| 13 Mar 2019 | 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 |
| 13 Mar 2019 | HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404 | Advanced Pharma Inc. | Drug | Class II | 19 |
| 12 Mar 2019 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10 | Akorn Inc | Drug | Class II | 1 |
| 11 Mar 2019 | Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8. (82397) | Iso-Tex Diagnostics, Inc | Drug | Class II | 1 |
| 11 Mar 2019 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93 | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 10 Mar 2019 | Ne-Mo's Chocolate Cake Square with Cream Cheese Icing, item 104; Net Wt. 3 oz. Case UPC: 2007606401046 4; Display pk 6 ea/pk UPC: 10076064010460 7 Individual unit UPC: 07606400104 8 Frozen product has a shelf life of 365 days from the date of production Refrigerated product has a shelf life of 30 days from the date… | Horizon Food Group | Food | Class II | 3 |
| 7 Mar 2019 | Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61. | Boehringer Ingelheim Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 7 Mar 2019 | Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Fever Reducer (acetaminophen 150mg) 2 fl. oz. bottle, Little Remedies Saline Spray/Drops (sodium chloride) 0.5 fl oz., Little Remedies Gripe Water (zingiber officinale (Ginger) Root Extract 5mg,… | Medtech Products, Inc. | Drug | Class II | 1 |
| 7 Mar 2019 | Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30 | Rising Pharmaceuticals, Inc. | Drug | Class II | 4 |
| 6 Mar 2019 | Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807. | Preferred Pharmaceuticals, Inc | Drug | Class II | 1 |
| 6 Mar 2019 | Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40. (82323) | Individual firm, name withheld | Drug | Class II | 1 |
| 6 Mar 2019 | Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01) | American Health Packaging | Drug | Class II | 1 |
| 5 Mar 2019 | Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15 | AVKARE Inc. | Drug | Class II | 3 |
| 4 Mar 2019 | ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres/1.1 US gallons per case, Petra Hygienic Systems, Concord, ON L4K 4RS/ Reno, NV 89511, NDC 42326-550-01, UPC 0 65936 10335 5. (82283) | Petra Hygienic Systems Int Ltd | Drug | Class III | 1 |
| 1 Mar 2019 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | AVKARE Inc. | Drug | Class III | 1 |
| 1 Mar 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885,… | Apotex Inc. | Drug | Class II | 1 |
| 1 Mar 2019 | Losartan Potassium Tablets, USP, 25 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045 NDC 68645-577-54 | Legacy Pharmaceutical Packaging LLC | Drug | Class II | 3 |
| 1 Mar 2019 | Garden Gate Tofu, Firm; Ingredients: Soybean, Filter water, Calcium Sulfate. Contains: soy Sold in 60 piece (bulk box) and 18 piece packages 73 oz. - UPC 7 83301 96198 1 Pasteurized/Perishable. Keep Refrigerated. Made in USA. (82299) | Golden Gate Soy Products, Inc. | Food | Class II | 1 |
| 1 Mar 2019 | Lamb's Supreme Starz, item S0026, is formed star-shaped potato product that has been par-fried and frozen. Product is packaged in a five-pound, food service, clear poly bag; the bags are boxed six bags per case (30 lbs net weight). Bags are placed in a corrugated cardboard case. UPC. 1 00 44979 19026 0. | Lamb Weston Inc | Food | Class II | 1 |
| 1 Mar 2019 | Recchiuti Key Lime Apples; Net Wt: 4 oz. Crispy slices of Granny-Smith Apples in Semi-sweet chocolate. Ingredient: Dark chocolate (cocoa beans, sugar, cocoa butter, soy lechthin (emulsifier), natural vanilla extract), apple, sugar, lime. CONTAINS: Soy Also has sticker: May Contain Dairy Made on equipment also shared… (82295) | Confections by Michael Recchiuti | Food | Class I | 1 |
