| 10 Jul 2017 | Sooji Coarse, Siva's brand, packaged in 2 lbs. and 4 lbs poly bags. UPC for 2 lbs. package is 8 46499 00316 1 UPC for 4 lbs. package is 8 46499 00186 5. The label is read in parts: "***Ingredients: Sooji Coarse***Siva's***LOW FAT, GOOD SOURCE OF IRON, SOURCE OF FIBER, CHOLESTEROL FREE***Imported & Marketed by… Event 77714 | Reshmi's Group Inc. | Food | Class II | 1 |
| 6 Jul 2017 | 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02. | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 6 Jul 2017 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01 | Hospira Inc., A Pfizer Company | Drug | Class III | 1 |
| 6 Jul 2017 | 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38 | Baxter Healthcare Corporation | Drug | Class II | 2 |
| 29 Jun 2017 | Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56 | Teva Pharmaceuticals USA | Drug | Class III | 2 |
| 28 Jun 2017 | parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigingivitis Toothpaste, 0.454% (0.15% w/v fluoride ion), 3.4 OZ (96.4 g) tube, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059, NDC 0135-0601-01. | GSK Consumer Healthcare | Drug | Class II | 1 |
| 28 Jun 2017 | Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only, Distributed by OMP, Inc., Long Beach, CA Made in USA, NDC 62032-222-02 | Valeant Pharmaceuticals North America LLC | Drug | Class III | 1 |
| 28 Jun 2017 | Starbucks PB & J Fruit and Veggies 7.4 oz. (210 g) UPC: 7 62111 23607 4 | Taylor Farms Texas, Inc. | Food | Class II | 1 |
| 26 Jun 2017 | Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL, 10 mL Total Volume in BD Syringe, For IV Use, PharMedium Services, LLC, Cleveland, MS --- NDC 61553-364-65 | PharMedium Services, Llc | Drug | Class II | 13 |
| 26 Jun 2017 | NatureBox Mini Crispy Snickerdoodles: Cinnamon-sugar cookies made with whole wheat. Contains: Wheat, Milk and Egg. | NatureBox, Inc. | Food | Class II | 1 |
| 22 Jun 2017 | Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06 | Lupin Pharmaceuticals Inc. | Drug | Class III | 1 |
| 22 Jun 2017 | QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. | Advanced Pharma Inc. | Drug | Class II | 4 |
| 21 Jun 2017 | MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are… | Elekta, Inc. | Device | Class II | 1 |
| 21 Jun 2017 | Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40 | SCA Pharmaceuticals | Drug | Class II | 4 |
| 21 Jun 2017 | Cristina” brand Egg Crackers (Galletas de Huevo), 4OZ, Clear plastic/film type bag, ready-to-eat, dry/ambient storage Event 77493 | Cracker King Corp. | Food | Class II | 1 |
| 21 Jun 2017 | Peanut Patties 2.5 oz. wrapped in cellophane | Name withheld | Food | Class II | 7 |
| 21 Jun 2017 | The Smokehouse of NY Smoked Norwegian Fish packaged as: 4oz & 8oz and whole sides Event 77656 | The Smokehouse of New York, LLC. | Food | Class I | 1 |
| 20 Jun 2017 | Futaba Sesame Hijiki Rice Seasoning; 2.29 oz. glass jar; 4 902533 023173 | J F C International Inc | Food | Class I | 1 |
| 19 Jun 2017 | Nussloch GmbH ASP6025 Tissue Processor | Leica Microsystems, Inc. | Device | Class II | 1 |
| 19 Jun 2017 | Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat… | Nova Biomedical Corporation | Device | Class II | 1 |
| 19 Jun 2017 | Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405 Event 77584 | Fagron Compounding Services LLC dba Fagron Sterile Services | Drug | Class II | 1 |
| 16 Jun 2017 | Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540 | Sandoz Incorporated | Drug | Class III | 1 |
| 16 Jun 2017 | Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc., Pine Brook, NJ 07058, NDC 47781-462-69 | Alvogen, Inc | Drug | Class II | 3 |
| 16 Jun 2017 | Cape Cod Cranberry Trail Mix; 25 lbs. bulk containers; cardboard box; expiration date 11/18/17. Event 77649 | Hmshost | Food | Class I | 1 |
