| 19 Oct 2018 | Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 19 Oct 2018 | Central Market All Natural Mediterranean Hummus, NET WT 10 OZ (284g), UPC: 0 41220 91513 2 | Cedar's Mediterranean Foods, Inc. | Food | Class II | 4 |
| 18 Oct 2018 | Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684 | Promise Pharmacy LLC | Drug | Class III | 1 |
| 17 Oct 2018 | Cedar's Chickpea Salad, packaged in an 8oz plastic container, UPC: 044115337767. Product is refrigerated. | Cedar's Mediterranean Foods, Inc. | Food | Class I | 1 |
| 15 Oct 2018 | Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31 | Heritage Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 13 Oct 2018 | Fire Roasted 1/2" Diced Red Peppers; Sold in 2 lb. and 25 lb. containers Brand name: Jon-Lin¿ | McCain Foods USA | Food | Class II | 63 |
| 11 Oct 2018 | HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80. | Lannett Company, Inc. | Drug | Class II | 1 |
| 10 Oct 2018 | Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to… (81134) | Philips Electronics North America Corp. | Device | Class II | 1 |
| 10 Oct 2018 | Raley's Country Macaroni Salad labeled as Raley's Country Potato Salad; 32 oz. (907g) clear plastic containers; UPC 4656768934 Ingredients: Ditalini Macaroni, Mayonnaise, Dijon Mustard, Red Onions, Eggs, Celery, Black Olives, Salt & Pepper. Some containers have a Raley's Country Potato Salad label - Ingredients:… | Taylor Farms Pacific Inc. (MacArthur Facility) | Food | Class II | 1 |
| 10 Oct 2018 | Quest Protein Bar Vanilla Almond Crunch Single Bar UPC# - 888849000494 12 ct. Box UPC # - 888849000500 (81209) | Quest Nutrition, LLC | Food | Class III | 1 |
| 9 Oct 2018 | Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 8 Oct 2018 | Sweet Me Creamery Brookie Dough ice cream, packaged in following configuration: 1 Pint (473 ML), UPC: 41483-04219 or 4-Pack of 1 Pint (473 ML) containers Net Half Gallon (1.89L), UPC 41483-04241. Vanilla ice cream swirled with sea salt fudge and pieces of cookie dough and brownies. (81216) | Kemps, LLC | Food | Class I | 1 |
| 5 Oct 2018 | Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60 (81168) | Individual firm, name withheld | Drug | Class II | 1 |
| 5 Oct 2018 | Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx only, Mfd. by: Stason Pharmaceuticals, Inc., Irvine, CA 92618, Dist. By: Amerigen Pharmaceuticals, Lyndhurst, NJ 07071. | Amerigen Pharmaceuticals Inc. | Drug | Class III | 1 |
| 5 Oct 2018 | LADYFINGERS GOURMET TO GO SIGNATURE SHAVED COUNTRY HAM ROLLS; ONE DOZEN PER PACKAGE (15oz - 425 grams); ALLERGEN INFORMATION: CONTAINS WHEAT, PRODUCED IN FACILITY THAT PROCESSES PEANUTS AND TREE NUTS. www.ladyfingersofraleigh.com; 919-828-2270; 627 East Whitaker Mill Rd Raleigh, NC 27608; UPC 8 56149 00509 9. (81175) | Ladyfingers Catering, LLC | Food | Class I | 1 |
| 4 Oct 2018 | Callie's Charleston Biscuits COCKTAIL HAM BISCUITS; 24 NET WT. 35 OZ (980 g) Callie's Charleston Biscuits; 1895 Avenue F, Charleston, SC 18405 843 577.1198; CALLIESBISCUITS.COM | Individual firm, name withheld | Food | Class I | 2 |
| 3 Oct 2018 | SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images,… | GE Medical Systems, LLC | Device | Class II | 1 |
| 3 Oct 2018 | Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03. | Pfizer Inc. | Drug | Class II | 1 |
| 3 Oct 2018 | Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15 | InvaGen Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 3 Oct 2018 | Son of Italy, Twin Pack Cheese Pizza Kit, 39 oz./2 pizzas per kit, Net Wt. 15.5 lbs. 6 pizza kits per case | K.B. Pizza, Inc. | Food | Class III | 2 |
| 2 Oct 2018 | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90. | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 28 Sep 2018 | Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. | Siemens Medical Solutions USA, Inc. | Device | Class II | 2 |
