| 27 Nov 2018 | Endoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment. | Individual firm, name withheld | Device | Class II | 3 |
| 9 Nov 2018 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11) | AMERICAN HEALTH PACKAGING | Drug | Class III | 1 |
| 9 Nov 2018 | Equi-Soft Foam, Antimicrobial Hand Soap, 0.55% Benzalkonium Chloride, 25 fl oz (750 mL), OTC, Ecolab, 370 Wabasha Street N, St. Paul, MN 55102, NDC 47593-521-41 | Ecolab Inc | Drug | Class II | 2 |
| 9 Nov 2018 | Recchiuti Bittersweet, Smooth, rich and complex. Net Wt. 3 oz. (85 G) Also sold in case of 12 UPC 8019895 00017 6 Ingredient: Dark chocolate {cocoa beans, sugar, cocoa butter, soy lecithin (emulsifier)} Natural vanilla extract, cacao paste. Contains: soy Made on equipment also shared with soy, milk, wheat, eggs,… | Confections by Michael Recchiuti | Food | Class I | 2 |
| 8 Nov 2018 | ERBITUX CETUXIMAB Injection, 200 mg/100 mL (2 mg/mL), 100 mL per single-use vial, Rx only, Manufactured by: ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, Branchburg, NJ 08876 USA. NDC: 66733-958-23 (81511) | Eli Lilly & Co | Drug | Class III | 1 |
| 7 Nov 2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31 (81530) | Individual firm, name withheld | Drug | Class II | 1 |
| 7 Nov 2018 | Wegmans Pumpkin Loaf, 19 oz., UPC 77890 27002 | Wegmans Food Markets, Inc. | Food | Class I | 2 |
| 6 Nov 2018 | Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed by DZA Brands, LLC, Salisbury, NC 28147, Scarborough, ME 04074], [HealthMart Pharmacy brand NDC: 62011-0295-1, Distributed by McKessen, One Post Street, San Francisco, CA 94104], [DG… | L. Perrigo Company | Drug | Class II | 1 |
| 6 Nov 2018 | AMITIZA (lubiprostone) capsules 8 mcg. 60-count bottle, Rx Only. Marketed by: Sucampo Pharma Americas, LLC, Rockville MD 20850 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Active Ingredient made in Japan, encapsulated in the United States. NDC 64764-080-60 (81518) | Takeda Development Center Americas, Inc. | Drug | Class III | 1 |
| 6 Nov 2018 | Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487, Manufactured by: Pharmaceutics International Inc. Hunt Valley, MD 21031 | Breckenridge Pharmaceutical, Inc. | Drug | Class III | 1 |
| 6 Nov 2018 | Margie Cheese. It is packaged with a green round label, wrapped in white milk paper in one-pound wheels. | Sprout Creek Farm, Inc. | Food | Class I | 1 |
| 5 Nov 2018 | puriton EYE RELIEF DROPS, 0.5 oz (15 ml) bottle, Kadesh Inc., NDC#7079600115, UPC 7 36972 16799 0. (81512) | Kadesh International | Drug | Class I | 1 |
| 2 Nov 2018 | Ascom Telligence Nurse Call System (81546) | Ascom (US) Inc. | Device | Class II | 1 |
| 2 Nov 2018 | RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product Usage: Instrument is used to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric subjects. Applications can be performed with the patient sitting,… (81444) | Virtual Imaging, Inc. | Device | Class II | 1 |
| 2 Nov 2018 | IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-640-90. | Golden State Medical Supply Inc. | Drug | Class II | 3 |
| 2 Nov 2018 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540 | Sandoz Inc | Drug | Class II | 6 |
| 2 Nov 2018 | DIDGFPGB, Food Grade Pre-Gel Corn Flour. Bulk (81549) | Fairview Mills Inc | Food | Class II | 1 |
| 1 Nov 2018 | The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System The S-ICD System is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular… | Boston Scientific Corporation | Device | Class II | 1 |
| 1 Nov 2018 | Little Salad Bar Cranberry Walnut Salad: Spring Mix, Dried Cranberries, Candied Walnuts, Feta Cheese, Flat Bread Chips, Raspberry Vinaigrette: Net Wt. 4.5 oz. Ingredient label on the bottom of the clear plastic container is for Chicken Caesar Salad. Distributed by Aldi Inc. Batavia, IL 60510 | Ready Pac Foods Inc | Food | Class III | 1 |
| 31 Oct 2018 | BEVACIZUMAB 2.5 MG/0.1ML, pre-filled syringe (deliverable dose of 1.25MG in normject syringe) Repackaged by Avella Specialty Pharmacy, 24416 N 19th Avenue, Pheonix, AZ 85085. NDC 42852-001-24 | Avella of Deer Valley, Inc. Store 38 | Drug | Class II | 1 |
| 31 Oct 2018 | Microwave Movie Theater Butter Popcorn, Naturally Flavored, Net Wt. 19.8 OZ (1 lb 3.8 OZ), Distributed by Schnuck Markets, Inc. St. Louis, MO 63146 (81476) | Gilster-Mary Lee Corporation | Food | Class II | 1 |
