| 10 Apr 2018 | Vasopressin 50 Units added to 250 mL 0.9% Sodium Chloride Injection USP (0.2 units per mL), Rx only, PharMEDium Services, LLC 12620 W. Airport Blvd #130 Sugar Land, TX 77478 | Pharmedium Services, LLC | Drug | Class III | 1 |
| 9 Apr 2018 | Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857 | Noven Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 9 Apr 2018 | Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amityville, NY 11701 for Leadiant Biosciences, Inc. Gaithersburg, MD 20878, NDC 54482-020-01 | LEADIANT BIOSCIENCES, INC | Drug | Class III | 1 |
| 6 Apr 2018 | Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05. | Sandoz Incorporated | Drug | Class III | 1 |
| 6 Apr 2018 | Amaranth Flour, Organic Whole Grain, Item Number: 6001C224, Net wt. 22 oz. UPC 0 39978 00911 1. The label is read in parts: "***Bob's Red Mill ***ORGANIC WHOLE GRAIN AMARANTH FLOUR STONE GROUND*** NET WT 22 OZ ***keeps best refrigerated or frozen***". | Bob's Red Mill Natural Foods, Inc. | Food | Class I | 1 |
| 6 Apr 2018 | HUNGRY JACK Original PANCAKE & WAFFLE MIX NET WT 32 OZ (2 LB) 907 g (79768) | The J.M. Smucker Company, Inc. | Food | Class II | 1 |
| 5 Apr 2018 | Formagere de la Brie brand, l' Explorateur, soft ripened cheese made from pasteurized milk, product comes in a 250g (8.8 oz), clear plastic package marked with lot # on the bottom, with UPC: 3 390010 004080. (79808) | Seacrest Foods International, Inc. | Food | Class I | 1 |
| 5 Apr 2018 | Bruschetta Mix packaged under the following brands and sizes: 1. Tastebuds, Net Wt. 12 oz. (340g), UPC 38232-37403. Shipping case: H. Brooks, 37403, Net wt. 12 oz. (340g), K*319, Keep Refrigerated, 6 units per case, Distributed by H. Brooks & Co Mpls. MN 55112. 2. Quick & Easy Fresh Cut, Net Wt. 12 oz. (340g) UPC… | Cut Fruit Express, Inc. | Food | Class I | 1 |
| 4 Apr 2018 | Buenas Grated coconut - frozen; Kinayod na Niyog Noix de Coco Rape; UPC: 4806514650443 Keep Frozen Net Wt. 16 oz., (4545 g) plastic bag Product of the Philippines Ingredients: Grated coconut Meat (95%) Water and preservative: Sodium Benzoate. (79733) | Global Commodities Corp. | Food | Class I | 1 |
| 4 Apr 2018 | Scotcharoo Valanga Gourmet, is a crispy rice cereal with peanut butter base, with semisweet chocolate and butterscotch melted on top. Individually wrapped, sold in boxes of 12. Net Wt. 3.2 oz (91g). UPC 814524611556. The product label is read in parts: "***VALANGA GOURMET Scotcharoo***Ingredients: Peanut Butter… (79737) | Avalanche Distributing, LLC | Food | Class II | 1 |
| 2 Apr 2018 | ACURE, clarifying acne, glycolic + zinc (salicyclic acid 0.5%) towelettes, 30-count pouch, Distributed by Better Planet Brands, Fort Lauderdale, FL 33316, UPC 8 54049 00358 0. | Diamond Wipes International, Inc. | Drug | Class II | 2 |
| 31 Mar 2018 | Club 13 Kratom Maeng Da Red powder; Pouches of 15, 30, 90, 150, 454 grams, and Club 13 Kratom Maeng Da Red powder in bulk bags. | Club 13 Enterprises Warehouse | Food | Class I | 3 |
| 30 Mar 2018 | Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15 | AVKARE Inc. | Drug | Class II | 1 |
| 30 Mar 2018 | PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 gram tube, UPC #851357003004, NDC #75940-111-60 (79689) | Marcas Usa Llc | Drug | Class II | 1 |
| 30 Mar 2018 | Original Smoked Oysters, packaged in vacuum pouches, net wt. 2.25 oz. or 16 oz.. UPC 47094 20002 (79688) | Taylor Shellfish Co | Food | Class II | 1 |
| 30 Mar 2018 | funky chunky Chocolate Pretzels. Pretzels, Caramel, Chocolate, Pecans. Sold in the following packaging configurations: 1. Small Bag Net Wt. 2 oz. (56g) UPC 91056-00045; 2. Large Bag Net Wt. 5 oz. (141g) UPC 91056-00040; 3. Mini Canister Net Wt. 8 oz. (227g) UPC 91056-00084; 4. Mini Stack Gift Pack (includes 8 oz.… (79785) | Funky Chunky LLC | Food | Class III | 1 |
| 30 Mar 2018 | Cali Green Malay Kratom all packages, all quantities | Nutrizone LLC | Food | Class I | 10 |
| 29 Mar 2018 | Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 29 Mar 2018 | Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL unit dose cups (NDC 50383-720-15) packaged in 100-count (10 x 10) cups per case pack (NDC 50383-720-18 or 50383-720-19), Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701. | Akorn, Inc. | Drug | Class III | 3 |
| 29 Mar 2018 | Zhong Hua Jiu (menthol 1%) Patch, Distributed by United Pacific Company, UPC 6 924938 100226, NDC 53614-001-02 (79693) | United Pacific Co Ltd | Drug | Class II | 1 |
| 29 Mar 2018 | Healthy Nut Factory ORGANIC COCONUT SMILES, Net Wt. 7 oz, UPC: 8 13449 02099 3 (79654) | Health Nuts | Food | Class I | 1 |
| 28 Mar 2018 | Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06 | Elroselabs Inc. | Drug | Class II | 3 |
