| 11 Sep 2018 | Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920. NDC: 13668-342-30 | Torrent Pharma Inc. | Drug | Class II | 1 |
| 7 Sep 2018 | White Corn Tortilla Chips packaged under the following brand names and sizes: 1. Shearer's White Restaurant Style Bulk, 12 ct. 16 oz., #203540212; 2. Shearer's White Round Tortilla Bulk, 12 ct. 16 oz., #210230212; 3. Shurfine Tortilla Chips, Net Wt. 30 oz (1 lb 14 oz) 851g, UPC 15400-85704; 4. Schnucks Tortilla Chips… | Shearers Foods, Llc | Food | Class II | 2 |
| 7 Sep 2018 | Sesame Noodle Salad Vegan, packaged in 8 oz. or 16 oz. plastic container. UPC of 8 oz. container: 0 211630 203994. UPC of 16 oz. container: 0 211637 807492. The label is read in parts: "***SESAME NOODLE SALAD VEGAN***Soba Noodles (wheat, our, buckwheat, tapioca starch, salt, water), Dressing (Toasted Sesame Oil, Soy… | Market of Choice Inc | Food | Class I | 1 |
| 6 Sep 2018 | 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31 | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 6 Sep 2018 | Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc.… | InvaGen Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 6 Sep 2018 | Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11 | Par Pharmaceutical, Inc. | Drug | Class III | 1 |
| 4 Sep 2018 | Leica M525 F20 Surgical Microscope System | Leica Microsystems, Inc. | Device | Class II | 1 |
| 4 Sep 2018 | Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153 Event 80953 | Name withheld | Drug | Class II | 1 |
| 4 Sep 2018 | Fish Balls, packaged in a red and white plastic bag with gold font, NET WT: 14OZ (400g), UPC: 6 953006 4 50093. Keep Frozen. | H & C Food Inc. | Food | Class I | 2 |
| 31 Aug 2018 | Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems | Accuray Incorporated | Device | Class II | 1 |
| 31 Aug 2018 | Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7 | Beaumont Bio-med, Inc. | Drug | Class II | 8 |
| 29 Aug 2018 | CedarLane Organic Salads; Couscous, Veggies & Chickpeas with Citrus Dressing. NET WT 9 oz. -Gluten Free -Vegetarian Perishable, Keep Refrigerated. UPC: 38794 99904 Manufactured and Distributed by: CedarLane Foods, Carson, CA 90746 Event 80937 | Cedarlane Natural Foods Inc/Frankly Fresh Foods Inc. | Food | Class II | 1 |
| 29 Aug 2018 | Campomex USA fresh cilantro: 5 dozens (60) per box. Event 80968 | CAMPOMEX USA CORP | Food | Class II | 1 |
| 28 Aug 2018 | VidiStar(TM) PACS & DICOM Viewer Software system Event 80896 | Hitachi Healthcare Americas Corp Informatics Division | Device | Class II | 1 |
| 28 Aug 2018 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01 | Pfizer Inc. | Drug | Class III | 1 |
| 27 Aug 2018 | MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03 | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 27 Aug 2018 | Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032. Event 80915 | SCA Pharmaceuticals, Inc. | Drug | Class I | 1 |
| 27 Aug 2018 | Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417. | QuVa Pharma, Inc. | Drug | Class I | 1 |
| 24 Aug 2018 | Disposable Insulin Syringe 0.3mL in 3 different sizes 29Gx1/2, 30Gx5/16, and 31G x 5/16. (10 syringes are packaged in a flexible plastic (poly bag) and 10 flexible plastic (poly bag) are packaged in one in box. Finally, pack the inboxes in the carton case.) Event 80944 | ShinChang Medical Co., Ltd. | Device | Class II | 1 |
| 24 Aug 2018 | Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01 | Akorn, Inc. | Drug | Class II | 1 |
| 24 Aug 2018 | Stewart's Ice Cream Caramel Cone Crunch Carton, 1 pint, keep frozen, UPC: 082086444718 | Stewart's Shops Corp. | Food | Class III | 1 |
| 24 Aug 2018 | Califia Farms 100% Arabica Coffee; Mocha Cold Brew Coffee with Almond Milk 48 fl. oz. plastic bottle. Dairy Free UPC: 852909003503 - USA 813636020584 (Canada) Distributed by Califia Farms, LLC, Los Angeles, CA Event 80844 | Califia Farms LLC | Food | Class II | 1 |
