| 16 Feb 2018 | Organic Creamy Wheat Hot Cereal, Item number 6097C244, Pack size: 24 oz bag, 4 bags in a case. UPC: 3997800992 | Bob's Red Mill Natural Foods, Inc. | Food | Class III | 1 |
| 13 Feb 2018 | Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues;… | Pentax of America Inc | Device | Class II | 1 |
| 13 Feb 2018 | Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02 | Nostrum Laboratories Inc | Drug | Class III | 1 |
| 9 Feb 2018 | Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500 g (NDC 58597-8003-7), d) 1000 g (NDC 58597-8003-8), RX only, packed by American Pharmaceutical Ingredients, 6650 Highland Road, Waterford, MI 48327. | American Pharmaceutical Ingredients LLC | Drug | Class II | 66 |
| 7 Feb 2018 | BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. (7.4 mL) spray bottles, Manufactured by WebRx Pharmacy Palace, Sarasota, FL 34232; NDC 70582-999-74 (79172) | Webrx dba RxPalace.com | Drug | Class III | 1 |
| 6 Feb 2018 | Weis Weis Markets, Inc., Sunbury, PA 17801-0471; Keep Refrigerated; Dried Beef Party Rye Dip; Ingredients: Hellman's Mayonaise, Sour Cream, Dried Beef (Cured with Water, Salt, Sugar, Sodium Nitrate, Sodium Nitrite), Parsley, Onion, Dill Weed; SELL BY RANGE up to 02/16/2018. | WEIS MARKETS | Food | Class I | 1 |
| 5 Feb 2018 | Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56 | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 5 Feb 2018 | Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canada, Distributed by Genentech USA, Inc. A Member of the Roach Group, 1 DNA Way South San Francisco, CA 94080-4990. NDC 0004-0068-01 | Genentech, Inc. | Drug | Class III | 1 |
| 5 Feb 2018 | Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, Rx only, Distributed by: Sun Pharmaceutical Ind. Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol - 389 350, Gujarat, India --- NDC 47335-779-91 | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 1 |
| 5 Feb 2018 | 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag, Rx only, PharMEDium Serivces, LLC | PharMEDium Services, LLC | Drug | Class II | 3 |
| 2 Feb 2018 | Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740) (79158) | Philips Consumer Lifestyle | Device | Class II | 1 |
| 2 Feb 2018 | Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810, Manufactured by: Aurobindo Pharma Limited Unit -VII (SEZ)) Mahabubnagar (Dt)_509302 India, NDC 65862-010-05. | Aurobindo Pharma Ltd. | Drug | Class III | 1 |
| 2 Feb 2018 | NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01. | ALLERGAN | Drug | Class III | 1 |
| 2 Feb 2018 | STAR WARS TIN WITH CARAMEL POPCORN NET WT 3.5 oz (99g) CONTAINS MILK AND SOY, MAY CONTAIN TREE NUTS AND PEANUTS DISTRIBUTED BY GALERIE HEBRON, KENTUCKY 41048 UPC 7 68395 51585 0 (79111) | Ross Acquisitions Company | Food | Class II | 1 |
| 1 Feb 2018 | Olde Thompson Sweet & Smoky BBQ Grinder NET WT. 6.7 oz. (189.9g) Olde Thompson Oxnard, CA Ingredients: Sea Salt, demerara sugar, Dehydrated garlic, chili pepper, mustard seed, paprika, black pepper, oregano, coriander seed, cumin seed, natural hickory smoke flavor, thyme, extractives of paprika: Serving size 1/4 tsp… | Olde Thompson, Inc. | Food | Class II | 1 |
| 1 Feb 2018 | Daisho Kimchi Hot Pot Soup Base; 1.60 lb pouch (10 units per case) Bar Code: 49 04621 04221 9 Product of Japan Imported by JFC International Inc., Los Angeles, CA. | J F C International Inc | Food | Class I | 1 |
| 1 Feb 2018 | Lemon Ginger Syrup, packaged in 100 mL or 250 mL glass bottle. 100 mL bottle has UPC 8 53142 00504 0. 250 mL bottle has no UPC code. These bottles are also sold in the following cocktail kits: -Portland Pony -Dark and Stormy -Whiskey Ginger Smash -Sun Hat -Hibiscus Margarita The label is read in parts: "***RAFT LEMON… | Individual firm, name withheld | Food | Class II | 2 |
| 30 Jan 2018 | VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride to make 2.5 mg/ mL final concentration, INTRAVENOUS INJECTION ONLY add 3.5 mL Sodium Chloride to 1 mg/mL final concentration, Rx Only, Distributed by MILLENNIUM Pharmaceuticals,… (79083) | Millennium Pharmaceuticals Inc. | Drug | Class II | 1 |
| 29 Jan 2018 | Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback… | Philips Electronics North America Corporation | Device | Class II | 2 |
