| 14 Jun 2018 | Kellogg's Honey Smacks, 15.3 oz. and 23 oz. | Kellogg Company | Food | Class I | 1 |
| 12 Jun 2018 | Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90 | Name withheld | Drug | Class III | 3 |
| 12 Jun 2018 | Melissa's Spicy Edamame: Lightly seasoned with Japanese Chile and Sesame Oil. 7 oz. (1.98g) Keep Refrigerated UPC: 0-45255-14637 6 count and 12 count cases; Ingredients: Soybeans, water Sesame oil, Soy Sauce (soy Beans, Wheat and salt) Rice Wine vinegar, Chaotian chile, pepper, sugar, garlic, sodium glutamate.… | World Variety Produce Inc. | Food | Class III | 1 |
| 11 Jun 2018 | Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08. Event 80277 | BioDiagnostic International | Drug | Class II | 1 |
| 7 Jun 2018 | Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01 | Mylan Pharmaceuticals Inc. | Drug | Class III | 1 |
| 5 Jun 2018 | HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ | PharMEDium Services, LLC | Drug | Class II | 1 |
| 4 Jun 2018 | Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL Event 80167 | HOSPIRA INC, LAKE FOREST | Drug | Class I | 1 |
| 31 May 2018 | Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1 | Apotex Inc. | Drug | Class II | 1 |
| 31 May 2018 | 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37 | ICU Medical Inc | Drug | Class II | 5 |
| 30 May 2018 | Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900 Event 80208 | Name withheld | Drug | Class II | 1 |
| 30 May 2018 | BISCUIT FOOD Cheese Biscuits, The product comes in a 16.5 oz. (468g), clear plastic package. The product UPC codes 6926145714029 and 6926145712902. Manufacturer: Dongguan Jiayou Food Co., Ltd. Product of China. Event 80223 | SDQ Trading Inc. | Food | Class II | 1 |
| 30 May 2018 | EconoMax Neopolitan, 4 quarts and 56 ounces | H-E-B GROCERY COMPANY LP DBA HEB | Food | Class II | 15 |
| 29 May 2018 | Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 29 May 2018 | Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05 | Pharmaceutical Associates Inc | Drug | Class III | 1 |
| 29 May 2018 | Milk Chocolate Covered Fudge Bites, 3.75oz, PET Pouch, 12 packages per case Event 80224 | Morley Candy Makers, Inc. | Food | Class II | 1 |
| 29 May 2018 | Meijer DILL PICKLE FLAVORED CLASSIC CRUNCH POTATO CHIPS***UPC 719283594365***LOT CODE*** | Shearers Foods, Llc | Food | Class I | 1 |
| 29 May 2018 | Commercial breaders and batters Product B58042 Breader XI- 50 pound bags Product B58915 Breader X1- 40 pound bags Product B29767 Batter Mix X1- 50 pound bags Product B57802 CTFSH BRDR X1 - 25 pound bags Product B91412 MSRM BRDR X1- 40 pound bags Product B97705 Breader X3 - 50 pound bags | Newly Weds Foods Inc | Food | Class II | 1 |
| 28 May 2018 | Trader Joe's Artisan Bread - Organic French Baguette; (Brown and Serve) Keep frozen; Product code 53835; 24 x 11.5 oz. (326g) - 24 loaves per case. UPC 0053 8350 Product of Canada Manufactured by Groupe Premiere Moisson Inc., 189 Harwood, Vaudreuil-Dorion, Quebec, Canada Distributed and sold exclusively by Trader… | Trader Joes Company | Food | Class II | 1 |
| 25 May 2018 | Valsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90 | Jubilant Cadista Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 25 May 2018 | X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505. | Shadow Holdings DBA Bocchi Labs | Drug | Class II | 4 |
| 25 May 2018 | Baskin Robbins Mint Chocolate Chip | Dean Foods, Inc. | Food | Class II | 1 |
| 25 May 2018 | WATAN DRY FRUITS PREMIUM QUALITY NATURAL DRIED APRICOT WITH PITT, NET WT. 1 LB, and 0.50 LB, PRODUCE OF PAKISTAN, IMPORT BY: GLOBAL COMMODITIES INC. NEW YORK USA, | Global Commodities Inc | Food | Class I | 1 |
| 25 May 2018 | Herd of Turtles confection milk chocolate, 4 oz. and 8 oz. packages. UPC of 4 oz: 6 55974 89004 3. UPC of 8 oz: 6 55974 89008 1. The label is read in parts: "***INGREDIENTS: MILK CHOCOLATE 35% (SUGAR, COCOA BUTTER, WHOLE MILK POWDER, EMULSIFIER, SOYA LECITHIN, VANILLA), CARAMEL (SUGAR, CREAM, MILK, CORN SYRUP, COCOA… | Name withheld | Food | Class III | 3 |
| 24 May 2018 | Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a… | Draeger Medical, Inc. | Device | Class II | 5 |
