| 13 Jul 2015 | Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30 (71732) | Purdue Pharma L.P. | Drug | Class III | 1 |
| 7 Jul 2015 | RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners. | Eizo Corporation | Device | Class II | 3 |
| 7 Jul 2015 | Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only, Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01 | Kremers Urban Pharmaceuticals, Inc. | Drug | Class II | 2 |
| 6 Jul 2015 | Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN… | CooperSurgical, Inc. | Device | Class II | 1 |
| 6 Jul 2015 | Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10 West Boerne, TX 78006. NDC 0178-0320-12 (71576) | BioComp Pharma, Inc. | Drug | Class III | 1 |
| 2 Jul 2015 | Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position. (71615) | Silhouette Lift, Inc. | Device | Class II | 1 |
| 2 Jul 2015 | 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68 | Hospira Inc. | Drug | Class II | 1 |
| 1 Jul 2015 | iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy… (71650) | Myoscience Inc | Device | Class II | 1 |
| 1 Jul 2015 | MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed. | Elekta, Inc. | Device | Class II | 1 |
| 1 Jul 2015 | GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 7 |
| 1 Jul 2015 | All You Need Bread, Each loaf is package in a bag with a net wt. 1 lb. 14 oz., sold under brand Great Harvest Bread Co. (71631) | Buckwheat Enterprises, Inc | Food | Class II | 1 |
| 30 Jun 2015 | KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49 | Hospira Inc. | Drug | Class II | 2 |
| 30 Jun 2015 | Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6. | Mylan Pharmaceuticals Inc | Drug | Class II | 1 |
| 30 Jun 2015 | Turkish Organic Diced Apricots with Rice Flour (5-7 mm), FOODIMPEX brand, Item# 17496, product is packged in a white cardboard box. Net wt. 28 lbs. (71617) | GloryBee Inc | Food | Class II | 1 |
| 29 Jun 2015 | HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL | Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 26 Jun 2015 | IMPAX Agility. IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for… | AGFA Healthcare Corp. | Device | Class II | 1 |
| 26 Jun 2015 | Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A… (71585) | Alere Scarborough, Inc. dba Binax, Inc. | Device | Class II | 1 |
| 26 Jun 2015 | Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons. Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21. | American Health Packaging | Drug | Class III | 1 |
| 26 Jun 2015 | Natural Grocers Caribbean Fruit & Nut Mix, Net Wt. (10 oz) (283g), packaged in plastic bag. | Vitamin Cottage Natural Food Markets, Inc. | Food | Class I | 1 |
| 24 Jun 2015 | HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening. | Hardy Diagnostics | Device | Class II | 1 |
| 24 Jun 2015 | 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 24 Jun 2015 | The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter… | EKOS Corporation | Device | Class II | 1 |
| 23 Jun 2015 | CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31 (71598) | Individual firm, name withheld | Drug | Class III | 1 |
| 23 Jun 2015 | La Mexicana Spinach Dip Net Wt. 14oz. clear, plastic cup Product is packaged in plastic white container. (71558) | Pages Produce Company Inc. | Food | Class II | 1 |
| 22 Jun 2015 | Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular… | Volcano Corporation | Device | Class II | 6 |
| 22 Jun 2015 | Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit). Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat. Endosseous dental implant instrument. | Nobel Biocare Usa Llc | Device | Class II | 1 |
| 19 Jun 2015 | Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or… | CooperSurgical, Inc. | Device | Class II | 1 |
| 19 Jun 2015 | Sour Caramel Apple Chewing, net wt .53 oz, Gum UPC 844911 002919. Sour Caramel Apple chewing gum tablet packed in 12ct metalized PET Pouch with zipper. (71542) | Project 7 | Food | Class II | 1 |
| 19 Jun 2015 | Project 7 CARAMEL APPLE Sugar Free Gum, approximately 32 lbs. -- Manufactured by: Ford Gum and Machine Company, 18 Newton Ave., Akron, New York 14001 --- The product was supplied in cardboard bulk boxes. with a label reading, "Project 7 CARAMEL APPLE, approximately 32 pounds Sugar Free Gum". Each gum piece is 1.35 g… (71536) | Ford Gum & Machine Company Inc | Food | Class II | 1 |
| 18 Jun 2015 | Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed. | Allergan Inc | Device | Class II | 2 |
