| 14 Dec 2018 | Nevirapine Extended Release Tablets, 400 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd. Verna Goa, India, Manufactured for: Cipla USA Inc. 9100 S Dadeland Blvd., Suite 1500 Miami, FL 33156, NDC 69097-403-02 | Cipla Limited | Drug | Class II | 1 |
| 14 Dec 2018 | Lubrisine eye drops (polyethylene glycol 400 0.4% and Propylene glycol 0.3%), 30 ML bottle, Manufactured and Distributed by: Results RNA, LLC, 1272 S 1380 W., Orem, UT 84058, UPC 7 9238230723 4 Event 81742 | Results RNA, LLC | Drug | Class I | 1 |
| 11 Dec 2018 | Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50 | KVK-Tech, Inc. | Drug | Class II | 1 |
| 11 Dec 2018 | Dyural-40 Injection Kit, 1 Dose, Single Use Only, Rx only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-0750-01 | Asclemed USA Inc. dba Enovachem | Drug | Class I | 2 |
| 11 Dec 2018 | Inspired Organic Sunflower Butter 16oz. plastic jar, 6 per case UPC #: 863669742526 refrigerate after opening | Lipari Foods Operating Company, LLC | Food | Class I | 4 |
| 10 Dec 2018 | Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31 Event 81748 | Name withheld | Drug | Class II | 1 |
| 10 Dec 2018 | Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8. Event 81719 | Gordon Laboratories | Drug | Class II | 1 |
| 10 Dec 2018 | Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube. | CBI Laboratories, Inc. | Drug | Class III | 2 |
| 7 Dec 2018 | Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack) | Sun Pharmaceutical Industries, Inc. | Drug | Class III | 1 |
| 7 Dec 2018 | The Salty Nutty Toffee Bar, brand ALMA, net weight 1.85 oz. UPC on individual bar: 8 58533 00602 8 UPC on master case 0 108585 330060 2 The label is read in parts: "***INGREDIENTS: Salty Nutty Toffee Bar *** Dark Chocolate (cocoa solids, cocoa butter, sugar, sunflower lecithin), Toffee (turbinado sugar, butter (milk,… | Moonstruck Chocolate Company | Food | Class II | 1 |
| 6 Dec 2018 | Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-01 | Pfizer Inc. | Drug | Class II | 1 |
| 6 Dec 2018 | Salmon packaged in a plastic container; HELLO QUALITY PACIFIC SILVERSIDE SALMON Hello FRESH NET WT. 10oz (283g) with Case Label: keep Frozen (0F or below) FARMED COHO SALMON 10 oz (283g) 2 X 5 oz portions. Event 81734 | Mariner Seafood, LLC | Food | Class II | 1 |
| 5 Dec 2018 | Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL total volume in a 60 mL BD Syringe, Rx Only, PharMEDium Services, LLC. 913 N. Davis Ave. Cleveland, MS 38732 NDC 61553-644-75. | Pharmedium Services, LLC | Drug | Class II | 2 |
| 5 Dec 2018 | LIGHT & FIT GREEK CRUNCH NONFAT YOGURT & TOPPINGS S MORES FLAVOR, 5 oz Preformed cups with a topper, Refrigeration required between 36F and 45F, UPC 36632 03825 Event 81722 | DANONE WATERS OF AMERICA INC | Food | Class I | 1 |
| 4 Dec 2018 | Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-089-01 Event 81729 | Epic Pharma, LLC | Drug | Class II | 1 |
| 4 Dec 2018 | Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93. | Mylan Laboratories Limited, (Nashik FDF) | Drug | Class II | 13 |
| 30 Nov 2018 | Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 0852 Made in India, NDC 65862-855-30 | Aurobindo Pharma USA Inc. | Drug | Class III | 1 |
| 30 Nov 2018 | NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771 | VistaPharm, Inc. | Drug | Class III | 1 |
| 30 Nov 2018 | Salmon fillets packaged inside Styrofoam boxes fully surrounded and covered in ice, which were stored inside a temperature controlled cooler Event 81681 | K & T Oriental Imports Inc. | Food | Class I | 1 |
| 28 Nov 2018 | Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure. | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 28 Nov 2018 | Sebastiano's Naturally Flavored Gourmet Syrups Hazelnut 25.4 fl oz (750 ml) Event 81692 | Frutarom USA Inc. | Food | Class II | 1 |