| 24 May 2018 | STAT-Check MANUAL RESUSCITATOR / VENTILATOR, REF SC9200MBP-1 | Sun Med, LLC | Device | Class II | 14 |
| 24 May 2018 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102 Event 80187 | Name withheld | Drug | Class III | 1 |
| 24 May 2018 | Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carton) NDC 0023-5862-31 (Outer carton) UPC 300235862290 | Allergan, PLC. | Drug | Class I | 1 |
| 24 May 2018 | Zoe's Cookies Vegan Tuxedo Fudge, 4 oz. (153 kg) individually wrapped cookie. INGREDIENTS: UNBLEACHED FLOUR (WHEAT FLOUR, NIACIN, IRON, THIAMINE MONONITRATE, RIBOFLAVIN, ENZYME, FOLIC ACID), EVAPORATED CANE JUICE, VEGAN WHITE CHOCOLATE CHIPS (NON-BONE CHAR PROCESSED SUGAR, VEGETABLE OIL, COCOA BUTTER, SOY LECITHIN,… Event 80178 | Dough-To-Go Inc | Food | Class I | 1 |
| 23 May 2018 | H-E-B Ode to Olives, Sliced Salad Olives, 10 oz. drained weight per jar/ 6 jars per case (this product is sold by the jar at the store level, not by the case), Best by November 3, 2019. Event 80253 | Agro Sevilla USA | Food | Class II | 1 |
| 23 May 2018 | simply delicious Divvies SEMI-SWEET PEPPERMINT BARS made to share CHOCOLATE bar BENJAMINT CRUNCH ALL NATURAL NUT & DAIRY FREE NET WT. 2.25 OZ. (63g) Event 80168 | Divvies LLC | Food | Class II | 1 |
| 22 May 2018 | READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count flexible pack. Manufactured by Medline Industries, Inc. Mundelein, IL 60060 USA. NDC 53329-066-58. Event 80192 | Medline Industries Inc (Northpoint Services) | Drug | Class II | 1 |
| 22 May 2018 | Ethanol Extraction 190 Proof Non-Denatured Grain Alcohol, Multiple sizes: 8 oz, 16 oz, 32 oz, 64 oz, 1 gal, 2.5 gals, 5 gals, 55 gallon drum, 8oz clear PVC cylinder bottles, all others heavy-duty polyethylene bottles (except single 55-gallon plastic drum). Event 80161 | Lake Michigan Distilling Co LLC | Food | Class I | 1 |
| 21 May 2018 | The Most Awesome Chocolate Bar EVER, packaged individually in a 1.5 oz bar. The UPC is 8 55966 00178 9. The label is read in parts: "***Lillie Belle Farms***The Most Awesome Chocolate Bar EVER! ***Ingredients: organic milk and dark chocolate (organic cocoa mass, organic cocoa liquor, organic sugar, organic vanilla,… Event 80166 | JJBL LLC | Food | Class II | 1 |
| 21 May 2018 | Meijer Dark Chocolate Covered Almonds, 18 ounces, packed in a Clear plastic container, 12 containers per case | Meijer, Inc #816 - Grand River Packaging | Food | Class II | 1 |
| 21 May 2018 | Broccoli cuts, All Natural, No Preservatives, Net Wt 16 OZ; Distributed by Foodhold USA, LLC, Landover, MD 20785; UPC: 688267009266, BEST BY 03/15/2020 Event 80183 | Ahold USA | Food | Class II | 1 |
| 21 May 2018 | Melanie Liubitelskie Cookies in a 17.6 oz (500g) clear plastic package with UPC 4770049011188. | Desly International Corp. | Food | Class I | 2 |
| 18 May 2018 | Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 18 May 2018 | Snak Club Tropical Trail Mix: 16 oz. plastic pouch: Ingredients: Raisins, Peanuts, Pineapple, Papaya, Banana Chips, Coconut Chips and Almonds. UPC: , 0-87076-64462-8 Yogurt Trail Mix contains Raisins, Peanuts, Dates, Yogurt Chips, Cashews and Almonds. New Century Snacks, Commerce, CA. | New Century Snacks LLC | Food | Class I | 1 |
| 18 May 2018 | Pious Lion Pure Premium Potent Limited Release Pink Bali, 1 oz plastic bag. 833-AVL-KRTM www.piouslion.com | Name withheld | Food | Class I | 2 |
| 18 May 2018 | Terry's Potato Salad, Packaged into the following sized containers: 1. Net Wt. 30 lbs. (13.68kg), Mfg No. 20117, UPC 10032345201177. 2. Net Wt. 5 lbs. (2.27Kg), Mfg. No. 21080, UPC 10032345190808 Keep Refrigerated between 35 - 38 F. MFG by Dawn's Foods, Portage, WI 53901 | Morski Brands Inc. dba Dawn's Fresh Foods | Food | Class II | 4 |
| 17 May 2018 | POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857 | Shoreside Enterprises Inc. | Drug | Class I | 2 |
| 17 May 2018 | Ziyad Brand Tahini, 8oz, 16oz, gal, 32oz., packed in glass jars Event 80134 | Ziyad Brothers Importing, Inc. | Food | Class I | 1 |
| 16 May 2018 | DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. | Zimmer Biomet, Inc. | Device | Class II | 13 |
| 16 May 2018 | Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ | Inopak Ltd | Drug | Class II | 1 |