| 28 Sep 2018 | Sweet corn, Net weight 20 pounds, Marshalltown IA (81129) | Iowa Choice Harvest, LLC. | Food | Class II | 1 |
| 28 Sep 2018 | Blackwing Meats. Inc., Ground Venison, 10/1lb, packed in cardboard sleeve/ roll stock film inside, in aRetail Box. (81196) | BLACKWING ORGANIC MEATS, INC. | Food | Class II | 1 |
| 28 Sep 2018 | La Mexicana Hot Salsa 16 oz., 24 oz., 48 oz., 64 oz., and 128 oz. Gourmet Style Hot Salsa 16 oz. | La Mexicana LLC | Food | Class I | 7 |
| 28 Sep 2018 | Margie Cheese, Pasteurized Cow's Milk Cheese, Sprout Creek Farm Poughkeepsie, NY 12603 Plant # 36-8436 | Sprout Creek Farm, Inc. | Food | Class II | 1 |
| 26 Sep 2018 | Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059. (81041) | Individual firm, name withheld | Drug | Class II | 1 |
| 26 Sep 2018 | Signature Reserve Bourbon Maple Blondie Ice Cream 14 FL OZ UPC 2113009912 | Albertsons Inc | Food | Class II | 1 |
| 26 Sep 2018 | Deep Pit Seasoning, net wt. 6 oz., packaged in a clear, wide mouth jar, black and white label with black lid. The product label is read in parts: "***Deep-pit Seasoning *** Ingredients: (Hydrolyzed vegetable & soy protein, lactose, salt, partially hydrogenated cottonseed & soy oil, potato starch, caramel color),… (81112) | Bounty Foods, Inc | Food | Class II | 1 |
| 25 Sep 2018 | Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India. | Baxter Healthcare Corporation | Drug | Class III | 1 |
| 25 Sep 2018 | Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450 | RXQ Compounding LLC | Drug | Class II | 1 |
| 25 Sep 2018 | 365 Everyday Value Brand White Corn Chips, Salted NET WT 20 oz. (1 LB 4 OZ) 567 g packaged in a plastic bag | Whole Foods Market | Food | Class II | 1 |
| 24 Sep 2018 | Harris Teeter Low Fat FROZEN YOGURT cookies & cream 1.5 QUART (1.42l) CONTAINS: MILK, WHEAT, SOY PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 UPC 0 72036 98182 0 (81086) | Individual firm, name withheld | Food | Class II | 1 |
| 24 Sep 2018 | Lutosa Foodservice Quality Plain Mashed Produced in Belgium 2.5 kg/5.5 lb (81109) | Individual firm, name withheld | Food | Class II | 1 |
| 21 Sep 2018 | BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and… | Becton Dickinson & Co. | Device | Class III | 1 |
| 21 Sep 2018 | Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India (81083) | Individual firm, name withheld | Drug | Class II | 1 |
| 21 Sep 2018 | Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 21 Sep 2018 | Victoria Taylor's Seasonings - Blackening Rub, 6.4 oz., UPC: 666227015274, packaged in a glass jar with a lid | Victoria Gourmet, Inc. | Food | Class III | 2 |
| 21 Sep 2018 | Lic's REESE'S OREO, ONE QUART (946 mL), packed in Plastic quart container (81111) | Lloyd'S Ice Cream Inc | Food | Class I | 1 |
| 20 Sep 2018 | AS-OBGYN Information System version 7.824.x (81057) | AS Software, Inc. | Device | Class II | 1 |
| 20 Sep 2018 | Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE (81176) | Micro-Tech (Nanjing) Co., Ltd. | Device | Class II | 1 |
| 20 Sep 2018 | Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2 | Pfizer Inc. | Drug | Class II | 1 |
| 20 Sep 2018 | Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11 | Pfizer Inc. | Drug | Class II | 1 |
| 20 Sep 2018 | Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 20 Sep 2018 | Product comes in a plastic bag which is labeled as follows: DandleLION MEDICAL DandleLION KISSES ORAL USE ONLY SINGLE PATIENT USE SINGLE APPLICATION 24% ORGANIC SUCROSE, D-12442 2mL; The Product Case Labeling is as follows: DandleLION MEDICAL D 12242 C384 DandleLION KISSES (2ML) 24% ORGANIC SUCROSE SOLUTION ORANGE… (81082) | Tarry Medical Products, Inc. | Food | Class II | 1 |
| 20 Sep 2018 | Formed Hash Brown Patties, packaged in cardboard trays covered with plastic film, frozen products. The following brands are subject to this recall. ***Brookshire's Golden Hash Brown Patties. Firm and address listed on label: "Brookshire Grocery Company PO Box 1411 Tyler, TX 75710-1411". -Tray UPC 0 92825 09630 6,… | Lamb Weston Inc | Food | Class II | 2 |