| 18 Jun 2015 | Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601 | Argon Medical Devices, Inc | Device | Class II | 2 |
| 18 Jun 2015 | Disulfiram tablets, USP, 500 mg, 100-count bottles, Rx only, Manufactured for and by Qualitest Pharmaceuticals 130 Vintage Drive Huntsville, AL 35811. NDC 0603-3432-21. | Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 18 Jun 2015 | Sysco International Whole Segments Mandarin Oranges In Light Syrup Net Wt. 6 LB 10 OZ (3.01 kg) NDC: 074865629065; 6 cans per case | Sysco Corporation | Food | Class III | 1 |
| 17 Jun 2015 | ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device. | Zimmer, Inc. | Device | Class II | 1 |
| 17 Jun 2015 | A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument. | Biomet, Inc. | Device | Class II | 1 |
| 17 Jun 2015 | Redwood Hill Farm Raw Milk Feta; Artisan Goat Cheese; Perishable, keep refrigerated. Ingredients: Raw goat milk, sea salt, Vegetarian enzyme, cultures. Packaged in a 3 lb. plastic bucket (in brine), Two buckets per case. Handmade in Sebastopol, CA Redwood Hill Farm & Creamery, Sebastopol, CA (71540) | Redwood Hill Farm | Food | Class I | 1 |
| 16 Jun 2015 | INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 16 Jun 2015 | Champ's Sliced Crimini Mushrooms, net weight 227 gram (8 oz), UPC 6 78286 88877 5. The product's label is read in parts: "***Champ's Mushrooms***Sliced Crimini Mushrooms***KEEP REFRIGERATED***Product of Canada***Aldergrove. B.C V4W 2Z6***". | United Salad Company | Food | Class I | 1 |
| 15 Jun 2015 | Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter… | Etac Supply Center Ab | Device | Class II | 1 |
| 15 Jun 2015 | Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273. | Pega Medical Inc. | Device | Class II | 1 |
| 15 Jun 2015 | Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Restorative for CEREC, Compatible with Sirona mill 2912x, 2914x, 3312x, 3314x. Lava Ultimate Restorative for E4D Compatible with E4D mills, same mandrel format as Planmill 3112x, 3114x, 4012x, 4014x. Lava Ultimate for… | 3M Company - Health Care Business | Device | Class II | 1 |
| 15 Jun 2015 | BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and… | BD Biosciences, Systems & Reagents | Device | Class III | 1 |
| 15 Jun 2015 | Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver,… (71525) | Mermaid Medical A/S | Device | Class II | 1 |
| 15 Jun 2015 | Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours. | Sorin Group USA, Inc. | Device | Class II | 6 |
| 12 Jun 2015 | Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic. | BioMerieux SA | Device | Class II | 1 |
| 12 Jun 2015 | GE Healthcare Precision 500D Classical R & F system. | GE Healthcare | Device | Class II | 4 |
| 12 Jun 2015 | ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force… | DePuy Orthopaedics, Inc. | Device | Class II | 10 |
| 12 Jun 2015 | GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and Fluoroscopic Systems. A universal diagnostic imaging system for radiographic and fluoroscopic examinations. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Legacy and Legacy D Table is… | GE Healthcare | Device | Class II | 1 |
| 12 Jun 2015 | Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter transition from the dilator. The dilator… | Medtronic Perfusion Systems | Device | Class II | 1 |
| 12 Jun 2015 | Raw, Fresh, Farmed Chilean Atlantic Salmon -Atl Fs Sal Chilean Fill Tr D 3-4 lbs 40lbs -Atl Fs Sal Chilean Fill Deep Skinned Tr E 3-4 lbs 10LBS -Atl Fs Sal Chilean Fill Tr E 3-4 lbs 40lbs -Chilean Fresh Atl Trim D 1-6 Factory 40lbs -Chilean Fresh Atl Factory 1-6 SK off 40lbs -ATL Fs Sal Chilean Fill Skin off FFO… | Marine Harvest | Food | Class I | 3 |
| 11 Jun 2015 | ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology. | Abbott Laboratories | Device | Class II | 1 |
| 11 Jun 2015 | SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 11 Jun 2015 | JustRight 5mm Stapler, JR-ST25-2.0 Stapler is packaged in cases of 6, placed in a tray and sealed with a Tyvek lid. Product Usage: The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for the resection, transection, and creation of anastomosis. | Justright Surgical, LLC | Device | Class II | 2 |
| 10 Jun 2015 | Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 10 Jun 2015 | NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. (69804) | Northern Digital Inc. | Device | Class II | 1 |
| 10 Jun 2015 | Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 10 Jun 2015 | OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA LLC., St. Louis, MO 63044, Distributed by Major Pharmaceuticals, Livonia, MI 48150, NDC 0904-6444-61. | The Harvard Drug Group, LLC | Drug | Class II | 1 |
