| 14 Mar 2016 | Bakery Fresh Goodness Apple Strudel 5 count, 24oz, packaged in Plastic container, distributed by King Soopers Bakery, Denver, CO. (73539) | King Soopers Bakery | Food | Class II | 1 |
| 10 Mar 2016 | DiGiorno Rising Crust Spinach and Mushroom Pizza, UPC 71921-00335, Keep Frozen. Net Wt. 30.3 oz (1 lb 14.3 oz) 858g | Nestle USA | Food | Class II | 9 |
| 2 Mar 2016 | Citrus Flavored Soda Mello Yello, 12 fl. oz. (355 ml), Canned under authority of The Coca-Cola Company, Atlanta, GA 30313, UPC 497250 | Coca-Cola Company (The) | Food | Class II | 1 |
| 1 Mar 2016 | Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82 | Sagent Pharmaceuticals Inc | Drug | Class II | 1 |
| 1 Mar 2016 | NP Nutra Spinach Powder Organic SKU: 790 Net Weight: 22.72kg Gross Weight: 24kg Product of USA (73423) | Individual firm, name withheld | Food | Class I | 1 |
| 1 Mar 2016 | Sea Salt Caramel Pretzel Ice Cream, Red Button Vintage Creamery, 56 fluid ounce, Paper Tub, 6 tubs per case, Distributed by Associated Foods, Inc. Utah; Manufactured by Caspers Ice Cream, Inc. Utah | Casper's Ice Cream, Inc | Food | Class II | 1 |
| 29 Feb 2016 | RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions. | Nidek Inc | Device | Class II | 1 |
| 29 Feb 2016 | The Vesa 75/100 adaptation with rotation is an accessory to a surgical camera intended to be used to record operative procedures. | Richard Wolf Medical Instruments Corp. | Device | Class II | 1 |
| 26 Feb 2016 | Spacelabs Healthcare Xhibit Central Station, Model 96102 is used to provide clinicians with central monitoring of patient data for those patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. | Spacelabs Healthcare Inc | Device | Class II | 1 |
| 26 Feb 2016 | Bi-Lo, Fresh Cantaloupe, Chunks Medium Container, Chunks Large Container, Halves and Slices, various net wt., in clear plastic containers. | Southeastern Grocers | Food | Class I | 4 |
| 25 Feb 2016 | Dried lactose powder, product sold under brand Wine-King Beer-King, packaged in three consumer-sized plastic bags of 4 oz., 1 Lb. and 5 Lb. net weight. (73409) | Northwest Specialty, Inc. | Food | Class II | 1 |
| 24 Feb 2016 | syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing during interventional procedures. . | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 23 Feb 2016 | Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The… (73438) | Covidien Medical Products (Shanghai) Manufacturing L.L.C. | Device | Class II | 1 |
| 23 Feb 2016 | cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 23 Feb 2016 | Dark Chocolate Covered Coffee Beans, packaged in 12 oz. tubs | Lipari Foods, Inc. | Food | Class I | 1 |
| 22 Feb 2016 | BioTex Reusable Adapter Kit, Part Number 401-021-1010, packaged non-sterile in a dedicated case for steam sterilization The Adapter Kit is used during surgical procedures as an instrument guide holder that maintains the position of an instrument after they have been aligned by the physician via stereotactic guidance… | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 22 Feb 2016 | NatureBox Cinnamon Yogurt Mini Grahams, 6 oz. (170g) customer stand up pouches. UPC 8 58590 00528 4 Ingredients: Graham Crackers (unbleached unenriched wheat flour, whole wheat graham flour, sugar, palm and palm kernel oil, molasses, honey, salt, sodium bicarbonate). Yogurt Coating (sugar, palm kernel and/or palm… | NatureBox, Inc. | Food | Class II | 1 |
| 18 Feb 2016 | ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System. | TEM Systems Inc | Device | Class II | 1 |
| 18 Feb 2016 | McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1. | Mckesson Medical Immaging | Device | Class II | 1 |
| 18 Feb 2016 | Chappaqua Crunch Simply Granola with Blueberries & Bananas, in 13 ounce clear plastic pouch. UPC:7 86516 16007 9 (73331) | Individual firm, name withheld | Food | Class I | 1 |
| 18 Feb 2016 | Label reads in part "***Watts Brothers FARMS SUPERSWEET CUT CORN***NET WT 20 LB*** Distributed by ConAgra Foods Kennewick, WA 99336 PRODUCT OF U.S.A.***" Product is blanched then frozen and placed in a plastic lined cardboard box. UPC 1 06 81241 05167 8 | ConAgra Foods Inc | Food | Class II | 1 |
| 17 Feb 2016 | ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11. Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. | Argon Medical Devices, Inc | Device | Class II | 1 |