| 27 Nov 2018 | Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40 | Glenmark Pharmaceuticals Inc., USA | Drug | Class III | 1 |
| 27 Nov 2018 | Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | Teva Pharmaceuticals USA | Drug | Class II | 8 |
| 27 Nov 2018 | Imperial Taste Fried Red Onion, Cu Hanh Phi; 24 x 8oz. Item #1760, UPC Code: 741861017607; 24 x 12oz. Item #1761, UPC Code: 741861017614; Ingredients: Red Onion, Palm Oil Product of Vietnam Distributed by Gemini Food Corporation, City Of Inductry, CA 91789 | Gemini Food Corporation Inc | Food | Class II | 2 |
| 27 Nov 2018 | Kwik Trip Granola, Bulk Granola, 09976. Net Wt 20 lbs / 9.1 kg. Manufactured by: Oakhouse Bakery, 2221 Mustang Way, Madison, WI 53718. Event 81648 | Oakhouse Bakery | Food | Class I | 1 |
| 27 Nov 2018 | Sprout Creek Farm Kinkead raw cows' milk cheese semi-firm savory brothy. The product is packaged with an orange label. | Sprout Creek Farm, Inc. | Food | Class I | 1 |
| 27 Nov 2018 | Kitchen Cravings Mixed Berry Parfait, Net Wt 8.25 oz (234g) Creamy Parfait Base, Strawberries & Blueberries with Sweetened Granola. Keep Refrigerated. UPC 39779-18436. Produced and Distributed by Kwik Trip, Inc., La Crosse, WI 54603 | Kwik Trip, Inc. | Food | Class I | 2 |
| 26 Nov 2018 | Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF procedure. | Howmedica Osteonics Corp. | Device | Class II | 1 |
| 26 Nov 2018 | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7. | Tris Pharma Inc. | Drug | Class II | 3 |
| 24 Nov 2018 | Tres Hermanos Bakery Telera and Bolillo Mexican White Bread, 1lb and 2 ounces per pkg Event 81634 | TRES HERMANOS BAKERY | Food | Class I | 1 |
| 23 Nov 2018 | HeartStart MRx, Rechargeable Li-Ion (lithium ion battery), REF: M3538A, which is a component of HeartStart MRx Monitor/Defibrillators. | Philips North America LLC | Device | Class II | 1 |
| 23 Nov 2018 | Organic Tahini sold under the following brand names: Pepperwood organic tahini, 428g, UPC: 860294001400; Pepperwood whole organic tahini, 428 g, UPC: 860294001417; Baron's organic Tahini, 454g, UPC: 816412011059; Galil, organic Tahini, 500g, UPC: 7290000572086; Soom organic Tahini, 18Kg, UPC: 718088347381; Soom… | Achdut | Food | Class I | 4 |
| 21 Nov 2018 | Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05 | QuVa Pharma, Inc. | Drug | Class III | 1 |
| 21 Nov 2018 | Ottogi Jin Ramen Spicy NET WT. 1lb 5.16oz, 600g (120gx5) 5PK 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 | 2 |
| 21 Nov 2018 | Tickled PEACHES Freestone Dices; Net wt 4.4 oz. (125g) sealed plastic cups; KEEP FROZEN; Palmetto Processing Solutions 5 RW Dubose Road Ridge Spring, SC 29129 UPC 0110817134020432 Event 81630 | Titan Farms, Inc. d/b/a Palmetto Processing Solutions | Food | Class II | 1 |
| 21 Nov 2018 | Jackie's Cookie Babies Classic Chocolate Chip Net Wt. 28oz Manufactured and distributed by: Jackie's Cookie Connection, 12109 Santa Monica Blvd., Los Angeles, CA 90025 UPC Code 8 55094 00688 5 Event 81636 | JACKIE'S COOKIE CONNECTION LLC | Food | Class II | 1 |
| 20 Nov 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93. | Mylan Pharmaceuticals Inc. | Drug | Class II | 8 |
| 20 Nov 2018 | Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN 38478 www.avkare.com, NDC 5026835427, UPC 3 50268 35408 | AVKARE Inc. | Drug | Class II | 1 |
| 20 Nov 2018 | Sebastiano s Naturally Flavored Gourmet Syrups French Vanilla Naturally Sugar Free, Sweetened with Stevia; 25.4 fl. oz. (750 ml) Event 81627 | Frutarom USA Inc. | Food | Class II | 1 |
| 20 Nov 2018 | Chocolate and Nut Tray. The product comes in a four-quadrant plastic tray, NET WT 37 OZ (2 LBS 5 OZ) 1.05KG, with UPC: 0 23637 43369 0. | First Source, LLC | Food | Class II | 1 |