| 10 Jun 2015 | Diet Bubba Cola, 20 FL. OZ (1.25 PT) 591 mL INGREDIENTS: CARBONATED WATER, HIGH FRUCTOSE CORN SYRUP, CARAMEL COLOR, PHOSPHORIC ACID, NATURAL FLAVOR, CAFFEINE. DISTRIBUTED BY: SAVE-A-LOT FOOD STORES, LTD. EARTH CITY, MO 63045 0 51933 34484 6 (71479) | Individual firm, name withheld | Food | Class III | 1 |
| 10 Jun 2015 | Garden Fresh Steakhouse Potato Salad Kit, CODE#1076, NET WT 10.75 LBS (4.876 KG) , UPC 0 01 11596 51076 4. | Garden-Fresh Foods, Inc. | Food | Class I | 1 |
| 10 Jun 2015 | Lemon Flavored Electrolyte bottled water, sold under brand HyVee, Raleys' Purely Made, Refreshe, and Simple Truth. Each bottle is 1 Liter (33.8 Fl. oz.). HyVee brand has the UPC 0 75450 12722 5; Raley's brand has the UPC 0 46567 02873 6; Refreshe brand has the UPC 0 21130 24207 8; Simple Truth has the UPC 0 11110… | The Sweetwater Co., Inc. | Food | Class III | 3 |
| 9 Jun 2015 | Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the… (71457) | Alliance Partners LLC | Device | Class II | 1 |
| 8 Jun 2015 | Natrelle Re-sterilizable Breast Implant Sizer, Size: 410 cc, Style No. MSZFX410. The product is packaged in a thermoformed tray (double sterile barrier) and enclosed in a labeled carton. (71428) | Allergan Inc | Device | Class II | 1 |
| 8 Jun 2015 | Baked Samosa Sweet Potato (Baked Indian pastry with a savory filling), Frozen package, Net wt. 7.5 oz., No UPC (71458) | Khara Enterprises, LLC | Food | Class II | 1 |
| 5 Jun 2015 | Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes | Cochlear Americas Inc. | Device | Class II | 1 |
| 5 Jun 2015 | Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550 (71441) | Geritrex Corp | Drug | Class III | 1 |
| 5 Jun 2015 | CapriSun Variety Pack, with a multi colored plastic wrap with white and yellow lettering, covering 4 cartons. The 4 cartons consist of fruit punch (the effected product), wild cherry, pacific cooler, and strawberry kiwi.Fruit Punch Flavored Juice Drink Blend in a blue box with white lettering and fruit pictures. The… (71422) | Kraft Foods North America | Food | Class II | 1 |
| 4 Jun 2015 | A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw | Biomet, Inc. | Device | Class II | 1 |
| 4 Jun 2015 | THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator | Gardner Denver Thomas Inc | Device | Class II | 3 |
| 4 Jun 2015 | A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries. | Biomet, Inc. | Device | Class II | 1 |
| 4 Jun 2015 | Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and… | Merit Medical Systems, Inc. | Device | Class II | 1 |
| 4 Jun 2015 | Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to… | Volcano Corporation | Device | Class II | 2 |
| 4 Jun 2015 | SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles. | Siemens Medical Solutions USA, Inc | Device | Class II | 2 |
| 4 Jun 2015 | Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20 | Fresenius Kabi USA, LLC | Drug | Class II | 1 |
| 4 Jun 2015 | Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578-035-05, b) 5 oz. Jar, NDC 10578-035-04, Manufactured by Indiana Botanic Gardens, Hobart, IN 46342 (71426) | Indiana Botanic Gardens, Inc | Drug | Class III | 1 |
| 4 Jun 2015 | Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC… | Actavis Inc | Drug | Class III | 1 |
| 4 Jun 2015 | Cambridge House Royal Smoked Salmon Sliced Side Products are packaged in Reduced Oxygen Package (ROP). Product is priced per pound. | The Santa Barbara Smokehouse, Inc. | Food | Class I | 9 |
| 3 Jun 2015 | Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy.… | Omnilife Science Inc. | Device | Class II | 1 |
| 3 Jun 2015 | Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial replacement of the articulating surfaces of the… | Biomet, Inc. | Device | Class II | 1 |
| 3 Jun 2015 | Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. | Perkinelmer | Device | Class II | 7 |
| 3 Jun 2015 | TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and… | Synthes, Inc. | Device | Class II | 1 |
| 3 Jun 2015 | Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures. | Biomet, Inc. | Device | Class II | 2 |
| 3 Jun 2015 | SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the hemostasis of blood vessels. (71385) | Individual firm, name withheld | Device | Class II | 1 |