| 23 Aug 2018 | Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01 Event 80874 | Name withheld | Drug | Class III | 1 |
| 23 Aug 2018 | Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0 Event 80876 | Pfizer Global Supply | Drug | Class II | 1 |
| 23 Aug 2018 | Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02 | Hellolife | Drug | Class I | 4 |
| 23 Aug 2018 | Dewey's BAKERY Soft Baked TRIPLE CHOCOLATE BROWNIE COOKIES NET WT. 6 OZ paper bag Dewey's BAKERY WINSTON-SALEM, NC 27103 (877) 339-3974 UPC 7 63027 21022 6 Event 80873 | Dewey's Bakery, Inc dba Salem Baking Company | Food | Class II | 1 |
| 21 Aug 2018 | Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01. | Accord Healthcare, Inc. | Drug | Class I | 1 |
| 21 Aug 2018 | 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18 | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 21 Aug 2018 | Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01. | Mayne Pharma Inc | Drug | Class III | 1 |
| 21 Aug 2018 | CoEnzyme-Q10 injectable, 20 mg/mL, 10 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Auro Pharmacies, Inc. | Drug | Class II | 12 |
| 21 Aug 2018 | Premo Brand Turkey & Cheese Wedge sandwiches 5 OZ retail UPC 612510002018 Plastic triangle sandwich wedge container with plastic film. Refrigerated. 4, 5 OZ retail units per wholesale case. Event 80877 | Lipari Foods Operating Company, LLC dba JLM Manufacturing | Food | Class II | 1 |
| 20 Aug 2018 | fMRI Hardware System VisualSystem allows video signals from the stimulus presentation PC to enter the shielded scanner room and presented by a set of coil-mounted displays or by an in-room LCD monitor. - LCD Monitor Power supply (LPS) for LCD Monitor, Versions 1.0 and 1.1 Event 80529 | Name withheld | Device | Class II | 1 |
| 20 Aug 2018 | Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0 | RemedyRepack Inc. | Drug | Class II | 1 |
| 20 Aug 2018 | Mexican Style Ricotta Cheese labeled, "Don Froylan Requeson***Mexican Style Ricotta Cheese***Ingredients: Pasteurized Whey, Salt***" 1lb. (16 oz.) and bulk plastic bags in 2lb. and 5lb. Event 80889 | Ochoa's Queseria LLC | Food | Class II | 1 |
| 18 Aug 2018 | Salad Mix (Green Kale, Green Cabbage, Broccoli Stems, Chicory, and Brussel Sprouts) | Air Stream Corp. | Food | Class I | 6 |
| 17 Aug 2018 | Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-068-90 | Torrent Pharma Inc. | Drug | Class II | 12 |
| 17 Aug 2018 | Blommer Natural Cocoa Butter Bulk Tanker Event 80906 | Blommer Chocolate Co., Inc. | Food | Class II | 1 |
| 17 Aug 2018 | Tipu's Chai - Sweetened Masala Chai, Net wt.7.5 oz. per box. UPC #: 7 19196 20035 3. Each box contains five single serve sachet packets of Chai Tea Latte. Single serve sachet Chai Tea Latte packets, net wt. 1.1 oz per packet. UPC 7 19196 20073 5. The LABEL of Sweetened Masala Chai is read in parts: "***SWEETENED… Event 80855 | Name withheld | Food | Class II | 1 |
| 17 Aug 2018 | Aztlan Mole Poblano; 10 kg plastic buckets (22 lbs); Ingredients: sugar, Ancho pepper, peanut, soybean oil, pasilla pepper, guajillo pepper, sesame seed, cookie, cocoa, corn flour, idozided salt, condiments and spices. Sodium benzoate as a preservative. Distributed by/distributed for: Jelley Crown Inc. City of… | Hidroponicos Brownia, S.P.R. de R.L. | Food | Class I | 2 |
| 15 Aug 2018 | da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation,… | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 15 Aug 2018 | Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair. Event 80686 | Permobil, Ab | Device | Class II | 1 |
| 15 Aug 2018 | Chocolate Chip Cookies, brand Cafe YUMM! Product is packaged in shrink wrapped master case. Each master case contains two boxes and each box contains 24 cookies. The master case is taped shut and labeled with the contents and production date, along with a lot code. The label on master case is read "***Cafe YUMM!… | Marsee Foods Inc | Food | Class I | 3 |
