| 18 Dec 2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10 | Osmotica Pharmaceutical Corp | Drug | Class III | 2 |
| 15 Dec 2017 | 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10 | B. Braun Medical Inc | Drug | Class II | 1 |
| 8 Dec 2017 | Sensations cinnamon roll UNCOOKED DOUGH 450g, UPC: 236821197 (78726) | AMS LLC dba Gagne Foods | Food | Class II | 1 |
| 7 Dec 2017 | BluePrint ORGANIC Beet Blast Vegetable & Fruit Drink 16 fl.oz.(473mL) USDA Organic. Keep Refrigerated. | The Hain Celestial Group, Inc. - Worldwide HQ | Food | Class III | 1 |
| 5 Dec 2017 | Choceur Dark Chocolate Bars, 5.29 oz., 20 units/case | Aldi Inc | Food | Class I | 1 |
| 5 Dec 2017 | HERB-OX Beef Flavor Granulated Bouillon, 4 ounce jars (78690) | Creative Contract Packaging Corporation, LLC | Food | Class I | 1 |
| 1 Dec 2017 | 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector. Intended for use in preventing deep vein thrombosis (DVT), diminishing post-operative pain and swelling, enhancing blood circulation and reducing wound healing time on the calf. | Stryker Sustainability Solutions | Device | Class II | 1 |
| 30 Nov 2017 | Raley's All Butter Meyer Lemon Cookie; Case of Raw Dough (168 cookies) 28.87 lbs - UPC 10659728; 1 cookie (85 g); 6 count package UPC 4656760890 sold in retail stores Individual cookies in Bakery Case - identifier 106 Ingredients: ENRICHED BLEACHED WHEAT FLOUR (WHEAT FLOUR, NIACIN, IRON, THIAMIN MONONITRATE,… (78734) | Individual firm, name withheld | Food | Class II | 1 |
| 29 Nov 2017 | SALSA HOT Net Wt. 15 oz (426 G) | Individual firm, name withheld | Food | Class II | 2 |
| 28 Nov 2017 | Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73. | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 28 Nov 2017 | Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Protection Cream, SPF 50+, Net. Wt. 2.8 oz (80 g) tube in a carton, Distributed by Vertra/EAI-JR286, 20100 S Vermont Ave, Torrance, CA 90502, Made In Australia, UPC 8 94140 00103 0. (78595) | EAI-JR286 INC | Drug | Class II | 1 |
| 28 Nov 2017 | Holi Aioli, Lemon Basil 12oz bottle (78649) | JP's Delicacies LLC | Food | Class II | 1 |
| 27 Nov 2017 | WOLDONG WORLD'S BEST KIMCHI WHOLE CABBAGE KIMCHI PREMIUM 3LBS (1.36kg), UPC: 8 46034 04853 9 and 7LBS (3.17kg), UPC: 846034048546. (78639) | H. A. R. Maspeth Corp. | Food | Class II | 1 |
| 22 Nov 2017 | Cashew Cranberry Cherry Jubilee (8 oz. bag), UPC 018142352161. Packaged in Plastic Zip Lock bags. No refrigeration needed. | Colorado Nut Co | Food | Class II | 5 |
| 22 Nov 2017 | Saranac Pasta and Seafood Salad 2x10lbs or 2x5lbs plastic tubs. (78632) | Saranac Brand Foods, Inc. | Food | Class I | 1 |
| 21 Nov 2017 | Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 21 Nov 2017 | Fit & Active Chocolatey Chip Protein Meal Bars; UPC: 41498 18695; Lot Code: Q209MY; Expiration date: May 24, 2018 (78630) | Leclerc Foods USA | Food | Class II | 1 |
| 20 Nov 2017 | Tapered Screw-Vent MTX Model TSVTB11 | Zimmer Dental Inc | Device | Class II | 1 |
| 20 Nov 2017 | Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534 | Zydus Pharmaceuticals USA Inc | Drug | Class II | 1 |
| 20 Nov 2017 | Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 20 Nov 2017 | Clover Hill Dairy, Soft Ricotta (78629) | Clover Hill Dairy | Food | Class III | 1 |
| 17 Nov 2017 | 89291 Cashew Tower (Plow and Hearth Chocolate Covered Cashews). Net weight: 10 ounces . The product is package as a Individual can is sealed tin with a plastic lid / Tower is packaged in a clear acetate (plastic) sleeve. (78633) | Individual firm, name withheld | Food | Class II | 1 |