| 19 Nov 2018 | Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is indicated in the United States (US) and European Union (EU) for use as a bridge to cardiac transplantation (BTT) as well as an alternative to transplantation as… | Heartware, Inc. | Device | Class II | 1 |
| 19 Nov 2018 | Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened. | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 19 Nov 2018 | Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10 | Pharm D Solutions, LLC | Drug | Class II | 1 |
| 16 Nov 2018 | Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient lift is to lift and transfer a patient from one surface to another, as from a bed to a wheelchair. The device includes straps and a sling to support the patient. | Invacare Corporation | Device | Class II | 1 |
| 16 Nov 2018 | fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105 | CAO Group, Inc. | Drug | Class II | 4 |
| 16 Nov 2018 | Ultra Dark Chocolate Amaretto Rainier Cherries, Chukar Cherries brand, packaged in 7.5 oz. plastic pouches. UPC 0 11261 22307 7. | Chukar Cherry Company | Food | Class I | 5 |
| 16 Nov 2018 | Jay Robb Unflavored Egg White Protein, Net Weight 24 oz (1.5lbs) 680g. Dietary Supplement. UPC 03907-00492. Jay Robb, Inc., Jupiter, FL 33458 Event 81591 | Agropur MSI Ingredients LLC | Food | Class I | 1 |
| 16 Nov 2018 | Tillamook Mudslide ice cream (item #63006), packaged in 3 gallon tub. UPC 0 72830 63006 1. The label is read in parts: "***TILLAMOOK MUDSLIDE ICE CREAM*** ALLERGEN INFORMATION: This product contains milk, peanut, soy, tree nut (coconut), egg. It is made with equipment that also makes product containing wheat.***" | TILLAMOOK COUNTY CREAMERY ASSOC | Food | Class II | 4 |
| 16 Nov 2018 | Milk Chocolate Maltballs: NET Wt. 15 lbs. Item number 992 Case UPC 00797817-00992-9 Allergy Information: This product contains Wheat, milk and soy and may contain peanuts and tree nuts. Event 81602 | Marich Confectionery Company, Inc. | Food | Class I | 1 |
| 15 Nov 2018 | Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081 | Philips Electronics North America Corporation | Device | Class II | 1 |
| 15 Nov 2018 | Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of nonresectable liver tumors. | Covidien LLC | Device | Class II | 3 |
| 15 Nov 2018 | SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610 | Fresenius Kabi USA, LLC | Drug | Class I | 2 |
| 15 Nov 2018 | 4Patriots Chicken a la King CONTAINS: Wheat, Coconut NET WT. 10.0 oz (284 g) Event 81590 | 4Patriots, LLC | Food | Class II | 1 |
| 15 Nov 2018 | TURKEY HILL Vanilla Bean Premium Ice Cream #501 3 GAL (11.36L) paper carton CONTAINS: MILK Distributed By: Turkey Hill Dairy 2601 River Rd. Conestoga, PA 17618, call 1-800-MY DAIRY or www.turkeyhill.com, Mfd. at plant #37-087, UPC 0 20735 13520 4 | Harris Teeter Supermarkets, LLC dba Hunter Farms | Food | Class II | 1 |
| 14 Nov 2018 | Staclot LA (REF 00600) The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2). | Diagnostica Stago, Inc. | Device | Class II | 2 |
| 14 Nov 2018 | Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India. Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 --- NDC 67877-248-01, UPC code: 3 67877-248-01 1 | Ascend Laboratories LLC | Drug | Class II | 1 |
| 14 Nov 2018 | Green Cedar Ackawi cheese in small clear plastic shrink wrapped packaging bearing a sell by date of March 26, 2019 or later. The sell by date is on a white sticker on the back of the product. , Keep Refrigerated Event 81575 | Harb Dairy, Inc. DBA Green Cedar Dairy | Food | Class I | 1 |
| 13 Nov 2018 | VITEK 2 Systems Software Version 9.01 Update Kit. | bioMerieux, Inc. | Device | Class II | 1 |
| 13 Nov 2018 | Smartypants Kids Complete, Non GMO Multi and omega 3's vitamin D3 for bones, vitamin B12 for Energy: 90 gummies. UPC 8 5136 00425 5 Distributed by SmartyPants Inc., Marina del Rey, CA 90292 Event 81559 | Name withheld | Food | Class II | 1 |
