| 13 Feb 2020 | PS# 58021 Honey BBQ Sauce Sauce (AFP) packed in 9 - 275 gallon totes | Pepper Source, Ltd. | Food | Class II | 4 |
| 13 Feb 2020 | Suja Organic Berry Zest Fruit + Veggie Smoothie, 12 oz. UPC: 81861702234 | Suja Life LLC | Food | Class II | 4 |
| 12 Feb 2020 | Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 11 Feb 2020 | Don Lee Farms Chipotle Black Bean Burger 12 pack/3Lbs. cartons UPC 087427438135, Item 1372617 Don Lee Farms Chipotle Black Burger 10 pack/2.5 lb. cartons UPC 087427430757/Item 997176SF Event 84956 | Don Lee Farms | Food | Class III | 1 |
| 11 Feb 2020 | 30 lb. cases of 480 1.0 oz frozen chocolate chip cookie dough, MDM # 10194622, Manufactured by Brill Inc. Tucker, GA 30084 1 866 982 7455 OR BRILLINC.COM | CSM Bakery Products | Food | Class II | 12 |
| 10 Feb 2020 | Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34. | Par Pharmaceutical Inc. | Drug | Class III | 1 |
| 10 Feb 2020 | Ready Pac Bistro - Spinach Dijon Salad with Sweet Onion Dijon Vinaigrette; Baby Spinach, Hard Boiled Eggs, Monterey Jack-Colby Cheese, Crispy Noodles, Almonds, Dried Cranberries with Sweet Onion Dijon Vinaigrette. Net Wt. 4.75 oz. (135 g). UPC: 0 77745 29795 8 Distributed by Ready Pac Foods Inc., Irwindale, CA | Ready Pac Foods, Inc. | Food | Class II | 1 |
| 7 Feb 2020 | Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20 | AuroMedics Pharma LLC | Drug | Class II | 1 |
| 7 Feb 2020 | Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister cards), Rx Only, Packaged and distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-606-21; NDC Unit Dose 68084-606-11 | American Health Packaging | Drug | Class II | 2 |
| 7 Feb 2020 | Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for Use in Newborns, Contains Benzyl Alcohol, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ, 08520, Made in India, NDC 55150-295-20. | AuroMedics Pharma LLC | Drug | Class III | 1 |
| 6 Feb 2020 | Vegetarian Lasagna With Gluten-Free Pasta, New Seasons Market brand. Product is packaged in a grab "n" go aluminum containter with a clear dome lid, and labeled with a scale PLU label. UPC 252390 706998. The CORRECT label reads in part: "*** VEGETARIAN LASAGNA WITH GLUTEN-FREE PASTA***Filling: Marinara [crushed… | New Seasons Market LLC | Food | Class II | 1 |
| 6 Feb 2020 | Forest View Bakery Kolaczki in 14oz plastic clam shell | Forest View Bakery | Food | Class II | 5 |
| 5 Feb 2020 | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30. | Pfizer Inc. | Drug | Class II | 2 |
| 3 Feb 2020 | Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8 | Contract Pharmacal Corporation | Drug | Class II | 2 |
| 3 Feb 2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray). | Pfizer Inc. | Drug | Class II | 1 |
| 31 Jan 2020 | Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included. | Cardinal Health 200, LLC | Device | Class II | 1 |
| 31 Jan 2020 | Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020 | Cardinal Health 200, LLC | Device | Class II | 1 |
| 31 Jan 2020 | UST-2265-2 Probe, Part Number: UST-2265-2 - Product Usage: The UST-2265-2 probe is intended to be used for diagnostic ultrasound imaging or fluid flow analysis of the human body as Continuous-wave Doppler (CWD) for Cardiac Adult, Cardiac Pediatric, and Peripheral Vessel. | Hitachi Medical Systems America Inc | Device | Class II | 1 |
| 31 Jan 2020 | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01. | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 31 Jan 2020 | Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8 | Efficient Laboratories, Inc. | Drug | Class II | 3 |
| 29 Jan 2020 | NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of… | Name withheld | Device | Class I | 17 |
| 29 Jan 2020 | Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816. NDC 29300-135-01 | UNICHEM PHARMACEUTICALS USA INC | Drug | Class III | 1 |
| 28 Jan 2020 | Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545 | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 28 Jan 2020 | Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11. | Graviti Pharmaceuticals Private Limited | Drug | Class II | 1 |