| 29 Jan 2018 | Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51 | Mckesson Packaging Services | Drug | Class III | 1 |
| 29 Jan 2018 | Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54. | Teva Pharmaceuticals USA | Drug | Class III | 4 |
| 29 Jan 2018 | Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05 | Individual firm, name withheld | Drug | Class III | 3 |
| 29 Jan 2018 | DON BOCARTE ARTE EN EL PALADAR MIGAS BONITO DEL NORTE PESCA SELECTA DEL CANTABRICO; UPC: 8 43700227144 (79071) | Despana Brand Foods | Food | Class II | 1 |
| 29 Jan 2018 | Live Better Drug Free Black Elderberry Syrup, 4 FL OZ (118 mL); DIETARY SUPPLEMENT, UPC 050428581186 | Kingston Pharma LLC | Food | Class II | 1 |
| 26 Jan 2018 | Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-601-16. | Primus Pharmaceuticals, Inc. | Drug | Class I | 4 |
| 26 Jan 2018 | ELWOOD FAT-FREE LOW SODIUM RANCH DRESSING ARTIFICIAL FLAVOR. Single serve. (79034) | Elwood International, Inc. | Food | Class II | 1 |
| 26 Jan 2018 | Frozen Sliced (blanched) Squash packed in 1400 lb. plastic totes. (79044) | Hanover Foods Corporation | Food | Class II | 1 |
| 25 Jan 2018 | PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60 | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 25 Jan 2018 | Larabar Chocolate Chip Cookie Dough, 5 - 1.6 oz (45g) bars Net Wt 8.0 oz(226g), UPC 21908-48817. Case UPC 000-21908-41675-5 | General Mills, Inc | Food | Class II | 1 |
| 25 Jan 2018 | WALNUT CREEK FOODS Caramel Popcorn NET WT 15 OZ (425g) Ingredients: Evaporated Can Juice, Popcorn, Butter (cream, salt), Salt, Sodium Bicarbonate, Cream of Tartar Contains: Milk Distributed by: Walnut Creek Foods, Walnut Creek, OH 44687 UPC 25555 99857 2 (79033) | Coblentz Distributing Inc dba Walnut Creek Foods | Food | Class II | 1 |
| 24 Jan 2018 | Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205 (78962) | JCB Laboratories LLC | Drug | Class III | 1 |
| 24 Jan 2018 | Panera Chive&Onion Reduced Fat Cream Cheese Spread, 2 oz. and 8 oz. | Panera, LLC | Food | Class I | 5 |
| 23 Jan 2018 | Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 23 Jan 2018 | 3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause… | 3M Company - Health Care Business | Device | Class II | 2 |
| 23 Jan 2018 | Bulletproof Unflavored Collagen Protein High Performance Building Blocks Dietary Supplement, packaged in a 16-oz. composite-film bag, UPC: 8 15709 02115 3. The label is read in parts: "***COLLAGEN PROTEIN***Ingredients: Hydrolyzed collagen powder***Processed in a facility that also processes tree nuts, peanuts, egg,… (79018) | Bulletproof 360 Inc | Food | Class I | 1 |
| 22 Jan 2018 | Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy | DeRoyal Industries Inc | Device | Class II | 1 |
| 22 Jan 2018 | Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10 | Astellas Pharma US Inc | Drug | Class II | 1 |
| 22 Jan 2018 | Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01 | Ascent Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 22 Jan 2018 | Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51 | AbbVie Inc. | Drug | Class III | 1 |
| 22 Jan 2018 | Prickly Ash Bark Powder Herbal Supplement, packaged in food grade stand up plastic pouches or plastic bags depending on quantity ordered, various net weights - 1-oz., 4-oz., 8-oz., 1-lb., 2-lb., 5-lb., 7-lb., 11-lb., 15-lb., and 16-lb. The label is read in parts: "***Prickly Ash Bark Powder***Zanthoxylum… (78998) | Mountain Rose Inc | Food | Class I | 1 |
| 22 Jan 2018 | Sun Noodle brand Tonkotsu Ramen, Packaged in plastic clear clamshell, Banded with Tonkotsu label, distinguishable with a yellow color. (12/case); UPC 0 85315 40003 5 (78986) | Sun Noodle New Jersey, LLC | Food | Class II | 1 |
| 20 Jan 2018 | Hologic Panther(R) Fusion(TM), Catalog number ASY-09600 Product Usage: The Panther instrument is a fully automated sample-to-result instrument, eliminating the need for batch processing and automates all aspects of nucleic acid testing on a single, integrated platform. The Panther can be test samples with random… | Hologic, Inc | Device | Class II | 1 |
| 20 Jan 2018 | Arthri-D 120ct | ABH Nature's Products, Inc. | Food | Class I | 2 |