| 27 Mar 2018 | Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system. | Teleflex Medical Europe Ltd | Device | Class II | 1 |
| 27 Mar 2018 | Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL packs ( NDC 68180-723-20) and (b) 100 mL packs ( 68180-723-10), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 | Lupin Pharmaceuticals Inc. | Drug | Class II | 1 |
| 27 Mar 2018 | FRANK & TONY'S NEW YORK STYLE RED ONION SAUCE, 15oz. (420g) glass jar, UPC: 6 00231 21502 2 (79647) | KALTEC FOOD PACKAGING INC. | Food | Class II | 1 |
| 27 Mar 2018 | Wegmans Yogurt Raisins, 9 OZ (255g), in a plastic tub, UPC: 0 77890 31832 4, | First Source, LLC | Food | Class I | 1 |
| 27 Mar 2018 | Signature Care Calcium Chews; Dietary Supplement; 500 mg Calcium; 25 mcg Vitamin D; Chocolate; 100 chews; Serving Size 1 chew; (79664) | Bestco, Inc. | Food | Class III | 1 |
| 27 Mar 2018 | Smoked Scallops, packaged and frozen in vacuum pouches, 4 oz & 16 oz packages. The 4 oz package has UPC 47094 20026 (79659) | Taylor Shellfish Co | Food | Class II | 1 |
| 25 Mar 2018 | Mrs. Gerry's Kwik Trip Egg Salad, Net Wt. 35 lb. (15.87kg), UPC 17839-61135. Keep Refrigerated. Manufactured by Mrs. Gerry's, Albert Lea, MN 56007 | Individual firm, name withheld | Food | Class II | 11 |
| 23 Mar 2018 | King Arthur Flour, 100% Organic, Finely Ground, Coconut Flour, UPC 0 71012 10702 5, Distributed by: The King Arthur Flour Co., Inc., Norwich, Vermont 05055 Product of the Philippines and/or Sri Lanka. (79594) | The King Arthur Flour Company, Inc. | Food | Class I | 1 |
| 23 Mar 2018 | Kitchen's Cravings Egg Salad Sandwich on Oat Multigrain Bread. Net Wt. 5.5 oz. (156g), Black bottom clear top plastic clamshell container, UPC 39779-00079 Keep Refrigerated. | Kwik Trip, Inc. | Food | Class I | 1 |
| 22 Mar 2018 | Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration. | Cook Inc. | Device | Class II | 2 |
| 22 Mar 2018 | Ascorbic Acid (Tapioca) 500 mg/mL, 50 mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 | Partell Specialty Pharmacy | Drug | Class II | 49 |
| 21 Mar 2018 | Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10. | Mayne Pharma Inc | Drug | Class III | 1 |
| 21 Mar 2018 | "Moskovski Batton" Supreme Bakery (79592) | Supreme Bakery LLC | Food | Class II | 1 |
| 21 Mar 2018 | diet Pepsi, 12 FL OZ, in aluminum cans packaged in 12 pk paper cartons (79617) | Pepsi Beverage Co | Food | Class III | 1 |
| 21 Mar 2018 | GFS Belgian Mini Chocolate Topped Eclairs, Keep Frozen, Net Wt . 700 g.; Signature Select Belgian Style Mini Eclairs, Keep Frozen, 420 g; Delizza Patisserie Belgian Custard Cream Mini Eclairs, 420 g. (79607) | Poppies International INC | Food | Class II | 1 |
| 21 Mar 2018 | Cole Slaw, Store Made. Packed in deli-style plastic containers: Weis, Weis Markets, Inc., Sunbury, PA; Cabbage, Carrots, Pineapple, White Onions, Sugar, Salt Pepper, Vinegar, Hellmanns Mayonnaise | WEIS MARKETS | Food | Class I | 1 |
| 21 Mar 2018 | Dr. Pepper Est. 1885 Diet, 20 FL Oz (1.25 PT), 591 mL | Swire Coca Cola USA | Food | Class II | 1 |
| 21 Mar 2018 | Soap Korner Herbalist Red MD Kratom, Green Kali, powder, soapkorner.com (79609) | Soap Korner | Food | Class I | 1 |
| 20 Mar 2018 | First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash# Size: Honeywell Part# K206125 LXXV - 75V " Economy Cabinet 3 Shelf R508016 Eye Wash " 4 oz. 32-000452-0000 K 206154 LXXV - 75V " Deluxe Cabinet ¿3 Shelf RS08016 Eye Wash - 4 oz. 32-000452-0000 K206210 FAC- 3… | Certified Safety Mfg Inc | Device | Class II | 1 |
| 20 Mar 2018 | Diet Pepsi; NOW ASPARTAME FREE; 6 PACK; 16 OZ BOTTLES; 6-16 FLOZ BOTTLES (96 FL OZ) (79616) | Pepsi Cola Bottling Company | Food | Class III | 1 |
| 19 Mar 2018 | Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-302-01. | Glenmark Pharmaceuticals Inc., USA | Drug | Class III | 1 |
| 19 Mar 2018 | Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Quality Care Products, Temperance, MI 48182 Mfr. CSPC Ouyl Pharm Co., Ltd. Shijazhuang, Hebei, China; NDC 55700-0412-01 (79640) | Lake Erie Medical & Surgical Supply Inc | Drug | Class III | 1 |
| 19 Mar 2018 | ECLIPSE Kratom Premium Maeng Da, 40 count capsules and 2 oz bottles, Distributed by Tamarack Inc. Cheyenne, WY (79565) | Tamarack, Inc. | Food | Class I | 1 |
| 17 Mar 2018 | Coconut Smiles - Retail: International Harvest Brand Organic Go Smile! Dried Coconut Raw, in a 9 oz. poly/plastic bag, UPC: 7 39446 40220 7 NON GMO; Bulk: 25 lb. boxes (79554) | International Harvest, Inc. | Food | Class I | 1 |
| 16 Mar 2018 | Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery. | Terumo Cardiovascular Systems Corporation | Device | Class II | 3 |