| 15 May 2018 | Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with… | Draeger Medical Systems, Inc. | Device | Class I | 2 |
| 15 May 2018 | Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber bottle with glass dropper, MBi Nutraceuticals, Lindon, UT 84042. Bar Code: 3 58301 04011 0 | MBi Distributing Inc. dba MBi Nutraceuticals | Drug | Class II | 7 |
| 15 May 2018 | Priano Rosso Pesto Sauce, 6.7oz glass jar Event 80117 | BLM Products U. Vertriebsges | Food | Class I | 1 |
| 14 May 2018 | Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass | Maquet Cardiopulmonary Ag | Device | Class II | 3 |
| 14 May 2018 | Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO | CryoLife, Inc. | Device | Class II | 2 |
| 11 May 2018 | Birmingham Hip Resurfacing Femoral Head: (a) Size 58 mm, REF 74121158 (b) Size 56 mm, REF 74123156 | Smith & Nephew, Inc. | Device | Class II | 2 |
| 11 May 2018 | Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode REF 75505, QTY 50 (b) Button Switchpen, w/ Standard Blade Electrode, REF 75530, QTY 50 (c) Rocker Switchpen, w/ Standard Blade Electrode, REF 75610, QTY 50 (d) Button Switchpen, w/ Extendable Blade Electrode, 10 mm Exposure, REF… | Olsen Medical | Device | Class II | 5 |
| 11 May 2018 | Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 11 May 2018 | Olympus JF-140F duodenoscopes (Model NumberJF-140F) | Olympus Corporation of the Americas | Device | Class II | 2 |
| 10 May 2018 | XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124 | Angiodynamics Inc. (Navilyst Medical Inc.) | Device | Class II | 38 |
| 10 May 2018 | Alfalfa Seeds Event 80070 | Caudill Sprouting LLC | Food | Class I | 1 |
| 8 May 2018 | Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet, UPC: 616784522715, Model Number 5227 A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure… | Dynarex Corporation | Device | Class II | 1 |
| 8 May 2018 | ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with… | MEDTECH SAS | Device | Class II | 1 |
| 8 May 2018 | Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood… | Baxter Healthcare Corporation | Device | Class II | 2 |
| 8 May 2018 | Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research. | Zeiss, Carl Inc | Device | Class II | 1 |
| 8 May 2018 | Sugarfina Sugar Cookies Distributed by Sugarfina, Inc. small candy cube, large candy cube, and 1.0oz. taster packet UPC Code: 840278109414; 840278113725; 840278116580 9495 Santa Monica Blvd., Beverly Hills, CA 90210 | Sugarfina, LLC | Food | Class II | 1 |
| 7 May 2018 | AmerisourceBergen PF Latex SG (Surgical Glove), Sterile, Powder Free, Size 6.5, Item No. 10112 Event 79992 | WRP Asia Pacific Sdn Bhd | Device | Class II | 1 |
| 7 May 2018 | Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples… | Roche Diabetes Care, Inc. | Device | Class II | 3 |
| 7 May 2018 | Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357 NDC 53807-158-12, UPC… | RIJ Pharmaceutical LLC | Drug | Class II | 12 |
| 4 May 2018 | Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures. | Vascular Solutions, Inc. | Device | Class II | 1 |
| 4 May 2018 | remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin, and oxacillin). Event 80068 | Name withheld | Device | Class II | 1 |
| 4 May 2018 | RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests. | Randox Laboratories | Device | Class II | 1 |
| 4 May 2018 | Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463 | Stryker GmbH | Device | Class II | 1 |
| 4 May 2018 | smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1) | Smith & Nephew, Inc. | Device | Class II | 1 |
| 4 May 2018 | Sauer - Red Pepper Seasoning (21 oz.) Net Weight: 21 oz., Number of Units per Package: 6 Package Type: clear, 32 fl. oz. polyethylene terephthalate bottle , Units per case: 6 | The C.F. Sauer Company | Food | Class II | 5 |
| 3 May 2018 | P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL… | Joerns Healthcare | Device | Class II | 2 |
| 3 May 2018 | HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 3 May 2018 | HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can… | Ethicon Endo-Surgery Inc | Device | Class II | 2 |