| 28 Jan 2020 | Kushim Tablets (Gushim) 45-count packages, Label in foreign language Event 84827 | B AND A TRADING CORPORATION | Drug | Class II | 1 |
| 28 Jan 2020 | Glycopyrrolate Tabs, USP, 1 mg, 30-count unit dose blister card, FOR INSTITUTIONAL USE ONLY, Rx Only, Packaged by Vangard, Glasgow, KY 42141; NDC 0615-8170-39. Event 84992 | NCS Healthcare of Kentucky Inc | Drug | Class II | 1 |
| 28 Jan 2020 | Beepa's Original Goulash Starter, 32 oz. (2 PTS) 946.35ml. UPC 60000-90711 Event 84821 | Beepas LLC | Food | Class I | 1 |
| 28 Jan 2020 | Yossef Roasting Co. Handcrafted Nuts Watermelon Seeds; 7oz. Event 84824 | Name withheld | Food | Class II | 1 |
| 27 Jan 2020 | fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once Event 84707 | Fridababy LLC | Device | Class II | 1 |
| 27 Jan 2020 | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01 | Teva Pharmaceuticals USA | Drug | Class II | 2 |
| 27 Jan 2020 | Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01 | Teva Pharmaceuticals USA | Drug | Class II | 2 |
| 24 Jan 2020 | ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000 - Product Usage:AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 24 Jan 2020 | Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09 | Macleods Pharma Usa Inc | Drug | Class III | 1 |
| 24 Jan 2020 | Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90. | Ascend Laboratories LLC | Drug | Class II | 1 |
| 24 Jan 2020 | QUESOS LA RICURA brand Queso Cotija; Cotija Cheese; AGED OVER 60 DAYS; Ingredients: Raw Milk, Salt, Enzyme and Cultures; KEEP REFRIGERATED/MANTENER REFRIGERADO; NET WT/PESO NETO 12 OZ. (340g); Plant No/Numero de Planta 36-1256; PRODUCT OF NICARAGUA Event 84785 | Quesos La Ricura, Ltd. | Food | Class I | 1 |
| 23 Jan 2020 | Kroger Unbleached All Purpose Enriched Flour, 5 lb. bag. Bar code: 011110861660 | Ardent Mills LLC | Food | Class II | 1 |
| 22 Jan 2020 | Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30. | Ascend Laboratories LLC | Drug | Class III | 1 |
| 22 Jan 2020 | Granuts BBQ Mix, Net Wt/Cont. Neto 16.93 oz (480g), Contains 12 units x 1.41 oz (40g) ea. and Net Wt/Cont. Neto 6.35 oz (180g) Event 84784 | Compania Nacional de Chocolates DCR S.A. | Food | Class II | 1 |
| 22 Jan 2020 | MORTON SALT;THIS SALT DOES NOT SUPPLY IODIDE; 26 oz (1LB., 10 OZ) 737 g; packed in 24 canisters per case | Morton Salt Inc. | Food | Class III | 1 |
| 21 Jan 2020 | All Dietary Supplement manufactured and distributed by ABH Nature's Products Inc. Event 84666 | ABH Nature's Products, Inc. | Food | Class II | 1 |
| 20 Jan 2020 | Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10 | Macleods Pharma Usa Inc | Drug | Class III | 1 |
| 17 Jan 2020 | SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only | Ormco/Sybronendo | Device | Class II | 2 |
| 17 Jan 2020 | Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND | COVIDIEN LLC | Device | Class II | 1 |
| 17 Jan 2020 | Ground Ginger in clear plastic bags; Sold in 1 lb. and 5 lb. bags Country of Origin: India 1 lb. UPC: 0 00000 94641 4 5 lb. UPC: 0 00000 94642 1 Pack by: H.L. FoodserviceInc. Event 84736 | H.L. Foodservice, Inc. dba H.L. Foods Co. | Food | Class II | 1 |
| 17 Jan 2020 | Flour Tortillas are packaged in clear plastic bags, 12 count per bag and sold under brands Red Apple. Product is also sold under Tres Coronas brand and it has 10 counts per bag. The Red Apple brand label is read in parts: "***Flour Tortillas *** INGREDIENTS: FLOUR, WATER, SALT, VEGETABLE SHORTENING, BAKING POWDER***. Event 84755 | Tres Coronas Bakery | Food | Class II | 1 |
| 16 Jan 2020 | Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11 Event 84757 | Shandex Personal Care Manufacturing Inc. | Drug | Class II | 1 |
| 15 Jan 2020 | i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematocrit in venous, arterial or capillary… | Abbott Point Of Care Inc. | Device | Class II | 2 |