| 16 Mar 2018 | GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician. | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | Device | Class II | 3 |
| 16 Mar 2018 | Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic… | Philips Electronics North America Corporation | Device | Class II | 13 |
| 16 Mar 2018 | Natural Grocers Organic Coconut Smiles, 10 oz. plastic resealable bag, Packaged by Vitamin Cottage Natural Food Markets, Inc. Lakewood, CO 80228 (303) 986-4600 | Natural Grocers by Vitamin Cottage | Food | Class I | 1 |
| 16 Mar 2018 | Taylor Farms 3/8" Diced Yellow Onion 4/5# bags - 20 lb, corrugated paper carton; 20 lb. box for food service distribution. Item number 1130025; Taylor Farms California Foodservice; Salinas, CA (79567) | Taylor Farms California Foodservice, Inc. | Food | Class I | 1 |
| 16 Mar 2018 | SANTA CRUZ organic APRICOT fruit spread NET WT 9.5 OZ (270 g) UPC 0 36192 10514 8 | Smucker Natural Foods, Inc. | Food | Class III | 6 |
| 16 Mar 2018 | River Valley Alfalfa Sprouts in 4 ounce Clam shell, UPC 87906-00027, 5 ounce plastic cup, UPC 87906-00006, and 2 lb. bag | River Valley Sprouts | Food | Class I | 3 |
| 16 Mar 2018 | EXO Cricket Protein Bar Blueberry Vanilla; Net Wt 2.1 Oz. packaged in a film wrapper, 12 units per case; UPC: 861703000069 | Aspire Food Group USA Inc. | Food | Class I | 3 |
| 16 Mar 2018 | J.M. Rosen's Cheesecake - New York Traditional; 6 - Unit- 4/46 oz in a case box; Product #56378 UPC 6 93892 99462 7; INGREDIENTS: Cream Cheese (Pasteurized Nonfat Milk, and Milkfat~ Whey Protein Concentrate, Cheese Culture. Salt, Whey, Stabilizers (Xanthan Gum, and/or Carob Bean Gum, and/or Guar Gum)}, Unbleached… | Individual firm, name withheld | Food | Class II | 2 |
| 15 Mar 2018 | Normed Charcot Osteotome Chisel (Various sizes) | Zimmer GmbH | Device | Class II | 1 |
| 15 Mar 2018 | Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502… | Teleflex Medical Europe Ltd | Device | Class II | 4 |
| 15 Mar 2018 | buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03 | InvaGen Pharmaceuticals, Inc. | Drug | Class III | 2 |
| 15 Mar 2018 | diet Pepsi Classic Diet Pepsi Taste, 12oz cans, sold as a 12 pk, ambient storage. (79638) | Pepsico Foods International | Food | Class III | 1 |
| 15 Mar 2018 | LOST CAJUN GUMBO BASE, T4014, PACK SIZE 45 lb bag, Blended by ALL AMERICAN SEASONINGS, 10600 E. 54th Ave., Units B & C, Denver, CO 80239 (79539) | All American Seasonings, Inc. | Food | Class II | 1 |
| 14 Mar 2018 | WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020 | Wright Medical Technology, Inc. | Device | Class II | 2 |
| 14 Mar 2018 | diet pepsi caffeine free Classic Diet Pepsi Taste, 12 FL OZ (355 mL), UPC: 0 12000 17230 4 | Pepsico Inc | Food | Class III | 1 |
| 14 Mar 2018 | Roast Beef Gravy Seasoning Manufacturer's code: PF07040000 packaged in a multi-walled paper bag with poly liner, 28 pounds (79557) | Precise Food Ingredients, Inc. | Food | Class II | 1 |
| 14 Mar 2018 | Southgate Hot Dog Chili Sauce 15 oz cans UPC 0 71846 95242 (79525) | Vietti Acquisitions, LLC | Food | Class I | 1 |
| 14 Mar 2018 | Au Jus Seasoning BM652767; bulk 50 lb boxes | Newly Weds Foods Inc | Food | Class II | 5 |
| 14 Mar 2018 | Davis Chocolate Peanut Morsels /Organic Peanut Chips (79551) | Davis Chocolate a division of Deco Chem, Inc. | Food | Class I | 1 |
| 14 Mar 2018 | Product Name Lot Number or ID Whiskey & Cola Type Flavored Seasoning 660373 | GRIFFITH FOODS | Food | Class II | 8 |
| 13 Mar 2018 | Chicken bacon, egg white and cheese on flat bread sandwich (79732) | Premier Food Management, LLC | Food | Class II | 1 |
| 13 Mar 2018 | Sour Patch Kids, 1.9 lb bag | Mondelez Global Llc | Food | Class II | 1 |
| 12 Mar 2018 | Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally infants and neonates in the hospital. | Hamilton Medical AG | Device | Class II | 2 |
| 12 Mar 2018 | Phoenix Nail System, intended for use with an intramedullary nail system for alignment, stabilization and fixation of fractures. 3.5mm Inserter Connector, Short; Model Number: 14-441045; Kit Model Numbers: 14-400082, 14-400082S, 14-440065S, 14-442000-00, 14-442000S, 14-444000-00, 979105, 14-441045-00, and 14-444000S | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 12 Mar 2018 | Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during transport. The device has a maximum safe working… | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 12 Mar 2018 | Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients… | TMJ Solutions Inc | Device | Class II | 1 |