| 17 Feb 2016 | CARROLL SHELBY'S(R) ORIGINAL TEXAS BRAND White CHICKEN CHILI KIT, NET WT 3 OZ (85g), DIST. BY REILY FOODS COMPANY, NEW ORLEANS, LA 70130, UPC 7239610019 | Reily Foods Co. | Food | Class II | 1 |
| 16 Feb 2016 | HipLOC CHS Plate/Lag Screw Introducer | Biomet, Inc. | Device | Class II | 1 |
| 16 Feb 2016 | Milex Arcing Diaphragm Size 95; Model Number: MXWS95 | CooperSurgical, Inc. | Device | Class II | 1 |
| 16 Feb 2016 | da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 16 Feb 2016 | Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly… | Biomet, Inc. | Device | Class II | 1 |
| 16 Feb 2016 | Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04. | Genzyme Corporation | Drug | Class II | 2 |
| 16 Feb 2016 | ShopRite Dry Roasted Unsalted Cashews 7 oz. (198 g) Distributed by Wakefern Food Corp., Elizabeth, NJ 07207 UPC 4119001620 (73356) | Wakefern Foods Corp. | Food | Class II | 1 |
| 16 Feb 2016 | ICA GOURMET SEASONINGS, No Salt Added, nsa SEASONING, House Seasoning, NET W. 20 oz (1 LB. 4 OZ.) 567g, Packed by Ingredients Inc., Memphis, TN | Ingredients Corporation Of America | Food | Class II | 6 |
| 15 Feb 2016 | Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007 | CareFusion 303, Inc. | Device | Class II | 1 |
| 15 Feb 2016 | Fruit & Nut Medley, Snacks Fit for a King, King Size, 12 per case. NP- UPC 61054645419 and 61054645119. (73302) | King Henry's, Inc. | Food | Class II | 1 |
| 12 Feb 2016 | Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092 | CareFusion 303, Inc. | Device | Class II | 1 |
| 12 Feb 2016 | Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures. | Zimmer Spine, Inc. | Device | Class II | 2 |
| 12 Feb 2016 | Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant | Ivoclar Vivadent, Inc. | Device | Class II | 1 |
| 12 Feb 2016 | Mammomat Inspiration with Tomosynthesis functionality | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 12 Feb 2016 | Scrub-Stat 4 (chlorhexidine gluconate) Foam Forming Solution, 4%, packaged in a) 800 mL Plastic (HDPE) Bottles (NDC 47593-265-36), b) 1250 mL Plastic (HDPE) Bottles (NDC 47593-468-59), OTC, Ecolab, St Paul, MN 55102 | Ecolab Inc | Drug | Class III | 1 |
| 12 Feb 2016 | 8pk Strawberry Waffy Wafers, Global Brands item UPC 876274000806 BB 8/14/16 20142nj, BB 10/27/16 20145nj (73296) | Dollar Only Wholesale | Food | Class II | 1 |
| 12 Feb 2016 | Bertolli Extra Virgin Olive Oil, 8.5 oz. and Carapelli Extra Virgin Olive Oil, 25.5 oz., packaged in glass bottles. (73280) | DEOLEO USA, Inc. | Food | Class III | 1 |
| 12 Feb 2016 | Faye's Texas Naturals Chili Petin Picante Muy Caliente Net Wt. 16 oz./452 grams in glass jars; 123 S. Courthouse Square Goliad, Texas 77963 (361)645-3136 FAYESTEXASNATURALS.NET | Faye's Texas Naturals | Food | Class II | 4 |
| 12 Feb 2016 | Wilderness Family Naturals Coconut Milk, Powdered, Organic packaged in the following sizes: 1) 16 oz foil pouch, UPC 98392-00769; 2) 12 lb. Case of 12 - 1 lbs packages, UPC 01002457 3) 5 lb. bag, UPC 98392-00770 4) 30 lb. Case of 6 - 5 lb. packages, UPC 01002458 5) Case of 1-55 lb. package, UPC 01002459 6) Trial… | Individual firm, name withheld | Food | Class I | 16 |
| 11 Feb 2016 | KAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The KAMRA inlay is indicated for the improvement of near visual acuity in one eye (usually the non-dominant eye) of a presbyopic patient. (73343) | AcuFocus, Inc. | Device | Class II | 1 |
| 11 Feb 2016 | M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 11 Feb 2016 | Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should… | Roche Diagnostics Operations, Inc. | Device | Class II | 1 |
| 11 Feb 2016 | Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4. | Sun Pharma Global Fze | Drug | Class II | 1 |
| 11 Feb 2016 | sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654 (73332) | J. Strickland and Co | Drug | Class III | 1 |
| 11 Feb 2016 | Carys Dark Chocolate Almond Toffee with Hawaiian Salt. Product is packaged in printed cardboard packages in 1.3 oz , 4 oz, and 8 oz sizes. There are 12 packages per case. UPC 8 31617 00515, net wt. 1.3 oz. UPC 8 31617 00504, net wt. 4 oz. UPC 8 31617 00580, net wt. 8 oz. (73279) | Cary's of Oregon LLC | Food | Class II | 1 |