| 15 Jan 2020 | FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B | Arrow International Inc | Device | Class II | 49 |
| 15 Jan 2020 | kindroot adaptogems; Peach Blossom Plant lozenges for lit looks. 20 lozenges net wt. 2.6 oz. 74 g - Dietary Supplement UPC: 8 60000 30544 0 Ingredients: Marine collagen Peptides, Ashwagandha Root Extract (organic). Other ingredients: Organic Brown Rice Syrup, malic acid and natural flavor. Unwrap one tablet as… Event 84734 | Kindroot LLC | Food | Class II | 1 |
| 15 Jan 2020 | Hungry Root Dairy free Garlic Parm sauce, Packaged in 9 oz. polypropylene dip containers with lidding film and lid, packed in 24 count master cases. Distributed by Hungry Root Inc. NY, NY 10003 Event 84740 | The Honest Stand | Food | Class I | 1 |
| 14 Jan 2020 | i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be used for the quantitative measurement of pH, pCO2, and pO2 in venous, arterial or capillary whole blood. | Abbott Point Of Care Inc. | Device | Class II | 1 |
| 14 Jan 2020 | Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram | Spectrum Laboratory Products | Drug | Class II | 1 |
| 14 Jan 2020 | Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16 | Pharmaceutical Associates Inc | Drug | Class II | 1 |
| 13 Jan 2020 | SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332 | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 3 |
| 13 Jan 2020 | Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440 | TELEFLEX MEDICAL INC | Device | Class II | 2 |
| 13 Jan 2020 | DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal… | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 13 Jan 2020 | The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured. | C.R. Bard Inc | Device | Class II | 1 |
| 13 Jan 2020 | Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydrophilic) Contact Lens (extended wear) | CooperVision Inc. | Device | Class II | 2 |
| 12 Jan 2020 | Marigold, INC. Granulated Cane Sugar Net Weight: 2000# | Cargill, Inc Corporate Headquarters | Food | Class II | 1 |
| 12 Jan 2020 | Granulate Pure Cane Sugar sold under the brand names of: Ahold 16 oz canister, DISTRIBUTED BY FOODHOLD USA, LLC, LANDOVER, MD 20758 UPC 6 88267 08529 1; N'Joy 22 oz canister, SUGAR FOODS CORPORATION NEW YORK, NY 10022, UPC 0 86631 00698 7; Speedway 22oz canister, DISTRIBUTED BY: SUGAR FOODS CORPORATION NEW YORK, NY… Event 84711 | Sugar Foods Corporation | Food | Class II | 1 |
| 11 Jan 2020 | AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA | Cardinal Health | Device | Class II | 39 |
| 10 Jan 2020 | Terumo Advanced Perfusion System 1 Roller Pump, 4 Inch, Catalog Number 816570 - Product Usage: is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical proffessional who is… | Terumo Cardiovascular Systems Corporation | Device | Class II | 4 |
| 10 Jan 2020 | ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma… | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 9 Jan 2020 | Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System | TELEFLEX MEDICAL INC | Device | Class II | 2 |
| 9 Jan 2020 | Meijer Joint Health Triple Strength Formula Glucosamine Hydrochloride 1500 mg; Helps Overall Joint Physical Function; Unit Size - 40 count and 80 count - 2 tablets per day. Item Numbers: MEIJER7754 (40 count) & MEIJER7755 (80 count) UPC Code: 713733563024 & 713733563031 respectively Distributed by Meijer Distribution… | Merical, LLC | Food | Class II | 2 |
| 8 Jan 2020 | Luminos dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as… | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 8 Jan 2020 | Luminos dRF Max, Model No. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as… | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 8 Jan 2020 | Organic IntegriPure Cold Milled Flaxseed, 50 lb Net Wt. and 2000 lb. totes Event 84675 | Healthy Food Ingredients, LLC | Food | Class II | 1 |
| 7 Jan 2020 | Cocoon Convective Warming System, Product Code: CWS4000 (110V). | Care Essentials Pty., Ltd. | Device | Class II | 2 |