| 30 Oct 2018 | Southwest Style Vegetable & Quinoa Protein Blend; Corn, Farro, Brown Rice, Red Bell Peppers, Black Beans, Poblano peppers, Scallions in a spicy citrus chili sauce. NET WT. 10 oz. (283G) Steam Ready, cooks perfectly in the bag! Keep Frozen Ingredients: Yellow Corn, Cooked Farro (water, Farro), Cooked brown rice… (81474) | The Perfect Bite Co. | Food | Class II | 1 |
| 29 Oct 2018 | Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA | Sciegen Pharmaceuticals Inc | Drug | Class II | 6 |
| 29 Oct 2018 | Fit & Active Southwest Veggie Stuffed Sandwiches NET WT 9 oz (255 g) KEEP FROZEN Distributed by ALDI Inc. Batavia, IL 60510 UPC 0 41498 15117 1 (81432) | J&J Snack Foods Handheld Corp | Food | Class II | 1 |
| 26 Oct 2018 | Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, NDC# 70518-0868-00 | RemedyRepack Inc. | Drug | Class III | 1 |
| 26 Oct 2018 | deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Made in the USA, Deb USA, Inc., Charlotte, NC 28217, NDC 11084-010-27. | Individual firm, name withheld | Drug | Class II | 2 |
| 26 Oct 2018 | MarieBelle brand Japanese Matcha Japanese Green Tea and White Chocolate Bar, NET Wt. 2.82 oz. UPC code: 877708005886 | Maribel's Sweets, Inc. | Food | Class I | 3 |
| 25 Oct 2018 | Apple juice concentrate and organic apple juice concentrate in 52 gallon drums, 5 gallon pails, 4 gallon pails, and 260 gallon totes (81427) | Valley Processing Inc. | Food | Class II | 1 |
| 24 Oct 2018 | Irbesartan Bulk Active Pharmaceutical Ingredient. (81442) | Aurobindo Pharma Limited (Unit I) | Drug | Class II | 1 |
| 24 Oct 2018 | Chocolate Cookies in plastic clamshell (12 count) | Cinnamon and Spice Bakery | Food | Class II | 8 |
| 24 Oct 2018 | Flav-R-Bites -Molasses Crunch-, *Gluten Free, Cereal Ingredients Inc. Leavenworth, Kansas, packaged in 50 lb bags (81431) | Cereal Ingredients Inc | Food | Class II | 1 |
| 23 Oct 2018 | Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc.,… | Janssen Pharmaceuticals, Inc. | Drug | Class II | 2 |
| 23 Oct 2018 | Curry powder packaged under bulk, retail, and food service labels. Bulk: CURRY POWDER Net Weight 55 LBS, DISTRIBUTED BY SIROB IMPORTS LINDENHURST, NEW YORK USA (sold in a 55 pound bag) Packaged under the following retail brands: Corrado 16 oz. UPC: 0 12729 01100 7 8 oz. UPC: 0 12729 01102 1 Orlando Imports 16 oz.… | Sirob Imports, Inc. | Food | Class I | 2 |
| 23 Oct 2018 | Organic green whole cardamom pods; 55.12 Pound bags; Product of Guatemala (81484) | Individual firm, name withheld | Food | Class I | 1 |
| 23 Oct 2018 | Inshell R/S 21/25 US- Select Pistachios; NET WT. 25 lb. (11.34kg) Product of the USA Production Date: 8/2018 ARO Pistachios Inc. 19750 Avenue 88, Terra Bella, CA 93270 (81406) | Sam Dry Fruits and Enterprises Inc. | Food | Class I | 1 |
| 23 Oct 2018 | Inshell R/S 21/25 US-Select Pistachios NET WT. 25 lbs. 11.34 kg Product of the USA ARO Pistachio Inc. 19570 Avenue 88, Terra Bella, Ca 93270 (81398) | ARO Pistachios, Inc. | Food | Class I | 1 |
| 22 Oct 2018 | Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126 | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 22 Oct 2018 | Catapres .2 (clonidine hydrochloride, USP) 0.2mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Made in Germany. NDC 0597-0007-01 | Boehringer Ingelheim Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 20 Oct 2018 | New Seasons Market Hot & Sour Broth, packaged in 24 oz glass jar. UPC 840600108672 | New Seasons Market LLC | Food | Class II | 1 |
| 19 Oct 2018 | ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with… | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 19 Oct 2018 | Morphine (1 mg/mL) in NS 100 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38 | Avella of Deer Valley, Inc. Store 38 | Drug | Class II | 5 |
| 19 Oct 2018 | Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120 mL) bottle, Dist. by Meijer Distribution, Inc., Grand Rapids, MI 40644, NDC 41250-106-08, UPC 7 13733 88578 2. | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class II | 3 |
| 19 Oct 2018 | Karlsburger Kitchens Roasted Onion Base, item # 23650, Net Weight 50 lbs (22.68 kg), UPC 60492-23650. Karlsburger Foods, Inc., Monticello, MN 55362 | Karlsburger Foods, Inc. | Food | Class II | 1 |
| 19 Oct 2018 | Posada Hatch Green Chile & Cheese Burrito, 72/4.5 oz burritos per case | AJINOMOTO WINDSOR INC | Food | Class II | 2 |