| 16 Jun 2017 | Cost Plus World Market My Favorite Macadamia Pancake and Waffle Mix, 24 oz. UPC Codes: 496960 | New Hope Mills Mfg., Inc. | Food | Class II | 1 |
| 16 Jun 2017 | Masas Gourmet Sweet and Sour Sauce, packaged in a glass jar with gold metal cap, net wt. 12 oz. (355 mL), UPC 786764406783 | Rikki USA, Inc. | Food | Class I | 3 |
| 16 Jun 2017 | Pacific Wave Frozen Tuna Loins; 30# case. Imported by Unified Seafood Co., Inc. www.unifiedseafood.com Event 77572 | Unified Seafood Company., Inc. | Food | Class I | 1 |
| 15 Jun 2017 | Ian’s Italian Panko Breadcrumb 9 oz UPC 4951277220 Event 77495 | Elevation Brands, LLC | Food | Class II | 1 |
| 15 Jun 2017 | Publix Tropical Fruit Medley, NET WT. 5.7 OZ (161.6g), Packaged and Distributed by Publix Super Markets, Inc., Lakeland, FL 33802 Event 77568 | Publix Bakery Plant | Food | Class I | 1 |
| 14 Jun 2017 | ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in… | Arjo, Inc. dba ArjoHuntleigh | Device | Class II | 1 |
| 14 Jun 2017 | go macro MACROBAR, coconut + almond butter + chocolate chips, in the following sizes: 1. Net Wt 0.9 oz / 25 G minbar, UPC 8 53555-00671 9 and 2. net Wt 2.3 oz / 65 G, UPC 8 53555-00668 9 | GoMacro, Inc. | Food | Class II | 3 |
| 14 Jun 2017 | New England Natural Bakers Organic Muesli -5lb and 25 lb. cases UPC: 00046689225013 | New England Natural Bakers, Inc. | Food | Class I | 4 |
| 14 Jun 2017 | Fudge Brownie Collagen Protein Bar. Each bar is packed in foil wrapper, net wt. per bar 1.58 oz (45g). There 12 bars packed in a box and the net wt. per box is 18.96 oz (540g). Individual Bar UPC 815709021498. Box UPC 815709020811. | Bulletproof 360 Inc | Food | Class I | 5 |
| 14 Jun 2017 | YouBar Whole Food Bar, Chocolate Peanut Butter; 1.58 oz. (45g); Gluten Free, Non GMO, Vegan; 12 bars per box Manufactured by YouBar Inc. Monterey Park, CA. | YouBar | Food | Class I | 33 |
| 14 Jun 2017 | Pacific Wave Yellow Fin Tuna loins; 30 lb. cases. Product of Indonesia; Imported by Unified Seafood Co., Inc. Event 77573 | P & E Foods Inc | Food | Class I | 1 |
| 14 Jun 2017 | Wildway Apple Cinnamon Grain-Free Granola 8 oz and 10 oz UPC: 85866005190 and UPC: 864352000015 packaged in plastic bag | Wildway LLC | Food | Class I | 5 |
| 13 Jun 2017 | Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication… | Merge Healthcare, Inc. | Device | Class II | 1 |
| 13 Jun 2017 | CVS Health Baby Eczema Moisturizing Cream(colloidal oatmeal 1.0%), Net Wt. 7.3 oz (207g) tubes, OTC, Distributed by CVS Pharmacy Inc., Woonsocket, RI --- UPC 050428568033 Event 77591 | Sigan Industries Inc. | Drug | Class II | 1 |
| 13 Jun 2017 | BAKEMARK CANADA White Cross Topping Mix 10 lb 4.54 kg; BakeMark NDS Item Code: 50623; UPC: 0 64278 50623 7 Event 77630 | Bakemark Ingredients Canada Lt | Food | Class II | 1 |
| 13 Jun 2017 | MEIJER ULTRA TRAIL MIX 18 OZ plastic pouch | Meijer Distribution, Inc | Food | Class III | 2 |
| 13 Jun 2017 | Simple truth Dry Roasted Macadamia Nuts 12 oz bags UPC 0 1111 00247 8 DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 Event 77549 | Kroger Corporate Food Technology Laboratory | Food | Class I | 1 |
| 12 Jun 2017 | Alaris PC Unit, Model 8015 | CareFusion 303, Inc. | Device | Class II | 1 |
| 12 Jun 2017 | Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology | Arrow International Inc | Device | Class II | 2 |
| 12 Jun 2017 | Alaris Pump Module model 8100 | CareFusion 303, Inc. | Device | Class II | 1 |
| 12 Jun 2017 | Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8. | Sanofi-Aventis U.S. LLC | Drug | Class III | 1 |
| 12 Jun 2017 | LA PASTA Dairy-Free Mushroom Ravioli, UPC 07970602217-3 , LOT #1536 Event 77547 | La Pasta, Inc. | Food | Class II | 1 |
| 12 Jun 2017 | Chili Pequino 0.25 oz packaged in a clear plastic bag; Product Code 10106 Event 77522 | Bolner's Fiesta Products, Inc | Food | Class II | 1 |