| 3 Jun 2015 | Eating Right Black Bean Soup; 1.3 oz paper container. Dried soup to which consumer adds hot water. USPC: 79893-80026; Ingredients: Ingredients: Black Beans*, Vegetables* (Tomato, Potato, Corn, Peppers, Garlic), Natural Flavor (Yeast Extract, Maltodextrin, Sunflower Oil, Silicon Dioxide, Natural Flavor), Spice, Salt,… (71396) | San Francisco Spice Company, Inc. | Food | Class II | 1 |
| 3 Jun 2015 | Ground Elk meat packaged individually for retail sale in hermetically sealed plastic with a black backing identified with Use or Freeze By 04-27-15. The stick-on finished product label is red, white, and black with red, white, and black print writing reading in part: "Natural DK Meats All Natural Ground Elk Net Wt 16… (71397) | Frontiere Natural Meats | Food | Class II | 1 |
| 2 Jun 2015 | EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus… | ArthroCare Corporation | Device | Class II | 1 |
| 2 Jun 2015 | Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 2 Jun 2015 | Accurus 2500 Standalone Vitreous Probe REF 8065741018; Accurus 23 GA Standalone Vitreous Probe REF 8065750821; Accurus 25+ 2500 CPM Standalone Vitreous Probe REF 8065751122; Anterior Accurus Probe with Infusion Needle REF 8065803650; Single Use Sterile Probes Rx only. Intended to provide the surgeon with a single-use… | Alcon Research, Ltd. | Device | Class II | 1 |
| 1 Jun 2015 | Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures. | Stryker Sustainability Solutions | Device | Class II | 3 |
| 1 Jun 2015 | Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators. | Hamilton Medical, Inc. | Device | Class II | 3 |
| 1 Jun 2015 | Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010-36H, 21762-010-41H, 21762-111-36H. (71455) | Sechrist Industries Inc | Device | Class II | 1 |
| 1 Jun 2015 | Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC 68084-498-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A… | American Health Packaging | Drug | Class II | 13 |
| 1 Jun 2015 | Dr. Praeger's California Veggie Burgers Gluten Free 11 oz. Manufactured by Dr. Praeger's Sensible Foods Elmwood Park, NJ 07047 www.drpraegers.com Made in the USA UPC 080868000602 (71381) | Ungar's Food Products, Inc. | Food | Class I | 1 |
| 1 Jun 2015 | Roseli Sundried Tomato Pesto sauce. #408744 (Dot Item) , # 627328 (Roseli item),3- 2 lbs tubs (poly) packed in corrugated shipper. Keep Frozen - Thaw under refrigeration. (71523) | Golden Plains Frozen Foods | Food | Class I | 1 |
| 29 May 2015 | The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around a central axis. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 29 May 2015 | Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile. The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated. | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | Device | Class II | 1 |
| 29 May 2015 | ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel,… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 29 May 2015 | Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite F500 is intended as a general… | Tecan US, Inc. | Device | Class II | 5 |
| 29 May 2015 | GE Healthcare Optima IGS 320. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures. | GE Healthcare | Device | Class II | 13 |
| 29 May 2015 | Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9 | Apotex Inc. | Drug | Class II | 4 |
| 29 May 2015 | Kraft Non-Dairy Creamer, Net WT/Contenido Neto 16 oz (454 g) SKU 2100042503. Kraft Non-Dairy Creamer, Net WT/Contenido Neto 6 oz (170g) SKU 2100042202. Country Barn, Coffee Creamer, Non-Dairy creamer, Net WT/Peso Neto 6 oz ( 170g), SKU 3540603606. Country Barn, Coffee Creamer, Non-Dairy creamer, Net WT/Peso Neto 11… | Kerry Foods | Food | Class II | 2 |
| 29 May 2015 | Nice! Powdered Sugar Mini Donuts 11.5 oz packaged in a white and pink box with with pink and black lettering. (71416) | Walgreen Company | Food | Class II | 1 |
| 28 May 2015 | Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components: Flexor RTPS Guiding Sheath, needle,… | Cook Inc. | Device | Class II | 2 |
| 28 May 2015 | Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis | Synthes, Inc. | Device | Class II | 1 |
| 28 May 2015 | Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and… | American Medical Systems Innovation Center - Silicon Valley | Device | Class II | 32 |
| 28 May 2015 | TPN 3:1, 2400 mL Bag, Qty: 6, Base Formula Sodium Chloride, Dextrose 70%, Travasol 10%, Intralipid 20%, Water for Inj.; Electrolytes KCL, K Acetate, Na Acetate, K Phos, MgSO4; Vitamins, trace elements and medications Trace Ele. -Ped, Multi Vitamin, Rx Only, Compounded by: United Medical IV Center (Little Rock) 1527… | Lincare, Inc. | Drug | Class II | 54 |