| 17 Nov 2017 | Plow & Hearth Chocolate Covered Cashews (78623) | Virginia Diner Inc | Food | Class II | 1 |
| 17 Nov 2017 | Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEMENT 180 CAPSULES UPC: 7 66298 00862 2 | Pure Encapsulations, Inc. | Food | Class III | 2 |
| 17 Nov 2017 | Ian's Gluten Free Original Panko Breadcrumbs, UPC# 7-49512-77550-0 | Elevation Brands, LLC | Food | Class III | 2 |
| 16 Nov 2017 | BAMBOO SHOOTS SAUCE (Marinated Bamboo) packaged in a glass jar, net wt. 220g. UPC: 6 930841 008230 (78700) | Sichuan Youjia Foodstuffs Co., Ltd | Food | Class II | 1 |
| 16 Nov 2017 | Maple Hill Creamery, Fiore Di Latte Fresh Mozzarella; 8-oz. (227g); UPC: 855088005474 (78586) | Maple Hill Creamery, LLC | Food | Class III | 1 |
| 16 Nov 2017 | Dark Chocolate Coffee Beans, Natural Dark Chocolate Coffee Beans | JLM Manufacturing LLC | Food | Class II | 5 |
| 15 Nov 2017 | Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The… | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 15 Nov 2017 | Roasted & Salted Cashews and Chocolate Covered Cashews; packaged in clear plastic containers; NET WT 18 oz. (1 LB 2 oz.), 510 g; UPC 8-86926-46877-9 | Meijer Distribution, Inc | Food | Class II | 1 |
| 15 Nov 2017 | Casa Sanchez Foods, Real Guacamole; Net Wt. 9 oz.. (255 g), 1/2 gallon UPC: 0 78732 00412 2; 78732 00431-3 ; 0-78732-00412-2 Ingredients: Avocados, tomatoes, cucumber, onions, pepper, lemon juice, sea salt, ascorbic acid and citric acid. | FANTE, Inc., dba Casa Sanchez Foods | Food | Class I | 2 |
| 14 Nov 2017 | Ahold-Own Brands Whole Kernel Sweet Corn, 16 oz. Plastic Bag : Stop & Shop Brand Frozen Whole Kernel Sweet Corn, 16 oz. GIANT/MARTIN S Brand Frozen Whole Kernel Sweet Corn, 16 oz. Giant Brand Frozen Whole Kernel Sweet Corn, 16 oz. (78576) | Ahold Usa | Food | Class II | 1 |
| 13 Nov 2017 | Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior… (78592) | Amendia, Inc dba Spinal Elements | Device | Class II | 1 |
| 13 Nov 2017 | Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC 42806-263-01, UPC 342806263013 (78502) | Elite Laboratories Inc. | Drug | Class III | 1 |
| 11 Nov 2017 | Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India | Renaissance Lakewood, LLC | Drug | Class III | 1 |
| 10 Nov 2017 | Raley's Purely Made Dry Roasted Unsalted Peanuts; 12 oz. (340 g) clear plastic bag. No artificial ingredients. Some packages may be labeled as Raley's Purely Made Macadamia Nuts, 6.5 oz. (184 g) clear bag | New Century Snacks LLC | Food | Class II | 1 |
| 10 Nov 2017 | Yorgos FOODS Original Hommus 8 oz. (227g) UPC: 7 56248 10002 5 and 16 oz. (454g) UPC: 7 56248 10005 6; 32 OZ UPC: 7 56248 10010 0; NET WT. 5 LBS 80 oz (2268g) UPC: 7 56248 10100 8. Product is packaged in a clear plastic container, keep refrigerated. | Yorgo Food's Inc. | Food | Class I | 22 |
| 10 Nov 2017 | Happy Belly Deluxe Mixed Nuts - roasted and salted with sea salt. Cashews, Almonds, Brazil nuts, pecans & Hazelnuts 16 oz. (454 g); Allergen information: contains Milk, Almonds, Wheat, Peanuts. UPC 48719 09577 Cranberry & Nuts Trail mix has dried cranberries, cashew & almonds. Allergen information: Almonds and cashews | New Century Snacks LLC | Food | Class III | 2 |
| 9 Nov 2017 | Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01 | Mayne Pharma Inc | Drug | Class II | 1 |