| 13 Nov 2018 | Purveyors Kitchen Pumpkin Pesto Tapenade; NET WT 7.75 oz. (220G) UPC: 0 37677 01624 9 Ingredients: Water, Pumpkin, Basil, Parsley, Canola Oil, Sugar, Garlic, Parmesan Cheese (pasteurized skim milk, cultures, salt, enzymes), Lemon juice [concentrate], Sea Salt, Spices. Manufactured by: Purveyors Kitchen, Auburn, CA Event 81567 | Nor Cal Food Solutions LLC | Food | Class I | 1 |
| 13 Nov 2018 | Cap'n Crunch's Peanut Butter Crunch Cereal packaged in 17.1 ounce and 16.5 ounce cardboard boxes. Distributed by The Quaker Oats Company, Chicago IL Event 81571 | Quaker Manufacturing, LLC | Food | Class I | 1 |
| 13 Nov 2018 | Gingerbread Popcorn. 8 ounce (227 grams) flexible plastic bag. Brand name of Disney Theme Park Merchandise or Disney Parks Distributed by Disney Theme Park Merchandise Lake Buena Vista, FL 32830 UPC Code 400020873569 Event 81612 | Thatchers Gourmet Specialties Inc. | Food | Class II | 1 |
| 12 Nov 2018 | Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for use with the EmpowerCT, EmpowerCTA and EmpowerCTA+ Injector Systems SKU 017344/6720 Empower FastLoad" CT Syringe Pack is a sterile, disposable syringe kit designed for use with EmpowerCT, EmpowerCTA and EmpowerCTA+ Injector Systems. It is used… Event 81616 | Name withheld | Device | Class II | 1 |
| 9 Nov 2018 | Centricity Universal Viewer Zero Footprint Client, Model Number 2090258-001, Software Versions 6.0 SP7, SP7.0.1, SP7.0.2, SP7.0.3, SP8, SP8.0.1, SP8.0.a and SP8.0.2, SP9 and SP9.0.1 display o orientation markers can become is incorrect. | GE Healthcare, LLC | Device | Class II | 1 |
| 9 Nov 2018 | Finax Muesli with 45% Fruit; 22.9-oz.; Heat sealed plastic bag; 10 bags/case Event 81580 | Chicago Importing Co | Food | Class II | 1 |
| 9 Nov 2018 | Queseria "La Milagrosa" La Delicia al Paladar. 1/2 kg and 1 kg sizes. Packaged in a plastic bag with a yellow label. Event 81551 | ALEBRIJE IMPORTS INC | Food | Class I | 1 |
| 9 Nov 2018 | Pictsweet Farms Steam'ables Asparagus Spears 8oz. pouch, 10 per case UPC 0 70560 97799 9 Frozen Event 81548 | Hart Freeze pack, LLC | Food | Class II | 1 |
| 9 Nov 2018 | Gatorade, Frost Glacier Freeze, Cont. Neto (600 mL) | The Gatorade Puerto Rico Co | Food | Class III | 8 |
| 9 Nov 2018 | Best Taste Brand DRIED BAMBOO SHOOT Mang Non. The product comes in a 12 ounce (340g) uncoded flexible plastic package with UPC: 6 9709 999 40196. Product of P.R.C. | Country Favor Inc. | Food | Class I | 1 |
| 8 Nov 2018 | SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems. | ICU Medical Inc | Device | Class II | 1 |
| 8 Nov 2018 | Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator,… Event 81649 | Konica Minolta Healthcare, Americas, Inc. | Device | Class II | 1 |
| 8 Nov 2018 | INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07 | ALLERGAN | Drug | Class II | 1 |
| 8 Nov 2018 | Schwan's Sea Salt Carmel Cashew Ice Cream (#206). Net Wt 56 oz. Event 81533 | Schwan's Global Supply Chain, Inc. | Food | Class II | 1 |
| 8 Nov 2018 | VANILLA WHIPPED ICING ARTIFICALLY FLAVORED Product Number: 09076 / UPC: 10049800090764 | Rich Products Corp | Food | Class II | 1 |
| 8 Nov 2018 | Parsley Flakes in 6 oz. and 24 oz. plastic bottles and 20 lb boxes | Black River Industries | Food | Class II | 3 |
| 7 Nov 2018 | Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard trays & HDPE 60 cc bottles in plastic… | RemedyRepack Inc. | Drug | Class III | 1 |
| 6 Nov 2018 | Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on stabilized human serum. All components contain sodium azide as a preservative and are provided in ready-to-use liquid… | The Binding Site Group, Ltd. | Device | Class II | 1 |