| 11 Jun 2017 | FIT&FOCUSED SUPPLEMENTS CLA 3000mg CONJUGATED LINOLEIC ACID LEAN BODY FORUMLA 135 SOFTGELS; UPC: 7 28028 44036 2 Event 77536 | Fit and Focused Supplements | Food | Class I | 1 |
| 9 Jun 2017 | Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for… | Penumbra Inc. | Device | Class I | 1 |
| 9 Jun 2017 | Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc. | Natus Neurology Inc | Device | Class II | 4 |
| 9 Jun 2017 | Giant Eagle; Toasted Crumb Tilapia; various weights; Dist. By: Giant Eagle, Inc., Pittsburgh, PA PLU #69123. UPC: 691237 0054548 | Giant Eagle, Inc. | Food | Class II | 1 |
| 9 Jun 2017 | Tempo Seafood Bake - Lemon Dill- packaged in 3.5 oz. (99g), small corrugated boxes containing one pouch of breadcrumb seasoning Item Code: 30281 UPC Code: 0 41409 00040 6 Event 77494 | Concord Foods, LLC | Food | Class II | 1 |
| 9 Jun 2017 | Green Tea Ice Cream: Sold under the brand names of: Trader Joe's Brand Matcha- 1 quart tubs, SKU 055740; Shirakiku brand Matcha and Fukuya brand, both in 3 gallon foodservice tubs. | Mikawaya | Food | Class II | 2 |
| 9 Jun 2017 | Classic Delight Ham & Cheese Net Wt. 4.0 oz (113 g) Contains: Wheat, Soy, Milk Distributed by Classic Delight Inc., St. Marys, OH 45885 UPC 0 20018 03226 8 | Classic Delight Inc | Food | Class I | 2 |
| 8 Jun 2017 | Tetracycline-ABC Brand Topical ointment First Aid Antibiotic, tetracycline (3%), 3 mL in a 5 mL bottle, sold over the counter Phillips Company, Millerton, OK -- NDC 4307410201 | Phillips Co. | Drug | Class II | 6 |
| 8 Jun 2017 | Robin Hood All Purpose Flour 1.8kg retial Pouch 6/1.8kg retial pouches per wholesale case Event 77501 | Element Food Solutions | Food | Class I | 1 |
| 8 Jun 2017 | Don's Salads; Egg Salad; Net Wt. 5 lbs., MFGD by Aldon Food Corp, Schwenksville, PA 19473; Sell by dates: 6/7, 6/9, 6/13, 6/15; UPC: 740247005061; AND; Block & Barrel Classic Egg Salad; Net Wt. 5 lbs; Distributed by Sysco Corporation, Houston, TX 77077; Sell By Dates: 6/7, 6/9, 6/13, 6/15; UPC: 074865655316; | Aldon Food Corp. dba Don's Salads & Don's Food Products | Food | Class II | 3 |
| 8 Jun 2017 | AMERICAS CHOICE B/D SHRIMP BEER BATTERED POPCORN 12/14 OZ | National Fish & Seafood, Inc. | Food | Class II | 33 |
| 7 Jun 2017 | DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure. | DeRoyal Industries Inc | Device | Class II | 1 |
| 7 Jun 2017 | MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures. | Mako Surgical Corporation | Device | Class II | 1 |
| 7 Jun 2017 | Amodio's Toasted Coconut Panko sold in an 8 oz bags packaged in cases of 8. Event 77475 | Amodio's, Inc. | Food | Class II | 1 |
| 7 Jun 2017 | Sea Watch Brand Beer Battered Clam Strips Pack Size: 24/4 oz. bags/case | Sea Watch International Ltd | Food | Class II | 4 |
| 7 Jun 2017 | Thin Cut Regular Batter: BLUE ACRES BATTERED ONION RINGS, NET WT. 10 lb (4.54 kg) - 33049; ATLANTIC GOLD BATTERED ONION RINGS NET WT. 4/2.5 lb (1.13 kg) 10 lb (4.54 kg) - 33219; ATLANTIC GOLD Regular Battered Onion Rings 4-40oz (2.5 lb) 1.13kg Packages (Net Weight 10 lb (4.54kg)) - 33205; RED LION BATTERED ONION… | Oxford Frozen Foods Plant 1 | Food | Class II | 6 |
| 7 Jun 2017 | Gourmet Bay - Toasted Crumb Breaded Tilapia, 5-7 oz. (Bulk 5 lbs container) refrigerated Product Code: 7396701 | Slade Gorton & Company, Inc. | Food | Class II | 3 |
| 7 Jun 2017 | Code: LM290; Keep Frozen; Lucky's Maryland Style Crab Cakes: Net Wt. 13.5 lbs; 72-3OZ; packed for Lucky's Markets, Niwot, CO 80503; Lot # LM042717; - Sell By 10/27/18 | Wicks | Food | Class II | 3 |
| 7 Jun 2017 | Meduri Farms Dried Strawberries/Sugar Infused, Catalog # 010282. Dried Strawberries sugar infused packaged in a 10, 20 or 25 lbs. corrugated box or 10kg corrugated box with food grade plastic liner. The label is read in parts: "***INGREDIENTS: Strawberries, Sugar, Ascorbic Acid, Sunflower Oil***. Event 77507 | Meduri Farms Inc | Food | Class II | 1 |