| 15 Aug 2018 | Sammy Salsa Happy Medium, packaged in 14 oz. plastic container, 6 units per case. UPC # 00868422000110. The label is read in parts: "***INGREDIENTS: Fresh Tomatoes, Fresh Onions, Fresh Chili Peppers, Fresh Cilantro, Fresh Garlic, Fresh Lime, Vinegar, Whole Peeled Tomatoes (calcium chloride, citric acid), Sea Salt,… | Sammy Food Products LLC | Food | Class II | 4 |
| 14 Aug 2018 | Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other… | Ohio Medical Corporation | Device | Class II | 1 |
| 14 Aug 2018 | Tyvaso Inhalation System Patient a) Starter Kit with TYVASO (treprostinil) Inhalation Solution. Treprostinil 1.74 mg/2.9 mL (0.6 mg/mL) (NDC 66302-206-01) b) TD-300/A Replacement Device Kit Material Number RTP3099 RX Only. Manufactured by United Therapeutics Corporation Research Triangle Park, NC 27709 | United Therapeutics Corp. | Drug | Class III | 1 |
| 14 Aug 2018 | Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in boxes of 20 cups), Rx Only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977 Dist. By: McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51 Event 80830 | Mckesson Corporation | Drug | Class II | 1 |
| 14 Aug 2018 | Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | AVKARE Inc. | Drug | Class II | 4 |
| 13 Aug 2018 | IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in combination with clinical evaluation of risk… | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 13 Aug 2018 | VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 418579 Product Usage: VITEK 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility… | bioMerieux, Inc. | Device | Class II | 2 |
| 13 Aug 2018 | remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720 | Remel Inc | Device | Class II | 3 |
| 13 Aug 2018 | Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin Lakes, NJ 07417 www.LivingWellRemedies.com. Made in the USA Event 80814 | Living Well Remedies, LLC | Drug | Class I | 1 |
| 13 Aug 2018 | Kale was shipped in card board boxes that are labeled with the firm name "Howard Calcagno, Aurora, OR 97002". | Howard Calcagno Farms | Food | Class II | 19 |
| 10 Aug 2018 | ev3 TurboHawk PERPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE, LARGE VESSEL XTENDED TIP FOR CALCIUM, Model THS-LX-C for peripheral vascular use. | Micro Therapeutics Inc, Dba Ev3 Neurovascular | Device | Class II | 1 |
| 9 Aug 2018 | MORTON NATURAL SEA SALT ALL PURPOSE***NET WET 26 OZ (1 LB 10 OZ) 737 g***Nutrition Facts***INGREDIENTS: SEA SALT PRODUCT OF BAHAMAS***MORTON SALE, INC, CHICAGO, IL 60606***QUESTIONS? CALL 1-800-789-SALT (7258) | MORTON SALT INC | Food | Class III | 1 |
| 8 Aug 2018 | Azelastine HCl Ophthalmic Solution 0.05%, 6 mL in 10 mL HDPE bottle, 1 bottle per box, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-718-10 | Akorn, Inc. | Drug | Class III | 1 |
| 8 Aug 2018 | Tomato Condensed Soup, 26 oz (1 LB 10 OZ) 737 g, 307 x 512 Can, Family Size, 12 cans per tray, shelf stable Event 80806 | Morgan Foods, Inc. | Food | Class II | 1 |
| 7 Aug 2018 | Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC… | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 7 Aug 2018 | Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01 | Mylan Pharmaceuticals Inc. | Drug | Class III | 2 |
| 3 Aug 2018 | Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388 | Invivo Corporation | Device | Class II | 1 |
| 3 Aug 2018 | Hostess Brownies Cookies 'n Crème packaged in the following ways: 1) 6 Brownies individually wrapped packaged in a cardboard box Net Wt. 8.68 OZ (246 g) UPC 888109113575; 2) 2 Brownies packaged in a cardboard box Net Wt. 2.89 OZ (82 g) UPC 888109012021 | Hostess Brands, LLC | Food | Class II | 1 |
| 3 Aug 2018 | Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle | VIRTUS PHARMACEUTICALS LLC. | Food | Class III | 2 |
| 3 Aug 2018 | Consumer Packaging (PET bottle): Minute Maid TROPICAL BLEND Flavored Juice Beverage 12 FL OZ (355mL), JAN0719NPA, UPC: 0 25000 06229 2. Master Case: packaged 24/12 fl.oz., GTIN number 00025000062414 (no UPC) | The Coca-Cola Company | Food | Class II | 1 |