| 1 Mar 2019 | El Rey Chocolitas 12.69oz (360gr) and 2.2lb (1 Kg) (82334) | Individual firm, name withheld | Food | Class II | 1 |
| 28 Feb 2019 | Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India | Camber Pharmaceuticals Inc | Drug | Class II | 3 |
| 28 Feb 2019 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59746-758-90) bottles, Rx only, Manufactured b Jubilant Generis Ltd, Roorkee, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 26 Feb 2019 | Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01. | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 25 Feb 2019 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: (1) Pulmonary thromboembolism when… | Cook Medical Incorporated | Device | Class III | 6 |
| 25 Feb 2019 | Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07 | Macleods Pharma Usa Inc | Drug | Class II | 3 |
| 25 Feb 2019 | JOY NATURAL TAMARIND CONCENTRATE Net Wt.: 14FL OZ. (400g), UPC: 6 80617 60020 8 and Net Wt.: 32 FL Oz. (915g) UPC: 6 80617 60021 5 | JOY GOURMET FOODS LLC | Food | Class II | 11 |
| 25 Feb 2019 | Signature Caf¿ Tomato Basil Bisque Soup: polypropylene cups with linear low density polyethylene caps, and with plastic film seal. NET WT: 24 oz. (1 lb.. 8 oz.) 680 g Perishable, Keep Refrigerated. UPC 0002113015645 Distributed by: Lucerne Foods, Inc., P. P. Box 99, Pleasanton, CA 94566-0009 | Albertsons Companies LLC | Food | Class II | 1 |
| 22 Feb 2019 | Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-450-05. | Ascend Laboratories LLC | Drug | Class II | 1 |
| 22 Feb 2019 | Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G Co., LTD, Head office: J29 Vo Thi Sau Street, Thong Nhat Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Manufactory: 148/9 Tan Tien Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Product… (82246) | Individual firm, name withheld | Drug | Class I | 1 |
| 22 Feb 2019 | Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10. | Akorn, Inc. | Drug | Class II | 1 |
| 22 Feb 2019 | Nova Salted Biscuit The product comes in a 14.08 ounce, paper box marked with manufacturing date of Apr 2018 and expiration date of June 2020 stamped on the side. (82293) | Asia Food Distributor | Food | Class I | 1 |
| 21 Feb 2019 | Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37 | Lannett Company Inc. | Drug | Class III | 1 |
| 21 Feb 2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10 | Macleods Pharma Usa Inc | Drug | Class II | 1 |
| 20 Feb 2019 | Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl. Oz. (1 QT) 946 mL bottle, Distributed By: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256 NDC 53943-871-45 UPC 0-93351-12758-8 | Vi-Jon, Inc. | Drug | Class II | 1 |
| 20 Feb 2019 | Meijer Ultimate Chocolate Mint Chip Cookie Cookies in clear plastic clamshell 12 count UPC 4125014563 20 count UPC 4125014564 | Meijer | Food | Class II | 1 |
| 20 Feb 2019 | Best Choice Pancake & Waffle Complete Mix Original 32oz. retail carton, 12 retail units per wholesale case. UPC# 70038 30212 | Gilster-Mary Lee Corp. | Food | Class II | 1 |
| 20 Feb 2019 | Victoria Marinara Sauce, 40 oz. (2.5 lb) 1133g, 6Jars / Case | B&G Foods North America, Inc | Food | Class I | 1 |
| 20 Feb 2019 | The London Underground Classic Chicken Salad, Whole Foods Market, Net Wt 6.2 oz (176g) | LEAN CULINARY SERVICES, LLC | Food | Class I | 4 |
| 19 Feb 2019 | smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510 | Smith & Nephew, Inc. | Device | Class II | 2 |