| 7 Jun 2017 | Kite Hill Almond Yogurt, Peach, NET WT. 5.3 oz (150G) Case UPC: 8-56624-00415-9 Distributed by Lyrical Foods, Hayward, CA. | Lyrical Foods Inc | Food | Class II | 4 |
| 6 Jun 2017 | Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722 | Draegar Medical Systems, Inc. | Device | Class II | 1 |
| 6 Jun 2017 | Tuna Salad Sandwich under the following labels: Enzas Choice Tuna Salad on Wheat Bread, 6.6 0z UPC 73508757486 Hannaford Tuna Salad on Club Roll, 5.1 0z UPC 41268165889 | GREENCORE USA | Food | Class II | 3 |
| 6 Jun 2017 | BIRDS EYE CHILIES MJG # 8178, Polybags Net wt. 25 Kg (50-55 Lbs.) Imported from Madagascar Event 77502 | Morris J. Golombeck, Inc. | Food | Class II | 1 |
| 5 Jun 2017 | EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21 | Bristol-myers Squibb Company | Drug | Class I | 1 |
| 5 Jun 2017 | Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME. Event 77615 | Apothecary By Design | Drug | Class II | 1 |
| 5 Jun 2017 | Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two plastic 12FL OZ (355 mL) bottles connected by one paper sleeve, TOTAL 24 FL OZ (1.5 pt)(710 mL), OTC, Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015 | L. Perrigo Company | Drug | Class III | 1 |
| 5 Jun 2017 | Carrot Cake Slice: Net Wt. 0 LB 7 OZ (198 g). Cake is assembled, iced, sliced and packaged at store level. Sliced wrapped individually in clear plastic clamshell and sold in bakery department. UPC Code: 0222132-000000 Sold under Albertsons Companies retail banners of Vons, Pavilions, Lucky and Albertsons. | Albertsons Inc | Food | Class II | 1 |
| 2 Jun 2017 | Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a… | St. Jude Medical, Inc. | Device | Class II | 6 |
| 2 Jun 2017 | G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 0713-0656-15), b) 30 g tube (NDC 0713-0656-31, c) 45 g tube (NDC 0713-0656-37), d) 60 g tube (NDC 0713-0656-60), Rx Only, Manufactured by G & W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080 | G & W Laboratories, Inc. | Drug | Class III | 1 |
| 2 Jun 2017 | BAKEHOUSE BREAD ARTISAN CRANBERRY ORANGE BREAD, 16 OZ UPC 8 64934 00004 4 Bakehouse Bread Company Tucson, AZ Event 77434 | Kroger Corporate Food Technology Laboratory | Food | Class I | 1 |
| 2 Jun 2017 | PRIMO MOLINO ITALIAN STYLE ENRICHED FLOUR, 50 lb, Packaged in paper bags, Store at Ambient Temperature, produced on 10/31/16, Product code 15031 | Ardent Mills, LLC | Food | Class I | 1 |
| 1 Jun 2017 | Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300 | Boston Scientific Corporation | Device | Class II | 2 |
| 1 Jun 2017 | da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is designed to assist a surgeon in the accurate control of surgical instruments such as endoscopes, scissors, forceps, and retractors during endoscopic surgery. The system has four universal manipulators (arms) which allow the surgeon… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 1 Jun 2017 | Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged in a 500 cc container (NDC: 58597-8082-4), b) 100 g packaged in 16 oz container (NDC: 58597-8082-6), c) 500 g packaged in a 2500 cc container (NDC: 58597-8082-7) and a 1,000 g packaged in 1 gallon container (NDC: 58597-8082-8). For… | American Pharmaceutical Ingredients LLC | Drug | Class II | 1 |
| 1 Jun 2017 | Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16 Event 77443 | Xttrium Laboratories Inc | Drug | Class II | 1 |
| 1 Jun 2017 | Salinity sea salt Saltwell, Saltwell 57 and Saltwell for Organic Use 50 lb. bags Event 77491 | AB HANSON AND MOHRING | Food | Class III | 1 |
| 1 Jun 2017 | 1) Schnucks Bakery, Cinnamon Pudding Cake Slice, NET WT 6.0 oz (170 g); 2) Schnucks Bakery, Half Cinnamon Pudding Cake, NET WT 1.06 lb (482 g); | Schnucks Markets Corporate Office | Food | Class I | 2 |