| 19 Jan 2018 | Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080. | G & W Laboratories, Inc. | Drug | Class III | 1 |
| 19 Jan 2018 | Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials | Flawless Beauty LLC | Drug | Class II | 12 |
| 19 Jan 2018 | Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. | AMERICAN HEALTH PACKAGING | Drug | Class II | 1 |
| 19 Jan 2018 | IQF Green beans, sold as Not Ready To Eat (NRTE) product for use in foodservice or manufacturing applications. The product cases are labeled with instructions to cook product. -No brand name, NFFC item #15001-01070, no UPC, packaged in 30 lbs. case. -Bountiful Harvest Foundations brand, NFFC item #22486-11918 and UPC… | National Frozen Foods Corporation--Seattle | Food | Class II | 2 |
| 19 Jan 2018 | Wienke's Market Apricot Jam, Net Wt. 8 oz (226g), UPC 14106-00201. Refrigerate after opening. Ingredients: Apricots, sugar, pectin. | Wienke LLC | Food | Class II | 47 |
| 19 Jan 2018 | Wegmans Ready To Cook Garlic Parmesan Tilapia, Single, 5 oz UPC: 2-16150-00000 and Wegmans Ready To Cook Garlic Parmesan Tilapia, Twin Pack, 15 oz UPC: 2-16154-00000 | Wegmans Food Markets, Inc. | Food | Class II | 4 |
| 17 Jan 2018 | Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient… | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 17 Jan 2018 | Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1. (78952) | Magno Humphries Laboratories, Inc | Drug | Class I | 1 |
| 17 Jan 2018 | Sea Salt Caramel Hearts, Net Wt 12 OZ (340 g), Made by Palmer Candy Company, Sioux City, Iowa. UPC 77232-17091 (78957) | Palmer and Company | Food | Class II | 1 |
| 17 Jan 2018 | Chobani Flip Key Lime Crumble - Key Lime Low-Fat Greek Yogurt with Graham Crackers & White Chocolate, 4-packs, 4/5.3 oz cups are packaged with a cardboard overwrap. The net wt. of each single serve up is 5.3 oz. and the net wt. of 4-pack is 21.2 oz. The 4-pack overwrap label has the UPC 8 18290 01484 9 and single… (78996) | CHOBANI | Food | Class II | 1 |
| 17 Jan 2018 | TITAN, 6 rellenos, Potato Puffs with Meat Flavor, Net Weight 26.4 oz (748g) | Empresas Barsan, Inc. | Food | Class II | 2 |
| 16 Jan 2018 | Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de… | Medtronic Perfusion Systems | Device | Class II | 2 |
| 16 Jan 2018 | Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10 | Fresenius Kabi USA, LLC | Drug | Class III | 1 |
| 16 Jan 2018 | Cherry Tomatoes, packaged in a pint sized plastic clamshell, no labeling (78965) | Frog Holler Ltd. | Food | Class I | 1 |
| 16 Jan 2018 | Ottogi Rice Cake Soup, 6.4oz. UPC 6 45175 89093 52; Item Number 29409101; Ingredients: 1. Rice Cake: Rice Water, Salt, Spirits; 2. Liquid Soup: Beef Bone Extract, Prim/starch syrup, coconut oil, sodium Caseinate, Water, Salt, Maltodextrin, Garlic, Chicken Extract Powder. (USA) Sugar, Black Pepper, monosodium… | Ottogi America Inc | Food | Class I | 1 |
| 15 Jan 2018 | Jarrow Formulas Liquid L-Carnitine; 16 fl oz. (475 ml) bottle, dietary supplement; product number 102006; UPC 7 90011 02006 6; Vitamin B5 10 mg; L-Carnitine 1000 mg; Other ingredients: Purified water, xylitol, glycerin, citric acid, natural lemon-lime flavor, nisin (as a preservative). Distributed exclusively by… (78967) | Jarrow Formulas Inc | Food | Class II | 1 |
| 12 Jan 2018 | HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892 (79168) | The Compounding Pharmacy of America | Drug | Class I | 1 |
| 12 Jan 2018 | Dried Anchovy, size (S), (M), (L), packaged in 1.5 kg. cardboard box without brand name. The cardboard box states "***IMPORTED BY: GOBUGI HOLDINGS, INC. 4520 SW 110TH AVE. BEAVERTON, OREGON 97005***PRODUCT OF REPUBLIC OF KOREA***". Small (S) Anchovy Korea, packaged in a clear plastic clam shell container, net wt. 9.6… (78940) | Gobugi Holdings Inc | Food | Class II | 1 |
| 12 Jan 2018 | Cheesecake Bars, PLU number 240801, 2 oz. UPC: 0240801001992 | Whole Food Market | Food | Class II | 1 |
| 12 Jan 2018 | BROLITE PRODUCT #6109 BREAD FLAVOR R, Net Wt. 50 Lbs | Brolite Products Inc | Food | Class II | 3 |
| 12 Jan 2018 | IASA COLATURA DI ALICI DI CETARA ANCHOVY EXTRACT; 100 ml and 250 ml sizes; UPC 100 ml - 7 93232 54200 3; UPC 250 ml - 7 93232 54203 4 Ingredients: Anchovies, Salt, Water. Product of Italy. Produced by ISA srl Pellezzano (SA) (79056) | Manicaretti Inc | Food | Class II | 1 |