| 3 May 2018 | CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179 | Maquet Datascope Corp - Cardiac Assist Division | Device | Class I | 1 |
| 2 May 2018 | MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to… | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 2 May 2018 | NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 Product Usage: This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.… | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 2 May 2018 | Part #: SAM XT-M, Model: Tactical Black or Military | The Seaberg Company Inc | Device | Class II | 3 |
| 2 May 2018 | Heartware Medtronic HVAD System for cardiac use. Including the following parts: (a) Controller / Controller Kits, Product numbers: 1400, 1401, 1403, 1407, 1420 (b) DC Adapter, Product numbers: 1435, 1440 (c) AC Adapter, Product numbers: 1425, 1430 (d) Battery Pack, Product number: 1650DE Indication for Use for OUS… | Heartware | Device | Class I | 1 |
| 1 May 2018 | Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for… | Keystone Dental Inc | Device | Class II | 1 |
| 1 May 2018 | Hobbs Bronchial Cytology Brushes, Model Number 4202; 4204; 4206 To be utilized by a trained physician and/or trained personnel through a flexible endoscope when brush cell samples are required for cytological analysis. | Hobbs Medical, Inc. | Device | Class II | 1 |
| 1 May 2018 | Heritage Shortbreaad Lemon Infused Ingredients: Enriched flour, pasteurized cream(milk),sugar, salt, pure crystallized ginger, organic ground ginger Mfg. by Heritage Shortbread, Inc. Hilton Head Island, SC 09926 Event 80026 | Heritage Short Bread, Inc. | Food | Class II | 1 |
| 30 Apr 2018 | IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350 | Philips Electronics North America Corporation | Device | Class II | 4 |
| 26 Apr 2018 | Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel. | Draeger Medical, Inc. | Device | Class II | 1 |
| 24 Apr 2018 | MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient. | Medline Industries Inc | Device | Class II | 6 |
| 20 Apr 2018 | SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans. | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 20 Apr 2018 | LINX Reflux Management System, Implant Suture, 12-17 Bead, 0.7T, Product Code LS-xx, sterile, Rx only. Labeled as: a. Product Code LS-12; b. Product Code LS-13; c. Product Code LS-14; d. Product Code LS-15; e. Product Code LS-16; f. Product Code LS-17; Laparoscopic, fundic-sparing anti-reflux procedure indicated for… | Torax Medical, Inc. | Device | Class II | 5 |
| 19 Apr 2018 | MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU rev. D The MicroAire Carpal Tunnel Release System is for use in patients diagnosed with carpal tunnel syndrome that is not associated with, or secondary to, any other known pathology (i.e., idiopathic… | MicroAire Surgical Instruments, LLC | Device | Class II | 1 |
| 19 Apr 2018 | VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT600DF AIM STP; 568821910, VLT600SF STP QL; 568821911, VLT600SF AIM STP QL; 568821960, VLT600DF STP… Event 79898 | Maquet SAS | Device | Class II | 1 |
| 19 Apr 2018 | Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers affected are EB8115, BB8159, and FB8275. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 17 Apr 2018 | Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650-129A (00821925008700) The cord consists of a single conductor stranded wire terminated with plugs that connect to a generator on one end and a plug that connects to a Gyrus ACMI working element on the other end. They are provided… | Gyrus Acmi, Incorporated | Device | Class II | 1 |
| 15 Apr 2018 | Driscoll's Blackberries; 6 oz. clamshell container; Keep refrigerated. Product of Mexico Driscoll's Inc. Watsonville, CA 95077 Event 79900 | Driscoll's Strawberry Associates, Inc. | Food | Class III | 1 |
| 13 Apr 2018 | Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19 | TriMed Inc. | Device | Class II | 4 |
| 11 Apr 2018 | The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation… | Becton Dickinson & Company | Device | Class II | 3 |
| 11 Apr 2018 | Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000 | Arrow International Inc | Device | Class II | 76 |