| 19 Feb 2019 | Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35. (82229) | Leiter's Enterprises, Inc. | Drug | Class II | 1 |
| 19 Feb 2019 | Marketside GREEN BEANS NET WT 12 OZ (340g) and Marketside GREEN BEANS NET WT 32 OZ (2 LB) 907g | Southern Specialties, Inc | Food | Class II | 4 |
| 16 Feb 2019 | Concord Fresh Success Mild Salsa Seasoning Mix, Packaged in a NET WT 1.05 OZ (30g) packet, UPC: 0 4140900229 5 (82192) | Concord Foods, LLC | Food | Class II | 1 |
| 15 Feb 2019 | Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures… (82244) | Covidien, PLC | Device | Class II | 1 |
| 15 Feb 2019 | Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31 | Heritage Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 15 Feb 2019 | Hot Smoked Salmon Variety Pack. ITEM # F3120SS9, Aldi ID# 51326. Each master case contains 12/4 oz. packs (4 packs of each flavor - Traditional, Cracked Black Pepper, and Cajun Flavored). Traditional, Hot Smoked Salmon, 4 oz. UPC 041498234881. Cajun Flavored, Hot Smoked Salmon, 4 oz. UPC 041498234904. Cracked Black… | Ocean Beauty Seafoods LLC | Food | Class II | 1 |
| 15 Feb 2019 | Nature's Path Organic Chocolate Choco Chimps Organic cereal. Net Wt. 10 oz (284 g), UPC 58449-87024. Nature's Path Foods, Inc., Blaine, WA 98230 | Nature'S Path Foods Inc | Food | Class II | 3 |
| 15 Feb 2019 | Gasc¿ Golden Egg Yellow Shade Food Color, Contains: 32 fl. oz. (946 mL) | Gasco Industrial, Corp. | Food | Class II | 2 |
| 15 Feb 2019 | Nita Crisp Spelt Bread Cracker, 8- & 16-ounce bags, In paper bags with a plastic window and has a re-closable ability and safety sealed. Storage: Ambient & Dry (82199) | Nita Foods Inc. | Food | Class II | 1 |
| 14 Feb 2019 | Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within… | ACell, Inc | Device | Class II | 2 |
| 13 Feb 2019 | Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gram powder (UPC 00859667007125), c) 100 gram powder (UPC 00859667007132), Sunstone Organics Springfield, Oregon 97473, 541-972-3327. | Todd Holiday dba Sunstone Organics | Drug | Class I | 4 |
| 13 Feb 2019 | JANSAL VALLEY DUKKAH NET WT 2.5 oz. (71 G). The product is packaged in a circular tin can with a clear lid. UPC: 7 08152 31773 0. | Friendly Fruit Market dba Sid Wainer & Son | Food | Class II | 1 |
| 13 Feb 2019 | Big Daddy s Bold Cheese Pizza, item No. 78985. 3-Pack. Contains 9-44.53 oz. Pizzas. Net Wt. 25.04 Lbs. (11.36 kg) For Institutional Use. Cook Before Serving. Keep Frozen. Manufactured by: SPC Global Supply Chain, Inc. Marshall, MN 56258 (82186) | Schwan's Global Supply Chain, Inc., Specialy Foods Plant | Food | Class II | 1 |
| 13 Feb 2019 | Smoked Silver Salmon, brand Smoked Alaska, packaged in 6.5 oz. glass jars or cans. The product label is read in parts: "***SMOKED WILD ALASKA SILVER SALMON*** SMOKED ALASKA*** NET WT. 6.5 OZS. Ingredients: Natural Alder Smoked Silver Salmon, Brown Sugar, Salt *** PO BOX 870250 WASILLA, AK 99687***" (82213) | Smoked Alaska Seafoods | Food | Class II | 1 |
| 12 Feb 2019 | Zarrin Pickled Cucumbers & Cornichons: Net Weight 101.4 oz. 3 kg. Ingredients: Cucumber, water, salt, acid (acetic acid, spices, food coloring (tartrazine). Refrigerate after opening. UPC 7 64363 18305 2 Product of the West Bank Packed for Blanish International, PO Box 20338, San Jose, CA 95160 www.zarrinfood.com | Kradjian Importing Co | Food | Class II | 2 |
| 12 Feb 2019 | Montmorency Tart Cherry Concentrate 100% Juice 32-oz bottle (sold individual and 12 per case), 16-oz bottle (sold individual and 12 per case), and 1-oz packet (sold individual and per 25, 50, 100, 250, 300, and 1000) (82091) | King Orchards | Food | Class II | 1 |