| 11 Jan 2018 | GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors… | GE Medical Systems Information Technologies, Inc. | Device | Class II | 1 |
| 11 Jan 2018 | Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35. | Premier Pharmacy Labs Inc | Drug | Class II | 1 |
| 11 Jan 2018 | Flexfrost Protein Ice Cream Chocolate Flexfrost L.L.C. 622 RT 10 Whippany, NJ 07981 | Flexfrost | Food | Class II | 5 |
| 11 Jan 2018 | Hiland Orange Juice, 1 GAL (3.78 L) Hiland Dairy, Springfield, MO. | Hiland Dairy Foods Company LLC | Food | Class I | 2 |
| 10 Jan 2018 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30 (78809) | Individual firm, name withheld | Drug | Class II | 1 |
| 10 Jan 2018 | Italian White Bread Dough Sticks | Aryzta North America | Food | Class II | 2 |
| 10 Jan 2018 | Rico Tofu Breakfast Burrito, 12 oz, wrapped in white paper. Frozen. (78931) | Rico Brand | Food | Class III | 1 |
| 10 Jan 2018 | Sapori di Mare Colatura di Alici di Cetura; Anchovy Sauce; 100 ml, Lot #'s 03/2017 or 09/2017. (78937) | Claudio Wholesale, Inc. (DBA) Claudio Specialty Foods | Food | Class II | 1 |
| 8 Jan 2018 | Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine: | Innovasis, Inc | Device | Class II | 1 |
| 8 Jan 2018 | Coat & Bake, Original Chicken, Seasoned Coating Mix For Chicken, Net Wt 5.5 OZ (156 g), Distributed by SuperValu Inc., Eden Prairie, MN. | Gilster-Mary Lee Corp. | Food | Class I | 1 |
| 8 Jan 2018 | Mary B's Jumbo, 10 Biscuits, Extra Large, NET WT. 35 oz (2LB 3OZ) 992g | Hom'ade Foods | Food | Class II | 8 |
| 5 Jan 2018 | Kvas, a fermented non-alcoholic drink, packaged in a gallon plastic jugs The label is read in parts: "***Mom's Kvas***1 Gallon***Ingredients: Water, Cane Sugar, Instant Coffee, Yeast, Apple Cider***Home made to your taste with Low Calories! Keep Refrigerated to Prevent from perishing***Mom's Delicious Kitchen, LLC,… (78919) | Mom's Delicious Kitchen LLC | Food | Class II | 1 |
| 4 Jan 2018 | Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with… | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 4 Jan 2018 | Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16 (78913) | International Laboratories, LLC | Drug | Class I | 1 |
| 4 Jan 2018 | SunGlow, Unsalted European Style Butter Blend Margarine (16953 SNG), Net Wt 16 oz (1 lb) 454 g. Keep Refrigerated. UPC 26700-13499. Outer case: Net Wt 36 lb (16.32 kg). UPC 1 00 26700 13499 6. Ventura Foods, Brea, CA 92821 | Ventura Foods Llc | Food | Class II | 2 |
| 4 Jan 2018 | Clover Valley¿ Iced Oatmeal Cookies NET WT 12 OZ (340 g) CONTAINS: WHEAT, SOY. DISTRIBUTED BY DOLGENCORP, LLC 100 MISSION RIDGE GOODLETTSVILLE, TN 37072 UPC 0 86106 03201 5 (78884) | Dollar General Corporation, Inc. | Food | Class I | 1 |
| 3 Jan 2018 | Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures. | Medtronic Perfusion Systems | Device | Class II | 1 |
| 3 Jan 2018 | Frozen Unbaked Biscuits sold under the brand names of Hilltop Hearth, Mary B's & Marshall. (78864) | Holsum Baking Company Warehouse | Food | Class II | 1 |
| 2 Jan 2018 | Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20 | Aurobindo Pharma Ltd. | Drug | Class I | 1 |
| 2 Jan 2018 | Mallorcas Pacheco NET WT 1LB (16OZ) | Productos Pacheco, Inc. | Food | Class I | 12 |
| 28 Dec 2017 | PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration. | Bard Access Systems Inc. | Device | Class II | 1 |
| 28 Dec 2017 | Southern Style Frozen Biscuits sold under the following brand names: Food Club, Food Lion, Laura Lynn, Lowes Foods, Marshalls, Morning Fresh Farms, Piggly Wiggly, Premium Pick 5, SE Grocers, Shur Fine, Southern Home & Valu Time (78836) | Sister Schubert's Rolls Division of T.Marzetti Company | Food | Class II | 1 |
| 27 Dec 2017 | Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, to backfill… | Ormco/Sybronendo | Device | Class II | 1 |
| 27 Dec 2017 | EMS products from Graham Medical, SnugFit(R) Expandable Mattress Cover, Code 72930, UPC 1 07 47036 72930 3 (78899) | LITTLE RAPIDS CORPORATION | Device | Class II | 1 |
| 27 Dec 2017 | HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging. | Pharmedium Services, LLC | Drug | Class II | 42 |