| 31 May 2017 | 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is… | Encore Medical, Lp | Device | Class II | 2 |
| 31 May 2017 | Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19 Event 77393 | Teva Pharmaceuticals | Drug | Class I | 1 |
| 30 May 2017 | 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle… | ICU Medical, Inc. | Device | Class II | 9 |
| 30 May 2017 | LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM | Smith & Nephew, Inc. | Device | Class II | 2 |
| 30 May 2017 | ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774. Event 77424 | Name withheld | Device | Class II | 1 |
| 30 May 2017 | BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10 | Mckesson Packaging Services | Drug | Class III | 1 |
| 30 May 2017 | Taste of Inspirations; Greek Pasta Salad, Net Wt. 10 oz.; Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074; | ASK Foods Inc | Food | Class I | 1 |
| 28 May 2017 | Whole Foods Cranberry Couscous- packaged in Clear plastic clamshell for 6oz, 14oz and 18oz, and white plastic pail for 10lb. UPC Codes: 036217162613(6oz), 036217162514(14oz), 036217261408(18oz), 036217110317(10lb) | Hans Kissle Company, LLC | Food | Class II | 1 |
| 26 May 2017 | Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327 | American Pharmaceutical Ingredients LLC | Drug | Class II | 1 |
| 26 May 2017 | Flour sold under the following brands: Golden Temple Durum Atta Flour Blend, 20LB, DISTRIBUTED BY: SMUCKER FOODS OF CANADA CORP., MARKHAM, ON L3R 0P3 PRODUCT OF CANADA UPC 0 59000 41556 7, Swad Durum Atta Flour, 20 LB MILLED FOR: RAJA FOODS 8110 N. St. Louis Avenue Skokie, IL 60075 57-03, 48th Street Maspeth, NY… | Smucker Foods of Canada Co. | Food | Class I | 2 |
| 25 May 2017 | Logic Fit Tibial Tamp Head | Exactech, Inc. | Device | Class II | 1 |
| 25 May 2017 | EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01 | Exactech, Inc. | Device | Class II | 6 |
| 25 May 2017 | DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) and Catalog 1060177 (China only) -- COMMON/USUAL NAME: DRX-Revolution --- The DRX-Revolution is a mobile system used to generate and control X-Rays for diagnostic procedures | Carestream Health Inc | Device | Class II | 1 |
| 25 May 2017 | BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08. | AstraZeneca Pharmaceuticals, LP | Drug | Class I | 1 |
| 25 May 2017 | Fat Cat Purry-Purry Sauce, Net Weight: 5 oz (141g) Event 77455 | United Natural Foods, Inc. | Food | Class I | 1 |
| 24 May 2017 | Mefenamic Acid, 250mg capsules, packaged in 30-count bottles, Rx Only, Distributed by: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981, NDC 66993-070-30 | Shionogi Inc. | Drug | Class III | 2 |
| 24 May 2017 | SOUTH AFRICAN STYLE PERl PERl ROASTED SPICE PASTE INGREDIENTS: VINEGAR, JALAPENO PUR E;(jalapeno peppers, salt, vinegar), ONION, MINCED GARLIC (garlic, soybean oil, citric acid),PAPRIKA, CANOLA OIL, GRANULATED ONION, BIRDS EYE CHILl PEPPER, SALT,LEMON JUICE CONCENTRATE,SPICE, OIL OF LEMON AND ROSEMARY EXTRACT.… Event 77440 | Eatem Foods Company Vineland | Food | Class I | 1 |
| 23 May 2017 | ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E | Onkos Surgical, Inc. | Device | Class II | 3 |
| 23 May 2017 | SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position | Shimadzu Medical Systems Usa Com | Device | Class II | 3 |
| 23 May 2017 | Leksell Gamma Knife Icon is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g., metastatic tumors, recurrent glioblastomas, trigeminal neuralgia, medically refractory essential tremor, orbital tumors,… | Elekta, Inc. | Device | Class II | 1 |
| 23 May 2017 | Kroger Dessert Cups yellow sponge cakes NET WT 6.5 oz (184g) INGREDIENTS: ***NONFAT M ILK***CONTAINS: WHEAT, EGGS, SOY. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 800-632-6900 www.kroger.com UPC 0 11110 18550 1 | The Kroger Co | Food | Class I | 1 |