| 12 Feb 2019 | Nature's Nectar High Pulp Orange Juice, Never from Concentrate. Item # 420025. Pasteurized. Net 52 FL OZ (1.6 QT) 1.53L. Kosher. UPC 4 099100 056907. Keep Refrigerated. Distributed by Aldi, Inc. Batavia, IL 60510. (82141) | Citrus Systems Inc | Food | Class II | 1 |
| 12 Feb 2019 | Aldi Bake Shop Lemon Loaf Cake 16 oz clear clam shell, 6 per tray (each tray includes 6 lemon loaf and 6 banana loaf) UPC 4099100018523 (82145) | GOLD COAST BAKERY | Food | Class II | 1 |
| 8 Feb 2019 | Monaco Radiation Treatment Planning (RTP) System | Elekta, Inc. | Device | Class II | 1 |
| 8 Feb 2019 | Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omnia is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnosis, endourology and minimal invasive urology/surgery). | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 8 Feb 2019 | Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric… | Draegar Medical Systems, Inc. | Device | Class II | 2 |
| 8 Feb 2019 | Watermelon, WTRMLNWTR Cold Pressured, 12fl oz, Watermelon Flavor, Refrigerated (82115) | World Waters, LLC dba WTRMLN WTR | Food | Class II | 1 |
| 7 Feb 2019 | DG Baby Gripe Water herbal supplement with organic ginger and fennel extracts, 4 FL OZ (120 mL) Liquid Dietary Supplement UPC: 8 54954 00246 3 | Kingston Pharma LLC | Food | Class I | 1 |
| 7 Feb 2019 | Craft Granola Goldenola Turmeric & Ginger, packaged in 3 oz. and 11 oz. poly bag, UPC: 860157002028 and 8601570020135 (82107) | Birdseed Food Co LLC | Food | Class II | 1 |
| 4 Feb 2019 | Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues. | CP Medical Inc | Device | Class II | 1 |
| 4 Feb 2019 | US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs. | US Endoscopy Group Inc | Device | Class II | 1 |
| 4 Feb 2019 | Stacy's Simply Naked Pita Chips 7 1/3 ounce bags | Frito-Lay, Inc. | Food | Class I | 1 |
| 1 Feb 2019 | Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures. | Cook Inc. | Device | Class I | 1 |
| 1 Feb 2019 | NexGenTrabecular Metal Tibial Half Block Augment, Right Lateral/Left Medial, Size 4 5MM Thickness W/Screws Item Number: 00544800426 Product Usage: The Trabecular Metal Tibial Cone Augments are intended for use where severe degeneration, trauma, or other pathology of the knee joint indicates total knee arthroplasty.… | Zimmer Trabecular Metal Technology, Inc. | Device | Class II | 2 |
| 1 Feb 2019 | LIFEPAK 15 Monitor/Defibrillator Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical… | Physio-Control Inc | Device | Class I | 2 |
| 1 Feb 2019 | Levoleucovorin Injection, 250 mg/25 mL, (10 mg/mL), 25 mL Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 U.S.A., Made in India. NDC: 67457-601-30 | Mylan Institutional Inc | Drug | Class I | 1 |
| 1 Feb 2019 | Hikari Enjuku Koji Miso Mutenka; 26.6 oz. plastic tub with lid. UPC 4 905663 003007 (82306) | Hikari Miso International, Inc. | Food | Class III | 1 |
| 1 Feb 2019 | Whole Foods Hipster Chipster Cookies; 9 oz. container with 6 cookies; UPC 0247449 006990 Sold at Whole Foods, Yulupa Ave., Santa Rosa, CA | Whole Foods Market | Food | Class I | 1 |
| 31 Jan 2019 | Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use | Microbiologics Inc | Device | Class II | 1 |
| 29 Jan 2019 | Prolact CR; Human Milk Caloric Fortifier (Human, Pasteurized); Product Code: 94000-10 4 - 10 mL (0.3 fl. oz) Bottles, Net 40 mL (1.2 fl.oz. Intended for premature/LBW Infants fed human milk. Ingredients: Human milk cream and human milk ultrafiltration permeate. Manufactured by: Prolacta Bioscience, Inc., City of… (82034) | Individual firm, name withheld | Food | Class III | 1 |