| 9 Nov 2017 | Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05 | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 9 Nov 2017 | Organic Dark Chocolate (Covered) Raisins; Wegmans organic Dark Chocolate Covered Raisins NET WT 14 OZ (396g), UPC: 0 77890 37787 1, Product code 5546291 | First Source, LLC | Food | Class II | 3 |
| 8 Nov 2017 | Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. 24 softgel tablets per paper carton, Distributed by Perrigo, Allegan, MI 49010, NDC 70085-151-01 | L. Perrigo Company | Drug | Class II | 1 |
| 8 Nov 2017 | Dark Chocolate Almonds, 10 oz. | Detroit City Nut, LLC | Food | Class II | 3 |
| 8 Nov 2017 | DARK CHOCOLATE CHERRY, 16 oz., 25 pound bulk case | Rocky'S Historic Eastern Market | Food | Class II | 2 |
| 7 Nov 2017 | Juanita's Brand OJOS Mexican Pastry. Product are pink balls of cake rolled in coconut packed in a flex plastic bag of varying weight. 6 units per bag. UPC 48867 00216. (78545) | Individual firm, name withheld | Food | Class II | 1 |
| 6 Nov 2017 | Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249 (78446) | Claris Lifesciences Inc | Drug | Class III | 1 |
| 6 Nov 2017 | Bean Boy Coffee Dark Chocolate Covered Espresso Beans (78584) | Pacific Rim Distribution Inc. | Food | Class II | 1 |
| 3 Nov 2017 | Everflex Self-Expanding Peripheral Stent with Entrust Delivery System Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from… | Medtronic Inc. | Device | Class II | 1 |
| 3 Nov 2017 | Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (240V) REF 400-0100.07; CORE Mobile Imaging System Refurbished REF 400-0100.07-R; CORE Mobile Imaging System (100V) REF 400-0100.08; CORE… | Volcano Corporation | Device | Class II | 1 |
| 3 Nov 2017 | BRAINLAB EXACTRAC VERO, Model/Catalog Numbers: 46228 EXACTRAC VERO 3.5 46238 EXACTRAC VERO 3.5 46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3 46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4 The ExacTrac Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System… | Brainlab AG | Device | Class II | 1 |
| 3 Nov 2017 | UniCel DxH800, Part Numbers: 629029 and B24802, automated hematology analyzer | Beckman Coulter Inc. | Device | Class II | 3 |
| 3 Nov 2017 | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit | Individual firm, name withheld | Device | Class II | 3 |
| 3 Nov 2017 | GourmetNut DARK CHOCOLATE COVERED ALMONDS NET WT 7oz (198g); UPC: 708747152203 (78468) | Gourmet Nut, Inc. | Food | Class II | 1 |
| 2 Nov 2017 | CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres. | Remel Inc | Device | Class II | 1 |
| 2 Nov 2017 | pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery. | Pro-Med Instruments Gmbh | Device | Class II | 1 |
| 2 Nov 2017 | Premio Strawberry Pralinati, Strawberry with Cocoa, 3.53oz, 10 units per case, packed in Paper Cartons (78447) | Gourmet International Inc. | Food | Class III | 1 |
| 2 Nov 2017 | DRIZZLED VANILLA POPCORN Net Wt. 3 oz (84.9g) Ingredients: Popcorn, corn syrup, sugar, lecithin***ALLERGY INFO: Manufactured in a facility that processes Milk, Wheat, Soy, Tree Nuts, Peanuts Stew Leonard's 100 Westport Ave., Norwalk, CT (78435) | Kellbran Candies and Snacks Inc | Food | Class II | 1 |
| 2 Nov 2017 | Krispy Kreme Doughnuts, Glazed Blueberry Cake Doughnuts, Net Wt. 13.5oz (half dozen), Manufactured under the authority of Krispy Kreme Doughnut Corporation, Winston-Salem, NC 27102. | krispy kreme doughnut corporation | Food | Class II | 7 |
| 2 Nov 2017 | GOYA Adobo, All Purpose Seasoning with Pepper, Goya Foods, Inc. 28 OZ | Tradewind Foods de Puerto Rico Inc. | Food | Class I | 2 |
| 1 Nov 2017 | Dark Chocolate Banana Chips, 12 oz. | Steve's Gourmet Confections | Food | Class II | 2 |