| 19 Sep 2018 | Philips DigitalDiagnost software 4.1.x and 4.2.x, A Stationary X-ray System Models: 712027, 712028, 712029, 712031, 712032701032, 712033, 712224, 712225, 712226, 712227, 712228. | Philips Medical Systems Gmbh, DMC | Device | Class II | 1 |
| 19 Sep 2018 | Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01 | Pfizer Inc. | Drug | Class II | 1 |
| 19 Sep 2018 | Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11 | Upsher Smith Laboratories, Inc. | Drug | Class II | 2 |
| 19 Sep 2018 | Guava Pastry. The product is packed in a cardboard box. The firm marks the Guava Pastry option printed on the box. Labeling for the cardboard box reads in part: WHOLESALE FROZEN BAKERY PRODUCTS, TRACY BAKERY, GUAVA PASTRY, HANDLING INSTRUCTIONS, PREPARATION & BAKING, INGREDIENTS. | Baker's Service of South Florida, Inc. | Food | Class II | 9 |
| 18 Sep 2018 | Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 18 Sep 2018 | SPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009 | Baxter Healthcare Corporation | Device | Class II | 1 |
| 18 Sep 2018 | Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28 tablets 70700-116-84) (81044) | Xiromed LLC | Drug | Class III | 1 |
| 18 Sep 2018 | Purus Labs MYOWHEY Premium Whey Protein, Chocolate Cookie Crunch, 75 True Servings, Net Wt. 5 lb / 2.26 kg. UPC 55734-00285. Manufactured for and distributed by Purus Labs, 2601 Resource Drive, Plano, TX 75704 (81056) | Purus Labs, Inc. | Food | Class I | 1 |
| 18 Sep 2018 | Oregon Heritage Farms Family Blend Apple Cider, 100% Juice, 1 gallon plastic container, UPC: 8 53581 00202 0. The label is read in parts: "***FAMILY BLEND Apple Cider 100% Juice Not from concentrate *** Pasteurized ***Refrigerate After Opening *** Ingredients: Apple Cider ***Pressed, Bottled, and Distributed: Oregon… (81062) | Oregon Heritage Developments Inc dba Oregon Heritage Farms | Food | Class II | 1 |
| 17 Sep 2018 | NucliSENS¿ Magnetic Extraction Reagents | BioMerieux SA | Device | Class II | 1 |
| 17 Sep 2018 | Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm curve type/71 cm length), Product Code STJ408310; (c) large curl (50 mm curve type/71 cm length),… | Sterilmed, Inc. | Device | Class II | 1 |
| 17 Sep 2018 | treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Distributed and Marketed by: Otsuka… | Otsuka Pharmaceutical Development & Commercialization, Inc. | Drug | Class III | 2 |
| 17 Sep 2018 | robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10. | Endo Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 14 Sep 2018 | Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical… | Ecolab Inc | Device | Class II | 4 |
| 13 Sep 2018 | Terumo¿ Advanced Perfusion System 1 Electronic Patient Gas System, Catalog#: 801188 | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 13 Sep 2018 | Bellona brand Milk Chocolate Flavored Coated Wafer with Hazelnut Cr¿me Filling and White Chocolate Flavor, 5.3 oz. (150g) package containing 7 single-serving, foil-wrapped chocolate wafers on a cardboard tray with foil overwrap. | Lidl US TRADING | Food | Class II | 1 |
| 13 Sep 2018 | Safeguard Soft Flr (GIV) packaged in 50 lb bags | Ardent Mills, LLC | Food | Class II | 1 |
| 13 Sep 2018 | Gotham Greens Classic Pesto 6.5 oz. plastic cup, 12 cups per case. Refrigerated. UPC 85392700334 | Brett Anthony Foods | Food | Class II | 1 |
| 13 Sep 2018 | Swanson Ultra, Himalayan Crystal Salt, #SWU403, Net Wt. 35.27 oz. (2.2 lbs) (1,000 grams). Product of Pakistan. Distributed by Swanson Health Products, Fargo, ND 58104. | Swanson Health Products, Inc | Food | Class II | 1 |