| 10 Feb 2016 | Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures. | Ambu Inc. | Device | Class II | 1 |
| 10 Feb 2016 | FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle. | Arrow International, Inc., Division of Teleflex Medical Inc. | Device | Class I | 9 |
| 10 Feb 2016 | LightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron… | GE Medical Systems, LLC | Device | Class II | 6 |
| 10 Feb 2016 | Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD). (73421) | Individual firm, name withheld | Device | Class II | 1 |
| 10 Feb 2016 | Clasen Quality Coatings NH Atlas 1M Creamy Peanut Drop, Item # 12649, Net Wt. 50 lbs (22.68 KG) (73294) | R&D Technical Center | Food | Class I | 1 |
| 9 Feb 2016 | Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava. | Bard Peripheral Vascular Inc | Device | Class II | 2 |
| 9 Feb 2016 | Cornstach packaged in a 50lb. bag with white and green label containing black lettering. | Ingredion Incorporated | Food | Class II | 1 |
| 9 Feb 2016 | Urban Oven Artisan-Baked Short Bread Cookies Classic Butter All Natural NET WT. 5 oz. UPC Code: 7 18122 06344 4 SKU #: C1000 | Urban Oven, LLC | Food | Class II | 4 |
| 8 Feb 2016 | TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment | Ormco/Sybronendo | Device | Class II | 1 |
| 8 Feb 2016 | Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN 38101-2026, UPC 0 70596 00422 5. | Keystone Laboratories Inc | Drug | Class II | 1 |
| 8 Feb 2016 | King Soopers City Market GOURMET BREAD PUDDING; Various Sizes, INGREDIENTS: HALF & HALF***APPLES, LIQUID EGG***SPICES, SALT***RAISINS, CINNAMON. CONTAINS EGG, MILK, SOY, WHEAT; UPC 2 47460 0XXXX | The Kroger Co | Food | Class I | 1 |
| 8 Feb 2016 | Dawn's Deviled Egg Potato Salad, Net Wt. 15 oz. (397g), UPC 32345-10107. Keep Refrigerated. | Dawn's Foods, Inc. | Food | Class I | 2 |
| 6 Feb 2016 | Fresh Express, Club Size, Chopped Romaine Lettuce, 32 oz., in clear flexible plastic bags, containing condiments in a separate clear flexible plastic bag. | Fresh Express Incorporated | Food | Class I | 1 |
| 5 Feb 2016 | Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them. | Volcano Corporation | Device | Class II | 2 |
| 5 Feb 2016 | Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher | Stryker Medical Division of Stryker Corporation | Device | Class II | 2 |
| 5 Feb 2016 | 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03 | Baxter Healthcare Corp. | Drug | Class II | 1 |
| 5 Feb 2016 | Tudorza Pressair (aclindinium bromide inhalation powder), 400 mcg per actuation, 60 Metered Doses per Inhaler, Rx Only. Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. Manufactured by: Forest Laboratories, Ireland Limited, Dublin 17 Ireland. Product of Spain. NDC: 0310-0800-60. | AstraZeneca Pharmaceuticals LP | Drug | Class II | 1 |
| 5 Feb 2016 | Oxygen, Compressed USP (Gaseous, Medical Oxygen, Aluminum Cylinders), Packaged in a) M6-Tanks, b) D-Tanks, and c) E-Tanks, Rx Only. Medical Park Homecare, 139 SE Katherine Ave., Bartlesville, OK 74006. (73342) | Medical Park Homecare, Inc | Drug | Class III | 1 |
| 5 Feb 2016 | Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 5 Feb 2016 | Land O Lakes, Fresh Buttery Taste Spread, 48% Vegetable Oil Spread, A product of Land O'Lakes Inc. Arden Hills, MN. Packaged in 5 gram plastic cups. | Ventura Foods LLC | Food | Class II | 1 |
| 5 Feb 2016 | Living Tree Community Foods Organic Macadamia Nuts, 4 oz. plastic pouch. Certified Organic | Living Tree Community Foods | Food | Class I | 2 |
| 4 Feb 2016 | Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. | Draeger Medical, Inc. | Device | Class I | 1 |
| 4 Feb 2016 | Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the… | Medtronic Perfusion Systems | Device | Class III | 1 |
| 4 Feb 2016 | Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA Centaur¿ Testosterone For in vitro diagnostic… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 3 |
| 4 Feb 2016 | MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the… (73243) | Individual firm, name withheld | Device | Class I | 1 |
| 4 Feb 2016 | (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography. | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 4 |
| 4 Feb 2016 | Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml, vol. 22 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA | Hartley Medical Center Pharmacy, Incorporated | Drug | Class II | 30 |