| 19 Oct 2018 | Pierre Philly Style Cheesesteak Sandwich, item 1125, 12 units packaged per case Net Wt. 4.65 LBS (2.11 kg) KEEP FROZEN | Tyson Foods Discovery Center | Food | Class II | 4 |
| 19 Oct 2018 | Tropical Dreams Super Premium Ice Cream Chocolate Coconut Macadamia Nut; Pint container; UPC 7 18122 41477 2 Ingredients: Cream, Sugar, Skim milk powder, water, cocoa powder, dark chocolate, pure vanilla, macadamia nuts, corn syrup, barley malt, carob bean gum and guar gum (stabilizer) dextrose, natural flavorings,… | Edney and Sellers, Ltd. | Food | Class II | 4 |
| 19 Oct 2018 | Rojo's Autentico Black Bean 5 Layer Dip; Layers of Black Beans, Guacamole, Salsa, sour Cream and Cheddar Cheese. NET WT. 40 oz. (2 Lbs. 9 oz.) 1.13 kg UPC: 047502 441269 Simply Fresh Foods, Inc., Buena Park, Ca 9-620 WWW Rojossalsa.com (81392) | Simply Fresh Foods, Inc | Food | Class II | 1 |
| 18 Oct 2018 | Signature Select Mexican Style Roasted Corn; 12 oz.; 12/12oz. units per case; Keep Frozen Until Ready To Use; UPC 02113094060; Item# 21130-09406 | Harvest Food Group | Food | Class II | 3 |
| 18 Oct 2018 | Organic Mind Body and Soul - Breakfast Blend Decaf, packaged in 2.25 oz. pillow packs. (81365) | Equal Exchange Cooperative dba Equal Exchange, Inc. | Food | Class II | 1 |
| 18 Oct 2018 | Roasted Corn Salsa; Net Weight: 10 lbs. (10 x 1 lb. bags) Corner Bakery Caf¿ Brand Ingredients: Corn, Red Onion, Jalapeno, Lime Juice, Canola Oil, Cilantro, Salt. Keep Frozen. Manufactured for Corner Bakery Caf¿, Cornet Bakery Caf¿, Callas, TZ 75251 | Cadence Gourmet LLC | Food | Class II | 4 |
| 18 Oct 2018 | Kroger brand. Frozen non-ready to eat Alaskan Salmon Bites, Net Wt 12 oz (340 g). SKU # 83091. UPC on retail package: 0 11110 83091 3. UPC on master case: 1 00 11110 83091 0 The label is read in parts: "***Kroger ***multi-grain Breaded ALASKAN SALMON BITES ***COOKING INSTRUCTIONS***KEEP FROZEN UNTIL READY TO… | Trident Seafoods Corporation | Food | Class II | 1 |
| 17 Oct 2018 | Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013 | Qualgen, LLC | Drug | Class II | 14 |
| 17 Oct 2018 | Sargento IQF Veggie Burger. Product 10001725 6/4 lb., and Product 4610035085 6/4lb. Keep Frozen. Manufactured by Sargento Foods, Inc., Plymouth, WI 53073 | Sargento Foods, Inc. | Food | Class II | 2 |
| 17 Oct 2018 | Chef Sensations Fire Roasted 1/2" diced onion/pepper blend Net Wt 20 lbs (81347) | The Wornick Company | Food | Class II | 1 |
| 17 Oct 2018 | Stewart's Shops, CRANBERRY APPLE REFRESHER, 16 oz., UPC: UPC 0 82086 31014 3 | Stewart's Shops Corp. | Food | Class I | 1 |
| 16 Oct 2018 | Mushroom & Thyme Flatbread Pizza, Item 70610. Net Weight 7.65 lbs. 48-2.55 oz. portions. Keep Frozen. For institutional use only. Buddy's Kitchen, Inc., Burnsville, MN 55337 | Buddy's Kitchen Inc | Food | Class II | 6 |
| 16 Oct 2018 | Hy-Vee Spinach, Tomato, Mozzarella Twice Baked Potatoes, Net Wt. 5 oz wrapped in clear plastic. | D & D Foods, Inc. | Food | Class II | 1 |
| 16 Oct 2018 | Spinach and Mushroom Pie, Net Wt. 6 OZ, packaged in a paper carton, Keep Frozen | Lone Star Bakery, Inc | Food | Class II | 2 |
| 16 Oct 2018 | Trader Joe's Hummus quartet; 20 oz. plastic container; Spicy Hummus Roasted Garlic Hummus, Regular Hummus and Tomato Basil Hummus. Perishable, Keep Refrigerated. SKU 39570 | Bakkavor Foods USA, Inc. | Food | Class II | 2 |
| 16 Oct 2018 | S & W White Beans, Net Wt 15 oz (425g), UPC 72273-38807. Distributed by Faribault Foods, 1818 2nd Ave NW, Faribault, MN 55021-3035. | Faribault Foods, Inc. | Food | Class III | 1 |
| 15 Oct 2018 | Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10 | Baxter Healthcare Corporation | Drug | Class III | 1 |
| 15 Oct 2018 | Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA (81436) | Zero Xtreme USA | Drug | Class II | 1 |
| 15 Oct 2018 | Kitchen Cravings Wood Fired Crust 4 Cheese Margherita Pizza, Net Wt. 28.39 oz (1 lb. 12.3 oz.) 804g. UPC 39779-00073. Produced & Distributed by Kwik Trip Inc., Lacrosse WI 54603 | Kwik Trip, Inc. | Food | Class II | 1 |
| 15 Oct 2018 | HOUSE BLEND Barbecue SAUCE INGREDIENTS: ***Contains 2% or less of Soybean Oil***Onion Powder***Calcium Disodium EDTA***DIAMOND CRYSTAL BRANDS, INC. SAVANNAH, GA 31405 | Diamond Crystal Brands, Inc. | Food | Class II | 1 |