| 10 Apr 2018 | Heinens Organic Nut Mix Net Wt. 9 oz (255g) Distributed By Heinens, Warrensville Hts., OH 44128 UPC 0-36232-01871-1 | Ohio Hickory Harvest Brand Products Inc. | Food | Class II | 6 |
| 9 Apr 2018 | VGI MEDICAL VerteLP LATERAL INTERBODY FUSION instrument kit Event 80012 | VGI Medical, LLC | Device | Class II | 1 |
| 6 Apr 2018 | Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C | Orthofix, Inc | Device | Class II | 20 |
| 3 Apr 2018 | cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and… | Roche Diagnostics Corporation | Device | Class II | 1 |
| 2 Apr 2018 | Bivona Tracheostomy Tube Tracheostomy Tubes | Smiths Medical ASD Inc. | Device | Class II | 1 |
| 30 Mar 2018 | C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications. | PENTAX of America Inc | Device | Class II | 1 |
| 30 Mar 2018 | Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 728231. Computed Tomography X-ray system | Philips Medical Systems (Cleveland) Inc | Device | Class II | 3 |
| 29 Mar 2018 | Manischewitz Brand, Dark Chocolate covered Potato Chips, 4.25 oz /12 per case, in mylar metalized bag in gable box, | R.A.B. Food Group LLC | Food | Class II | 1 |
| 27 Mar 2018 | ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT Chemistry Systems | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 23 Mar 2018 | The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A microorganism differentiation and identification… | BioMerieux SA | Device | Class II | 9 |
| 5 Mar 2018 | Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set | Synthes (USA) Products LLC | Device | Class II | 3 |
| 5 Mar 2018 | ST-AIA PACK AFP; Part Number: 025252 Assay, Tumor Marker | Tosoh Bioscience Inc | Device | Class II | 35 |
| 1 Mar 2018 | XZB Grilled Crispy Shrimp (20g*20 and 16g*24) UPC Code (16g) 6923006800082 Event 80158 | KUIYI INTERNATIONAL INC. | Food | Class II | 1 |
| 26 Feb 2018 | Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery. Event 80024 | Genesee BioMedical, Inc. | Device | Class II | 1 |
| 13 Feb 2018 | BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x75mm 3.5ml PLBL Gold, Catalog No. 367983 | Becton Dickinson & Company | Device | Class II | 2 |
| 30 Jan 2018 | TL-HEX TruLok Hexapod System, Double Row Footplates, TL-HEX Sterile, All Sizes: 120 MM, 140 MM, 160 MM, 180 MM, 200 MM. The TL-HEX TrueLock Hexapod System (TL-HEX) consists of rings, foot plates and struts to be used in conjunction with the TruLok external fixation system. The system is a metal bone fixation device… | Orthofix Srl | Device | Class II | 1 |
| 25 Jan 2018 | Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer… | GE Healthcare | Device | Class II | 2 |
| 19 Jan 2018 | Restoris MCK Onlay Insert Extractor. | Mako Surgical Corporation | Device | Class II | 1 |
| 12 Jan 2018 | Sonialvision Safire II, Model #: DAR-8000f Product Usage: This angiographic x-ray system device intended to be used for the radiography in the hospital with X-ray devices. This device is operated and used by the physicians and X-ray technologist. The object of this device is total patient population. | Shimadzu Medical Systems | Device | Class II | 1 |
| 21 Dec 2017 | 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints. | Stryker Corporation | Device | Class II | 1 |
| 21 Dec 2017 | Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest… Event 80179 | Quantimetrix Corporation | Device | Class III | 1 |
| 20 Dec 2017 | Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a sterile state and are single-use only. Used to drill cranial holes using a stereotactic frame. | Ad-Tech Medical Instrument Corporation | Device | Class II | 1 |
| 19 Dec 2017 | P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments. | Paragon 28, Inc. | Device | Class II | 1 |
| 18 Dec 2017 | ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500 tests) | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 14 Dec 2017 | DermaPro Waterproof Silicone Tape, SNS57232 | Safe N Simple, LLC | Device | Class II | 1 |
| 13 Dec 2017 | Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522) | C.R. Bard, Inc. | Device | Class II | 1 |