| 4 Feb 2016 | Refrigerated, fresh, Panko breaded cod fillet packed in blue foam tray with plastic overwrap. Label reading: Giant Eagle Japanese Breaded Cod Fillet various weights. Distributed by: Giant Eagle, Inc., Pittsburgh, PA 15238 Sold from August 2015 to present with various expiration dates. | Giant Eagle, Inc. | Food | Class I | 1 |
| 4 Feb 2016 | Bean Snacks (NA-PIA-JO), Net Wt. 10.60 oz (300G), 50 bgs/case (73239) | T.F. Foods Incorporated | Food | Class I | 1 |
| 4 Feb 2016 | HEB Creamy Creations Caramel Pecan Turtle Ice Cream Half Gallon/Cont. Net. 1.89 L packaged in cardboard container | HEB Retail Support Center | Food | Class III | 1 |
| 4 Feb 2016 | Asiago Cheese Sauce Seasoning NET CONTENTS: 44.3 POUNDS 20.1 KILOGRAMS packed in flexible bags (73247) | Illes Food Ingredients Ltd. | Food | Class I | 1 |
| 3 Feb 2016 | Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3). (73265) | Zimmer Spine, Inc. | Device | Class II | 1 |
| 3 Feb 2016 | PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings | Medical Action Industries Inc | Device | Class II | 1 |
| 2 Feb 2016 | Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are… | Teleflex Medical | Device | Class II | 1 |
| 2 Feb 2016 | QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease) | Qiagen Sciences LLC | Device | Class II | 1 |
| 2 Feb 2016 | Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities | Volk Optical Inc | Device | Class III | 1 |
| 2 Feb 2016 | Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109 | Isomeric Pharmacy Solution, LLC | Drug | Class III | 1 |
| 2 Feb 2016 | Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0. | Hospira Inc. | Drug | Class III | 1 |
| 31 Jan 2016 | Braga Organic Farms Organic Pistachio Kernels, Raw; Certified Organic, USDA Organic. Packed in 8 oz. 1 lb. 2. lb and 5 lb clear or green standup bags. Ingredients: Organic Pistachios Braga Organic Farms, Madera, CA. | Braga Organic Farms, Inc. | Food | Class I | 3 |
| 29 Jan 2016 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Inc. | Device | Class II | 1 |
| 29 Jan 2016 | Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony… | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 29 Jan 2016 | Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended… | Biomet, Inc. | Device | Class II | 1 |
| 29 Jan 2016 | software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 29 Jan 2016 | GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video laryngoscope system (GlideScope Titanium System) consists of a sterile-packaged, single-use video laryngoscope, multi-use Smart Cable and portable GlideScope video monitor. The system incorporates a high-resolution, full-color digital camera… | Verathon, Inc. | Device | Class I | 1 |
| 29 Jan 2016 | Apple Caramel Almond Tea, Bag Size - 2lbs Minimum, Bulk Packaging, Item No. FB-004 (73175) | International Tea Importers | Food | Class I | 1 |
| 28 Jan 2016 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111 | ConforMIS, Inc. | Device | Class II | 1 |
| 28 Jan 2016 | Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed sterile in Tyvek bag. Catalog #: GIS-28 Lot #: 61442434 Expiration Date: 2018/04 (73151) | Gi Supply | Device | Class II | 1 |
| 27 Jan 2016 | Karma Flexx Wheelchair Manual Wheelchair. (73159) | Karman Healthcare Inc | Device | Class II | 1 |
| 27 Jan 2016 | UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract. | Cook Inc. | Device | Class II | 2 |
| 27 Jan 2016 | Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77 | Golden State Medical Supply Inc. | Drug | Class III | 4 |
| 27 Jan 2016 | Purple Cow Limited Edition Cookie Butter Ice Cream, 8 oz. cups, packed in paper cartons | House Of Flavors, Inc. | Food | Class I | 1 |
| 26 Jan 2016 | Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel) | QiG Group LLC | Device | Class II | 3 |
| 25 Jan 2016 | BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. | Becton, Dickinson and Company, BD Biosciences | Device | Class III | 1 |
| 25 Jan 2016 | Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 25 Jan 2016 | Freeze Dried Mango Powder, Item no. 30042. Nutrifruit brand. Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00110 4. | Scenic Fruit Company | Food | Class II | 2 |