| 15 Oct 2018 | SOUTHWEST CRIMINI STUFFED MUSHROOM; 7oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0081851202683 | Caito Foods LLC. | Food | Class II | 7 |
| 15 Oct 2018 | Evol Butternut Squash & Sage Ravioli 8oz. UPC 98997 80974 Frozen 6, 8oz. units per case | Request Foods Incorporated | Food | Class II | 31 |
| 14 Oct 2018 | Product 8x8 " individually packaged in black plastic trays with clear plastic dome lid is cornbread and it was MIS-LABELED as Angel Food Cake Bar. The label of Angel Food Cake Bar has the UPC 111110-02100. The label is read in parts: "***Angel Food Cake Bar *** Net wt. 12 oz *** Contains: Wheat and Eggs ***… (81288) | Fred Meyer Inc. | Food | Class I | 1 |
| 12 Oct 2018 | Sunnyside Orchards Apple Cider in Half-Gallon and Gallon plastic containers. Keep Refrigerated. Processed by: Sunnyside Orchards, 6051 NW 75th St, Pennock MN 56279 (81401) | Individual firm, name withheld | Food | Class II | 1 |
| 12 Oct 2018 | Wegmans Hummus, NET WT 32 OZ (2 LB) 908g, UPC: 77890-26221 and NET WT 8 OZ (227g), UPC: 77890-26213 | Wegmans Food Markets, Inc. | Food | Class II | 1 |
| 12 Oct 2018 | Mast Store Provisioners, Dried Okra, Net Wt. 4 OZ. clear plastic bag | Lehi Valley Trading Co. | Food | Class II | 9 |
| 11 Oct 2018 | Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation displays medical images (including mammograms) and data from various imaging sources. | GE Healthcare, LLC | Device | Class II | 2 |
| 11 Oct 2018 | Foodstirs Modern Baking; Organic Minute Mug Cake Mix Celebration Confetti - 4 - 2.54 oz. (72g) Pouches per carton -Carton Net Wt. 10.16 oz. (288g) Carton UPC; 816524 02789 Master case UPC: 816524 020796 (81268) | FOODSTIRS | Food | Class II | 1 |
| 11 Oct 2018 | feel good foods VEGETABLE FRIED RICE NET WT 9 OZ (255G), UPC: 8 99039 00212 9. Frozen. | Feel Good Foods Inc | Food | Class I | 1 |
| 10 Oct 2018 | SUGAR MELON CANDY / WAX GOURD The product comes in a 7.04oz plastics package marked with barcode 6912567116718. | SLR FOOD Distribution, Inc. | Food | Class I | 1 |
| 10 Oct 2018 | Fruits Du Sud brand Golden Seedless Raisins packed in 30 Lb. boxes with Lot No. FDS T499/18 and Production date of April 2018. Product of South Africa. (81342) | P. East Trading Corp. | Food | Class I | 1 |
| 10 Oct 2018 | simple truth organic Red Quinoa Ingredients: organic red quinoa Distributed by The Kroger Co, Cincinnati, OH UPC1111086333 NET WT 16 oz (1 lb) | The Kroger Co | Food | Class III | 1 |
| 9 Oct 2018 | Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879 NDC 61096-0035-1 | Sprayology | Drug | Class II | 22 |
| 9 Oct 2018 | Melissa's Hatch Chile Clean Snax, with Chia and flaxseed; 6.5 oz. plastic clamshell tub. Ingredients: Peanuts, Almonds, Cashews, Flaxseed, White Sesame Seeds, Evaporated Cane Juice, Green Match Chile Powder, Chia Seeds, Rice Syrup (Rice, Rice Milk Water), S=Honey, Sea, Salt. Allergen information: Contains Tree Nuts… | World Variety Produce Inc. | Food | Class II | 1 |
| 8 Oct 2018 | VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793) | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 8 Oct 2018 | Insulia Diabetes Management Companion (81508) | Voluntis | Device | Class II | 1 |
| 8 Oct 2018 | bioM¿rieux NucliSENS easyMAG Lysis Buffer ref. 280134 | bioMerieux, Inc. | Device | Class II | 1 |
| 8 Oct 2018 | The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option | Stryker Medical Division of Stryker Corporation | Device | Class II | 2 |
| 8 Oct 2018 | 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045 | ICU Medical Inc | Drug | Class II | 2 |
| 8 Oct 2018 | Forager Project Organic Protein Plant Shake Nuts & Vanilla 12 fl oz. UPC: 8 14558 02038 6 (81207) | Forager Project LLC | Food | Class II | 1 |
| 6 Oct 2018 | BAZZINI S ROASTED & SALTED IN-SHELL PISTACHIOS SUPER COLOSSAL NATURAL 5 LBS BAG UPC #0 75062 30701 5 THE BAGS ARE RED, WHITE AND BLUE. | Bazzini LLC | Food | Class I | 5 |
| 5 Oct 2018 | EVO Excel, Emission Computed Tomographic System, Material Number 10910501 | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 5 Oct 2018 | AIA-900 Analyzer, Product code 022930, 022930R | Tosoh Bioscience Inc | Device | Class II | 1 |
| 5 Oct 2018 | Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is completely covered with… | Covidien LLC | Device | Class II | 1 |