| 11 Mar 2018 | Gourmet Cream Cheese Cinnamon Rolls, packaged in a 16 oz. plastic clam shell container and sold under the Schwartz Brothers Bakery brand. The product UPC is 7 17887 65082 1. The product is read in parts: "***GOURMET CREAM CHEESE CINNAMON ROLLS***NET WT. 16 OZ***Produced By Schwartz Brothers Bakery Seattle, WA… | Schwartz Brothers Restaurants dba Schwartz Brothers Bakery | Food | Class II | 1 |
| 10 Mar 2018 | 1.5 oz. cup with seal on label reading: Thai Sweet Chili Sauce; Ingredients: Thai Sweet Chili Sauce (Sugar, Water, Pickled Red Chili, Vinegar, Garlic, Salt, Xanthan Gum); Net Wt. 1.5 oz.; coded: BB 07/04/18, BB 07/05/18 (79511) | Lancaster Fine Foods Inc. | Food | Class I | 1 |
| 10 Mar 2018 | Wegmans Thai Sweet Chili Sauce Cup 1.5 oz. (UPC 7-66630-98023) | Wegmans Food Markets, Inc. | Food | Class I | 3 |
| 9 Mar 2018 | Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (¿2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site… | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 9 Mar 2018 | Proclaim DRG Implantable Pulse Generator, Model Number 3664 | St. Jude Medical, Inc. | Device | Class II | 1 |
| 9 Mar 2018 | Dreyer's Slow Churned Vanilla Bean Ice Cream; 1.5 qt, (48-fl oz.); Lid is for Dreyer's Slow Churned Butter Pecan Ice Cream UPC 41548 00386 (79484) | Nestle Dreyers Ice Cream Company | Food | Class II | 1 |
| 8 Mar 2018 | SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. (79653) | Southern Implants, (Pty.) Ltd. | Device | Class II | 1 |
| 8 Mar 2018 | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w), 454 g tube, Rx only, Manufactured by E-Z-EM Canada Inc. for E-Z-EM Inc. a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 0883, NDC 32909-770-01 | Bracco Diagnostics Inc. | Drug | Class II | 1 |
| 8 Mar 2018 | Red Zone Xtreme 3000 Capsules, Dietary Supplement Product, 1 count blister pack, UPC 8 91656 00200 9, Exp Date 12/31/2021 (79476) | Individual firm, name withheld | Drug | Class I | 1 |
| 8 Mar 2018 | Provim ESP Vita Wheat Gluten, Product code 6303, 50 lb bag (79509) | ADM Agri Industries | Food | Class II | 1 |
| 7 Mar 2018 | Product: Milford Smartbase Model # 9934105 Pride SmartBase Pride product codes: LSMPLCG A & LSMPLCG B (79627) | Autochair | Device | Class II | 1 |
| 7 Mar 2018 | D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R | Smith & Nephew, Inc. | Device | Class II | 1 |
| 7 Mar 2018 | Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25. | Apollo Care | Drug | Class II | 2 |
| 7 Mar 2018 | Mushroom Condensed Soup, brand Chef Edwin's, packaged in glass pint Kerr jars, Net wt. 14 oz. UPC 7 00424 66845 8. The product label is read in parts: "***Chef Edwin's *** Mushroom Condensed Soup***Oregon Wild Berries Inc. 77129 Watach Dr., Clatskanie, OR 97016***". (79470) | Oregon Wild Berries, Inc. | Food | Class II | 1 |
| 6 Mar 2018 | Josie's Homestyle #1 Pralines Net Wt. 2 oz (57 g) bag INGREDIENTS: Sugar, Cream, Pecans, Butter, Vanilla, if (Rum) Rum Flavoring. If (Coconut) Coconut. Made By: Josie's Homestyle #1 Pralines, etc. 718 1/2 Filmore St. Kenner, LA 70062 UPC 6 71572 00718 8 (79535) | Josie's Homestyle Pralines Etc. Inc. | Food | Class II | 1 |
| 6 Mar 2018 | The Peru Chef Dry Potato, Product of Peru, Net Wt. 15oz/425gr, Imported and Distributed by MAS FOOD SERVICES Co., (79651) | M.a.s Food Services Co | Food | Class I | 1 |
| 6 Mar 2018 | Maurice's Honey Southern Gold BBQ Sauce; Net Wt. 18 oz. bottles; UPC Code 0 7561654332 6 and Carolina Gold Honey Sauce; Net Wt. 18 oz. bottle; UPC Code 0 7561654383 8 (79473) | Piggie Park Enterprises Inc | Food | Class I | 1 |
| 5 Mar 2018 | Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37 | InvaGen Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 5 Mar 2018 | Wild Meadow Raw Goat Milk Cheese. The product is packaged in various sizes of sealed flexible plastic packaging, displaying the plant number 36-1315. (79486) | Good Fields Farm/The Maiden's Creamery | Food | Class I | 1 |
| 5 Mar 2018 | IDLife Protein Bar Chocolate and Peanut Butter (SKU 16-0012) Organic, non-GMO and gluten-free protein bar. Individually wrapped bars, packaged 10 to a box | IDLife, LLC | Food | Class II | 3 |
| 2 Mar 2018 | Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts)… | Getinge Disinfection Ab | Device | Class II | 2 |
| 2 Mar 2018 | BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370 | Beckman Coulter Inc. | Device | Class II | 1 |
| 2 Mar 2018 | Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10 | Renaissance Lakewood, LLC | Drug | Class III | 1 |
| 1 Mar 2018 | Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40 | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 28 Feb 2018 | Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction | Biomet, Inc. | Device | Class II | 1 |