| 2 Aug 2018 | OptiView DAB IHC Detection Kit, Catalog Number 06396500001, model 760-700 Immunohistochemistry (IHC) for in vitro diagnostic use. | Ventana Medical Systems Inc | Device | Class I | 21 |
| 2 Aug 2018 | Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009 | Pharmcore Inc. | Drug | Class II | 9 |
| 1 Aug 2018 | sterEOS workstation Event 80938 | Name withheld | Device | Class II | 1 |
| 1 Aug 2018 | AIRO Mobile CT System Model # MobiCT-32 | Mobius Imaging, LLC | Device | Class II | 1 |
| 1 Aug 2018 | Ararat Imambayeldy; 18.3 oz. glass jar; Ingredient: Eggplant, tomato paste, onions, vegetable oil, garlic, green salt Product of Armenia; Exclusively imported and distributed by: Kradjian Importing Co., Inc. Glendale, CA | Artashes LLC | Food | Class II | 4 |
| 30 Jul 2018 | CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO | Civco Medical Instruments Co. Inc. | Device | Class II | 2 |
| 30 Jul 2018 | ARROW Bipolar Electrode Catheter with shrouded pins, 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording | Arrow International Inc | Device | Class II | 1 |
| 30 Jul 2018 | Garden Highway Mt. Olympus Greek Salad, 8 oz. UPC 0826766009374 | Caito Foods LLC. | Food | Class II | 12 |
| 29 Jul 2018 | Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355 | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 27 Jul 2018 | Sysmex XN-Series Fluorocell PLT, Catalog #CD994563. Distributed in the U.S.A. by Sysmex America, Inc., Lincolnshire, IL. Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers. | Sysmex America, Inc. | Device | Class II | 1 |
| 27 Jul 2018 | Fresh Express Chopped Romaine 1 lb | Fresh Express Incorpated | Food | Class II | 3 |
| 27 Jul 2018 | El Guapo Jamaica Hibiscus Flowers in flexible pouches , 1 oz., 2 oz., 8 oz., 16 oz., and 10 lb. box . Event 80695 | Mojave Foods Corp. | Food | Class I | 1 |
| 26 Jul 2018 | Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319 | Covidien LLC | Device | Class II | 1 |
| 26 Jul 2018 | AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical… | Steris Corporation | Device | Class II | 1 |
| 25 Jul 2018 | PR1000 Pivot Rehab Bed AC powered adjustable bed. | Med-Mizer, Inc. | Device | Class II | 1 |
| 24 Jul 2018 | Stryker Mako Vizadisc Knee Procedure Tracking Kit | Mako Surgical Corporation | Device | Class II | 2 |
| 24 Jul 2018 | Diagnostica Stago STA Noplastine CI Plus, 10 ml vial. In-Vitro Diagnostic for determination of the prothrombin time (PT) in plasma. (REF 00667) The STA - Noplastine CI Plus kits provide reagents for the determination of the prothrombin time (PT) in plasma with STA-R, STA Compact and STA Satellite. (In the USA… | Diagnostica Stago, Inc. | Device | Class II | 2 |
| 24 Jul 2018 | GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems | GE Medical Systems China Co., Ltd. | Device | Class II | 3 |
| 23 Jul 2018 | Freedom EV0-2 with any version of EVOware and EVOware Sample Tracking Add-On V1.0 or higher | Tecan US, Inc. | Device | Class II | 1 |
| 20 Jul 2018 | Gentle Thread PLGA Round Head Interference Screw, 7x20mm, Item Number 905612 | Zimmer Biomet, Inc. | Device | Class II | 2 |
| 20 Jul 2018 | equate High Performance Protein Shake: Chocolate, Naturally & Artificially Flavored, ready to drink; 11 FL OZ (325 mL), sold in 12 pack case: Case UPC: 6 81131 01580 6 Distributed by: Wal-Mart, Inc. Bentonville, AR Event 80694 | California Natural Products | Food | Class II | 1 |
| 19 Jul 2018 | Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indications include ophthalmic, general and… Event 80846 | Name withheld | Device | Class II | 1 |
| 18 Jul 2018 | P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 | DePuy Orthopaedics, Inc. | Device | Class II | 1 |
| 18 Jul 2018 | AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90 | Avkare Incorporated | Drug | Class II | 5 |