| 7 Jan 2020 | Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malaysia APPLICATOR:Made in China STERILE (01)40889942587583(10)0000000000 (17)000000(30)20 Packaged for Medline Industries, Inc., Northfield, IL 60093 USA. 1-800-MEDLINE www.medline.com WINGED SPONGE:Made in Mexico | Medline Industries Inc | Device | Class II | 1 |
| 7 Jan 2020 | cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 7 Jan 2020 | Ingredion ULTRA-TEX4 Food Starch in 50lb paper bags, product code 32166102CA | Ingredion Incorporated | Food | Class II | 1 |
| 7 Jan 2020 | Garbanzo Beans, Merlino Foods brand, sold in 5 lb. Polybag. No UPC. Event 84700 | Attilio A Merlino and Associates Inc | Food | Class III | 1 |
| 7 Jan 2020 | ASK Foods Inc., KRAB SALAD, NET WT. 5 LB (2.27 kg), Plastic tub with a plastic lid,Keep Refrigerated, 2786-140 | ASK Foods Inc | Food | Class II | 1 |
| 7 Jan 2020 | Garlic Parmesan Sauce; DP# 4478 FG# 02620 8/16 fl. oz (4.73 ml) pouches; NET WT. 8.05 lbs (3.65 kg) Produced for Domino's Pizza Ann Arbor MI 48105 | Golden State Foods | Food | Class II | 4 |
| 6 Jan 2020 | ROSA Brain 3.0 Application-Brain | MEDTECH SAS | Device | Class II | 2 |
| 6 Jan 2020 | GORE EXCLUDER AAA Endoprosthesis | W. L. Gore & Associates Inc. | Device | Class II | 2 |
| 6 Jan 2020 | Razzoo's Gumbo Base 10X4 LBS (1.8KG) Pouches Net Case Weight; 40 LBS STORE FROZEN | National Food & Beverage, Inc | Food | Class II | 3 |
| 6 Jan 2020 | Fresh Grab Ham & Swiss on Pretzel Sub Bun, 6 oz., UPC: 612510001028 | Lipari Foods Operating Company, LLC. | Food | Class I | 32 |
| 3 Jan 2020 | Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm,… | ROi CPS LLC | Device | Class II | 1 |
| 3 Jan 2020 | Vaginal Verification Panel Ref 8208 Lot 8208-11 | Microbiologics Inc | Device | Class II | 1 |
| 3 Jan 2020 | Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture. | Ethicon, Inc. | Device | Class II | 1 |
| 3 Jan 2020 | Pentax Video Colonoscope Model: EC34-i10L | Pentax of America Inc | Device | Class II | 2 |
| 3 Jan 2020 | SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block. | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 3 Jan 2020 | Jeni's Dairy Free Cold Brew with Coconut Cream Pints frozen dessert | Jeni's Splendid Ice Creams LLC | Food | Class I | 1 |
| 3 Jan 2020 | Ducktrap River of Maine Herring Center Cuts in Wine Sauce, 12 oz. Event 84621 | Ducktrap River of Maine LLC | Food | Class I | 1 |
| 2 Jan 2020 | Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011 Event 84614 | Clinical Diagnostic Solutions, Inc. | Device | Class II | 1 |
| 31 Dec 2019 | Rachael's brand and Big Y brand Protein Snack Packs; containing one hard boiled egg, diced roasted turkey, and roasted almonds; packaged in 6x6 plastic containers, Net. wt. 4.25 oz. Event 84751 | Rachael's Food Corporation | Food | Class I | 1 |
| 31 Dec 2019 | Sienna Chocolate Turtle Brownie (frozen); 108 OZ (6.75 LB) Uncut, 4 trays per case; UPC: 93901541857 SSC:10093901541854 Event 84596 | Name withheld | Food | Class I | 1 |
| 30 Dec 2019 | TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 30 Dec 2019 | Fresh From Meijer diced hard boiled eggs sold by weight from the salad bar area in clear plastic clamshell PLU 8505, UPC 0-0-8505-2 | Meijer | Food | Class I | 1 |
| 27 Dec 2019 | WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220 | Wright Medical Technology, Inc. | Device | Class II | 2 |
| 27 Dec 2019 | Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00 | RemedyRepack Inc. | Drug | Class I | 1 |
| 27 Dec 2019 | 3.1-oz. packages containing "EGGLANDS BEST HARD-COOKED EGG BACON & CHEDDAR" | Sun Valley Foods | Food | Class I | 2 |
| 24 Dec 2019 | Prometra Programmable 20mL Pump. Catalog No. 11827 The device is an implantable infusion pump. GTIN-14 00810335020082 | Flowonix Medical Inc | Device | Class II | 6 |
| 24 Dec 2019 | Clover sprouts packaged in 4 oz packages, Sprouts Unlimited, Inc. Marion, IA Event 84573 | Sprouts Unlimited Inc | Food | Class I | 1 |
| 24 Dec 2019 | Fresh Location Protein Snack Tray 6.44oz, UPC: 8-5511000804-6 | The H.T. Hackney Co. LLC | Food | Class I | 2 |