| 27 Feb 2018 | Bard(R) Premature Infant Feeding Tube, ENFit(TM), REF EN0036400 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube feeding, lavage fluid and medications Feeding… | C.R. Bard, Inc. | Device | Class II | 4 |
| 26 Feb 2018 | Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and transplantation into a recipient. (79378) | Preservation Solutions, Inc. | Device | Class II | 1 |
| 26 Feb 2018 | Evamist (estradiol transdermal spray), 1.53mg estradiol/spray, 0.27 fl oz (8.1 mL) per bottle, Rx Only, Manufactured for Perrigo, Minneapolis, MN 55427. NDC: 0574-2067-27 | Paddock Laboratories, LLC. | Drug | Class II | 1 |
| 23 Feb 2018 | GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the… | GE Healthcare | Device | Class II | 1 |
| 23 Feb 2018 | IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient. | Deerfield Imaging, Inc. | Device | Class II | 2 |
| 23 Feb 2018 | ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003 | Orthofix, Inc | Device | Class II | 2 |
| 23 Feb 2018 | IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600 | Deerfield Imaging, Inc. | Device | Class II | 4 |
| 23 Feb 2018 | MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602 Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single pediatric use, only. The PadPro 2602 electrodes provide the conductive interface between… | ConMed Corporation | Device | Class II | 5 |
| 23 Feb 2018 | Hippie Cookie, Marsee Baking brand, six 3.2oz cookies individually wrapped in plastic (Grab and Go) or six unwrapped, bulk packed on baking paper and placed in a paperboard box (Fresh Case). Product labeled in part, "Ingredients:***Coconut***Allergens: Contains Eggs, Tree Nuts (brazil nuts, cashews, hazelnuts,… | Pinks Bakery Seattle, Inc. | Food | Class II | 2 |
| 21 Feb 2018 | Brilliance 64 with 4.1.7 XX026 software version model number 728231 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 analysis and display… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 21 Feb 2018 | Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the… | Datascope Corporation | Device | Class II | 3 |
| 21 Feb 2018 | Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751 Multi-parameter, physiologic patient monitoring of… | Draegar Medical Systems, Inc. | Device | Class II | 1 |
| 21 Feb 2018 | F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports, (79613) | Allen Medical Systems | Device | Class II | 1 |
| 21 Feb 2018 | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad, India 382213, NDC 36000-002-10 | Renaissance Lakewood, LLC | Drug | Class II | 1 |
| 19 Feb 2018 | Gordon Choice Asian Sesame Ginger Dressing, Net Contents/Contenido Neto 128 FL OZ; For Distribution Exclusively By Gordon Food Service Wyoming, MI 49509 | Ventura Foods, LLC | Food | Class II | 1 |
| 16 Feb 2018 | Doyen-Collin Mouth Gag 120MM/ General Instruments | Aesculap Implant Systems LLC | Device | Class III | 2 |
| 15 Feb 2018 | Teleflex MEDICAL WECK Visistat 35. Used for the external skin closure of lacerations. | Teleflex Medical | Device | Class II | 1 |
| 15 Feb 2018 | Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain anatomic images of the human body and PET… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 14 Feb 2018 | MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer. | Siemens Medical Solutions USA, Inc | Device | Class II | 6 |
| 12 Feb 2018 | ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471 | Mesa Laboratories Bozeman Manufacturing Facility | Device | Class II | 2 |
| 9 Feb 2018 | Kratom capsules labeled in the following ways: 1) Divinity Kratom 10 Capsule Dietary Supplement, Divinity Product LLC, Blue Springs, MO 64015; 2) Divinity Bali Kratom, 10PK Capsules; 3) Divinity Bali Kratom, 20PK Capsules; 4) Divinity Bali Kratom, 40PK Capsules; | Divinity Product Distribution LLC | Food | Class II | 2 |
| 8 Feb 2018 | Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES… | Tornier, Inc | Device | Class II | 1 |
| 8 Feb 2018 | Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system 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 display… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 12 |
| 7 Feb 2018 | Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); b. HALYARD* 12 FR TRACH CARE DSE ENDO; c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); d. HALYARD* 12FR TRACH CARE… | Halyard Health, Inc | Device | Class II | 3 |
| 7 Feb 2018 | Human Fetal Hemoglobin (HBF-1) FITC Conjugate | Life Technologies Corporation | Device | Class II | 1 |