| 17 Jul 2018 | 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2 | Arrow International Inc | Device | Class II | 2 |
| 17 Jul 2018 | Affixus Hip Fracture Nail Right 125¿ 9 mm x 280 mm, Item Number: 814309280 | Zimmer Biomet, Inc. | Device | Class II | 129 |
| 16 Jul 2018 | Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the… | Roche Diagnostics Corporation | Device | Class II | 1 |
| 16 Jul 2018 | RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321238, 10322347, 10328278, 10328302, 10336784 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, hematocrit, neonatal total… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 4 |
| 13 Jul 2018 | Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements. | Exactech, Inc. | Device | Class II | 1 |
| 13 Jul 2018 | Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH. | Smiths Medical ASD Inc. | Device | Class III | 1 |
| 13 Jul 2018 | 2008T HEMODIALYSIS SYS, WITH CDX, Part Number 190713, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy. | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 2 |
| 13 Jul 2018 | Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic perioperative autotransfusion system indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures | Haemonetics Corporation | Device | Class II | 2 |
| 12 Jul 2018 | Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot,… | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 12 Jul 2018 | Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108 | Medical Components, Inc dba MedComp | Device | Class II | 11 |
| 11 Jul 2018 | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry… | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 11 Jul 2018 | VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum and plasma using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. | Ortho-Clinical Diagnostics | Device | Class III | 2 |
| 11 Jul 2018 | VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600… | Ortho-Clinical Diagnostics | Device | Class III | 1 |
| 11 Jul 2018 | 400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD | COVIDIEN LLC | Device | Class II | 6 |
| 10 Jul 2018 | Lenny's Maryland Crab Mix Event 80622 | Lenni's Crab Mix, Inc | Food | Class II | 1 |
| 5 Jul 2018 | DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries | Pro-Med Instruments Gmbh | Device | Class I | 3 |
| 3 Jul 2018 | Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontToric) Zenlens TPC + MV- (Toric Peripheral… | Alden Optical | Device | Class III | 2 |
| 29 Jun 2018 | Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device. | Quasar Bio-Tech, Inc. | Device | Class II | 3 |
| 28 Jun 2018 | Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253 | Bayer Medical Care, Inc. | Device | Class II | 3 |
| 22 Jun 2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and… | Stryker Leibinger GmbH & Co. KG | Device | Class II | 18 |
| 21 Jun 2018 | Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the… | Degania Silicone, Ltd. | Device | Class II | 32 |
| 19 Jun 2018 | VTI 8 MHz Surgical Doppler Transceiver Selectabable Channel Ref. Number: 108910 Intraoperative (microvascular and vascular), Intraoperative Neurological, Transesophageal, Transrectal, Laparoscopic and Peripheral Vascular. Event 80527 | Vascular Technology, Inc. | Device | Class II | 1 |
| 19 Jun 2018 | AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration. | LeMaitre Vascular, Inc. | Device | Class II | 1 |
| 15 Jun 2018 | Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10 BX/CS; c. Item Number DYK1002DBSE, BRUSH, CLEANING,… | Medline Industries Inc | Device | Class II | 1 |
| 15 Jun 2018 | Calcitriol Oral Solution, 1 mcg/mL, 15 mL bottle, Rx Only, Distributed by: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA, NDC 63304-241-59 | Validus Pharmaceuticals, Inc. | Drug | Class III | 2 |
| 12 Jun 2018 | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep… | Inspire Medical Systems Inc. | Device | Class II | 1 |