| 12 Sep 2018 | Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired… | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 12 Sep 2018 | 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 12 Sep 2018 | Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854, NDC 31722-596-90 (81017) | Individual firm, name withheld | Drug | Class III | 1 |
| 12 Sep 2018 | Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India. NDC 55111-688-52 | Individual firm, name withheld | Drug | Class III | 2 |
| 12 Sep 2018 | CAFFEINE FREE Diet Coke 12 FL OZ (355 ml) CONTAINS PHENYLALANINE CAFFEINE FREE THE COCA-COLA COMPANY FOR CONSUMER INFORMATION CALL 1-800-438-2653 UPC 0 496130 1 | Individual firm, name withheld | Food | Class II | 3 |
| 12 Sep 2018 | TRADER JOE'S Cinnamon Coffee Cake; NET WT. 16 OZ (1 LB) 454g; SKU# 94235; UPC: 00942355 (81013) | Pin Hsiao & Associates, LLC dba Zen Bakery | Food | Class III | 1 |
| 12 Sep 2018 | Caffeine-Free Barq s Root Beer 12 Pack, 12 oz cans | Swire Coca Cola USA | Food | Class III | 1 |
| 12 Sep 2018 | Miso Milo Chocolate (cookies); A Sarap Asian Fusion Product; Net Wt. 70 G/Cookie; Contains: Flour, eggs, Baking Soda, Baking Powder, Milk Powder, White Sugar, Brown Sugar, Salt, Butter, Miso, Milo cacao, vanilla extract, milk chocolate. MFG at 12042 West St. Garden Grove, CA 92840 | Individual firm, name withheld | Food | Class II | 4 |
| 11 Sep 2018 | Love Corn, Sea Salt , Net WT. 1.6 Oz. Bags of 10 per cases (81022) | LOVE CORN USA | Food | Class II | 1 |
| 10 Sep 2018 | Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG).… | Boston Scientific Corporation | Device | Class II | 1 |
| 10 Sep 2018 | ESSENTIO Pacemaker | Boston Scientific Corporation | Device | Class II | 5 |
| 10 Sep 2018 | Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30 (80964) | Takeda Development Center Americas, Inc. | Drug | Class II | 1 |
| 10 Sep 2018 | Meijer Taco Seasoning Mix, Net wt. 4.5 oz. | McCormick & Company, Inc. - Flavor Manufacturing Center | Food | Class I | 1 |
| 10 Sep 2018 | Hodgson Mill Cookie Mix Gluten Free 12oz. cardboard carton retail unit; 6 retail units per case. UPC Code 0 71518 02125 2 (80975) | Hodgson Mill Inc | Food | Class III | 1 |
| 7 Sep 2018 | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets | Bayer Medical Care, Inc. | Device | Class II | 1 |
| 7 Sep 2018 | Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8 | Noven Pharmaceuticals, Inc. | Drug | Class II | 4 |
| 7 Sep 2018 | Shelled eggs in blank cardboard cases at 2.5 dozen a case. Shelled eggs in dozen cartons labeled as "Gravel Ridge Farms Cullman County, Alabama***CAGE FREE***Free Range***ANTIBIOTIC FREE***One Dozen Grade A***Large Eggs". (80977) | Gravel Ridge Farms | Food | Class I | 1 |
| 6 Sep 2018 | Altrix¿ Precision Temperature Management System Model: 8001Product Usage: The Altrix system is intended for circulating temperature controlled warm or cold water via patient contact thermal transfer devices for the application of regulating human body temperature in situations where a physician or clinician with… | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 6 Sep 2018 | CryoPatch SG Pulmonary Hemi-Artery, 1 graft | CryoLife, Inc. | Device | Class II | 1 |
| 5 Sep 2018 | Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System. | Thoratec Switzerland GMBH | Device | Class II | 1 |
| 5 Sep 2018 | EVERYBURGER - Burger-Shaped Chocolate Cookies: NET WT. 2.32 oz. (66 g) There are 2 packing sizes; 10 items per case and 80 items per case UPC 8 055880 00701 0 Manufactured by Bourbon 1-3-1 Ekimae Kashiwazaki Nigata 945-8611 Japan Product of Japan (81019) | Wismettac Asian Foods (USA) dba Nishimoto Trading Co Ltd | Food | Class II | 1 |
| 4 Sep 2018 | McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P Product Usage: Indication of Use: Injection of U-100 insulin only. | Cypress Medical Products LLC | Device | Class II | 1 |
| 4 Sep 2018 | GE Healthcare CARESCAPE Monitor B450 Product Usage: Intended uses of CARESCAPE B450 in 510(k) countries [UR_CRSCP-885]: The CARESCAPE Monitor B450 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B450… | GE Healthcare Finland Oy | Device | Class II | 2 |