| 7 Feb 2018 | VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911 ARD568811951, ARD568811961 The device is designed to illuminate the body of a patient during surgical operations, diagnostics and treatment. These surgical lights may be installed in surgical… | GETINGE US SALES LLC | Device | Class II | 1 |
| 6 Feb 2018 | AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE 800508330 NAIL TIB DYN 08X33.0 - STERILE… | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 5 Feb 2018 | 6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, Item A1009-NS, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides… | ICU Medical, Inc. | Device | Class II | 6 |
| 30 Jan 2018 | AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to… | Encore Medical, Lp | Device | Class II | 1 |
| 29 Jan 2018 | Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction. | Encore Medical, Lp | Device | Class II | 5 |
| 29 Jan 2018 | AQUIOS CL Flow Cytometer System, Catalog #B30166. The AQUIOS CL Flow Cytometer system is an automated analyzer that use a no-wash sample preparation process.The firm name on the label is Beckman Coulter Ireland, Inc., Co. Clare, Ireland. | Beckman Coulter Inc. | Device | Class II | 1 |
| 26 Jan 2018 | Ray Station 4.9 Ray Station 5, Ray Station 6 and Ray Station 7 Software build numbers: 4.9.0.42, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7 or 7.0.0.19 UDI: 0735000201006820171130 | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 26 Jan 2018 | QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the… | Inova Diagnostics Incorporated | Device | Class II | 2 |
| 24 Jan 2018 | DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed to provide a… | Invivo Corporation | Device | Class II | 1 |
| 24 Jan 2018 | Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations. | Keystone Dental Inc | Device | Class II | 1 |
| 24 Jan 2018 | Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912) | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 24 Jan 2018 | Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis. | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 24 Jan 2018 | Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-3200 and BC-3600… | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 2 |
| 22 Jan 2018 | DS Titanium Ligation Clip, used in laparoscopic surgery | Aesculap Implant Systems LLC | Device | Class II | 2 |
| 21 Jan 2018 | The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser The FEMTO LDV(TM)Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of… (79379) | SIE AG, Surgical Instrument Engineering | Device | Class II | 1 |
| 18 Jan 2018 | Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems. | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 1 |
| 18 Jan 2018 | Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back… (79559) | Individual firm, name withheld | Device | Class II | 1 |
| 12 Jan 2018 | MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture. | Cook Inc. | Device | Class II | 2 |
| 12 Jan 2018 | Progressa Bed - AC-powered adjustable hospital bed | Hill-Rom, Inc. | Device | Class II | 1 |
| 12 Jan 2018 | Solid state x-ray imager (flat panel/digital imager) Solid state x-ray imager (flat panel/digital imager) Medical | NeuroLogica Corporation | Device | Class II | 1 |
| 11 Jan 2018 | Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Number HXDRIVER-3.5AO | TriMed Inc. | Device | Class II | 1 |
| 11 Jan 2018 | VITROS Immunodiagnostic Products TSH Reagent Pack (79508) | Clinical Diagnostic Systems | Device | Class III | 1 |
| 10 Jan 2018 | Syngo.via software is intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a standalone device or together with a variety of cleared and unmodified syngo based software options. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 10 Jan 2018 | PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle | Ethicon, Inc. | Device | Class II | 3 |
| 9 Jan 2018 | LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only. | Magellan Diagnostics, Inc. | Device | Class II | 2 |
| 8 Jan 2018 | Syngo.via. Medical Device Software. Picture archiving and communications system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 3 Jan 2018 | HEMASHIELD Knitted Double Velour Cardiovascular Fabric | GETINGE US SALES LLC | Device | Class II | 1 |
| 22 Dec 2017 | Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin). | Roche Diagnostics Corporation | Device | Class II | 1 |
| 22 Dec 2017 | (1) MAC Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters, Product Number: ASK-11242-PHP; (2) Arrow¿ MAC" Two- Lumen Central Venous Access Kit, Product Number: CDC-11242-1A | Arrow International Inc | Device | Class II | 14 |
| 21 Dec 2017 | Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments. (79533) | W & H DentalWerk Burmoos GMBH - Site 1 | Device | Class II | 1 |