| 22 Jan 2016 | Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose… (73129) | Sekisui Diagnostics P.E.I. Inc. | Device | Class II | 1 |
| 22 Jan 2016 | Covidien Dover CATCH KIT SOAP Item Code: 5205 Castile soap towelettes are used to clean the genital area for male and female patients | Covidien LLC | Device | Class II | 34 |
| 22 Jan 2016 | Mary's Gone Crackers Thins, Light and Tasty Snack Crackers; Lightly salted. Organic, gluten free, non gmo, vegan; NET WT. 4.5 oz (127 g); UPC: 10897580000707; Mary's Gone Crackers, Inc. 199 Kentucky St., Gridley, CA 95948 (73136) | Mary's Gone Crackers, Inc. | Food | Class II | 1 |
| 22 Jan 2016 | Classic Garden Salad, 12 oz. bag: Aldi, Kroger 24 oz. bag. - Kroger All marketed Dole and private label salads produced in the Springfield, OH facility. Product may be identified by an A in the upper right hand corner of the package. | Dole Fresh Vegetables Inc | Food | Class I | 49 |
| 21 Jan 2016 | EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are… | EKOS Corporation | Device | Class II | 1 |
| 21 Jan 2016 | Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding. | Covidien LLC | Device | Class II | 2 |
| 21 Jan 2016 | Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments. | Stryker Howmedica Osteonics Corp. | Device | Class II | 18 |
| 21 Jan 2016 | Izzie Macs! Macadamia Nuts - Salted. Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 6 oz. plastic bag and 16 oz. plastic bag. UPC - 6 oz.: 689076792677; UPC 16 oz.: 689076792974. Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704 | Individual firm, name withheld | Food | Class I | 5 |
| 20 Jan 2016 | Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices | Cook Inc. | Device | Class II | 1 |
| 20 Jan 2016 | Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to… | Hill-Rom, Inc. | Device | Class II | 1 |
| 20 Jan 2016 | Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope | Integrated Medical Systems Inc | Device | Class II | 22 |
| 19 Jan 2016 | Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use. | Centurion Medical Products Corporation | Device | Class II | 1 |
| 19 Jan 2016 | CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is… | Sorin Group USA, Inc. | Device | Class III | 1 |
| 18 Jan 2016 | Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients.… (73428) | Individual firm, name withheld | Device | Class II | 1 |
| 18 Jan 2016 | Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. (73177) | Individual firm, name withheld | Device | Class II | 1 |
| 18 Jan 2016 | Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis | Fresenius Medical Care Renal Therapies Group, LLC | Device | Class II | 1 |
| 15 Jan 2016 | Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO. | Mako Surgical Corporation | Device | Class II | 1 |
| 15 Jan 2016 | Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation. | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Device | Class II | 1 |
| 15 Jan 2016 | Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement, Rx, 100 count bottles, Manufactured For: Virtus Pharmaceuticals, Tampa, FL | Virtus Pharmaceuticals, Llc | Drug | Class III | 1 |
| 14 Jan 2016 | 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation… (72824) | Cardiac Science Corporation | Device | Class II | 1 |
| 14 Jan 2016 | BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 2 |
| 14 Jan 2016 | Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is intended for use with the ceiling-suspended tube support, high voltage generator, and bucky stand or bucky table incorporating a fixed or detachable (portable) flat panel detector for radiography of the head, chest, abdomen, spine, neck, and… | Toshiba American Medical Systems Inc | Device | Class II | 1 |
| 14 Jan 2016 | risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06. | Zydus Pharmaceuticals USA Inc | Drug | Class III | 1 |
| 14 Jan 2016 | Heartland Flax 14 Mesh Brown RCM Flax Certified Organic, Net WT 50 lbs. Product packaged in 50 lb Food Grade Plastic bags. (73119) | Heartland Products, Inc. | Food | Class I | 1 |
| 13 Jan 2016 | Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 4 |
| 13 Jan 2016 | Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system | Olympus Scientific Solutions Americas | Device | Class II | 1 |