| 5 Jun 2018 | Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090, M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450150, M003WE0250200, M003WE0300200, M003WE0350200, M003WE0400200, M003WE0450200 Event 80204 | Name withheld | Device | Class II | 1 |
| 31 May 2018 | N Latex CDT Kit | CSL Behring GmbH | Device | Class II | 1 |
| 30 May 2018 | FLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x Malleable Tip Trimmable Tip***Baxter***." The pouches inside the cartons are labeled in part, "Floseal SPECIAL APPLICATOR TIPS***Baxter***"." | Baxter Healthcare Corporation | Device | Class II | 1 |
| 16 May 2018 | Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory. Event 80688 | Ceterix Orthopedics, Inc. | Device | Class II | 1 |
| 16 May 2018 | Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designed for self-testing by persons with diabetes and the monitoring of glucose concentrations for… | Medtronic Inc. | Device | Class II | 1 |
| 14 May 2018 | Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction. | Encore Medical, Lp | Device | Class II | 1 |
| 10 May 2018 | Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing… | Zimmer Dental Inc | Device | Class II | 1 |
| 8 May 2018 | Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. | Exactech, Inc. | Device | Class II | 1 |
| 8 May 2018 | Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection. | Luminex Corporation | Device | Class II | 1 |
| 7 May 2018 | WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523. | Biosense Webster, Inc. | Device | Class I | 1 |
| 30 Apr 2018 | PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole blood and plasma. | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products, Llc | Device | Class II | 2 |
| 18 Apr 2018 | DRAD-3000E (Radrex-i) TFP-4336W (Wireless FPD) | Canon Medical System, USA, INC. | Device | Class II | 1 |
| 13 Apr 2018 | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication independent from that of the systems. The… | Cardiovascular Systems Inc | Device | Class II | 1 |
| 22 Mar 2018 | GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and… | GE Medical Systems Ultrasound & Primary Care Diagnostics, LL | Device | Class II | 8 |
| 21 Mar 2018 | Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads. Product Packaging: Three (3) PVP-I prep pads are packed into each urine collection kit carton along with a pre-connected drainage funnel, specimen container, funnel lid, specimen lid and a room label. | Bard Medical Division | Device | Class II | 1 |
| 15 Mar 2018 | URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with CK20 is a cocktail of mouse monoclonal and… | Biocare Medical, LLC | Device | Class II | 1 |
| 12 Mar 2018 | McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is… Event 80723 | McKesson Israel Ltd. | Device | Class II | 1 |
| 7 Mar 2018 | Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized. | SPS Sterilization, Inc | Device | Class II | 15 |
| 8 Feb 2018 | Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany. | Stanbio Laboratory, LP | Device | Class II | 1 |
| 1 Feb 2018 | Medline 0.9 % Sodium Chloride Injection, USP 5 mL in 10 mL Syringe ZR Intended for flushing IV catheters and IV tubing only. | Medline Industries Inc | Device | Class II | 1 |
| 12 Jan 2018 | Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care… | Tecan US, Inc. | Device | Class II | 1 |
| 27 Dec 2017 | Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical… | Mako Surgical Corporation | Device | Class II | 1 |
| 25 Sep 2017 | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212 | PerkinElmer Life and Analytical Sciences, Wallac, OY | Device | Class III | 1 |
| 12 Apr 2017 | Art-Line Surgery Pack-LF, STERILE, 40 packs each per case. | Medline Industries, Inc. | Device | Class II | 5 |
| 18 Nov 2016 | ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging Event 80981 | Swissray Medical | Device | Class II | 1 |