| 5 Oct 2018 | Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by Orexigen therapeutics, Inc., La Jolla, CA 92037, NDC 51267-890-99 (81505) | Orexigen Therapeutics, Inc. | Drug | Class III | 1 |
| 5 Oct 2018 | Pre Proof Danish Net Wt: 13.7lbs (6.2Kg) Contains: Eggs, Milk, Soy and Wheat KEEP FROZEN AT 0 F OR BELOW Bake One, Inc. Smyrna, GA 30082 UPC 8 10509 01152 6 (81195) | Bake One, Inc. | Food | Class II | 1 |
| 4 Oct 2018 | Caramels et Chocolats. Each retail tube contains four varieties on chocolate bonbons. Net wt per tube 3.8 oz. (81186) | Individual firm, name withheld | Food | Class II | 1 |
| 4 Oct 2018 | Orange plus Citrus Beverage from Concentrate (81245) | Campofresco Corp. | Food | Class II | 1 |
| 4 Oct 2018 | Ukrop's Black Forest Ham & Provolone Sub NET WT 7.8 OZ (221g) UPC 72251525153 | Ukrop's Homestyle Foods, LLC | Food | Class I | 12 |
| 3 Oct 2018 | Native Remedies VertiFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-253-02 | Silver Star Brands | Drug | Class I | 6 |
| 2 Oct 2018 | Liquid Cardiac Control, CQ5051 | Randox Laboratories Ltd. | Device | Class II | 3 |
| 2 Oct 2018 | Medtronic CareLink 2090 Programmer | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class II | 2 |
| 2 Oct 2018 | Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in… | Straumann Manufacturing, Inc. | Device | Class II | 1 |
| 2 Oct 2018 | Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. | Zimmer Biomet, Inc. | Device | Class II | 8 |
| 2 Oct 2018 | Houlihan's Creamy Garlic Ranch Dressing potentially labeled as Horseradish Sauce, 1 gal containers Mfg. exclusively for: Houlihan's Restaurant, Inc. Leawood, KS (81157) | CFS West Holdings Inc | Food | Class I | 1 |
| 2 Oct 2018 | Mini Roll, The product comes in a 2.469 ounce pink plastic package marked with a production date of 2018.03.20 stamped on the back. The product UPC code is 6 946050 104746. Product of China. (81287) | APOLLO FOOD INTERNATIONAL INC. | Food | Class I | 1 |
| 1 Oct 2018 | PremierPro Aluminum Adjustable Walker (81367) | SVS LLC | Device | Class II | 1 |
| 1 Oct 2018 | LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile Model # 2014-10 | LeMaitre Vascular, Inc. | Device | Class II | 1 |
| 1 Oct 2018 | Gatorade Vanilla Protein Shake, 330-mL, Primary Package HDPE in a 12pk case (81146) | Individual firm, name withheld | Food | Class II | 1 |
| 1 Oct 2018 | Toxin Absorber with Organic Ginger Root - 14 packets and 30 packets | NUTRANEXT BUSINESS LLC | Food | Class II | 8 |
| 28 Sep 2018 | AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by… | Tosoh Bioscience Inc | Device | Class II | 1 |
| 28 Sep 2018 | Tosoh AIA-900 immunoassay Analyzer | Tosoh Bioscience Inc | Device | Class II | 1 |
| 28 Sep 2018 | Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension¿ EXL 200 00630414593579; Dimension¿ EXL with LM 00630414593500; Dimension¿ EXL with LM with STM 00630414593593; Dimension¿ RxL Max 00630414949789; Dimension¿ RxL Max HM 00630414949796; Dimension¿ RxL Max HM STM… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 28 Sep 2018 | Tesamorelin, 1mg/vial, 6mL vial, Lyophilized Powder for Reconstitution and Subcutaneous Injection, Rx Only, Tailor Made Compounding, Nicholasville, KY 40356 (81337) | Individual firm, name withheld | Drug | Class II | 1 |
| 28 Sep 2018 | Fresh Herb Basil 62/4oz., LB 2489, 135/5Bulk, 24/8oz., 12/10 bulk Product of Mexico (81131) | GOURMET SPECIALTIES INC. | Food | Class II | 1 |
| 28 Sep 2018 | No Sugar Added Vanilla Ice Cream, 3 gallons | Working Cow Homemade Inc. | Food | Class I | 172 |
| 27 Sep 2018 | Aisys Anesthesia System. Sold under the following product names: AISYS, AISYS 10.X TO 11.X UPGRADE KIT DUTCH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH, AISYS 10.X TO 11.X UPGRADE KIT ENGLISH FOR USA, AISYS 10.X TO 11.X UPGRADE KIT FRENCH, AISYS 10.X TO 11.X UPGRADE KIT GERMAN, AISYS 10.X TO 11.X UPGRADE KIT JAPANESE. | GE Healthcare, LLC | Device | Class II | 3 |
| 27 Sep 2018 | INFUSE Bone Graft X SMALL KIT REF 7510100 | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 27 Sep 2018 | Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 27 Sep 2018 | Millville Maple & Brown Sugar Instant Oatmeal 15.1 oz. 10 individual serving size packets per 15.1oz retail unit. UPC: 041498 149628 | Aldi Inc | Food | Class II | 1 |
| 26 Sep 2018 | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The… | Oscor, Inc. | Device | Class I | 1 |