| 13 Jan 2016 | iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001 | Beckman Coulter Inc. | Device | Class II | 1 |
| 13 Jan 2016 | Parade Salted Peanuts Dry Roasted, Net Wt. 8 oz Distributed by Federated Group, Inc. 3025 W. Salt Creek Ln Arlington Heights, IL 60005 UPC 050700569376 | Star Snacks Co., Llc. | Food | Class II | 1 |
| 12 Jan 2016 | Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and Radiopaque Tip Marker Band Contents: 1: . . . . . . . . . Sheath*: *** Super Arrow-Flex Radiopaque with Integral… | Arrow International Inc | Device | Class II | 1 |
| 11 Jan 2016 | Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. (73139) | Individual firm, name withheld | Device | Class II | 1 |
| 11 Jan 2016 | LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders,… | Zimmer Biomet, Inc. | Device | Class II | 21 |
| 11 Jan 2016 | Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as… | Zimmer Manufacturing B.V. | Device | Class II | 72 |
| 8 Jan 2016 | Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast… | Cook Inc. | Device | Class II | 1 |
| 7 Jan 2016 | Maquet Getinge Group 1180.19XO Extension Device. Manufacturer MAQUET GmbH, Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 6 Jan 2016 | Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH. | Cook Inc. | Device | Class I | 4 |
| 4 Jan 2016 | Philips IntelliVue Measurement Module X1 Model: M3001A | Philips Electronics North America Corporation | Device | Class II | 2 |
| 31 Dec 2015 | CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an atraumatic transition… | Cordis Corporation | Device | Class II | 1 |
| 31 Dec 2015 | NORepinephrine Bitartrate, 4 mg (16 mcg/mL) added to 250 mL 0.9% Sodium Chloride Injection USP, in 250 mL Viaflex Bag, Rx only, PharMEDium Services, LLC, Sugar Land, TX NDC 61553-134-61 | Pharmedium Services, LLC | Drug | Class III | 2 |
| 30 Dec 2015 | This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 29 Dec 2015 | Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023 (72958) | TexasStar Pharmacy | Drug | Class II | 1 |
| 29 Dec 2015 | CJ Extra Fancy Long Grain Enriched Rice. NET WT. 80 lbs (36.20 kg); nylon bag; Product of USA. Item number RG80 (72989) | CJ Distribution (Oakland) Inc. | Food | Class II | 1 |
| 28 Dec 2015 | Chocolate Chile Pecan Mini Miracle Tart 4.87 oz (138g) NET WT Party Pack of 6 in formed plastic tray (72949) | Hail Merry LLC | Food | Class III | 1 |
| 23 Dec 2015 | Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 23 Dec 2015 | EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated… | Xeridiem Mediem Medical Devices Inc | Device | Class II | 105 |
| 23 Dec 2015 | Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver). | Pro-Dex Inc | Device | Class II | 2 |
| 22 Dec 2015 | Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 22 Dec 2015 | The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion,… | Hospira Inc. | Device | Class II | 1 |
| 21 Dec 2015 | VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and… | Ortho-Clinical Diagnostics | Device | Class II | 5 |
| 21 Dec 2015 | Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89 | Teva North America | Drug | Class II | 1 |
| 21 Dec 2015 | STREGA Araldi allo (Chocolate nougat) (73165) | Penta Intenational, Inc. | Food | Class II | 1 |
| 18 Dec 2015 | NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box. 3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5. 3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2. 3.0T GEM Flex Coil 16-M Array, NC033000,… (72976) | NeoCoil, LLC | Device | Class II | 1 |
| 18 Dec 2015 | Custom Assembly, Custom FCFFM x/8.2 cm Tubing Extension, Model Number: FCA026-001, Manufactured by: Value Plastics dba Nordson MEDICAL, 805 West 71st Street, Loveland, CO 80538, packaged in Bags consisting of 100, 500 or 1,000 stopcocks. (72961) | Value Plastics, Inc. | Device | Class II | 1 |
| 18 Dec 2015 | Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space. (73180) | Individual firm, name withheld | Device | Class II | 1 |
| 17 Dec 2015 | Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the… | Arthrex, Inc. | Device | Class II | 1 |
| 17 Dec 2015 | BrightView are gamma cameras; Designed for single or dual detector nuclear imaging. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 3 |