| 4 Sep 2018 | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator/Heat Exchanger that is used to cool or warm blood during cardiopulmonary bypass procedures lasting six hours or less. The… | Cincinnati Sub-Zero Products LLC, a Gentherm Company | Device | Class II | 1 |
| 4 Sep 2018 | Colpo-Pneumo Occluder, Part CPO-6 | CooperSurgical, Inc. | Device | Class II | 1 |
| 4 Sep 2018 | Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 4 Sep 2018 | Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures. | CooperSurgical, Inc. | Device | Class II | 1 |
| 4 Sep 2018 | Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC… | Boehringer Ingelheim Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 4 Sep 2018 | FP0191, Confidence, Bone-Lock WITHGENISTEIN AND CHLOROPHYLL, A Dietary Supplement, 60 tablets per bottle, UPC: 8 92483 00145 8 | Confidence Inc./Confidence U.S.A. Inc. | Food | Class II | 2 |
| 31 Aug 2018 | VirtuoSaph Plus Endoscopic Vessel Harvesting System, Catalog Number: VSP550EX Product Usage: The VittuoSaph¿ Plus Endoscopic Vessel Harvesting System VSP550EX is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surge1y… | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 31 Aug 2018 | Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments. (81085) | Widex A/S | Device | Class II | 1 |
| 31 Aug 2018 | NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02 (81011) | BioLyte Laboratories, LLC | Drug | Class II | 1 |
| 30 Aug 2018 | Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00 | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 30 Aug 2018 | Mitek Screw and Washer Depth Gauge, Product Code 219024 | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 1 |
| 30 Aug 2018 | Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher. | GE Healthcare, LLC | Device | Class II | 1 |
| 30 Aug 2018 | O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and… | Medtronic Navigation, Inc.-Littleton | Device | Class II | 10 |
| 30 Aug 2018 | Unna-Z: Unna Boot Compression Wrap with Zinc Oxide and Calamine, Item Numbers: a) NONUNNA3 and b) NONUNNA4 Product is packaged in a foil pouch, which is inserted in a box carton. There are 12 cartons in each case. | MEDLINE INDUSTRIES INC | Device | Class II | 1 |
| 30 Aug 2018 | Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298, NDC 7807-0170-11 (81147) | Alkano Chemicals, Inc | Drug | Class II | 1 |
| 29 Aug 2018 | IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]). | Data Innovations, LLC | Device | Class II | 1 |
| 29 Aug 2018 | INSORB SUBCUTICULAR SKIN STAPLER, REF 2030 (81008) | Incisive Surgical Inc | Device | Class II | 1 |
| 28 Aug 2018 | CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use. | Alcon Research, LTD. | Device | Class I | 4 |
| 28 Aug 2018 | Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery,… | Heartware, Inc. | Device | Class II | 1 |
| 28 Aug 2018 | Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763 | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 28 Aug 2018 | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-8077-43 Packaged by: Humco Texarkana, TX 75501 | Humco Holding Group, Inc | Drug | Class II | 3 |
| 27 Aug 2018 | Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53. | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 24 Aug 2018 | Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use | Life Technologies, Corp. | Device | Class II | 4 |
| 24 Aug 2018 | Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172 | Vision RT Ltd | Device | Class II | 1 |
| 24 Aug 2018 | Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028 | Valeant Pharmaceuticals North America LLC | Drug | Class II | 3 |
| 24 Aug 2018 | Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00 | RemedyRepack Inc. | Drug | Class II | 1 |