| 23 Dec 2019 | SIGNA Premier Nuclear Magnetic Resonance Imaging System - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. | GE Healthcare, LLC | Device | Class II | 4 |
| 23 Dec 2019 | Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 23 Dec 2019 | Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The device is a dental burr. Event 84709 | Jjgc Industria E Comercio De Materials Dentarios Sa | Device | Class II | 1 |
| 23 Dec 2019 | VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura… | Philips North America, LLC | Device | Class II | 1 |
| 23 Dec 2019 | Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03 Event 84931 | GSK Consumer Health, Inc | Drug | Class II | 1 |
| 23 Dec 2019 | Egg Salad Sandwich Event 84574 | Great American Deli, LLC | Food | Class I | 1 |
| 21 Dec 2019 | Trader Joe's Egg White Salad with Chives NET 6 OZ (170g) DIST. & SOLD EXCLUSIVELY BY: TRADER JOES MONROVIA, CA 91016 UPC 0066 6695 | Bakkavor Foods USA Inc. | Food | Class I | 2 |
| 20 Dec 2019 | Custom Healthcare Systems, Inc. Inpatient Dialysis Kit PAK-19244. Single use. Dialysis kit | Custom Healthcare Systems, Inc. | Device | Class II | 1 |
| 20 Dec 2019 | Arrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1 | Arrow International Inc | Device | Class II | 20 |
| 20 Dec 2019 | Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro Pharmaceutical Industries Ltd. Haifa Bay, Israel 2624761 Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4131-1. | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class I | 1 |
| 20 Dec 2019 | 12lb plastic bucket of Egg Salad Sold as 2 - 12lb buckets per case | Knotts Fine Foods Inc | Food | Class I | 2 |
| 19 Dec 2019 | CombiDiagnost GCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose. | Philips Medical Systems Gmbh, DMC | Device | Class II | 2 |
| 19 Dec 2019 | RayStation stand-alone software treatment planning system. Models 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 19 Dec 2019 | ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 19 Dec 2019 | 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes Net Wt 7.75 oz (220g) UPC 9948247605 Paper carton boxes sold individually | Whole Foods Market | Food | Class I | 2 |
| 19 Dec 2019 | Bulk Pail Product -- Almark Foods HARD COOKED BROKEN EGG WHITES 20 LB pail, DIST BY: ALMARK FOODS, GAINESVILLE, GA 30504 UPC 0 44984 42020 1 | Almark Foods, LLC | Food | Class I | 29 |
| 18 Dec 2019 | ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 4 |
| 18 Dec 2019 | Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL461 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue. | Covidien LLC | Device | Class II | 27 |
| 18 Dec 2019 | DHEA/Pregnenol One 10.25 MG Cap | MPRX, Inc. dba Medical Park Pharmacy | Drug | Class II | 18 |
| 17 Dec 2019 | Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide | Arthrex, Inc. | Device | Class II | 1 |
| 17 Dec 2019 | (1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140 | Vitreq Bv | Device | Class II | 16 |
| 16 Dec 2019 | LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument). | Smith & Nephew, Inc. | Device | Class II | 1 |
| 16 Dec 2019 | 2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field. | Synthes, Inc. | Device | Class II | 5 |
| 16 Dec 2019 | VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG Product Code: 1662659 | Ortho Clinical Diagnostics Inc | Device | Class II | 1 |
| 16 Dec 2019 | Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation. | Nextremity Solutions | Device | Class II | 1 |
| 16 Dec 2019 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10. | Akorn Inc | Drug | Class II | 1 |
| 16 Dec 2019 | Munk Pack Keto Nut and Seed Dark Chocolate Sea Salt Bar, 35 g, individual unit | MUNK PACK INC | Food | Class II | 4 |
| 13 Dec 2019 | Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml | Randox Laboratories Ltd. | Device | Class III | 1 |
| 13 Dec 2019 | HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit | TELEFLEX MEDICAL INC | Device | Class I | 4 |