| 1 Nov 2017 | Dark Chocolate Almond, Net 11 oz., Contains Almond and Soy, Distributed By: Dutch Valley Food Distributors, Inc., Myerstown, PA 17067; UPC: 77245 00605; Lot#, Best By dates: 20160512, 05/12/17; 20160609, 06/9/17; 20160811, 08/11/17; 20160923, 09/23/17; 20161115, 11/15/17; 20170119, 01/19/18; 20170321, 03/21/18;… | Dutch Valley Food Distributors Inc. | Food | Class II | 2 |
| 31 Oct 2017 | The Toothsome Chocolate Emporium Dark Chocolate Coffee Beans. The affected product is packaged in 8 oz. clear bag within a gold Toothsome Chocolate Emporium box, 24/case | Individual firm, name withheld | Food | Class II | 3 |
| 31 Oct 2017 | Gia Russa Spaghetti Dinner Sauce Mushrooms NET WT. 1 Lb. 8 oz (24 oz) 680 grams INGREDIENTS: Tomato Puree***Canola Oil, Sugar, Modified Food Starch, Salt, Mushrooms, Garlic, Onions, Citric Acid, Oregano, Basil Distributed By: Gia Brands Inc., Boardman, OH 44512 UPC 0 26825 00830 4 | John Zidian Co | Food | Class II | 2 |
| 30 Oct 2017 | ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS… | ICU Medical Inc | Device | Class II | 1 |
| 30 Oct 2017 | Dark Chocolate Almond Bark 5oz &1lb Clear plastic tubs (78482) | NUTCO Inc. dba Germack Pistachio Co. | Food | Class II | 1 |
| 30 Oct 2017 | Dark Chocolate Almonds packaged under the brand names: (1)Wegmans, 23 OZ (1 LB 7 OZ) 652g tub UPC: 0 77890 328200 4 and 11.5 oz. (326g) tub UPC: 0 70784 50743 9; (2)Alpine Valley 11.5 OZ (326 g). tub UPC 0 23637 41099 8; (3)Tops 11.5oz . tub (326 g) UPC: 0 70784 50743 9; (4) Circle K Favorites (113 g) bag UPC: 0… | First Source, LLC | Food | Class II | 7 |
| 30 Oct 2017 | All Natural Dark Chocolate Covered Almonds INGREDIENTS: Natural Dark Chocolate (Sugar Chocolate Liquor, Cocoa Butter, Chocolate Liquor Processed W/Alkali, Soy Lecithin (An Emulsifier), Vanilla, Salt,), Almonds And Confectioners Glaze. DIST BY THE KROGER CO CINCINNATI, OHIO 45201 | The Kroger Co | Food | Class II | 6 |
| 27 Oct 2017 | LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector. | Physio-Control, Inc. | Device | Class I | 2 |
| 26 Oct 2017 | Cookies N Cream Ice Cream 3 gallons | Working Cow Homemade Inc. | Food | Class I | 3 |
| 24 Oct 2017 | ABL800 analyzer with FLEXQ module. Device intended for in vitro testing of samples of whole blood for the parameters pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) - in vitro testing of samples of expired… | Radiometer America Inc | Device | Class II | 1 |
| 24 Oct 2017 | The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF | Medacta Usa Inc | Device | Class II | 1 |
| 16 Oct 2017 | Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as… (78394) | Individual firm, name withheld | Device | Class II | 1 |
| 16 Oct 2017 | Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level… (78441) | Fukuda Denshi Co., Ltd. | Device | Class II | 1 |
| 16 Oct 2017 | DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: a) Incision and Drainage Tray, REF 47-763.04 b) Incision and Drainage Tray, REF 47-763.06 c) Incision and Drainage Tray, REF 47-763.07 d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 e) Incision and Drainage Tray, REF 89-6818.02 f)… | DeRoyal Industries Inc | Device | Class II | 1 |
| 16 Oct 2017 | Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric… | C.R. Bard, Inc. | Device | Class II | 1 |
| 13 Oct 2017 | FLAVORx Sweetening Enhancer , the product is packaged as follows: "Sweetening Enhancer AQ, 4oz & 1oz Bottles, Lot #161269 / Exp. Date 12/2018 "Sweetening Enhancer AQ, 4oz & 1oz Bottles, Lot #170361 / Exp. Date 03/2019 #100 per box 1oz bottles, #50 per box 4oz bottles Package type: Amber Glass Boston Round Bottles | FLAVORx Inc. | Food | Class II | 3 |