| 22 Aug 2018 | THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang,… | Syntec Pharma Corp | Drug | Class II | 2 |
| 21 Aug 2018 | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO | OriGen Biomedical, Inc. | Device | Class II | 1 |
| 21 Aug 2018 | Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during… | OriGen Biomedical, Inc. | Device | Class II | 6 |
| 21 Aug 2018 | Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery | Exactech, Inc. | Device | Class II | 1 |
| 21 Aug 2018 | Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11 (80892) | Sichuan Friendly Pharmaceutical Co.,Ltd. | Drug | Class II | 1 |
| 20 Aug 2018 | ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or… | ICU Medical, Inc. | Device | Class II | 1 |
| 20 Aug 2018 | TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. | Varian Medical Systems | Device | Class II | 2 |
| 20 Aug 2018 | Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30. | Hetero Labs Limited Unit V | Drug | Class II | 1 |
| 17 Aug 2018 | EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. | COVIDIEN LLC | Device | Class II | 1 |
| 17 Aug 2018 | Crazy About Cookies***GLUTEN FREE CHOCOLATE CHIP COOKIE DOUGH**Net Wt. 2 lbs. (907.18g)**Nutrition facts***Ingredients: Whole grain sorghum flour, cane sugar, semi sweet chocolates**Contains eggs, milk and soy.***Manufactured in the same equipment that manufactures peanut, walnut, pecan, macadamia nut, milk, soy,… (80926) | Neighbors LLC | Food | Class I | 1 |
| 17 Aug 2018 | Trader Darwin s Chewable Peppermint Flavored Melatonin Dietary Supplement Number of units per package: 100 tablets Package type: Bottle Units per case: 36 (80967) | Church & Dwight Co | Food | Class II | 1 |
| 16 Aug 2018 | Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 (80919) | Individual firm, name withheld | Device | Class III | 1 |
| 15 Aug 2018 | DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and… (81046) | Individual firm, name withheld | Device | Class II | 1 |
| 15 Aug 2018 | VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413 | Ortho-Clinical Diagnostics | Device | Class II | 2 |
| 15 Aug 2018 | Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30 | Hetero Labs Limited Unit V | Drug | Class I | 1 |
| 14 Aug 2018 | APTIO INPUT/OUTPUT MODULE | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 9 |
| 13 Aug 2018 | CHS Custom Convenience Kit-DR. NANDA CLOSING TRAY(CONMED HYFRECATOR SHARP) Product Number: B9-15934B | Custom Healthcare Systems, Inc. | Device | Class II | 29 |
| 13 Aug 2018 | AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are… (80971) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Aug 2018 | Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines. (81076) | A M Systems Inc | Device | Class II | 1 |
| 10 Aug 2018 | Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00 | Westlab Pharmacy, Inc. dba Westlab Pharmacy | Drug | Class II | 3 |
| 9 Aug 2018 | Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000 (81009) | Besmed Health Business Corporation | Device | Class II | 1 |
| 9 Aug 2018 | C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification (80943) | Rayner Intraocular Lenses Limited | Device | Class II | 1 |
| 9 Aug 2018 | HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of… | Biomet UK Ltd. | Device | Class II | 4 |
| 8 Aug 2018 | Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures | Zimmer Biomet, Inc. | Device | Class II | 48 |
| 8 Aug 2018 | Bronchovideoscope BF-160 | Olympus Corporation of the Americas | Device | Class II | 30 |
| 8 Aug 2018 | Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper. | Bausch & Lomb Inc | Device | Class II | 13 |
| 6 Aug 2018 | Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation (80970) | Dannoritzer Medizintechnik GmbH & Co. KG | Device | Class III | 1 |
| 6 Aug 2018 | Polyisoprene condomns Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease). | Reckitt Benckiser LLC | Device | Class II | 1 |