| 26 Sep 2018 | PCEA ASV Yellow Microbore, Catalog Numbers 30893, 30893-07 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3.… | Becton Dickinson & Company | Device | Class II | 2 |
| 26 Sep 2018 | CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. | Accuray Incorporated | Device | Class II | 1 |
| 25 Sep 2018 | Giraffe OmniBed Carestation. Neonatal incubator. Device sold under the following product names: Carestation and Carestation CS1 | GE Healthcare, LLC | Device | Class II | 6 |
| 25 Sep 2018 | Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. | Cook Medical Incorporated | Device | Class II | 39 |
| 25 Sep 2018 | DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint. | DT MedTech, LLC | Device | Class II | 2 |
| 25 Sep 2018 | Progesterone SR 100 mg Capsules, packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054 817-282-9376. NDC 99999-0104-55 | Right Value Drug Stores, Inc. | Drug | Class III | 4 |
| 24 Sep 2018 | Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.:… | Roche Diagnostics Corporation | Device | Class II | 1 |
| 24 Sep 2018 | Xper Flex Cardio Physiomonitoring System, Software version 1.6.0.0388 | Invivo Corporation | Device | Class II | 1 |
| 24 Sep 2018 | BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX… | Becton Dickinson & Co. | Device | Class II | 2 |
| 21 Sep 2018 | RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6 and RayStation 7, a stand-alone software treatment planning system. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 21 Sep 2018 | StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 21 Sep 2018 | Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus… | Arrow International Inc | Device | Class II | 1 |
| 20 Sep 2018 | Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 | Maquet Datascope Corp - Cardiac Assist Division | Device | Class I | 2 |
| 20 Sep 2018 | Village Baker SPECIALTY ARTISAN BREADS CINNAMON CHIP SOURDOUGH. The product is whole sliced loaves packed in clear plastic bags that are closed with a twist tie. The net weight is 1.5 lbs. The loaves were sold as individual units. The UPC is 6 42739 00121 9. The product's label is read in parts: "***CINNAMON CHIP… (81078) | Artisan Baking Company, LLC. | Food | Class II | 1 |
| 17 Sep 2018 | BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments | Leica Microsystems, Inc. | Device | Class II | 1 |
| 17 Sep 2018 | Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R | Medtronic Navigation, Inc.-Littleton | Device | Class II | 1 |
| 17 Sep 2018 | SparkleFresh Fluoride Toothpaste, Sodium Monofluorophosphate 0.76%, a) 17 g tube (NDC 53329-083-92, product number NONTP6I), b) 24 g tube (NDC 53329-083-93, product number NONTP85I), c) 42.5 g (NDC 53329-083-21, product number NONTP15I), d) 24 g tube (NDC 53329-081-93, product number DGN1000), Made in Malaysia for… | Medline Industries Inc | Drug | Class II | 1 |
| 14 Sep 2018 | VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria. | Luminex Corporation | Device | Class II | 1 |
| 14 Sep 2018 | GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System | GE Healthcare, LLC | Device | Class I | 3 |
| 13 Sep 2018 | CoaguChek¿ XS System Prothrombin time test: CoaguChek XS PT Test 2X24 Strips, Catalog Number: 04625315160; CoaguChek XS PT Test 6 Strips, Catalog Number: 04625374160; CoaguChek XS PT Test 24 Tests, Catalog Number: 07797826160; | Roche Diagnostics Corporation | Device | Class I | 1 |
| 13 Sep 2018 | 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: Actuation Driver, 6.2mm Reamer, 3.2mm Reamer, 2 mm Drill, Spade Tip Guide Wire, and 1.6mm x 12 K-Wire. | Arthrex, Inc. | Device | Class II | 1 |
| 12 Sep 2018 | EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. | Baxter Healthcare Corporation | Device | Class II | 5 |
| 12 Sep 2018 | IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards | CMP Industries, Llc | Device | Class II | 2 |
| 11 Sep 2018 | R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 | R & D Systems, Inc. | Device | Class III | 1 |
| 10 Sep 2018 | DeltaVision OMX SR Imaging System Model Number: 29115476 The DeltaVision OMX SR Imaging System is a piece of laboratory equipment for super resolution imaging offluorescently-la beling biological samples. Techniques such as 3D Structured Illumination, Total Internal Reflection Fluorescence and localization microscopy… (81454) | GE Healthcare Biosciences | Device | Class II | 1 |