| 28 May 2015 | Vietnamese LP Cashew Kernels, 50 lbs. bulk cartons, HONG DUC COMPANY LIMITED, FDA No. 16153193186 --- The imported cashews are shelled and raw, and were distributed in bulk cartons/cases weighing 50 lbs. --- NOTE: The shelf life is 12 months from pack date which is November 3, 2014. (71368) | The Hemisphere Group | Food | Class I | 1 |
| 27 May 2015 | PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. | Bard Access Systems | Device | Class III | 4 |
| 27 May 2015 | Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only. | Musculoskeletal Transplant Foundation, Inc. | Device | Class II | 1 |
| 27 May 2015 | DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions. | Synthes, Inc. | Device | Class II | 1 |
| 27 May 2015 | E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01 | Bracco Diagnostic Inc | Drug | Class III | 1 |
| 27 May 2015 | Dill Pickle Lite Works Popcorn , lot number 15111, packaged in a 4 oz foil white bag with black and green lettering. (71358) | Popcorn Factory, The | Food | Class I | 1 |
| 26 May 2015 | Bausch & Lomb SofPort Advanced Optics Aspheric Lens | Bausch & Lomb Surgical, Inc. | Device | Class II | 2 |
| 26 May 2015 | Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or… | Medtronic Navigation, Inc. | Device | Class II | 1 |
| 26 May 2015 | Bedessee Brown Betty BRAND COCONUT MILK Powder Mix, NET WT: 1) 1.76 OZ (50 g) and 2) 10.6 OZ. IMPORTED BY BEDESSEE IMPORTS LTD. Brooklyn, NY USA 11208. PRODUCT OF VIETNAM. | Bedessee Imports, Inc | Food | Class I | 1 |
| 23 May 2015 | Jivara Lactee Milk Chocolate Valrhona; 40% Ingredients: Cocoa Butter, whole powdered milk, sugar, cocoa beans, brown sugar, natural vanilla extract, soya lecithin, malt extract, Natural Vanilla Flavor. Contains: Soy,. May contain trace amounts of dairy, eggs, nuts and gluten as it produced on the same machinery. UPC… | Whole Foods Market | Food | Class II | 1 |
| 22 May 2015 | 0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 Rover Ultra (230V) 0702-002-000ES, Neptune 2 Rover (230V) Spanish 0702-002-000FI, Neptune 2 Ultra Rover (230V) Finnish 0702-002-000IT, Neptune 2 Rover (230V) Italian… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 22 May 2015 | Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 22 May 2015 | Natural Grocers Raw Macadamia Nuts, Net Wt. 10 oz. package, Sealed plastic bag. | Vitamin Cottage Natural Food Markets, Inc. | Food | Class I | 1 |
| 22 May 2015 | Mediterranean Seasoned Wild Alaska Salmon, brand name Orca Bay, IVP frozen packages, ready to cook product. Products are keta salmon fillets with a brown spice rub. Each fillet is individually vacuum-packed in a clear plastic film and ranges from 1-2 lbs. UPC 2 08617 60XXX X (UPC is labeled at retail stores). The… (71317) | Orca Bay Seafoods, Inc. | Food | Class II | 1 |
| 22 May 2015 | Conventional Desiccated Coconut - Medium Shred 25 lb. bags. Exp date: 20.11.2015 Item code: 001120; UPC: 086700011201 Imported by Falcon Trading Company Inc/Sun Ridge Farms, Royal Oaks, CA Country of Origin - Sri Lanka | Falcon Trading Co., Inc. | Food | Class II | 2 |
| 21 May 2015 | Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication. (71332) | Individual firm, name withheld | Device | Class II | 1 |
| 21 May 2015 | Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies),… | Exactech, Inc. | Device | Class II | 2 |
| 21 May 2015 | Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent Lab System software version 3.6.1. In vitro diagnostic analyzer. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 21 May 2015 | Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l) x 13mm(H) Implant,… | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | Device | Class II | 1 |
| 21 May 2015 | CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99. (71516) | Takeda Pharmaceuticals North America, Inc. | Drug | Class II | 1 |
| 21 May 2015 | Frozen Tuna Ground Indonesia/Wild Caught Label on outer shipping cardboard box: Frozen Tuna Fillet Restaurant Supply Only Packed For: Mutual Trading Co., Inc. LA, CA 90013 Product of Indonesia Product is ROP. Packages are packed in a white cardboard box and then in a larger shipping cardboard box. (71312) | Osamu Corporation | Food | Class I | 1 |
| 20 May 2015 | NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field. (71350) | Northern Digital Inc. | Device | Class II | 1 |
| 20 May 2015 | NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates. | Fresenius Medical Care Holdings, Inc. | Device | Class II | 1 |