| 13 Dec 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61 | The Harvard Drug Group | Drug | Class III | 1 |
| 13 Dec 2019 | Essential Everyday, Unbleached Flour, Enriched All-Purpose Pre-Sifted, packaged in a 5lb paper bag | UNFI General Corporate | Food | Class II | 1 |
| 12 Dec 2019 | Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Model No. 32-8105-027-04. UDI (01)00889024274006 (17)241031(10)64481139 The device is a Humeral component; elbow joint metal/polymer constrained cemented prosthesis. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 12 Dec 2019 | ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150 | ResMed Ltd. | Device | Class I | 1 |
| 11 Dec 2019 | Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures. | Brasseler USA I Lp | Device | Class II | 1 |
| 11 Dec 2019 | Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M1231533, M1225025, M1224961, M1224958, M1224957, M1224959, M1224963, M1225773, M1225066, M1224960, M1225059, M1225023, M1225060, M1225063, M1225064, M1225024, M1231622, M1236303, M1238489, M1238490, M1238492, M1238493, M1238495, M1238499,… Event 84562 | Lumitex Inc | Device | Class II | 1 |
| 11 Dec 2019 | Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001 | Roche Diabetes Care, Inc. | Device | Class II | 3 |
| 11 Dec 2019 | Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2510 CIRCUMCISION TRAY W/1.1 CM CLAMP CIT2530A… | Centurion Medical Products Corporation | Device | Class II | 54 |
| 10 Dec 2019 | VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit | bioMerieux, Inc. | Device | Class II | 1 |
| 10 Dec 2019 | Excellent tahina (sesame tahini) 800 g and 400 g jars, UPC 6214002717420 and 6214002717413 Event 84719 | FIVE STAR FOOD INC | Food | Class I | 1 |
| 10 Dec 2019 | Catsmo brand Gold (sliced, whole, 4oz); Scottish (Whole, Sliced, Whole No Skin, 1lb, 4oz); Loin; Organic (4oz); Double Smoked (4oz); Irish (4oz); Wallkill Farms brand Nova (Sliced, Whole); Daniel Boulud brand sliced; First Course brand sliced smoked salmon products manufactured on 11/19/19 by Catsmo Acquisition LLC… | CATSMO LLC | Food | Class I | 7 |
| 9 Dec 2019 | BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring)) | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 2 |
| 4 Dec 2019 | Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11 | American Health Packaging | Drug | Class II | 1 |
| 3 Dec 2019 | Healon GV PRO 0.85 mL, Model (U.S.): 10-2400-14, Model (O.U.S.): 10-2705-14, 10-2715-14, 10-2725-14, and 10-2755-14 | Johnson & Johnson Surgical Vision Inc | Device | Class II | 1 |
| 3 Dec 2019 | Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint work total or hemi- arthroplasty is determined by the… | Exactech, Inc. | Device | Class II | 2 |
| 29 Nov 2019 | Laubscher Cheese Co.; Shredded Cheese; Net Wt. 5 LBS. and 2 LBS.,Cryovac sealed plastic bags, Distributed By: Laubscher Cheese Co. Mercer, PA 16137 Event 84386 | Laubscher Cheese Company, Ltd. | Food | Class I | 1 |
| 24 Nov 2019 | Terumo AZUR Peripheral Coil System, Detachable 18, Helical HydroCoil Embolization System, REF numbers 45-481015, 45-481020, 45-481215, 45-481220, 45-481515, 45-481520, 45-482020, 45-482030, 45-480202, 45-480204, 45-480310, 45-480302, 45-480305, 45-480410, 45-480415, 45-480420, 45-480405, 45-480610, 45-480615,… | Microvention, Inc. | Device | Class II | 6 |
| 21 Nov 2019 | Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only | Medtronic Inc. | Device | Class I | 4 |
| 20 Nov 2019 | Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters. | Datascope Corporation | Device | Class II | 3 |
| 20 Nov 2019 | Outlook Safety Infusion System Y-type Blood Set, Catalog Number 477005 | B. Braun Medical, Inc. | Device | Class II | 7 |
| 20 Nov 2019 | DaVinci Gourmet, Classic Caramel Flavored Sauce, 128 FL OZ (1 GAL), in plastic jugs | Kerry, Inc | Food | Class I | 1 |
| 20 Nov 2019 | 103200 - TIDAL SEAFOOD YELLOWFIN TUNA 10 lb, 2x10 lb cases and 103205 - TIDAL SEAFOOD YELLOWFIN TUNA 10 lb, 2x10 lb packed by Truong Phu Xanh Co. Ltd., in Vietnam Event 84731 | WORLDWIDE SEAFOOD PRODUCTS LLC | Food | Class II | 1 |