| 12 Oct 2017 | Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Jeedimetla,Hyderabad - 500 055, India, NDC 31722-574-47 (78287) | Individual firm, name withheld | Drug | Class II | 1 |
| 11 Oct 2017 | Zimmer Dental GemLock RHD2.5 Hex Driver. The label shows the product is Manufactured by Zimmer Dental Inc., Carlsbad, CA. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of… | Zimmer Dental Inc | Device | Class II | 4 |
| 10 Oct 2017 | ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implant is a two-piece implant for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate… | Implant Direct Sybron Manufacturing, LLC | Device | Class II | 1 |
| 6 Oct 2017 | No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by NEW RELIANCE TRADING, INC., 5563 59th St., Maspeth, New York, 11378-2358, UPC 8993138993349, 5842109854239. (78304) | NEW RELIANCE TRADING, INC. | Drug | Class II | 1 |
| 28 Sep 2017 | Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator | Philips Electronics North America Corporation | Device | Class II | 1 |
| 20 Sep 2017 | Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility. | Philips Electronics North America Corporation | Device | Class III | 1 |
| 15 Sep 2017 | Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearance Therapy and promote… (78100) | HILL-ROM MANUFACTURING, INC. | Device | Class II | 1 |
| 15 Sep 2017 | RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224 | Gadget Island, Inc | Drug | Class I | 4 |
| 1 Sep 2017 | Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments. | Elekta Inc | Device | Class II | 1 |
| 31 Aug 2017 | Berry Flavor Immune Support Dietary Supplement Effervescent Tablets 10 Tablets/bottle. Product is sold under the following brand names: Discount Drug Mart UPC 0 93351 01230 3; Good Neighbor Pharmacy UPC 0 87701 41330 8; Hyvee UPC 0 75450 09537 1; Kinray Preferred Plus UPC 0 23513 01010 6; Live Better UPC 0 41310… | Reese Pharmaceutical Company | Food | Class II | 2 |
| 30 Aug 2017 | Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-6531-02 | Pfizer Inc. | Drug | Class I | 1 |
| 28 Aug 2017 | Primera Negra, Artificial Vanilla Flavoring NET WT 4 OZ and 8 OZ (78121) | GONZALEZ WHOLESALE DISTRIBUTOR,L | Food | Class II | 1 |
| 18 Aug 2017 | Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive investigations of heart and vascular disease when non-invasive indicators warrant such. | Invivo Corporation | Device | Class II | 1 |
| 18 Aug 2017 | Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes,… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 17 Aug 2017 | All Sterile Products within expiry (77978) | Vital Rx, Inc. dba Atlantic Pharmacy and Compounding | Drug | Class II | 1 |
| 10 Aug 2017 | Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15 | Premier Pharmacy Labs Inc | Drug | Class II | 1 |
| 7 Aug 2017 | Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-925-16 (77899) | International Laboratories, Inc. | Drug | Class I | 1 |
| 3 Aug 2017 | Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84 | Amneal Pharmaceuticals of New York, LLC | Drug | Class I | 1 |
| 1 Aug 2017 | NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC. (77859) | The Ampt Life, LLC | Drug | Class I | 1 |
| 28 Jul 2017 | Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. Intended to relieve symptoms, obstructions, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is indicated for men greater or equal to 50 years of age… (77797) | NXTHERA | Device | Class II | 1 |