| 22 Dec 2017 | Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only | Medtronic Sofamor Danek USA Inc | Device | Class II | 1 |
| 22 Dec 2017 | Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30 | Hetero Labs Limited Unit V | Drug | Class II | 1 |
| 21 Dec 2017 | Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3 | Taro Pharmaceuticals U.S.A., Inc. | Drug | Class III | 1 |
| 20 Dec 2017 | Model #: CG8900, Medtronic Clip Gun Scalp Clip Kit (Qty 1); Model #: CG8901, Medtronic Clip Gun Scalp Clip Kit (Qty 10); Model #: CG8901A, Medtronic Clip Gun Applicator (Qty 10) (78997) | Individual firm, name withheld | Device | Class II | 1 |
| 20 Dec 2017 | Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51 | AuroMedics Pharma LLC | Drug | Class I | 1 |
| 19 Dec 2017 | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO. | LivaNova USA | Device | Class III | 1 |
| 19 Dec 2017 | Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); EXPANSION: d. Amplia MRI CRT-D DF1 (Product No. DTMB1D1) Implantable… | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) | Device | Class I | 8 |
| 15 Dec 2017 | BrightView X, Model #882478 Product Usage: BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 5 |
| 14 Dec 2017 | PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5 | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 14 Dec 2017 | Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA. | Kalila Medical | Device | Class II | 2 |
| 14 Dec 2017 | SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47 | Boehringer Ingelheim Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 11 Dec 2017 | Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data.… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 11 Dec 2017 | Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe Product Usage: A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is indicated for the treatment of pain in… (78792) | Individual firm, name withheld | Device | Class II | 1 |
| 7 Dec 2017 | Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by Johnson & Johnson Consumer Inc. Skillman, NJ 08558, UPC 0 70501 11131 4 | Individual firm, name withheld | Drug | Class II | 3 |
| 4 Dec 2017 | Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00 | AuroMedics Pharma LLC | Drug | Class I | 1 |
| 4 Dec 2017 | Jicama Julienne, Brand Produce (78729) | Premier Produce | Food | Class I | 1 |
| 2 Dec 2017 | VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are… | Cyberonics, Inc | Device | Class II | 1 |
| 30 Nov 2017 | All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. | Intrathecal Compounding Specialist, LLC | Drug | Class II | 4 |
| 30 Nov 2017 | Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL (78666) | BYL Solutions Inc. | Drug | Class III | 1 |
| 29 Nov 2017 | Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200 | Hologic, Inc. | Device | Class II | 2 |
| 29 Nov 2017 | BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5 (78634) | Blue Fusion Natural | Drug | Class I | 1 |
| 27 Nov 2017 | Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Product Usage: A dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat… (78173) | Cincinnati Sub-Zero Products LLC | Device | Class II | 1 |
| 21 Nov 2017 | OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11, and 1.21r13. The firm name on the label is OCULUS Optikgerate GmbH, Made in Germany. The Pentacam AXL is designed to take photos of the anterior segment of the eye, which includes the cornea, pupil, anterior chamber, and lens of the eye,… | Oculus Optikgeraete GMBH | Device | Class II | 1 |
| 21 Nov 2017 | 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400 | Horiba Instruments, Inc dba Horiba Medical | Device | Class II | 2 |
| 20 Nov 2017 | Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559 | Glenmark Pharmaceuticals Inc., USA | Drug | Class II | 1 |
| 14 Nov 2017 | Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay… | Alere San Diego, Inc. | Device | Class II | 1 |
| 14 Nov 2017 | Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal. (78885) | Carl Zeiss Metrology Inc | Device | Class II | 1 |