| 16 Dec 2015 | AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubing Set (cat#905103) is to deliver pressurized saline from a syringe to the AccuLIF implant for… (73179) | Individual firm, name withheld | Device | Class II | 1 |
| 16 Dec 2015 | Fabi-Saa Mote Blanco Net Wt. 14 oz. (397 g) Imported and Distributed by Fabi-Saa Inc. Belleville, NJ 07109 UPC 874093000090 Made in USA (73262) | FABI - SAA Inc. | Food | Class III | 1 |
| 15 Dec 2015 | MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated. | MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK | Device | Class II | 1 |
| 10 Dec 2015 | Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal… | Maquet Cardiovascular Us Sales, Llc | Device | Class I | 1 |
| 9 Dec 2015 | BD Intelliport Medication Management System Sensor The system is indicated for use by healthcare professionals in a hospital or medical center setting with patients who are receiving manually administered bolus intravenous injections as part of their care to facilitate documentation of the medications. | Becton Dickinson & Company | Device | Class II | 1 |
| 8 Dec 2015 | Great Pacific Bagel & Cream Cheese, product is wrapped with flexible clear plastic, net weight 4.5 oz. The UPC is UPC 92438 00300 (72845) | Vern's & Son Food Service Distributing | Food | Class II | 1 |
| 4 Dec 2015 | Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers. | Steris Corporation | Device | Class II | 1 |
| 3 Dec 2015 | Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the… | Stryker Medical Division of Stryker Corporation | Device | Class II | 1 |
| 3 Dec 2015 | Jody's Gourmet Popcorn, Fabulous Fudge Chocolate Walnut, net weight 8 oz. , one unit per package, packed in clear clamshell, expiration date 12/22/15 (73160) | Individual firm, name withheld | Food | Class II | 1 |
| 3 Dec 2015 | Whole Foods Market Raspberry Brownie; sold as a single item (2. oz.) or a 4 pack (15 oz.); Ingredients: Unbleached wheat flour, sugar, butter (pasteurized cream, salt), eggs, cocoa, vanilla, raspberry preserves (raspberries, sugar, fruit pectin, citric acid), baking soda and seal salt, non-stick spray (soy, soy… | Whole Foods Market | Food | Class II | 7 |
| 2 Dec 2015 | PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use. (72936) | Gsi Group Inc | Device | Class II | 1 |
| 2 Dec 2015 | Cashew Cardamom - Sprouted Cashew Almond Spread. Product is packaged in glass jars, sold under brand name JEM Raw Organics. Net wt. 1 oz., UPC 6 09728 97861 7; Net wt. 6 oz., UPC 6 09728 97860 0; Net wt. 16 oz., UPC 6 09728 97854 9; The product is labeled in parts: "***ORGANIC INGREDIENTS Almonds, Cashews, Coconut… | Jem Raw Chocolate, LLC | Food | Class I | 5 |
| 30 Nov 2015 | Columbus Revision Knee System, EnduRo Knee System Product Usage: The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint. | Aesculap, Inc. | Device | Class II | 1 |
| 30 Nov 2015 | BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636. | Verathon, Inc. | Device | Class II | 1 |
| 29 Nov 2015 | Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01 (72796) | AGA Gas Inc | Drug | Class II | 1 |
| 25 Nov 2015 | Philips Healthcare IntelliVue Info Center iX, A.0 866023 | Philips Electronics North America Corporation | Device | Class II | 3 |
| 24 Nov 2015 | Gouda Cheese packaged under the brand names: Smith's Farmstead Gouda and Jansal Valley Mountain Gouda, Packaged in 11 lb. waxed wheel in saran wrap. 5 lb. Half wheels wrapped in shrink pack packaging. | Smith's Country Cheese, Inc. | Food | Class III | 9 |
| 20 Nov 2015 | WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at Walgreens***WARM Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies (72837) | Bigwall Enterprises | Device | Class II | 1 |
| 19 Nov 2015 | NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL | Teva Pharmaceuticals USA | Drug | Class III | 1 |
| 19 Nov 2015 | FROZEN KINGFISH STEAK, QF, IVP, Size: 10/12 OZ, WEIGHT 22 LBS, IMPORTER:PRESIDENT EAST COMPANY, PRODUCT OF TAIWAN, individual pieces are held within clear plastic vacuum-sealed packaging. (72696) | President East Company | Food | Class III | 1 |
| 18 Nov 2015 | Simply Roundy's Natural Authentic Italian Butternut Squash Ravioli, Net Wt. 9 oz (255g). Packaged in a paper tray inside a plastic bag and wrapped around with paper band. Made in Italy. UPC 11150-50750 (72772) | Roundys Supermarkets, Inc. | Food | Class I | 1 |