| 22 May 2017 | Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer… | Exactech, Inc. | Device | Class II | 1 |
| 22 May 2017 | PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823,… | Flowonix Medical, Inc. | Device | Class II | 1 |
| 22 May 2017 | 3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required. | 3M Company - Health Care Business | Device | Class II | 1 |
| 22 May 2017 | Coulter PrepPlus, Part Number 286600, Product Usage: The COULTER PrepPlus is a microprocessor-controlled pipetting and diluting system designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples. | Beckman Coulter Inc. | Device | Class II | 2 |
| 22 May 2017 | DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and… | Euro Diagnostica AB | Device | Class III | 1 |
| 22 May 2017 | The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160¿ - ~170¿ F for 30 minutes. Catalog Number/Description: 007168 PM3500 ASSY (15KW… | Natus Medical Incorporated | Device | Class II | 1 |
| 22 May 2017 | Ava's brand Organic Cashews Roasted & Salted 8 oz. tubs, UPC 8-10111-01035-1 | Severn Peanut Co., Inc. DBA Hampton Farms | Food | Class I | 3 |
| 19 May 2017 | Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO | Medacta Usa Inc | Device | Class II | 1 |
| 19 May 2017 | BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J | CryoLife, Inc. | Device | Class II | 1 |
| 19 May 2017 | Finola, Style Octopus in Pickled Sauce, Product of Spain, Wild Caught, Net Weight 4.1/10oz (115g), Empacado para:/Packaged for: Bacalafoods Corp., San Juan, PR 00936-8060 | Bacalafoods Corp | Food | Class II | 3 |
| 18 May 2017 | Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01 Event 77433 | Lantheus MI Radipharmaceuticals Inc. | Drug | Class III | 1 |
| 18 May 2017 | Dawn's Foods Tropical Fruit Dip. Nwt WT. 4 lbs. (1.82Kg) Keep Refrigerated. For Foodservice Use only. | Morski Brands, Inc. dba Dawn's Fresh Foods | Food | Class II | 1 |
| 18 May 2017 | HIPP Anti-Reflux AR Bio-Spezialnahrung, 500g (4/case) | 3CS ORGANICS LLC | Food | Class II | 9 |
| 18 May 2017 | Item 11952 - TURKEY HAM LUNCH>36 TRAYS/CS, Frozen, Net. Wt. 24.76 lbs. | Correctional Industries Food Factory | Food | Class III | 60 |
| 16 May 2017 | Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer, | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 16 May 2017 | Mr. Hyde, Fruit Punch, 30 servings; Mr. Hyde Fruit Punch (V2); Mr. Hyde 30 INT'L Fruit Punch; Mr. Hyde Fruit Punch RTD; Mr. Hyde V2 domestic Fruit Punch | ProSupps USA LLC | Food | Class II | 8 |
| 15 May 2017 | Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note:… Event 77267 | Perkinelmer Life Sciences, Inc. | Device | Class II | 1 |
| 15 May 2017 | VIDAS Testosterone, Ref 30418 | bioMerieux, Inc. | Device | Class II | 1 |
| 15 May 2017 | Beckman Coulter Synchron AQUA CAL Level 1, Part No. 471288 Product Usage: Used for the system calibration of Na, K, Cl, Urea N, Urea, Glucose Creatine, Ca, CO2, and P in UniCel DxC Systems. | Beckman Coulter Inc | Device | Class II | 1 |
| 14 May 2017 | Sabor Mexicano Homemade Corn Chips: Packaged in 12 oz. (9 units per case), UPC 8-53094-00417-7, and Fun size 5 oz. ( 12 units per case), UPC 8-53094-00418-4. Event 77504 | Name withheld | Food | Class II | 1 |
| 12 May 2017 | New Punjab Sweets, Jalebi | New Punjab Sweets Inc. | Food | Class II | 1 |
| 12 May 2017 | Nutri-Dyn Calcium D-Glucarate Plus, Dietary Supplement, 60 Capsules, UPC 7 13757-09611 9 Event 77432 | Nutri-Dyn Midwest, Inc. | Food | Class II | 1 |
| 11 May 2017 | De Mi Pais, Queso Fresco, Whole Milk Cheese, Net Wt 16 oz.. (1 lb) | Global Garlic, Inc. | Food | Class I | 2 |
| 10 May 2017 | Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958. | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 9 May 2017 | Covidien Endo Peanut 5mm Auto Suture Blunt Dissector Item Code: 173019 The instrument has indications in endoscopic surgery for swabbing small amounts of fluid or for blunt dissection of soft tissue(s) and structures, or as an aid in controlling minor intraoperative bleeding | Covidien LLC | Device | Class II | 1 |