| 13 Dec 2017 | 11-VI Incorporated Laser diode component Non-certified laser diode component used in laser sights for firearms Event 80020 | Name withheld | Device | Class II | 1 |
| 11 Dec 2017 | Medical Action Industries Inc. Blue OR Towel Non X-Ray Detectable (6 Towels per Pack) / product # AVID266 Sterile This OR towel product is intended for external use only. These towels are intended to be used as absorbent towels for hand drying, cleanup, and to provide increased absorbency of blood and bodily fluids.… | Medical Action Industries Inc | Device | Class II | 1 |
| 8 Dec 2017 | CARESCAPE R860 ventilators with software version 10SP05 Product Usage: 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 ventilator is a microprocessor based, electronically controlled,… | Datex-Ohmeda, Inc. | Device | Class II | 1 |
| 4 Dec 2017 | CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and… Event 80137 | Cellavision AB | Device | Class II | 1 |
| 28 Nov 2017 | lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical… Event 80096 | Alere San Diego Inc. DBA Immunalysis Corporation | Device | Class III | 1 |
| 27 Nov 2017 | Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 21 Nov 2017 | Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes. Event 78975 | SANTA JOY ORNAMENT & GIFTWARE CO | Device | Class II | 1 |
| 20 Nov 2017 | Xper Flex Cardio Physiomonitoring System The Xper Flex Cardio physiomonitoring system is used to facilitate invasive investigation of heart and vascular, disease when non-invasive indicators warrant such. The Xper Flex Cardio physiomonitoring system may be used to display and analyze surface ECG (electrocardiogram),… | Invivo Corporation | Device | Class II | 1 |
| 13 Nov 2017 | VNS Therapy Programmer, Model 3000, v1.0 System | Cyberonics, Inc | Device | Class II | 1 |
| 10 Nov 2017 | CritiCore Automated Urine Output and Temperature Monitor | C.R. Bard, Inc. | Device | Class II | 1 |
| 6 Nov 2017 | Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components… | CareFusion 303, Inc. | Device | Class II | 1 |
| 28 Oct 2017 | fMRI Hardware System - AudioSystem, Version 1.0 The AudioSystem allows auditory signals from the stimulus presentation PC to enter the scanner room and to be presented to the patient. A communication console allows the operator to adjust the sounds from the PC and to speak to the patient through a built-in microphone. Event 78848 | Name withheld | Device | Class II | 1 |
| 1 Sep 2017 | Respire Pink Series EF+ Oral Sleep Apnea Device. | Respire Medical | Device | Class II | 5 |
| 27 Jul 2017 | Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with… | Datascope Corporation | Device | Class II | 3 |
| 28 Oct 2016 | 12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system. | Ion Beam Applications S.A. | Device | Class II | 1 |
| 16 Sep 2016 | 12C | Ion Beam Applications S.A. | Device | Class II | 2 |
| 7 Aug 2016 | Proteus 235 The PTS 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 room dedicated to the treatment of patients with localized tumors and… | Ion Beam Applications S.A. | Device | Class II | 1 |
| 11 Mar 2016 | Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588 | Datascope Corporation | Device | Class III | 3 |
| 3 Jul 2015 | nordicICE v 2.3.14 nordicICE is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images.… Event 78467 | Name withheld | Device | Class II | 1 |
| 15 Dec 2014 | nordicTumorEx 1.0 nordicTumorEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of medical images.… Event 78460 | Name withheld | Device | Class II | 1 |
| 17 Sep 2014 | nordicBrainEx 2.0 provides analysis and visualization capabilities of dynamic MRI data of the brain, presenting the derived properties and parameters in a clinically useful context. Event 78466 | Name withheld | Device | Class II | 1 |
| 12 Sep 2014 | nordicICE 2.3.14 Image processing software package used by trained professionals, including physicians and medical technicians. Event 78463 | Name withheld | Device | Class II | 1 |
| 21 Dec 2012 | nordicBrainEX Product Usage: nordicBrainEx is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard off-the-shelf PC workstation and can be used to perform image viewing, processing and analysis of… Event 80162 | Name withheld | Device | Class II | 1 |