| 17 Nov 2015 | ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use in dental surgery such as: -Augmentation or reconstructive treatment of alveolar ridge -filling of defects after root resection, apicoectomy and cystectomy -Filling of extraction sockets to enhance preservation of the alveolar ridge -elevation of… | Collagen Matrix Inc | Device | Class III | 1 |
| 12 Nov 2015 | Butternut Squash Triangoli, Net Wt. 8.8 oz (250g) | Trader Joes Company | Food | Class I | 1 |
| 11 Nov 2015 | Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient. | ConvaTec, Inc | Device | Class II | 1 |
| 5 Nov 2015 | ORGANIC HOMESTAT FARM Quick STEEL CUT OATS & CHIA with Flax and Rye Flakes NET WT 42 OZ (2 LB. 10 OZ.) INGREDIENTS:***organic milled flaxseed*** Distributed by Homestat Farm LTD 6065 Frantz Rd. Suite 206, Dublin, OH 43017 UPC 8 35882 00620 4 (72620) | Homestat Farm Ltd | Food | Class I | 1 |
| 4 Nov 2015 | Tofu Curry Cous Cous Salad packaged in a clear plastic 16 oz box with a white and green label with black lettering. | Brett Anthony Foods | Food | Class I | 1 |
| 4 Nov 2015 | Swai Fillets ( 7-9 oz.) packaged in a 15 lb. blue and white box with blue and white lettering. (72717) | Restaurant Depot/Jetro | Food | Class III | 1 |
| 3 Nov 2015 | Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K7024 SMN: 10445889 Lot #15246MA Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 2 Nov 2015 | Irrigation Clip 30; Intended to position and hold irrigation tubing during surgical procedures. | The Anspach Effort, Inc. | Device | Class II | 1 |
| 2 Nov 2015 | Heartland Flax Meal, Net Wt. 50 lbs. | Specialty Commodities, Inc. | Food | Class I | 1 |
| 28 Oct 2015 | Hannaford CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074 UPC 0 41268 19400 1 | Frozen Specialties Inc | Food | Class III | 3 |
| 28 Oct 2015 | Labeled "CSFISHERY COMMUNITY SUPPORTED FISHERY Wild Albacore Tuna, 64 oz.., Ingredients: Oregon Albacore Tuna, Sea Salt" Label is black ink on an off white label. No UPC (72536) | CSFPDX, LLC | Food | Class II | 1 |
| 28 Oct 2015 | East-West Classic Sweet & Sour Sauce, 12 fl. Oz., Glass bottle, 6/case, Refrigerate after opening, Distributed by East-West Specialty Sauces, Inc. Denver, CO 80204 (72689) | East-West Specialty Sauces, Inc. | Food | Class I | 1 |
| 20 Oct 2015 | Maesri Brand Shrimp Powder, 6.oz | Eastland Food Corporation | Food | Class II | 1 |
| 7 Oct 2015 | Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide. | Cook Inc. | Device | Class I | 1 |
| 1 Oct 2015 | Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and… | Philips Electronics North America Corporation | Device | Class II | 1 |
| 25 Sep 2015 | RHINO 7 3000, 6 count Bottle, Distributed by Rhino 7, Made in USA | Tf Supplements | Drug | Class I | 2 |
| 17 Sep 2015 | Picnic Gourmet Spreads ( Red Pepper Feta Cheese Spread) 8 oz containers .12 Containers per case | Picnic Gourmet Spreads LLC | Food | Class I | 5 |
| 25 Aug 2015 | NuOSS Cancellous Intended for use in dental surgery. | Collagen Matrix Inc | Device | Class II | 1 |
| 6 Jul 2015 | SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system | Philips Electronics North America Corporation | Device | Class II | 1 |
| 18 Feb 2015 | The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine… (73422) | CHG Hospital Beds Inc | Device | Class II | 1 |
| 8 Jan 2015 | Pilling Modular Verres Body/Obturator, Product Code 140880 | Teleflex Medical | Device | Class II | 1 |
| 14 Nov 2014 | Synthes Small Electric Drive (SED) | The Anspach Effort, Inc. | Device | Class II | 1 |
| 18 Nov 2013 | IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base. | CMP Industries, Llc | Device | Class II | 1 |
| 13 May 2013 | NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive treatment of alveoloar… | Collagen Matrix Inc | Device | Class II | 1 |
| 26 Feb 2013 | Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage: The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are… (73407) | Neurotherm, Inc. | Device | Class II | 1 |
| 15 Aug 2012 | Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259 | Sorin Group USA, Inc. | Device | Class II | 1 |
| 1 Jul 2008 | GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. (72515) | Regulatory Insight, Inc | Device | Class II | 1 |