| 25 Jan 2019 | PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and… (82123) | Individual firm, name withheld | Device | Class III | 1 |
| 24 Jan 2019 | AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility | Maquet Cardiovascular, LLC | Device | Class II | 1 |
| 24 Jan 2019 | Mediterranean Stuffed Salmon packaged in plastic nonflexible containers | Whole Foods Market | Food | Class I | 34 |
| 22 Jan 2019 | VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 22 Jan 2019 | Good Neighbor Pharmacy, Co Q10 200mg Capsule, Dietary Supplement, UPC: 0-87701-40817-5, 30 capsules. | Twenty-First Century Healthcare, Inc | Food | Class III | 2 |
| 22 Jan 2019 | Gilda Industries, Panque - Butter Pound Cake, Manufactured by and Distributed for Gilda Industries (82075) | Gilda Industries, Inc. | Food | Class II | 1 |
| 21 Jan 2019 | Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty | Stryker GmbH | Device | Class II | 1 |
| 21 Jan 2019 | Simple Truth Organic Banana, Strawberry & Apple Fruit Puree with Nonfat Greek Yogurt, 113 g, packed in a laminate pouch, Each case has 6 cartons with 6 pouches per carton. Total of 36 pouches per case. | Perrigo Company PLC | Food | Class II | 1 |
| 18 Jan 2019 | Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20 | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Drug | Class II | 1 |
| 17 Jan 2019 | JANSAL VALLEY Cocoa Dusted Chocolate Covered Almonds, Net Weight: 6 OZ (170 G), packed in a plastic clamshell, UPC: 7 08152 32988 7 | Friendly Fruit Market dba Sid Wainer & Son | Food | Class II | 1 |
| 17 Jan 2019 | Klaire Labs Melatonin Lozenge Formula Fast Dissolving 1 mg tablets; Packed in a 75 cc HDPE Bottle 60 Tablets UPC: 8 28054 17845 8; SKU: ML1 (82010) | ProThera, Inc. dba SFI USA | Food | Class III | 1 |
| 16 Jan 2019 | Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10 (81943) | Rx Pak Division of McKesson Corporation | Drug | Class II | 1 |
| 16 Jan 2019 | Tegral Satin Gold CL Cr¿me Cake, packaged in 50 lb. bag. (81947) | Puratos Corporation | Food | Class I | 1 |
| 15 Jan 2019 | Fujifilm FDR Go PLUS, Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR)> | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 15 Jan 2019 | Ottogi Ramen Sari (Extra Noodle) 3.88oz x 48ea Item #21101009 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249 | Ottogi America Inc | Food | Class I | 17 |
| 14 Jan 2019 | BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a… | Shimadzu Medical Systems Usa Com | Device | Class II | 1 |
| 14 Jan 2019 | SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR). | Shimadzu Medical Systems Usa Com | Device | Class II | 1 |
| 14 Jan 2019 | BD MAX Enteric Bacterial Panel -For In Vitro Diagnostic Use with the BD MAX System Catalog Number: 442963 The BD MAX Enteric Bacterial Panel performed on the BD MAX System is an automated in vitro diagnostic test for the direct qualitative detection and differentiation of enteric bacterial pathogens. | Becton Dickinson & Co. | Device | Class II | 1 |
| 11 Jan 2019 | aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use. | AAP Implantate Ag | Device | Class II | 1 |
| 11 Jan 2019 | Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AST-N248, REF 413397, l) ASR-GN67, REF 413399, m)… (81934) | Organon Teknika Inc | Device | Class II | 1 |
| 9 Jan 2019 | Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically, forceps may be used in conditions where it is… | ConvaTec, Inc | Device | Class II | 4 |
| 8 Jan 2019 | Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights. | GETINGE US SALES LLC | Device | Class II | 4 |