| 24 Jul 2017 | LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health. | EZWeightLossTX LLC | Drug | Class I | 2 |
| 22 Jul 2017 | QIAamp DSP Virus Kit Cat. No. 60704 | Qiagen, GmbH | Device | Class II | 1 |
| 13 Jul 2017 | CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care… | GE Medical Systems Information Technologies, Inc. | Device | Class II | 1 |
| 5 Jul 2017 | Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog¿, 100 units/mL (Ux100) [insulin aspart… | Novo Nordisk Inc | Device | Class II | 1 |
| 3 Jul 2017 | Comforts FOR BABY Purified Water with Flouride Added. 1 GAL (3.78 L) DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202 | The Kroger Co | Food | Class II | 1 |
| 27 Jun 2017 | TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J | Terumo Cardiovascular Systems Corporation | Device | Class II | 2 |
| 16 Jun 2017 | ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 15 Jun 2017 | FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200, Catalog: Visionary Suite (FMSU Marketing Name) The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine… | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 14 Jun 2017 | SMARTABLATE RF System Generator | Biosense Webster, Inc. | Device | Class II | 1 |
| 9 Jun 2017 | NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged in 5 x 5 (TWENTY FIVE) syringes per box, Rx only, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054, NDC 15082-818-61. | Advanced Pharma Inc. | Drug | Class I | 7 |
| 8 Jun 2017 | Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017 The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood… | Roche Diabetes Care, Inc. | Device | Class II | 1 |
| 7 Jun 2017 | Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY | Terumo Medical Corp | Device | Class II | 17 |
| 5 Jun 2017 | SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073 | CSL Behring GmbH | Device | Class II | 2 |
| 2 Jun 2017 | Arctic Sun ArcticGel Pads - Medium, Product Code 317-07 | C.R. Bard, Inc. | Device | Class III | 1 |
| 1 Jun 2017 | BD PhoenixTM AP, Catalog Number 448010 The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD… | Becton Dickinson & Co. | Device | Class III | 1 |
| 1 Jun 2017 | BLUE BURN SHEET, STERILE, 60" x 96"; Item 7305, GAM item 30-01 Product Usage - May provide a sterile, barrier environment to protect patient from infection. (77673) | Dukal Corp. | Device | Class II | 1 |
| 1 Jun 2017 | Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the… | Arrow International Inc | Device | Class II | 4 |
| 31 May 2017 | BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection. | Becton Dickinson & Company | Device | Class II | 1 |
| 25 May 2017 | BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutaneous injection of insulin | Becton Dickinson & Company | Device | Class II | 1 |
| 23 May 2017 | Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10469516 (OUS), Product Code KC710U (US) and KC710 (OUS); IVD | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 4 |
| 22 May 2017 | TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM), Catalog Number 221261 Trypticase Soy Agar with 5% or 10% Sheep Blood is used for cultivating fastidious microorganisms and for the visualization of hemolytic reactions produced by many bacterial species. | Becton Dickinson & Co. | Device | Class II | 1 |
| 17 May 2017 | PENTARAY NAV High-Density Mapping Catheter. | Biosense Webster, Inc. | Device | Class II | 2 |