| 9 May 2017 | Access Total T3, A34435H, Catalog No. 33830 | Beckman Coulter Inc. | Device | Class II | 4 |
| 8 May 2017 | Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two different purposes. They either serve as an extension between an EP catheter and equipment out of reach or they interface an EP… | Sterilmed Inc | Device | Class II | 1 |
| 8 May 2017 | GnuPharma Fit 100% Herbal Supplement 60 Capsules | GnuPharma Corp. | Food | Class II | 6 |
| 5 May 2017 | NUTMAN CHOCOLATE PEANUTS 5 oz (140 g) bags Ing: Peanuts, Sugar, Whole Milk, Liqueur, Coca Butter, Partially Hydrogenated Cocoa Powder, Choc, Salt, Lecithin (emulsifier) Vanilla (art flav..) MANUFACTURED IN A FIRM THAT ALSO PROCESSES PEANUTS Massillon, Ohio 44547 1-330-833-6660 UPC 7 93724 29000 9 | LJA Enterprises | Food | Class I | 4 |
| 4 May 2017 | Ben & Jerry'’s Pint Slices Chocolate Fudge Brownie 3 chocolate ice cream bars Net 9 FL OZ. UPC code 076840657940 | Unilever United States, Inc. | Food | Class II | 1 |
| 3 May 2017 | B30434, BREADER, NET WT 50 LBS, Manufactured By: Newly Weds Foods, Inc., Chicago, IL 60639 | Newly Weds Foods Inc | Food | Class II | 369 |
| 2 May 2017 | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 | GE Healthcare, LLC | Device | Class II | 1 |
| 1 May 2017 | XARIO 100 TUS-X100 diagnostic ultrasound system | Toshiba American Medical Systems Inc | Device | Class II | 5 |
| 1 May 2017 | Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile, 3.5 g tube, RX only, Manufactured by Allergan, Irvine, California, 92612, U.S.A., NDC: 0023-0313-04. | Allergan Sales, LLC | Drug | Class II | 1 |
| 28 Apr 2017 | TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters. | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 27 Apr 2017 | Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8 | Noven Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 21 Apr 2017 | Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent. | JAS Diagnostics Inc. | Device | Class II | 1 |
| 20 Apr 2017 | Seasoning blends IFF Inc. Carrollton 1620 West Crosby Carrollton TX 75006 Net Weight 50.00 LBS 22.680 Event 77078 | International Flavors & Fragrances, Inc. | Food | Class I | 1 |
| 19 Apr 2017 | High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications. | Olympus Corporation of the Americas | Device | Class II | 1 |
| 19 Apr 2017 | SAMIRA'S HOMEMADE Muhammara Roasted Red Pepper Dip with Walnuts & Pomegranate Molasses, All Natural, NET WT. 8 OZ (229G) Keep Refrigerated Event 77074 | Name withheld | Food | Class I | 1 |
| 18 Apr 2017 | UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied in 2, 4 and 10 count packages, Distributed by AH Distribution, DelRay, Beach, FL ---- UPC Code 680474229260 | Organic Herbal Supply | Drug | Class I | 11 |
| 13 Apr 2017 | CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals.… Event 77025 | CardioTek BV | Device | Class II | 1 |
| 13 Apr 2017 | 7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical applications. | Pentax of America Inc | Device | Class II | 4 |
| 7 Apr 2017 | Exactech Optetrak Logic CC 15mm Tibial Augment Screws | Exactech, Inc. | Device | Class II | 1 |
| 4 Apr 2017 | Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 31 Mar 2017 | ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM… | Oscor, Inc. | Device | Class I | 2 |
| 17 Feb 2017 | Ultrasonic Endoscope Model Number EG-530UT A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 15 Feb 2017 | Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chloride Injection in 400 mL, Rx Only, Compounded by PharMEDium Services, LLC, Sugar Land, TX 77478, NDC: 61553-256-09 | Pharmedium Services Llc | Drug | Class III | 7 |