| 19 May 2015 | ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP… | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 19 May 2015 | VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids. | Remel Inc | Device | Class II | 2 |
| 19 May 2015 | CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 19 May 2015 | Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02 | Hospira Inc. | Drug | Class III | 1 |
| 18 May 2015 | The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy. | Varian Medical Systems Inc | Device | Class II | 1 |
| 18 May 2015 | Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set. | Varian Medical Systems Inc | Device | Class II | 1 |
| 15 May 2015 | Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. | Vascutek, Ltd. | Device | Class II | 2 |
| 15 May 2015 | EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy,… | ArthroCare Medical Corporation | Device | Class II | 2 |
| 14 May 2015 | Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during… | Teleflex Medical | Device | Class I | 1 |
| 14 May 2015 | LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a… | Cook Inc. | Device | Class II | 1 |
| 14 May 2015 | Raw Macadamia Nuts, packaged in 8 oz. plastic cup, packaged under the Aurora and private labels as follows:Belmont Market, Citarella, Ernest & Klein, Gourmet Garage, Harvest Co Op Market, Le District, Lees, Palmers Market, Walter Stewart, Whole Food Market and Wild By Nature. Refer to Best By Date | Aurora Products, Inc. | Food | Class I | 1 |
| 13 May 2015 | StoneLight 30 Laser System (NS3000). For use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery. (71346) | New Star Lasers, Inc. | Device | Class II | 1 |
| 13 May 2015 | The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error. | Bio-Rad Laboratories, Inc. | Device | Class III | 1 |
| 12 May 2015 | SNOBIZ CHEESECAKE SHAVE ICE FLAVOR, 10 pouches/carton; 8 cartons/case (80 pouches total per case), 104 gram per pouch, metallized pouch. (71335) | Crystal Fresh | Food | Class I | 1 |
| 11 May 2015 | ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation. | Orthofix, Inc | Device | Class II | 1 |
| 11 May 2015 | Fruit Juice Candy Bonbons de Jus de Fruits, Net Wt 8 oz (227g), UPC Code 6 923648 832113, Manufacturer. Jin Shun FA Food Co., Ltd. 147 community shops Southwest District Luoshan Street Jinjiang of Fujian, Sole Agent of U.S.A.: Fine Land Corp. 376 Vernon Ave, Brooklyn, NY 11206, Sole Agent of Canada: PT Trading… (71288) | Fine Land Corp | Food | Class II | 1 |
| 11 May 2015 | Deskins Candies, Chocolate No Bakes, Net Wt. 16-oz., packaged in 1 lb. plastic containers containing 8-10 cookies / 12 containers per case. Deskins Wholesale, Bluefield, WV. (71453) | Deskins Wholesale, LLC | Food | Class I | 1 |
| 8 May 2015 | 0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 8 May 2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers:… | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | Device | Class I | 2 |
| 8 May 2015 | Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy… | Ethicon, Inc. | Device | Class II | 1 |
| 8 May 2015 | DASANI Purified Water, 24/20 fl. oz. (1.25 pt) 591 mL, pack, Desani, The Coca Cola Company, Atlanta, GA 30313. (71286) | World of Coca-Cola | Food | Class II | 1 |
| 7 May 2015 | Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. | Viewray Incorporated | Device | Class II | 1 |
| 7 May 2015 | Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000 | Atrium Medical Corporation | Device | Class II | 4 |
| 7 May 2015 | Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma. | Roche Diagnostics Operations, Inc. | Device | Class II | 12 |
| 6 May 2015 | The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in arterial, venous and capillary whole blood samples. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 2 |
| 6 May 2015 | Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. | Terumo Cardiovascular Systems Corp | Device | Class II | 1 |
| 6 May 2015 | IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 6 May 2015 | Tortilleria Provincia Refrigerate After Purchase White Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleria Provincia, 1200 B Clay St. Bowling Green, KY 42101 (270) 842-7733 | Individual firm, name withheld | Food | Class II | 3 |
| 5 May 2015 | Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic,… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 4 May 2015 | Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set. Product Usage: The Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three… (71497) | Spine Wave, Inc. | Device | Class II | 1 |