| 6 Nov 2018 | IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining… | Deerfield Imaging, Inc. | Device | Class II | 4 |
| 6 Nov 2018 | NOW Vitamin B-50 Complex with C 100 Veg Caps | NOW Foods | Food | Class III | 1 |
| 6 Nov 2018 | Organic Cardamom Green Whole. Product of Guatemala. Product is labeled with a paper label son onto each 25-kg poly-lined, poly-weave "double bag". The label reads - Certified Organic Cardamom Pod Mixed Grade, Certified Organic by Mayacert, Product of Guatemala, Net Weight 25.00 KGS /55.115 LBS, Tare Weight 0.21 KGS /… Event 81506 | NEW FOREST LLC | Food | Class I | 1 |
| 5 Nov 2018 | Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 | Capintec Inc | Device | Class II | 2 |
| 5 Nov 2018 | Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 5 Nov 2018 | enVista One Piece Hydrophobic Acrylic Intraocular lens - Is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous lens has been removed. The lens is intended for placement in the capsular bag. | Bausch & Lomb Surgical, Inc. | Device | Class II | 1 |
| 5 Nov 2018 | 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826 | COVIDIEN LLC | Device | Class II | 1 |
| 5 Nov 2018 | Apricot Chai Tea, 8 oz. Loose. UPC 41427-96317 Event 81536 | Cedar Lake Tea | Food | Class II | 1 |
| 5 Nov 2018 | Duncan Hines Classic Classic White cake mix 15.25oz. 12 retail units per case 644209307500 | ConAgra Foods, INc. | Food | Class II | 4 |
| 5 Nov 2018 | Baked Macaroni and Cheese, NET WT 12 OZ (340g), CONTAINS: WHEAT, MILK, EGG, Produced By BAKKAVOR USA, 2700 Westinghouse Blvd. Charlotte, NC 28273, Phone: 704-522-1977, UPC 7 61088 80502 3 | Bakkavor Foods USA Inc. | Food | Class I | 1 |
| 2 Nov 2018 | STEPHANIX D2RS Digital Dynamic Remote Systemhttp://cts.fda.gov/division-tracking/images/trash.png Product The D2RS Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures. It is also indicated for… Event 81582 | Stephanix | Device | Class II | 1 |
| 2 Nov 2018 | CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is CIVCO, Kalona, IA. | CIVCO Medical Instruments Co., Inc. | Device | Class II | 15 |
| 2 Nov 2018 | 16 count Smartfood Delight Variety Pack Sack | Frito-Lay, Inc. | Food | Class I | 2 |
| 2 Nov 2018 | Red Bull Energy Drink, 8.4 Fl. oz. (250 mL) Ingredient: Carbonated water, Sucrose, Glucose, Citric Acid, Taurine, Sodium Bicarbonate, Magnesium, Carbonate Caffeine, Nicainamide, Calcium Pantothenate, Pyridoxine HCL, Vitamin B12, Natural and artificial Flavors, colors. UPC CODES: 6 11269 99100 0 (ON THE CANS) AND… Event 81503 | Red Bull North America Inc. | Food | Class III | 1 |
| 1 Nov 2018 | ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion exchange chromatography. For in vitro diagnostic use only. | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | Device | Class II | 5 |
| 1 Nov 2018 | Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10. | Sandoz, Inc | Drug | Class II | 1 |
| 31 Oct 2018 | Avenir Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the… | Zimmer GmbH | Device | Class II | 1 |
| 31 Oct 2018 | Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and to prevent the distention of the stomach. | COVIDIEN LLC | Device | Class II | 1 |
| 31 Oct 2018 | NexGen Complete Knee Solution Femoral Augment Block Distal only, 15mm, Size E with Screw Item Number: 00599003523 NexGen Distal Femoral Augment Block is used when femoral components can neither be downsized nor can be distally augmented by increasing the thickness of the cement mantle. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 31 Oct 2018 | FoundationOne CDx Test Results | Foundation Medicine, Inc. | Device | Class II | 1 |
| 31 Oct 2018 | Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | Cardinal Health 200, LLC | Device | Class II | 8 |