| 7 Jan 2019 | AVE 2 Birthing Bed | Linet Spol. S.r.o. | Device | Class II | 1 |
| 3 Jan 2019 | icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. | ICU Medical, Inc. | Device | Class I | 1 |
| 3 Jan 2019 | Organic Green Beans, 1" cut, IQF 1500# tote (82073) | Arbre Farms, Inc. | Food | Class II | 1 |
| 2 Jan 2019 | ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine. | Abbott Laboratories, Inc | Device | Class II | 1 |
| 31 Dec 2018 | Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90 | Aurobindo Pharma USA Inc. | Drug | Class II | 5 |
| 27 Dec 2018 | Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent. | Cardinal Health 200, LLC | Device | Class II | 1 |
| 26 Dec 2018 | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220 | Boston Scientific Corporation | Device | Class II | 2 |
| 21 Dec 2018 | Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 21 Dec 2018 | Prodiva CS, Model Number 781069. Nuclear Magnetic Resonance Imaging System | Philips Medical Systems Nederlands | Device | Class II | 64 |
| 21 Dec 2018 | Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764 | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 21 Dec 2018 | Wild Dungeness Crab Cake; Net Weight: 12 lb - 48 x 4.0 oz. Keep Frozen Manufactured for Whole Foods Market | Southwind Foods LLC dba Great American Seafood Imports Co. | Food | Class I | 1 |
| 20 Dec 2018 | AMSCO 3000 Series Washer/Disinfector Model # 3052 | Steris Corporation | Device | Class II | 2 |
| 20 Dec 2018 | The WinStation Retinal Imager, also known as Merge Eye Station. DCF-1024 & DCF-512 Digital Imaging System Product Usage: The WinStation Retinal Imager has the same intended use as other fundus cameras. It is specifically used to produce color or black and white images of the retina (fundus imaging) and anterior… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 20 Dec 2018 | Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222 | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 20 Dec 2018 | Phoenix AST-s Indicator, Catalog Number 246009 | Becton Dickinson & Co. | Device | Class II | 3 |
| 19 Dec 2018 | Durex Real Feel, synthetic polisoprene male condom, SKU 02340-89456-14 02340-89455-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-95767-00 02340-89456-14 02340-89457-00 02340-89456-14 02340-89456-14 02340-89455-00 02340-89455-00 02340-95767-00 02340-95767-00 | Reckitt Benckiser LLC | Device | Class II | 2 |
| 19 Dec 2018 | Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Order Number G35569 The Entuit Secure Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the stomach to the abdominal wall prior to the introduction of interventional catheters. | Cook Inc. | Device | Class II | 2 |
| 19 Dec 2018 | Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875 (82305) | Roberts Home Medical LLC | Drug | Class II | 1 |
| 19 Dec 2018 | Finax Muesli with Nuts and fruit 22.9-oz. Heat sealed plastic bag; 10 bags/case UPC: 7311142201402 (82327) | Chicago Importing Co | Food | Class II | 1 |
| 18 Dec 2018 | Produce Packaging, Inc. Cauliflower, Rice 6/11 oz | Produce Packaging Inc | Food | Class I | 22 |
| 17 Dec 2018 | Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract. | Olympus Corporation of the Americas | Device | Class II | 4 |
| 14 Dec 2018 | Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated… (81973) | BrosMed Medical Co.,Ltd. | Device | Class II | 1 |