| 10 Nov 2017 | BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature. | C.R. Bard, Inc. | Device | Class II | 1 |
| 10 Nov 2017 | Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10 | Baxter Healthcare Corporation | Drug | Class I | 1 |
| 8 Nov 2017 | Protura Software which utilizes Elekta's iCOM interface: MT6XSM1.4.0, MT6XSM1.4.0-1, MT6XSM1.4.0-2, MT6SXM1.4.0-3, MT6XSM1.5.0-2, MT6XSM1.6.0-1, MT6XSM1.7.2, MT6XSM1.7.2-1, MT6XSM1.7.2-3, MT6XSM1.7.3, MT6XSM1.7.3-1, MT6XSM1.7.3-3. The Protura Software is intended to interface between record and verify systems, linear… | Med Tec Inc | Device | Class II | 1 |
| 7 Nov 2017 | Apple Streusel Pie - Baked whole/half pies and Frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873 | Individual firm, name withheld | Food | Class II | 13 |
| 6 Nov 2017 | Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: Product Usage: The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA)… | Boston Scientific Corporation | Device | Class II | 2 |
| 3 Nov 2017 | bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications. | Beaver-Visitec International Inc. | Device | Class II | 5 |
| 1 Nov 2017 | ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9 | 3M Company - Health Care Business | Device | Class II | 1 |
| 1 Nov 2017 | Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 26 Oct 2017 | SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802. Intended for use as an ostomy protector providing a protective barrier to patient skin. | ConvaTec, Inc | Device | Class II | 1 |
| 23 Oct 2017 | Disposable Curved Circular Staplers Product Usage: Staplers have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses. | Ethicon Endo-Surgery Inc | Device | Class II | 1 |
| 17 Oct 2017 | ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet | Arrow International Inc | Device | Class II | 1 |
| 17 Oct 2017 | Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; Exp. Dates Feb 2018 - Nov 2018 | Arrow International Inc | Device | Class II | 12 |
| 16 Oct 2017 | Fresh Cilantro BRENCKLE FARMS INC Hartville, Ohio (78314) | Brenckle Farms | Food | Class I | 1 |
| 13 Oct 2017 | Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system… | Ecolab, Inc. | Device | Class II | 1 |
| 11 Oct 2017 | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 | GE Medical Systems China Co., Ltd. | Device | Class II | 2 |
| 10 Oct 2017 | Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provides upload support for the iPro2 Recorder. The CareLink iPro software is used to upload glucose… | Medtronic Inc. | Device | Class II | 1 |
| 9 Oct 2017 | Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of… | Exactech, Inc. | Device | Class II | 1 |
| 9 Oct 2017 | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test. | Cepheid | Device | Class II | 1 |
| 6 Oct 2017 | Allen Medical Bow Frame Model A-70800. Surgical platform used to position patients for lumbar spine procedures. | Allen Medical Systems | Device | Class II | 2 |
| 6 Oct 2017 | Philips Brilliance 64 computed tomography x-ray system | Philips Medical Systems (Cleveland) Inc | Device | Class II | 4 |
| 2 Oct 2017 | Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 29 Sep 2017 | Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 29 Sep 2017 | BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature. | C.R. Bard, Inc. | Device | Class II | 1 |
| 21 Sep 2017 | GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile… | Covidien LLC | Device | Class II | 1 |
| 21 Sep 2017 | Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal space. The… (78406) | Individual firm, name withheld | Device | Class III | 1 |
| 21 Sep 2017 | Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1 | Medline Industries Inc | Drug | Class II | 68 |
| 14 Sep 2017 | Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. | Cardiovascular Systems Inc | Device | Class II | 2 |
| 13 Sep 2017 | Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. | Covidien LLC | Device | Class II | 1 |
| 11 Sep 2017 | BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 8 Sep 2017 | JS Series SterilContainer S2 System | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 5 Sep 2017 | ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING ROSENBURR+ D1.4 ELAN 4 1-RING ROSEN BURR D1.8 ELAN 4 1-RING ROSEN BURR+ D1.8 ELAN 4 1-RING ROSEN BURR TC… | Aesculap Implant Systems LLC | Device | Class II | 3 |
