. Event 86674 | Enterix, Inc. | Device | Class II | 1 |
| 8 Oct 2020 | CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Canon Interventional Angiography System, Model numbers: Infinix-8000C and Infinix-8000H - Product Usage: This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for… | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 8 Oct 2020 | RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 5 Oct 2020 | Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector tubing & prime tube. Catalog/REF Number: FLEXD-150-SPK Description: 2 - 150 mL FLEX syringes, 2… | Bayer Medical Care, Inc. | Device | Class II | 1 |
| 5 Oct 2020 | BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry. | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 1 |
| 29 Sep 2020 | BladderScan Prime Plus Probe REF 0570-0395 - Product Usage: intended to be used for measuring the urine volume in the bladder noninvasively. | Verathon, Inc. | Device | Class II | 1 |
| 26 Sep 2020 | AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada CI Q30 Sound Processor (CI-5260) for cochlear implant. | Advanced Bionics, LLC | Device | Class III | 2 |
| 24 Sep 2020 | SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 . Event 86497 | AA PRODUCTS INC | Drug | Class II | 1 |
| 22 Sep 2020 | ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers Event 86484 | Flexicare Medical Ltd. | Device | Class I | 1 |
| 21 Sep 2020 | iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replacement components as well as the following patient specific components: femoral stem and single use instrumentation. | Conformis, Inc. | Device | Class II | 1 |
| 31 Aug 2020 | 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spiros, Bag Hanger Drop-in Red Cap, 4 Units, REF: CH3330-C; 60 IN (152 cm) Appx 1.1 ml, Smallbore Set, MicroClave Clear, Spiros, REF: CH3353; 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse… | ICU Medical, Inc. | Device | Class II | 13 |
| 25 Aug 2020 | V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml), UPC 7 16053 70499 3; c) 33.8 fl. oz. (1000 ml) bottles: 716053704993; Manufactured by: Asiaticon S.A. de C.V. Conkar 62, Jardines del Ajusco. Tlalpan Cuidad de Mexico. 14200 ; | Asiaticon, SA de CV | Drug | Class II | 2 |
| 13 Aug 2020 | Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Membrane Test ROM-5025, ROM-6025 | Clinical Innovations, LLC | Device | Class II | 1 |
| 6 Aug 2020 | Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism. | Carl Zeiss Meditec AG | Device | Class II | 2 |
| 30 Jul 2020 | CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close… | CME America, LLC | Device | Class II | 6 |
| 1 Jul 2020 | REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which provides access for the administration… | ICU Medical, Inc. | Device | Class II | 1 |
| 19 Jun 2020 | EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007. | Encore Medical, LP | Device | Class II | 2 |
| 30 Apr 2020 | MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor… | Medtronic Inc. | Device | Class II | 3 |
| 23 Mar 2020 | B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01 Event 86680 | Janus Trade Group | Device | Class II | 1 |
| 25 Feb 2020 | BELLEFONTAINE PEANUT BUTTER & BROWNIES DAIRY FREE FROZEN DESSERT 1 PINT (473 ML) packaged in paper cup Event 86856 | Name withheld | Food | Class III | 1 |
| 7 Oct 2019 | Star 8 Rolling Walker/Rollator, Items: 4258/ BK(Black)/ BL(Blue)/ DB(Sky Blue)/ PL(Purple)/ RD(Red) | Nova Ortho-Med Inc | Device | Class II | 1 |
| 11 Sep 2019 | Microsurgical Operating Room Tables;7300B (18-350-70); | Mizuho America, Inc. | Device | Class II | 2 |