| 10 Sep 2018 | -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray¿ ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The FilmArray… | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 10 Sep 2018 | Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist… | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 10 Sep 2018 | Acetylcysteine Injection 10 mg/5 mL (2 mg/mL), Pharm D Solutions, Houston, Texas ---- NDC 69699-1424-10 | Pharm D Solutions, LLC | Drug | Class II | 79 |
| 7 Sep 2018 | Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL method is an in vitro diagnostic test for the quantitative measurement of lipase in human serum and plasma on the Dimension¿ clinical chemistry system. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 5 Sep 2018 | FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851,… | BioFire Diagnostics, LLC | Device | Class II | 1 |
| 5 Sep 2018 | Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for… | Cordis Corporation | Device | Class II | 1 |
| 5 Sep 2018 | Pizza Turnover, Elaboracion Felo, Inc. Avenida Yumet No. 112, Aguadilla, PR 00603 | Elaboraciones Felo, Inc. | Food | Class I | 4 |
| 4 Sep 2018 | Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 30 Aug 2018 | BD Vacutainer Urine Collection Cups, Cat. No. 364941 | Becton Dickinson & Company | Device | Class II | 4 |
| 30 Aug 2018 | Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: Lack of usable peripheral IV sites, Central… | Arrow International Inc | Device | Class II | 1 |
| 28 Aug 2018 | Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and… | Stryker GmbH | Device | Class II | 4 |
| 28 Aug 2018 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489 For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 27 Aug 2018 | Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device. | Arthrex, Inc. | Device | Class II | 1 |
| 24 Aug 2018 | FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing, (81124) | Individual firm, name withheld | Device | Class II | 1 |
| 23 Aug 2018 | Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart. | Stryker Sustainability Solutions | Device | Class II | 1 |
| 23 Aug 2018 | BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Nexiva device or catheter) (see Figure below) incorporates a passive needle shielding mechanism that is activated as part of… | Becton Dickinson & Company | Device | Class II | 1 |
| 22 Aug 2018 | Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315 | Safe N Simple, LLC | Device | Class II | 2 |
| 22 Aug 2018 | Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy. | Zimmer Biomet, Inc. | Device | Class II | 6 |
| 21 Aug 2018 | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation. | Coltene Whaledent Inc | Device | Class II | 1 |
| 18 Aug 2018 | 60% Dark Chocolate Chips, packaged in poly-lined cardboard boxes, net wt. 30 lbs. The label is read in parts: "*** Pitch Dark Chocolate*** 60% Dark Chocolate ***Bulk 30lbs *** Produced in a facility that also processes: Peanuts, tree nuts, dairy ***". (80856) | Portland Chocolate Company LLC | Food | Class II | 1 |
| 16 Aug 2018 | BioMend Extend, REF# 0142Z, Synthetic bone grafting material. | Collagen Matrix, Inc. | Device | Class III | 1 |
| 10 Aug 2018 | Pointe Scientific AutoHDL/LDL Cholesterol Calibrator, Catalog Number H7545-CAL - Product Usage: For the calibration of Pointe Scientific s autoHDL and autoLDL Cholesterol Reagent Set in serum or plasma. For in vitro diagnostic use only. | Medtest Holdings, Inc. | Device | Class III | 1 |
| 9 Aug 2018 | Chef s Request professional steak marinade and Buckhead wildlife marinade, 12oz, 64oz, 1 gallon; shelf stable, refrigerate after opening (80835) | Deli Star Ventures Inc. dba King's Food Products | Food | Class II | 1 |
| 8 Aug 2018 | Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in fresh whole blood. This… | Magellan Diagnostics, Inc. | Device | Class II | 1 |
| 6 Aug 2018 | AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body. | Siemens Medical Solutions USA, Inc | Device | Class II | 3 |