| 4 May 2015 | Natural Creations Glucosamine MSM 90 capsules packaged in 250 cc white plastic containers with 52 bottles per case. (71249) | Natural Creations Inc | Food | Class II | 1 |
| 1 May 2015 | Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed… | Integra LifeSciences Corp. d.b.a. Integra Pain Management | Device | Class II | 1 |
| 30 Apr 2015 | ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 29 Apr 2015 | HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure. | HeartWare Inc | Device | Class II | 1 |
| 29 Apr 2015 | LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl. (71292) | LifeHealth, LLC | Device | Class II | 1 |
| 29 Apr 2015 | EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and post-analytic functions in conjunction with multiple instruments, the laboratory information system (LIS) and Siemens StreamLAB Automation Solutions. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 28 Apr 2015 | Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11 | Teva Pharmaceuticals USA | Drug | Class I | 1 |
| 27 Apr 2015 | Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant. (71129) | Sheffield Pharmaceuticals, LLC | Device | Class II | 1 |
| 27 Apr 2015 | Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding… | Boston Scientific Corporation | Device | Class II | 1 |
| 27 Apr 2015 | Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605;… | DeRoyal Industries Inc | Device | Class II | 1 |
| 23 Apr 2015 | Palindrome SI Chronic Catheter Kit 14.5 Fr x 19cm Item Code: 8888245062 The Palindrome SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. | Covidien LLC | Device | Class II | 62 |
| 23 Apr 2015 | Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02. | Hospira Inc. | Drug | Class I | 1 |
| 22 Apr 2015 | Philips GoSafe Communicator 7000L Personal emergency response system. (71208) | Lifeline Systems, Incorporated | Device | Class II | 1 |
| 22 Apr 2015 | Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01. | Wockhardt Usa Inc. | Drug | Class II | 35 |
| 21 Apr 2015 | PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS 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. (71056) | Hitachi America, Ltd., Power Systems Division | Device | Class II | 1 |
| 20 Apr 2015 | Breast Pack - contains Devon Light Glove Used during surgery | Stradis Healthcare, LLC. | Device | Class II | 51 |
| 16 Apr 2015 | Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE | Covidien LLC | Device | Class II | 14 |
| 13 Apr 2015 | McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures | CooperSurgical, Inc. | Device | Class II | 1 |
| 9 Apr 2015 | Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar. (71443) | BTE Technologies, Inc. | Device | Class II | 1 |
| 9 Apr 2015 | New Punjab Burfi is an Indian snack cut into 1lb or 0.5 lb. squares. Product is packaged in clear plastic container with a clear plastic lid. | New Punjab Sweets Inc. | Food | Class II | 7 |
| 7 Apr 2015 | Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400 | X Spine Systems Inc | Device | Class II | 1 |
| 1 Apr 2015 | Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. | Viewray Incorporated | Device | Class II | 1 |
| 1 Apr 2015 | Diet Dr. Pepper, 8 x 12 fl. oz. PET bottle, Bottled under the authority of Dr. Pepper Company, 5301 Legacy Drive, Plano, TX 85024. | Coca-Cola Company (The) | Food | Class II | 1 |
| 25 Mar 2015 | Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty. | Nidek Inc | Device | Class II | 2 |
| 24 Mar 2015 | 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02 | Baxter Healthcare Corp. | Drug | Class I | 4 |
| 20 Mar 2015 | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative… (70992) | Axis-Shield Diagnostics, Ltd. | Device | Class II | 1 |
| 17 Mar 2015 | Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. | Philips Medical Systems (Cleveland) Inc | Device | Class II | 3 |
| 17 Mar 2015 | American Catheter / Cholangiogram Catheter 9100 Series. (71263) | American Catheter Corp | Device | Class II | 1 |
| 13 Mar 2015 | BLUE BELL COUNTRY COOKIE VANILLA ICE CREAM & CHOCOLATE CHIP COOKIE SANDWICH 5.75 FL OZ (170 mL) | Blue Bell Creameries, L.P. | Food | Class I | 286 |
| 12 Mar 2015 | Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component. | Biomet Spine, LLC | Device | Class II | 1 |
| 12 Mar 2015 | GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour. | GE Healthcare | Device | Class II | 1 |