| 6 Aug 2018 | Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 | Teva Pharmaceuticals USA | Drug | Class II | 7 |
| 3 Aug 2018 | Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology Suite/Cardiology Suite) when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality… | Agfa Healthcare NV | Device | Class II | 1 |
| 3 Aug 2018 | Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 3 Aug 2018 | DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3. | Product Quest Manufacturing LLC | Drug | Class I | 54 |
| 3 Aug 2018 | Powerful Red Vein Bali Premium Kratom, Zakah Life Dietary Supplement, Mitragyn Speciosa, packaged in 1) 90 capsules, 500 mg per capsules bottles, or 2) 3.52 oz // 100 grams of Kratom bags. Distributed by Zakah Life LLC Ankeny IA. | Zakah Life LLC | Food | Class I | 3 |
| 2 Aug 2018 | Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 1 Aug 2018 | Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of… | Instrumentation Laboratory Co. | Device | Class II | 1 |
| 1 Aug 2018 | Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing. | COVIDIEN LLC | Device | Class II | 6 |
| 31 Jul 2018 | CAPNOSTREAM 20 (US) N, Part Number CS08651 | Oridion Medical 1987 Ltd. | Device | Class II | 37 |
| 31 Jul 2018 | ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, BA22-40/I20-40, BA22-120/I16-40, BA22-100/I16-40, BA22-80/I16-40, BA22-60/I16-40, BA22-40/I16-40, BA22-120/I13-40, BA22-100/I13-40, BA22-80/I13-40, BA22-60/I13-40,… | Endologix | Device | Class I | 4 |
| 30 Jul 2018 | Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound and simple shaft fractures Proximal,… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 26 Jul 2018 | Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002 | Stryker GmbH | Device | Class II | 1 |
| 24 Jul 2018 | ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 5 |
| 24 Jul 2018 | BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy,… | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 1 |
| 23 Jul 2018 | Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted disease). | Reckitt Benckiser LLC | Device | Class II | 1 |
| 20 Jul 2018 | CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous… | B. Braun Medical, Inc. | Device | Class II | 93 |
| 20 Jul 2018 | United Fitness Mix 25LB box, Almonds, Walnuts, Pumpkin Seeds, Cashews, Blueberries***Manufactured or packed in a facility that uses tree nuts, peanuts, milk, soy, and wheat products" Distributed by: Truly Good Foods, Orlando, FL 32811 UPC 0 94154 00803 7 | Tropical Nut & Fruit Company | Food | Class II | 1 |
| 18 Jul 2018 | Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction. (81042) | Surge Medical Sales, LLC (DBA Surge Cardiovascular) | Device | Class II | 1 |
| 18 Jul 2018 | The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE… (80865) | Shockwave Medical, Inc. | Device | Class II | 1 |
| 17 Jul 2018 | Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations. (80911) | Liko AB | Device | Class II | 1 |
| 16 Jul 2018 | Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA. (80734) | Valeris Medical, LLC | Device | Class II | 1 |
| 16 Jul 2018 | da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 16 Jul 2018 | INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions | Philips Electronics North America Corporation | Device | Class II | 27 |
| 13 Jul 2018 | G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. | Tosoh Bioscience Inc | Device | Class II | 1 |
| 12 Jul 2018 | VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 | Ortho Clinical Diagnostics Inc | Device | Class II | 4 |
| 12 Jul 2018 | OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L. | Orthosensor, Inc. | Device | Class II | 6 |
| 6 Jul 2018 | smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients. | Smiths Medical ASD Inc. | Device | Class III | 5 |