| 14 Dec 2018 | Draco Enzymatic Deep-Cleaning Pads, Product Number HY0305Z Product Usage: Multi-tiered enzymatic detergent contains lipase, carbohydrase, amylase and protease. It effectively dissolves blood, fat, tissue, protein and most other forms of organic material Ready to use. Non-toxic, latex-free and neutral pH. Safe to use… (81971) | Individual firm, name withheld | Device | Class II | 1 |
| 12 Dec 2018 | Dimension Vista 500, Analyzer, chemistry Model no. 10284473 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 11 Dec 2018 | DAHlicious ORGANIC Lassi India -Style DRINKABLE YOGURT, Grassland Plain, , 32 FL OZ (946 mL), UPC: 7 93573 01459 7 | DAHLICIOUS | Food | Class II | 2 |
| 7 Dec 2018 | Planetary Herbals Mullein Lung Complex; 1000 mg; 15 count, item number PF0003; 90 count - Item number PF0002; 180 count, Item number PF0106 and 90 + 90 count, PF 7013 white plastic bottles. Proprietary Blend: Platycodon root, Ophiopagon Rhizome, Long Pepper Fruit, Black Cherry Bark, Cassia Bark, Elecampane Root,… | Threshold Enterprises Ltd | Food | Class II | 1 |
| 5 Dec 2018 | Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty,anatomic hemi-arthroplasty,or reverse total arthroplasty is determined by the surgeon to be the… | Exactech, Inc. | Device | Class II | 1 |
| 4 Dec 2018 | Diatomaceous Earth packaged in the following ways: 1) Perma-Guard, Fossil Shell Flour, Anti-caking agent, Food Chemical Codex Grade, Weight: 50 lb/22.6 kg, Bountiful, UT; 2) 100% Food Grade Diatomaceous Earth, Shell Flour, Packaged by: Earthworks Health, Norfolk, NE, Net Weight 2.5 Pounds 3) 100% Food Grade… (81662) | Earthworks Health | Food | Class II | 1 |
| 3 Dec 2018 | Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems. | Randox Laboratories Ltd. | Device | Class II | 3 |
| 3 Dec 2018 | C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifically for endoscopic application and the ablation of dysplastic Barrett s Esophagus. | PENTAX of America Inc | Device | Class II | 1 |
| 29 Nov 2018 | Sensis Vibe System, Model Number 11007642, with software version VD10B. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 21 Nov 2018 | Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK BASIC VIII CFH - 2073903, Tray Number: LSRCFBVIIIPKE; d. Tray… | American Contract Systems, Inc. | Device | Class II | 1 |
| 13 Nov 2018 | Raindrop Near Vision Inlay, REF: RD1-1, Sterile, Rx Only, Manufacturer ReVision Optics, Inc. (81812) | RVO 2.0, INC | Device | Class I | 1 |
| 2 Oct 2018 | AF w/AS 550 x 1-14ML/HR CPNB, Product code MVBXL- CPNB, Arrow AutoFuser Disposable Pain Control Pump | Arrow International Inc | Device | Class II | 17 |
| 30 Jul 2018 | Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the… | Zimmer Biomet Spine Inc. | Device | Class II | 3 |
| 27 Jul 2018 | Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures… | Stryker Sustainability Solutions | Device | Class II | 1 |
| 20 Jul 2018 | Dr. King's aquaflora Candida High Potency, 8 fl. oz. (236 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 35795580018, NDC 57955-8020-89 | King Bio Inc. | Drug | Class I | 465 |
| 17 Jul 2018 | Alcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification visualization during ophthalmic surgical procedures for cataract, retina and cornea. (82024) | Alcon Research Laboratories Ltd. | Device | Class II | 1 |
| 5 Jul 2018 | CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050 | CTL Medical Corporation | Device | Class II | 2 |
| 3 Jul 2018 | PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices). (82015) | Individual firm, name withheld | Device | Class II | 1 |
| 21 Jun 2018 | Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK | Individual firm, name withheld | Device | Class II | 8 |