| 1 Sep 2017 | The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery. | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 31 Aug 2017 | Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment. | Exactech, Inc. | Device | Class II | 2 |
| 28 Aug 2017 | Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 25 Aug 2017 | G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function and mobility to the damaged joint. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 25 Aug 2017 | AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty. | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 24 Aug 2017 | AArtis Q/ Q.Zen biplane Artis zee biplane Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 24 Aug 2017 | Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 24 Aug 2017 | Lyophilized Chemistry Calibrator Level 1 Product Usage: Beckman Coulter Chemistry Calibrators are intended for use when calibrating methods run on the Beckman Coulter AU series of chemistry analyzers. Beckman Coulter Chemistry Calibrators are lyophilized, human serum based products formulated for use as a reference… | Beckman Coulter Inc. | Device | Class II | 1 |
| 23 Aug 2017 | Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 22 Aug 2017 | Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus | Siemens Medical Solutions USA, INC | Device | Class II | 1 |
| 22 Aug 2017 | Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer and Y-Connector, 2 Suction Toothbrush packages and Antiplaque solution, 4 Suction Oral Swab packages with Perox-A-Mint solution. Manufactured by: Sage Products, LLC., 3909 Three Oaks Road, Cary, IL 60013 Product Code: 6434; UPC 6 18029 83035 7 | Sage Products Inc | Drug | Class II | 64 |
| 18 Aug 2017 | Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 10 Aug 2017 | NS357R Vega PS Tibia Trial/Preparation Plateau size T4 (Component of the Vega Knee System Set #ST0468) The affected part is provided in the Vega Knee System Set #ST0468. The Vega Knee System is used for reconstruction of the diseased knee joint. | Aesculap Implant Systems LLC | Device | Class II | 1 |
| 10 Aug 2017 | Norian Drillable Inject | Synthes USA | Device | Class II | 2 |
| 7 Aug 2017 | LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments | Synthes, Inc. | Device | Class II | 1 |
| 7 Aug 2017 | Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1 | Covidien LLC | Device | Class II | 6 |
| 7 Aug 2017 | Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM | Zimmer Biomet, Inc. | Device | Class II | 65 |
| 4 Aug 2017 | Aspire HD (for FDR-1000AWS) The Fujifilm Digital Mammography System, Aspire HD (FDR MS-l000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as… | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 4 |
| 3 Aug 2017 | Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501 | Ivoclar Vivadent, Inc. | Device | Class III | 4 |
| 3 Aug 2017 | Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation | OrthoPediatrics Corp | Device | Class II | 1 |
| 31 Jul 2017 | Central Venous Catheter Set Triple Lumen Polyurethane, Catalog Identifier: C-UTLM-501J Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute… | Cook Inc. | Device | Class II | 5 |
| 28 Jul 2017 | Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001 | Roche Diagnostics Corporation | Device | Class II | 1 |
| 28 Jul 2017 | AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg). | Brainlab AG | Device | Class II | 1 |
| 27 Jul 2017 | A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. . | Zimmer Surgical Inc | Device | Class II | 2 |
| 27 Jul 2017 | Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures. | Baxter Healthcare Corporation | Device | Class II | 1 |
| 26 Jul 2017 | 7x10" Small Utility Positioner with Cover | Molnlycke Health Care, Inc | Device | Class II | 2 |
| 25 Jul 2017 | ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter | Arrow International Inc | Device | Class II | 2 |
| 24 Jul 2017 | NexGen LPS Femoral Component, Left and Right, Size G Replaces the femoral condyle of the knee joint in Total Knee Arthroplasty. (78960) | ZIMMER ORTHOPEDIC MFG LTD | Device | Class II | 1 |