| 30 Oct 2018 | Schnucks BIG & FLAKY CRESCENT ROLLS, 6 ROLLS, NET WT 11.25 OZ UPC 0 41318 57046 5 Event 81462 | English Bay Batter L.P. | Food | Class II | 1 |
| 30 Oct 2018 | Luckyberry Cold-Pressed Juice, NoCoast, Kale, Cucumber, Green Apple, Celery, Lemon, Ginger, 16 FL OZ, Manufactured at Luckyberry Juice Café, Lawrence, KS | Luckyberry | Food | Class II | 9 |
| 29 Oct 2018 | Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Distributed by GE Healthcare Inc., Marlborough, MA 01752 U.S.A.; Manufactured by GE Healthcare AS, Oslo, Norway; NDC 0407-1411-20. Event 81691 | GE Healthcare Inc. Life Sciences | Drug | Class II | 1 |
| 29 Oct 2018 | Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60 | Akorn, Inc. | Drug | Class III | 1 |
| 29 Oct 2018 | Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-119-01; b) 90 count bottle NDC 69367-119-03 | Westminster Pharmaceuticals Llc | Drug | Class II | 3 |
| 28 Oct 2018 | Feast Mode Flavors Garlic Beer Seasoning, Nt. Wt. 5 oz, plastic bottles Event 81694 | Name withheld | Food | Class II | 1 |
| 26 Oct 2018 | Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 25 Oct 2018 | QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. | Maquet Cardiovascular Us Sales, Llc | Device | Class I | 2 |
| 24 Oct 2018 | NEOCONNECT, Enteral Extension with ENFit connector, REF EXT-60NC The NeoMed NeoConnect Enteral Only Extension Set is intended for use as an extension set for nasogastric/oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors which help mitigate the risk of accidental connection of an I.V.… Event 81452 | Neomed Inc | Device | Class III | 1 |
| 24 Oct 2018 | Biomet 20mm Compress Device Short Anchor Plug With Drill Set / With Pin Inserter Ion Implant Item number: 178562 Product Usage: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma.… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 23 Oct 2018 | Wegmans Roasted Corn and Bean Salad; 13 oz. Plastic Container, 40 oz. Plastic Container, 4.5 lb. Plastic Bulk Container | ASK Foods Inc | Food | Class II | 6 |
| 22 Oct 2018 | ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for one patient during hospital stay and assists the caregiver with everyday patient handling routines,… | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | Device | Class II | 1 |
| 22 Oct 2018 | PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures… | WOM World of Medicine AG | Device | Class II | 1 |
| 22 Oct 2018 | Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis. | Zimmer Biomet, Inc. | Device | Class II | 13 |
| 22 Oct 2018 | BD BBL Trypticase Soy Agar with 5% Sheep Blood, Catalog No. 221261, (non-selective, non-differential) | Becton Dickinson & Co. | Device | Class II | 1 |
| 22 Oct 2018 | VITEK 2 Antimicrobial Susceptibility Testing (AST) using one or more of these susceptibility products: Catalog # 410028, VITEK 2 AST-ST01 Catalog # 420915, VITEK 2 AST-ST02 Catalog # 421040, VITEK 2 AST-ST03 The VITEK 2 Streptococcus Susceptibility Card is intended for use with the VITEK 2 Systems in clinical… | bioMerieux, Inc. | Device | Class II | 1 |
| 22 Oct 2018 | Weis Chocolate Whoopie Pie 16 oz (454g)/ 4 4 oz Whoopie Pies Clamshell Packaging 4 Whoopie Pies per Unit Event 81400 | Shirleys Cookie Company Inc. | Food | Class II | 1 |
| 19 Oct 2018 | VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Product Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. | Ortho-Clinical Diagnostics | Device | Class II | 4 |
| 19 Oct 2018 | Baraka Hot Curry Powder packed in 7 OZ Plastic Jar | U.B.C. Food Distributors INC. | Food | Class I | 2 |
| 18 Oct 2018 | HemoTrol Level 2- In Vitro Diagnostic Hematology quality control mixture Catalogue number: 171.002.002 Eurotrol HemoLin is an assayed hemoglobin control intended for professional use in the verification of the linearity of the HemoCue Hb 201 systems | EUROTROL INC | Device | Class II | 2 |