| 21 Dec 2017 | (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP… | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 20 Dec 2017 | Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000 | OraSure Technologies, Inc. | Device | Class III | 1 |
| 20 Dec 2017 | AUTO REF/KERATOMETER ARK-1s | Nidek Inc. | Device | Class II | 1 |
| 20 Dec 2017 | ACE Trochanteric Nail System ACE TROCH NAIL 125 DEG. X 11MM ACE TROCH NAIL 130 DEG. X 11MM ACE TROCH NAIL 135 DEG. X 11MM ACE TROCH NAIL 125 DEG. X 13MM ACE TROCH NAIL 130 DEG. X 13MM ACE TROCH NAIL 135 DEG. X 13MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur… | Zimmer Biomet, Inc. | Device | Class II | 11 |
| 19 Dec 2017 | Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number: G19871 Product Usage: Used to place in vitro fertilized (IVF) embryos into the uterine cavity. Intended for one-time use | Cook Inc. | Device | Class II | 4 |
| 18 Dec 2017 | ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01). ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. To be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000. | Phadia US Inc | Device | Class II | 2 |
| 18 Dec 2017 | COACH¿ Self-Adhering Sports Wrap (size: 2in) | Johnson & Johnson Consumer, Inc. | Device | Class II | 6 |
| 18 Dec 2017 | Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use only in the exh¿acorporeal circuit for… | Terumo Cardiovascular Systems Corp | Device | Class II | 1 |
| 18 Dec 2017 | c6000, Chemistry (Photometric, Discrete), for clinical use. - cobas e 601 module: Immunoassay Analyzer, Catalog Numbers: 04745922001, 05036348001, 05860652001, 04745922692, 05036348001 & 05036348692 | Roche Diagnostics Corporation | Device | Class II | 3 |
| 15 Dec 2017 | Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals… | GE Healthcare, LLC | Device | Class II | 2 |
| 15 Dec 2017 | Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630) The CONFIDENCE SPINAL CEMENT SYSTEM¿ 11cc Kit is intended for percutaneous delivery of CONFIDENCE 11cc Spinal Cement, which is indicated for fixation of pathological fractures of the… | DePuy Spine, Inc. | Device | Class II | 1 |
| 15 Dec 2017 | ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B | Arrow International Inc | Device | Class II | 1 |
| 15 Dec 2017 | Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays . Sofia 2 is intended for professional and laboratory use. | Quidel Corporation | Device | Class II | 1 |
| 15 Dec 2017 | Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1 (79610) | Amneal Pharmaceuticals | Drug | Class II | 1 |
| 14 Dec 2017 | 2008 K2 Hemodialysis Machine with software version 5.40, Models: (1) Hemodialysis SYS OLC/Diasafe PLS 190610, UDI 00840861100859 (+Serial Number), (2) Machine Short Cap, OLC.DP HP 190630, UDI 00840861100866 (+Serial Number) ndicated for acute and chronic dialysis therapy. | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 14 Dec 2017 | Dynavox T10 Speech Generating Device ( including Batteries) | Dynavox Systems Llc | Device | Class II | 2 |
| 13 Dec 2017 | CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route. | Halyard Health, Inc | Device | Class II | 1 |
| 13 Dec 2017 | Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for… | Covidien LLC | Device | Class II | 1 |
| 12 Dec 2017 | PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 6 Dec 2017 | Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor. (79601) | Reliance Medical Products Inc | Device | Class II | 1 |
| 4 Dec 2017 | Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and… | Life Technologies Corporation | Device | Class II | 1 |
| 4 Dec 2017 | Sonimage HS1 Ultrasound Kit AC adapter, Product Number: A7AP, UDI: 04560141940031 | Konica Minolta Medical Imaging USA, Inc. | Device | Class II | 4 |
| 1 Dec 2017 | Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion… | Ohmeda Medical | Device | Class II | 1 |
| 1 Dec 2017 | Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and… | Mindray DS USA, Inc. dba Mindray North America | Device | Class III | 1 |
| 29 Nov 2017 | Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Model Number: 42-5399-035-12; (5) 14mm block, Model Number: 42-5399-035-14 A spacer block is used to ensure the tibial… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 29 Nov 2017 | Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10. | Zimmer Dental Inc | Device | Class II | 2 |
| 28 Nov 2017 | Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling. (79425) | Cook Vascular Inc. | Device | Class II | 1 |
| 22 Nov 2017 | 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 21 Nov 2017 | Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the… | Covidien LLC | Device | Class II | 1 |