| 19 Nov 2019 | Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804 | Dexcom Inc | Device | Class II | 1 |
| 19 Nov 2019 | TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels,… | Cardiac Assist, Inc | Device | Class II | 1 |
| 19 Nov 2019 | ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA Chemistry systems for the CardioPhase hsCRP assay. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 19 Nov 2019 | Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate accessories. | Philips Respironics, Inc. | Device | Class I | 13 |
| 15 Nov 2019 | PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition. Event 84296 | Tytek Medical Inc | Device | Class I | 1 |
| 11 Nov 2019 | Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500 | Medicrea International | Device | Class II | 1 |
| 5 Nov 2019 | King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12 | King Systems Corp. dba Ambu, Inc. | Device | Class I | 1 |
| 5 Nov 2019 | GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later… | Collagen Matrix Inc | Device | Class II | 6 |
| 5 Nov 2019 | 3/8" diced IQF zucchini in 45 pound poly lined carton Event 84449 | Hart Freeze Pack, LLC | Food | Class II | 1 |
| 28 Oct 2019 | iChemVELOCITY, Urine Chemistry System, Catalog numbers: 700-7176-001, 700-7177-001, B75502 - Product Usage: used to automate the urine chemistry analysis profile using iChem VELOCITY Urine Chemistry Strips. | Beckman Coulter Inc. | Device | Class II | 2 |
| 28 Oct 2019 | Genius 2 Tympanic Thermometer (discontinued) Item Code: 303000 | Cardinal Health 200, LLC | Device | Class II | 5 |
| 24 Oct 2019 | Taspen's Organics Breathe Easy Herbal Tincture Dietary Supplement, sold in 1 oz, 2 oz, and 4 oz amber glass bottles with dropper. | Green Water, LLC | Food | Class II | 3 |
| 22 Oct 2019 | BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation | Biomerieux Inc | Device | Class II | 1 |
| 21 Oct 2019 | CS5/5+ Fastpacks, 225 mL, 150¿ Res Autotransfusion Device - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma. | Haemonetics Corporation | Device | Class II | 22 |
| 18 Oct 2019 | Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F; Esophageal TTS Stent, REF: EST1806F, EST2012F, EST2012B, EST2015F, EST2008F, EST1808F, EST1814F, EST1810F, EST2010F Event 84742 | Taewoong Medical Co., Ltd. | Device | Class II | 1 |
| 11 Oct 2019 | Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 The Atellica CH 930 Analyzer is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 11 Oct 2019 | Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R, | Implant Direct Sybron Manufacturing LLC | Device | Class II | 1 |
| 8 Oct 2019 | Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001 | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 7 Oct 2019 | Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 | Implant Direct Sybron Manufacturing LLC | Device | Class II | 1 |
| 2 Oct 2019 | Medicrea TLIF-B Holder, short intended for Intervertebral body fusion device Catalog: Number A24200010 | Medicrea International | Device | Class II | 1 |
| 28 Sep 2019 | Bakers Corner All Purpose Flour in 5 lb. bags | Name withheld | Food | Class I | 19 |
| 27 Sep 2019 | EQ-400-RH-QZ and EQ-400-LH-BK products Product Usage: The device is a very broadband light source emitting incoherent non-laser light from the Deep UV through the visible wavelengths. Event 84378 | Energetiq Technology Inc | Device | Class II | 1 |
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System - Product Usage: Indicated for the temporary relief of knee pain. | Theralase Inc. | Device | Class III | 1 |
| 26 Sep 2019 | TLC-2000 Therapeutic Medical Laser System | Theralase Inc. | Device | Class III | 1 |
| 22 Sep 2019 | Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002 Event 84713 | Name withheld | Device | Class II | 1 |
| 19 Sep 2019 | Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205 | Pacific Medical Group Inc. | Device | Class II | 7 |