| 29 Jun 2018 | Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 6 |
| 27 Jun 2018 | BACT/ALERT VIRTUO system, A Unit, with Version R2.0 Firmware Product Usage: The BacT/ALERT VIRTU Microbial Detection System is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and… | bioMerieux, Inc. | Device | Class II | 3 |
| 25 Jun 2018 | Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01 | Carl Zeiss Meditec AG | Device | Class II | 1 |
| 20 Jun 2018 | Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0, | Boston Scientific Corporation | Device | Class II | 1 |
| 18 Jun 2018 | J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures. | Bovie Medical Corporation | Device | Class II | 1 |
| 15 Jun 2018 | TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures. | Shimadzu Medical Systems Usa Com | Device | Class II | 1 |
| 13 Jun 2018 | Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 13 Jun 2018 | Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229 | Smith & Nephew, Inc. | Device | Class II | 3 |
| 11 Jun 2018 | MyLab Alpha, Model 7400 | Individual firm, name withheld | Device | Class II | 3 |
| 7 Jun 2018 | GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL # R350), 1.5T SIGNA ECHOSPEED, 1.5T SIGNA EXCITE,… | GE Medical Systems, LLC | Device | Class II | 3 |
| 6 Jun 2018 | Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0T MR750W GEM (5499460-10, 5481490-2); D. 3.0T… | GE Medical Systems, LLC | Device | Class II | 1 |
| 4 Jun 2018 | NeoMed Enteral Feeding Tubes with Enteral Only Connectors, French sizes 4.0Fr, 5.0Fr, 6.5Fr, 8.0Fr, and lengths 40cm, 60cm, 90cm. The product consists of a polyurethane feeding tube with an attached hub and tethered plug to close the hub when the feeding tube is not in use. Product Usage: Intended for use in neonatal… (81116) | Neomed Inc | Device | Class II | 1 |
| 1 Jun 2018 | Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible. | Nakanishi Inc. | Device | Class II | 8 |
| 1 Jun 2018 | Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542 | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 30 May 2018 | Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body. | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 29 May 2018 | Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure. | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 25 May 2018 | ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting. | Radiometer America Inc | Device | Class II | 1 |
| 9 May 2018 | OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116,… | Johnson & Johnson Surgical Vision Inc | Device | Class II | 1 |
| 5 May 2018 | VITROS Sodium Slides, Catalog # 837 9034 | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 3 May 2018 | Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use (80657) | Individual firm, name withheld | Device | Class II | 1 |
| 2 May 2018 | AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator. (80652) | Individual firm, name withheld | Device | Class II | 1 |
| 11 Jan 2018 | ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery. (80569) | Ellex iScience, Inc. | Device | Class II | 1 |
| 15 Nov 2017 | Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementless use in total or partial hip arthroplasty in primary or revision surgery. | Medacta Usa Inc | Device | Class II | 1 |
| 30 Sep 2017 | Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in a two-step process to provide consumers with information concerning the presence or absence of drugs or their… | Ameditech Inc | Device | Class III | 1 |
| 4 Apr 2017 | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x 15mL Stopping… | Helena Laboratories, Inc. | Device | Class II | 1 |
| 9 Aug 2016 | ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging (81045) | Swissray Medical | Device | Class II | 1 |
| 7 Dec 2015 | GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. | GE Medical Systems, LLC | Device | Class II | 2 |