| 2 Mar 2015 | The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847 FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to… | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 2 Mar 2015 | Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece. | Hill-Rom, Inc. | Device | Class II | 1 |
| 27 Feb 2015 | Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp. | Volk Optical Inc | Device | Class III | 1 |
| 24 Feb 2015 | Epi breads, 7" French Hoagie Sliced, Net Weight 10.4 lbs., Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236. | Lavoi Corporation d/b/a/ Epi De France | Food | Class II | 22 |
| 17 Feb 2015 | Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes… | US Endoscopy Group Inc | Device | Class II | 1 |
| 11 Feb 2015 | Milestone Wand STA Handpiece for the delivery of local anesthesia to dental tissue. Model Number STA-5050-305. The Wand STA handpiece is a single use syringe used in conjunction with the CompuDent STA computer controlled dental injection system. (70742) | Milestone Scientific, Inc. | Device | Class III | 1 |
| 10 Feb 2015 | G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. Product Usage: G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7. | Tosoh Bioscience, Inc. | Device | Class III | 1 |
| 31 Jan 2015 | Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen. | Western / Scott Fetzer Company | Device | Class I | 1 |
| 9 Jan 2015 | Ancho & Molasses Barbecue Sauce, Rub with Love brand, Net wt. 16 oz., UPC 6-72361-00044-1 | Paradigm Foodworks, Inc | Food | Class II | 20 |
| 2 Jan 2015 | Cumin, Ground NET WT. 50 LBS. DISTRIBUTED BY: SOUTHERN STYLE SPICES PO BOX 20 MANOR, TX 78653 PHONE: (512)272-5621 (70180) | Southern Style Spices | Food | Class II | 1 |
| 24 Dec 2014 | Spicy Black Bean Burger powder mix, packaged in 30 LB poly-lined Kraft bags. (70135) | Coalescence LLC | Food | Class II | 1 |
| 21 Dec 2014 | 10% Soft-Serve Chocolate Ice Cream Mix, sold under Snoqualmie brand. Product is sold in 2.5 gallon clear flexible plastic bags. No UPC. | Individual firm, name withheld | Food | Class I | 117 |
| 19 Dec 2014 | SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc. | Bethel Nutritional Consulting, Inc | Drug | Class I | 1 |
| 18 Dec 2014 | Del Campo Alino Casero Seasoning Paste, 15oz; Product Code: 03138; UPC: 7 751227 000894. Product is in a glass bottle. (71472) | Megabusiness LLC | Food | Class III | 1 |
| 11 Dec 2014 | Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The product is a non-sterile automatic subcutaneous injection device which delivers insulin. | Owen Mumford USA, Inc. | Device | Class II | 1 |
| 27 Nov 2014 | Golden Chocolate ROGALIK PAPAYA, Net Wt. 1Lb. (454 g). Manufactured for and Distributed by: Golden Chocolate, Brooklyn, NY 11231. | Golden Chocolate International, Inc. | Food | Class III | 3 |
| 7 Nov 2014 | Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care (69760) | Breas Medical AB | Device | Class II | 1 |
| 5 Nov 2014 | Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only. | Custom Healthcare Systems, Inc. | Device | Class II | 1 |
| 2 Oct 2014 | Natural Knee II Revision Femoral Stem, 125mm, item 6215-12-185. packaged in configuration 803/791. Knee Prosthesis component. | Zimmer, Inc. | Device | Class II | 1 |
| 31 Jul 2014 | Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n. | Philips Electronics North America Corporation | Device | Class II | 1 |
| 22 Jul 2014 | ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays. | Abbott Laboratories | Device | Class II | 1 |
| 23 Sep 2013 | Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures. | Volcano Corp | Device | Class II | 3 |
| 5 Sep 2013 | Chocolate covered wafers (Bocadin) in plastic packaging sold under the Mi Costenita brand and packaged and distributed by Yoli, Inc. (66428) | Yoli, Inc. dba Mi Costenita | Food | Class I | 1 |
| 22 Feb 2013 | Grassplot Ginger Slice, NET WT. 3.5 OZ. (100g) , UPC 7246 6247, PRODUCT OF CHINA --- Firms on label: Manufactory: Grassplot Foodstuff Factory ADD: Huangshan Road, Huangshan Mansion, suite 417 Shantou, Guangdong, China -- Distributed by: LION PAVILION LIMITED --- Nutrition Facts: Serving Size 25 g Servings Per… (64466) | Lion Pavilion Ltd. | Food | Class I | 1 |
| 9 Jan 2013 | Foil bags containing 2.2 lbs. each of almond flavored powder and sold under the Boba Direct, Inc. brand. | Boba Direct, Inc. | Food | Class II | 24 |
| 6 Mar 2009 | Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments. | Exactech, Inc. | Device | Class II | 1 |