| 11 Sep 2019 | Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus TOCO Cable Assembly, NFCM9320; Pacific… | Pacific Medical Group Inc. | Device | Class II | 10 |
| 11 Sep 2019 | Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614 | Respironics California, LLC | Device | Class II | 4 |
| 10 Sep 2019 | Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017 | Philips North America LLC | Device | Class II | 2 |
| 10 Sep 2019 | Frozen Yellowfin Tuna, Product of Vietnam, Packaged under the following brands and cuts: Tidal Seafood Tuna Round Steak, size 6 - 8 oz, Size 8 - 10 oz, pack 2X10 lbs; and Sea Mart PREMIUM FROZEN YELLOWFIN TUNA LOINS 5-8 LBS IVP, 30 LBS; Sea Mart GRADE AAA FROZEN YELLOWFIN TUNA SAKU 12-16 IVP, 10 LBS; Sea Mart PREMIUM… Event 84572 | Truong Phu Xanh Co., | Food | Class II | 1 |
| 28 Aug 2019 | 1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201 | Ethicon, Inc. | Device | Class II | 3 |
| 14 Aug 2019 | Bard Conquest 40 PTA Dilation Catheter, 8mm X 20mm x 75cm (CQF7582), 8mm x 40mm x 75cm (CQF7584); Recommended Guidewire .035"; Recommended Introducer 6F; Nominal Pressure 8atm, Rated Burst Pressure 40atm; Syringe inflation 1cc; UDI: (01)00801741060533(17)220228(10)REDQ3444 | Bard Peripheral Vascular Inc | Device | Class II | 1 |
| 13 Aug 2019 | VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1) | LivaNova USA Inc | Device | Class II | 1 |
| 8 Aug 2019 | AQURE basic sytem, FLEXLINK, REF 933-599, Version: 2.3.3 (17), CE IVD, Rx Only, UDI: (01)05700699335999 Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. | Radiometer Medical ApS | Device | Class II | 1 |
| 29 Jul 2019 | OPTILITE IgM Kit, REF: NK012.OPT.A, IVD, UDI: 05051700017565 | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 26 Jul 2019 | da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures. | Intuitive Surgical, Inc. | Device | Class II | 3 |
| 19 Jul 2019 | Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197 | Stryker Corporation | Device | Class II | 2 |
| 12 Jul 2019 | Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is… | Dexcom Inc | Device | Class II | 1 |
| 3 Jul 2019 | PediaLift Access Device, Device Identifier: B751PDLFT0 Event 84591 | PediaLift LLC | Device | Class II | 1 |
| 18 Mar 2019 | HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant. | Advanced Bionics, LLC | Device | Class III | 1 |
| 14 Mar 2019 | Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants | Nobel Biocare Usa Llc | Device | Class II | 24 |
| 14 Feb 2019 | Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. Santa Ana, CA 92704 | McGuff Compounding Pharmacy Services, Inc. | Drug | Class II | 1 |
| 28 Jan 2019 | LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. | LivaNova USA Inc. | Device | Class III | 1 |
| 9 Jan 2019 | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 | Implant Direct Sybron Manufacturing LLC | Device | Class II | 1 |
| 4 Jan 2019 | Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590 | Cook Inc. | Device | Class II | 20 |
| 4 Dec 2018 | Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298 | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 16 Nov 2018 | Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator. | LivaNova USA Inc | Device | Class II | 2 |
| 15 Nov 2018 | Revanesse Versa, PN40081 Event 83834 | Prollenium Medical Technologies Inc. | Device | Class II | 1 |
| 23 Oct 2018 | The da Vinci SP surgical system is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the SP system and its primary function is to support the positioning of the surgical port (cannula) and to manipulate the surgical… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 17 Nov 2017 | EDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.) | Edan Diagnostics | Device | Class II | 1 |
| 19 Oct 2017 | bliss anti-stress formula Dietary Supplement, 60 Tablets; Manufactured For and distributed by: Market America, Inc., 1302 Pleasant Ridge Road, Greensboro, NC 27409; UPC 8 48570 00470 3 Event 84537 | Market America Inc | Food | Class II | 1 |