| 16 May 2017 | Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue… | Exactech, Inc. | Device | Class II | 2 |
| 15 May 2017 | Fish Cake in Polybag 20/1lb., Item no. 13125 UPC Code 087703131256 | Individual firm, name withheld | Food | Class I | 5 |
| 11 May 2017 | BD Phoenix PMIC-107, Catalog Number 448417, UDI #s (01)30382904484171, (10)7031818(17)180228(30)0025, IVD. PMIC-107 is a Gram positive AST Only panel used to test antibiotic susceptibility. The inducible macrolide-linosamide-steptogramin B (iMLSb) resistance D-test screen for Staphylococcus species is used to… | Becton Dickinson & Co. | Device | Class II | 1 |
| 26 Apr 2017 | enGen Track System with TCAutomation Software Version 4.2 | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 18 Apr 2017 | Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz. (NDC 10631-206-02) HDPE bottles, Rx only, Manufactured for: Ranbaxy Laboratories Inc. Jacksonville, FL 32257 USA, Distributed by: Sun Pharmaceutical Industries, Cranbury, NJ 08512 | Sun Pharmaceutical Industries, Inc. | Drug | Class II | 1 |
| 17 Apr 2017 | Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures. | ConMed Corporation | Device | Class II | 1 |
| 13 Apr 2017 | ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species. | BioMerieux SA | Device | Class II | 2 |
| 3 Apr 2017 | Solus Flexible wire-reinforced laryngeal mask airways under the following sizes: 1) small pediatric size 2 catalog #8002001, 2) large pediatric size 2.5 catalog #8025001, 3) small adult size 3 catalog #8003001, 4) medium adult size 4 catalog #8004001 and 5) large adult size 5 catalog #8005001 Patent airway management. | Intersurgical Inc | Device | Class II | 1 |
| 13 Jan 2017 | Morning Life, Model WIC2008S & WIC2008, UDI 8809293 870336 Product Usage: Intended for limb massage utilizing air compression. It is specially designed to improve venous and lymphatic circulation by compressing and releasing air pressure programmed on the device. It helps to prevent the blood blockage in… | Won Industry Co. | Device | Class II | 2 |
| 14 Dec 2016 | Cheddar & Sour Cream flavored Potato Chips packaged under the following brands and sizes: 1. Old Dutch Ripples, 2 oz, UPC 74690-024066; 8 oz., UPC 74690-230290; and 15.5 oz., UPC 74690-205694. 2. Old Dutch Rip-L Family Pack, 9.5oz, UPC 74690-201160 3. Roundy's, 2 oz, UPC 11150-041430; 10.5 oz, UPC 11150-224826; and… | Old Dutch Foods, Inc | Food | Class I | 5 |
| 9 Dec 2016 | I-125 CE Marked QuickLink Cartridges; Sterile; Bard Brachysource Radioactive Seeds in QuickLink Cartridges Indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Implants are indicated to treat residual tumors following completion… | C.R. Bard, Inc. | Device | Class II | 1 |
| 28 Nov 2016 | Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central… | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 13 |
| 25 Aug 2016 | United Nuclear Scientific High Power Handheld Lasers. Laser products (78389) | United Nuclear Scientific Supplies, LLC | Device | Class II | 1 |
| 29 Oct 2015 | Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 5 Sep 2014 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 11 Dec 2013 | Organic traditions brand DARK CHOCOLATE HAZELNUTS, NET WT. 3.5 oz (100 g) - UPC 8 54260 01400 6, and NET WT. 8 oz (227 g) - UPC 8 54260 00701 5 -- Product of Italy --- Distributed by Organic Traditions - Cheektowaga, NY 14227 | Health Matters America Inc. | Food | Class I | 4 |
| 10 Feb 2013 | ROSA Surgical Device 2.5.8 | Zimmer Biomet, Inc. | Device | Class II | 1 |