| 20 Nov 2017 | Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument, article number 12-3900-01 and EliA Assays. This recall is for any Phadia Prime software version up to and including the current version, 2.1.4. | Phadia Ab | Device | Class II | 1 |
| 17 Nov 2017 | IntelliVue X3 Patient Monitor. | Philips Electronics North America Corporation | Device | Class II | 1 |
| 13 Nov 2017 | HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator. (79010) | Lifeline Systems Company | Device | Class II | 1 |
| 10 Nov 2017 | iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800-3931, 800-3933, 800-3934, 800-3935, 800-3937, 800-3950, 800-3951, 800-3042, 800-3043, 800-3044, 800-3049, 800-3050, 800-7190, 800-7713,… | Beckman Coulter Inc. | Device | Class II | 1 |
| 9 Nov 2017 | Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product for the calibration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), and estradiol (E2) methods on the Dimension Vista System. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 9 Nov 2017 | Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 13 |
| 3 Nov 2017 | First Step Flexible Endoscope Bedside Pre-Clean Kit, EP-4. Intended for pre-clean of outer surface of flexible scopes and surgical instruments to remove gross contamination prior to manual cleaning and disinfection. Product Labeling: "The multi-tiered enzymatic detergent starts working instantly to break down all… (79402) | Individual firm, name withheld | Device | Class II | 1 |
| 27 Oct 2017 | Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic. | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 26 Oct 2017 | Radial Artery Catheterization Kit; Model: AK-04018 | Arrow International Inc | Device | Class II | 7 |
| 25 Oct 2017 | A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI: 00887868044670989403 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 24 Oct 2017 | Large Volume Abdominal Paracentesis Kit | Arrow International Inc | Device | Class II | 3 |
| 24 Oct 2017 | Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 19 Oct 2017 | ACUVUE OASYS Brand Contact Lenses with HYDRACLEAR PLUS | Johnson & Johnson Vision Care, Inc. | Device | Class II | 3 |
| 17 Oct 2017 | Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and for monitoring breathing by providing a means to sample exhaled CO2. | Southmedic, Inc. | Device | Class II | 1 |
| 16 Oct 2017 | STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K | Keystone Dental Inc | Device | Class III | 1 |
| 16 Oct 2017 | The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software and creation of a pathway into the pedicle. The instrument has three types of buttons to remotely control the software: the UP, DOWN and SELECT buttons. The Pedicle Feeler is laser marked in 10 mm… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 4 Oct 2017 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. | GE Healthcare, LLC | Device | Class II | 2 |
| 28 Sep 2017 | Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Main Filters Product Usage For the treatment of major depressive disorders in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in… | The Magstim Company Limited | Device | Class II | 1 |
| 26 Sep 2017 | 6F Taiga Guiding Catheter | Medtronic Inc | Device | Class I | 1 |
| 18 Sep 2017 | BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic drug monitoring and zinc testing in plasma… | Becton Dickinson & Company | Device | Class II | 1 |
| 14 Sep 2017 | HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3 Product Usage Intermittent catheters are intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical… | C.R. Bard, Inc. | Device | Class II | 3 |
| 3 Aug 2017 | Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system (79548) | Gyrus ACMI, Inc. | Device | Class II | 1 |
| 11 Apr 2017 | EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of calibrant, one for each calibration level, and an insert sheet. | Medica Corporation | Device | Class II | 1 |
| 7 Mar 2017 | Midwest Northern Nut Roasted Salted Natural Almonds. Packaged in the following sizes: 1. Net Wt. 16 oz. (454G), UPC 38043-90002. 2. Net Wt. 5 lbs. 3. Net Wt 10 lbs. 4. Net Wt. 30 lbs. Midwest Northern Inc., Minneapolis, MN 55118 | Midwest Northern Inc | Food | Class II | 66 |
| 23 Feb 2017 | Manometer, 550 ml three-Way Stopcock; STERILE; | Carefusion 2200 Inc | Device | Class II | 6 |
| 15 Feb 2017 | Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more… | Baxter Healthcare Corporation | Device | Class II | 1 |
| 1 Jan 2017 | Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat. (79362) | Seiler Instr. & Mfg. Co. Inc. | Device | Class II | 1 |