| 3 Aug 2018 | Multix Fusion system is a radiographic system: Models: Multix Fusion Analog (model number 10746665) with Tube stand 3D V (model number 7042042 or 7042059); Multix Fusion Digital Portable (model number 10746666) with Tube stand 3D V (model number 7042042); Multix Fusion Digital Integrated (model number 10746667) with… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 2 Aug 2018 | Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter spp. In a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans. | Acumedia Manufacturers, Inc. | Device | Class III | 1 |
| 2 Aug 2018 | Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other… | Acumedia Manufacturers, Inc. | Device | Class III | 1 |
| 25 Jul 2018 | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid… | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 23 Jul 2018 | EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications… | Qiagen Sciences LLC | Device | Class II | 1 |
| 18 Jul 2018 | Sedecal NOVA FA DR System. for diagnostic radiography. (81377) | Individual firm, name withheld | Device | Class II | 1 |
| 6 Jul 2018 | 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. | 3M Company - Health Care Business | Device | Class II | 1 |
| 21 Jun 2018 | Abbott TECNIS 1-Piece Aspheric Acrylic IOL with the TECNIS iTEC Preloaded Delivery System, Lens Model PCB00, Sterile, Rx - Product Usage: The lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are… | Johnson & Johnson Surgical Vision Inc | Device | Class II | 1 |
| 20 Jun 2018 | Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5 (GTIN:5060358120367) Product Usage: Tissue Retrieval sac made from ripstop nylon. The EMP160ECO-US-5 is a semi-automatic sac, which incorporates a monofilament drawstring around the mouth of the bag, so that it can be pulled closed and… (81003) | Espiner Medical Ltd | Device | Class II | 1 |
| 24 May 2018 | Intelligent Peri-Analytical Workstation (HW+SW), Catalog #: A89492 (iPAW Software v4.2.1), Beckman Coulter, Inc. The iPAW ((intelligent Peri-Analytical Workstation) can act as: a software client for specimen tracking and workload statistics or a physical workstation for manual sorting and label printing. | Beckman Coulter Inc. | Device | Class III | 7 |
| 14 May 2018 | Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon¿ clinical sample concentrators are for in vitro diagnostic use and are intended for concentrating… (81122) | Merck Millipore Ltd. | Device | Class II | 1 |
| 20 Apr 2018 | Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe… | CareFusion 303, Inc. | Device | Class II | 1 |
| 16 Apr 2018 | Euphoric Premium Male Performance Enhancer capsules, packaged in a)1-count blister cards, UPC 6 96859 28646 9, b) 3-count bottle, UPC 6 96859 28647 6 and c) 12-count bottle, UPC 6 96859 28648 3. (79842) | Epic Products, LLC | Drug | Class I | 1 |
| 6 Apr 2018 | OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G | AROA Biosurgery, LTD. | Device | Class II | 21 |
| 27 Feb 2018 | FlareHawk Interbody Fusion System (previously XCage Interbody Fusion System) Instructions for Use (IFU's) only. Product Usage: Indicated for spinal intervertebral body fusion with autogenous bone graft in skeletally mature individuals with degenerative disc disease. | Integrity Implants Inc. | Device | Class II | 1 |
| 19 Feb 2018 | EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions. | Zimmer Biomet, Inc. | Device | Class I | 2 |
| 12 Jan 2018 | 1) Cytomics FC 500 With CXP Software BECKMAN COULTER 2) Cytomics FC 500 MPL With MXP Software BECKMAN COULTER flow cytometer for in vitro diagnostics | Beckman Coulter Inc. | Device | Class I | 2 |
| 2 Dec 2017 | Volumat MC Agilia Volumetric Infusion Pump, Model No. Z021135, Software version 1.7. Product Usage - The Volumat MC Agilia is a piece of transportable medical equipment intended to be used in healthcare facilities environment by healthcare trained professionals according to hospital protocols on adults, pediatrics… (81208) | Fresenius Vial Sa | Device | Class II | 1 |
| 5 Sep 2017 | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company | Device | Class II | 1 |
| 30 Jun 2017 | Heron toilet and bath chair Model 880505-01 & 880505-11 | R82 A/S | Device | Class II | 1 |
| 7 Jun 2017 | Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 9 |
| 28 Dec 2016 | Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and contaminants when conducting surgery, as well as when… | American Contract Systems, Inc. | Device | Class II | 1 |
| 30 Mar 2015 | REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six… | OriGen Biomedical, Inc. | Device | Class I | 1 |