| 24 Jul 2017 | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. | Device | Class II | 5 |
| 24 Jul 2017 | Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that… | ConforMIS, Inc. | Device | Class II | 1 |
| 21 Jul 2017 | MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 21 Jul 2017 | 11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile | Synthes (USA) Products LLC | Device | Class II | 1 |
| 17 Jul 2017 | Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements… | Covidien LP | Device | Class II | 1 |
| 14 Jul 2017 | TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00 | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 14 Jul 2017 | PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3 | Panoramic Rental Corp. | Device | Class II | 1 |
| 13 Jul 2017 | The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures. | Microline Surgical, Inc. | Device | Class II | 1 |
| 13 Jul 2017 | Video Cystoscope models ECY-1570 and ECY-1570K | Pentax of America Inc | Device | Class II | 1 |
| 12 Jul 2017 | MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in… | Philips North America, LLC | Device | Class I | 1 |
| 12 Jul 2017 | CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 | DePuy Orthopaedics, Inc. | Device | Class II | 2 |
| 11 Jul 2017 | Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool | Exactech, Inc. | Device | Class II | 1 |
| 10 Jul 2017 | Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels. | Arrow International Inc | Device | Class II | 1 |
| 10 Jul 2017 | Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby. (78237) | AMEDA, INC. | Device | Class III | 1 |
| 5 Jul 2017 | Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCNK-10-C & 20)… (78704) | Cosman Medical, LLC | Device | Class II | 1 |
| 5 Jul 2017 | cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated, random access, computer controlled… | Roche Diagnostics Corporation | Device | Class II | 2 |
| 3 Jul 2017 | AVID Medical QA Pack AV10654-10 | Avid Medical, Inc. | Device | Class II | 1 |
| 27 Jun 2017 | Safety-Deluxe Lumbar Puncture Tray, Catalog # 974 Product Usage: Surgical procedure | Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables | Device | Class II | 7 |
| 21 Jun 2017 | Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle. | B. Braun Medical, Inc. | Device | Class II | 10 |
| 20 Jun 2017 | Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or… | Keystone Dental Inc | Device | Class II | 1 |
| 12 Jun 2017 | DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 11 Jun 2017 | Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series. | Tosoh Bioscience Inc | Device | Class II | 2 |
| 8 Jun 2017 | Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 | Roche Diabetes Care, Inc. | Device | Class II | 1 |
| 7 Jun 2017 | ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 5 Jun 2017 | M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide… | Zimmer Biomet, Inc. | Device | Class II | 5 |
| 5 Jun 2017 | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue. | Angiodynamics, Inc. | Device | Class II | 6 |
| 25 May 2017 | 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition… | Medical Components, Inc dba MedComp | Device | Class II | 1 |
| 22 May 2017 | Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. (78765) | Maquet | Device | Class II | 1 |
| 22 May 2017 | SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone | MicroAire Surgical Instruments, LLC | Device | Class II | 1 |
| 1 May 2017 | ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons. | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 7 Mar 2017 | Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language | A&H Focal Inc. | Drug | Class I | 21 |
| 21 Feb 2017 | Bobo's Coconut Oat Bar 3oz. Packaged in overwrap film per single bar (78987) | Simply Delicious, Inc. dba Bobo's Oat Bars | Food | Class II | 1 |
| 20 Jan 2017 | Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 200265 Intended for identification of the systemic fungal pathogens. (78731) | Gibson Laboratories LLC | Device | Class II | 1 |
| 15 Jul 2016 | Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag. | Smiths Medical ASD, Inc. | Device | Class II | 1 |