| 18 Oct 2018 | Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment… | Philips Medical Systems (Cleveland) Inc | Device | Class II | 6 |
| 17 Oct 2018 | Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel. | Numed Inc | Device | Class II | 2 |
| 17 Oct 2018 | Laser Fiber Assy-Single Use-LFS-272-RT-0.22NA-SMA905- Slim Extension Sleeve Silver-Sterile ETO- Private label: SU-200-RT SmartScope Packaging. The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue… | Leoni Fiber Optics GmbH | Device | Class II | 5 |
| 17 Oct 2018 | NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis. | NxStage Medical, Inc. | Device | Class II | 8 |
| 16 Oct 2018 | Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711 | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 2 |
| 16 Oct 2018 | Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in, 10 CT. White, bleached, non-woven, rayon/polyester sterile Gauze Pad 3 inch x 3 inch, 12-ply 10 count cardboard box | ASO, LLC | Device | Class II | 1 |
| 16 Oct 2018 | Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 15 Oct 2018 | Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable, JHI-202 Lithium-ion Battery Cable, JHI-204 Extensions Cable, JHI-201 Pedestal Cable Event 81709 | Jarvik Heart Inc | Device | Class II | 1 |
| 15 Oct 2018 | Refrigerated Mary's Harvest Fiesta Corn Salsa 16 oz. UPC# 088724158450, in rigid plastic container | Mary's Harvest Fresh Foods, Inc. | Food | Class II | 2 |
| 12 Oct 2018 | Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128 | Atrium Medical Corporation | Device | Class II | 1 |
| 12 Oct 2018 | Zimmer Compress Devices and Instruments: Item Number/Item Description 178350 Compress Device Anti-Rotation Spindle 178353 Compress Device Anti-Rotation Spindle 178356 Compress Device Anti-Rotation Spindle 178359 Compress Device Anti-Rotation Elliptical Spindle 178537 Compress Device Centering Sleeve 15mm 178541… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 12 Oct 2018 | Oreo Limber. 6 dozen per case of 6.5 oz each Event 81428 | La Casa del Limber, Inc. | Food | Class II | 1 |
| 11 Oct 2018 | Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for the quantitative measurement of lactate dehydrogenase in human serum and plasma on the Dimension Vista System.Cat. No. K2054, Mat. No. 10464323 | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 11 Oct 2018 | St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY St. Jude Medical Plano, TX Instructions For Use: Lead and Extension Kits for… | St. Jude Medical, Inc. | Device | Class II | 1 |
| 10 Oct 2018 | IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 10 Oct 2018 | Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394 | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 9 Oct 2018 | BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and… | Synaptive Medical Inc | Device | Class I | 1 |
| 9 Oct 2018 | Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class III | 3 |
| 9 Oct 2018 | Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle. Event 81537 | Theragenics Corporation | Device | Class II | 1 |
| 5 Oct 2018 | Hemoglobin A1c Control, Part no. 220232 for use as quality control material to monitor the precision of laboratory testing procedures for HbA1c quantitation. | Tosoh Bioscience Inc | Device | Class III | 1 |
| 5 Oct 2018 | GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. The CARESCAPE R860… | GE Healthcare, LLC | Device | Class I | 1 |
| 5 Oct 2018 | AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Product Usage: The AIA-900 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction… | Tosoh Bioscience Inc | Device | Class II | 1 |