| 3 Feb 2017 | Artis zee,x-ray system, angiographic Artis zee 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. Procedures that can be performed with the Artis zee include cardiac angiography,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 17 Jan 2017 | Video Duodenoscope 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; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and… | Pentax of America Inc | Device | Class II | 1 |
| 1 Jan 2017 | Standex International Bakers Pride Microwave Ovens Model E300 Event 77581 | Standex Intl Corp | Device | Class II | 1 |
| 22 Dec 2016 | IMPAX Cardiovascular The IMPAX CV Reporting module consists of a database and graphical user interface (GUI) that allows users to document procedure and clinical findings as structured data, with representation in printed or electronic formats | AGFA Healthcare Corp. | Device | Class II | 1 |
| 21 Dec 2016 | Agfa Healthcare NX 3.0.8950 Imaging Processing Software | AGFA Healthcare Corp. | Device | Class II | 1 |
| 15 Dec 2016 | Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN) | Boston Scientific Corporation | Device | Class II | 1 |
| 13 Dec 2016 | Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment… | Ion Beam Applications S.A. | Device | Class II | 1 |
| 16 Sep 2016 | BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062 | Becton Dickinson & Company | Device | Class II | 7 |
| 18 May 2016 | Proteus 235 and Proteus ONE proton therapy systems | Ion Beam Applications S.A. | Device | Class II | 1 |
| 15 Apr 2016 | Merge LIS software. The firm name on the label is Merge Healthcare. Merge LIS system is a complete system for ordering, managing and reporting a patient s laboratory work, from the time of order entry to the time the laboratory test results are reported. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 4 Apr 2016 | SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2,… | Merge Healthcare, Inc. | Device | Class II | 4 |
| 10 Mar 2016 | The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software. | Merge Healthcare, Inc. | Device | Class II | 1 |
| 29 Feb 2016 | Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module; Product Usage: Calibrations of ISE Model for integrated electrolyte system analysis. Event 77481 | AMS Diagnostics, LLC | Device | Class III | 1 |
| 30 Sep 2015 | Burn Relief, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns. | O-Two Medical Technologies, Inc. | Device | Class II | 1 |
| 11 Sep 2015 | Source Naturals Hydrogen Boost Capsule: 6 Count Trial, 30 Count, 60 Count; Ingredient: Maltodextrin, Cellulose (Capsules, Silica and magnesium stearate; 30 count Bottle - Product SN1855: 60 count Bottle - Product SN1856; 6 count Bottle - Product SN2314; 30 count + 30 count bottle - Product SN7171 Manufactured for… | Threshold Enterprises Ltd | Food | Class II | 2 |
| 23 Jun 2015 | O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients | O-Two Medical Technologies, Inc. | Device | Class II | 1 |
| 12 Jun 2015 | On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positions | CryoLife, Inc. | Device | Class II | 1 |
| 17 Oct 2014 | Tenaxis Medical ArterX(TM) Surgical Sealant, (a) 4mL, REF 9002, and (b) 5mL REF 9006, STERILE R, Store at 2oC - 8oC Adjunct to sutures in vascular surgery. Event 77482 | Mallinckrodt Manufacturing LLC | Device | Class II | 1 |
| 1 Feb 2013 | The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple… | ICU | Device | Class II | 9 |
| 19 Oct 2011 | Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum. | Medtest Holdings, Inc. | Device | Class III | 1 |
| 22 Nov 2010 | The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit | Medtest Holdings, Inc. | Device | Class III | 1 |
| 21 Jul 2009 | Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide… | Medtest Holdings, Inc. | Device | Class III | 1 |