| 2 Oct 2018 | Thermacare Muscle Pain Therapy HeatWraps: a) UPC 0573301314 b) UPC 0573301303 Product Usage: Provides heat therapy for temporary relief of minor muscular and joint aches and pains associated with overexertion, sprains, and arthritis. | Pfizer Inc. | Device | Class II | 3 |
| 28 Sep 2018 | AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. | Tosoh Bioscience Inc | Device | Class II | 2 |
| 24 Sep 2018 | PerkinElmer QSight 210 MD Mass Spectrometer Simplicity 3Q MD v1.0 with Hot Fix 2 Software intended to identify compounds in human samples by ionizing the compound and separating the resulting ions. Part Number: BC004872 Event 81266 | PerkinElmer Health Sciences Canada, Inc. | Device | Class II | 1 |
| 18 Sep 2018 | Puritan Bennett 980 (PB980) ventilator series: Puritan Bennett" 980 Pediatric Adult Ventilator Puritan Bennett" 980 Neonatal Ventilator Puritan Bennett" 980 Universal Ventilator Product Usage: The Puritan Bennett 980 Series Ventilator is designed for use on patient population sizes from Neonatal (NICU) through Adult… | COVIDIEN LLC | Device | Class I | 1 |
| 14 Sep 2018 | GE LOGIQ E10 Ultrasound System, Model #530000E10. The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculoskeletal… | GE Healthcare, LLC | Device | Class II | 1 |
| 13 Sep 2018 | Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capillary whole blood. List Number/UDI# : 03P88-25 ,(01)10054749000163(17)181028(10)L18059 | Abbott Point Of Care Inc. | Device | Class II | 1 |
| 11 Sep 2018 | PROCARE B20 Patient Monitor, V1; and B20 Patient Monitor, V2. The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during… | GE Healthcare, LLC | Device | Class II | 5 |
| 31 Aug 2018 | Dash 3000 Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients. | GE Healthcare, LLC | Device | Class II | 6 |
| 24 Aug 2018 | Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1 Event 81606 | LGM Pharma LLC | Drug | Class II | 1 |
| 23 Aug 2018 | AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated Immunoassay Analyzer is for use in vitro diagnostic to provide testing for a broad menu of assays in a unique patented dry reagent format. | Tosoh Bioscience Inc | Device | Class II | 1 |
| 6 Jul 2018 | UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract Event 81576 | Neotract Inc | Device | Class II | 1 |
| 19 Jun 2018 | Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator… | Stryker Sustainability Solutions | Device | Class II | 1 |
| 14 Jun 2018 | RT-5100 Refractor, a component of the Epic-5100 System. | Nidek Inc. | Device | Class III | 1 |
| 24 May 2018 | Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. | GE Healthcare, LLC | Device | Class II | 3 |
| 7 Feb 2018 | GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric… Event 79584 | Advanced Instruments, LLC | Device | Class II | 1 |
| 28 Sep 2017 | AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. | Tosoh Bioscience Inc | Device | Class II | 1 |
| 30 Mar 2017 | Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119). Event 81239 | Name withheld | Device | Class II | 1 |
| 22 Mar 2017 | AIA-360 Analyzer is capable of performing two methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK… | Tosoh Bioscience Inc | Device | Class II | 1 |
| 24 Feb 2017 | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY | Helena Laboratories, Inc. | Device | Class II | 1 |
| 7 Nov 2016 | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to aid in the… | Helena Laboratories, Inc. | Device | Class III | 1 |
| 20 Apr 2016 | Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin… | Helena Laboratories, Inc. | Device | Class II | 1 |
| 26 Nov 2014 | Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative Kit (KIT0295), accessory used with the Renaissance System (TPL0038). Indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It is intended to be used whenever the clinician and/or… | Mazor Robotics Ltd | Device | Class II | 1 |