| 10 Sep 2015 | ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7. (72172) | EMD Serono, Inc. | Drug | Class III | 1 |
| 9 Sep 2015 | Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 4 Sep 2015 | Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza Brooks City-Base, Texas 78235. NDC:… (72039) | Healthpoint, Ltd | Drug | Class II | 1 |
| 2 Sep 2015 | 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38 | Baxter Healthcare Corporation | Drug | Class II | 1 |
| 1 Sep 2015 | Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures. | Medtronic Inc. Cardiac Rhythm Disease Management | Device | Class II | 1 |
| 31 Aug 2015 | Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 31 Aug 2015 | ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05 | Oasis Medical, Inc. | Drug | Class III | 1 |
| 27 Aug 2015 | CD4 (SK3), FITC; Contains CD4 FITC with gelatin and 0.1% sodium Azide. Catalog number 340133 in vitro diagnostic used in Hematology: The SK3 monoclonal antibody reacts with human CD4, a 59-kDa cell surface receptor expressed by a majority of thymocytes, a subpopulation of mature T helper cells, and at low levels on… | Becton, Dickinson and Company, BD Biosciences | Device | Class III | 1 |
| 27 Aug 2015 | Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures (72079) | Bien Air Dental SA | Device | Class II | 1 |
| 26 Aug 2015 | ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive… | Edwards Lifesciences, LLC | Device | Class II | 1 |
| 25 Aug 2015 | Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). For cardiac use. | Boston Scientific Corporation | Device | Class II | 2 |
| 25 Aug 2015 | 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02 | Hospira, Inc. | Drug | Class II | 1 |
| 25 Aug 2015 | FRESH ORIGINS Microgreens Celery NET WT 4 OZ San Marcos, CA 92069 packed in clear plastic clam shell. (72041) | Hardies Fruit & Vegetable Co., LP | Food | Class I | 1 |
| 25 Aug 2015 | Smoked Tofu is tofu sandwich on bread or a bun, enclosed in a clam shell with label | Individual firm, name withheld | Food | Class II | 6 |
| 25 Aug 2015 | Sam Mills Gluten Free Chocolate Chip Granola Bars with Dark Chocolate 5 bars/4.4oz Box (0.88oz each bar) (72050) | Sam MillsUSA LLC | Food | Class I | 1 |
| 25 Aug 2015 | Jansal Valley brand Raw Macadamia Nuts, packaged in 1 lb and 8 oz. plastic bags (72043) | Friendly Fruit, Inc. dba Sid Wainer & Son | Food | Class I | 1 |
| 24 Aug 2015 | Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usage: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in… | Siemens Healthcare Diagnostics Inc | Device | Class II | 4 |
| 24 Aug 2015 | Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter | C.R. Bard, Inc. | Device | Class II | 1 |
| 24 Aug 2015 | Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a… | Terumo Cardiovascular Systems Corp | Device | Class II | 7 |
| 24 Aug 2015 | Refresh Lacri-Lube (Mineral Oil 42.5% and White Petrolatum 56.8%) Lubricant Eye Ointment, packaged in a) Net wt. 0.12 oz (3.5 g) tubes (NDC 0023-0312-04) UPC 3 0023-0312-04 2 and b) Net wt. 0.25 oz (7 g) tubes (NDC 0023-0312-07) UPC 3 0023-0312-07 3, Allergan, Inc., 2525 Dupont Drive, Irvine, CA 92612. | Allergan Sales, LLC | Drug | Class II | 4 |
| 24 Aug 2015 | Trader Joe's Dark Chocolate covered Honey Grahams with Sea Salt NET Wt. 8oz. (227g) SKU #0055 0246 Product is packaged in 8oz. clear tubs. (72040) | Individual firm, name withheld | Food | Class I | 1 |
| 21 Aug 2015 | Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70 (71952) | Silarx Pharmaceutical, Inc. | Drug | Class III | 1 |
| 20 Aug 2015 | Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone | Orthovita, Inc., dBA Stryker Orthobiologics. | Device | Class II | 1 |
| 20 Aug 2015 | Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05 | Hospira Inc. | Drug | Class II | 1 |
| 20 Aug 2015 | Deep All Natural Spices Coriander Powder, Net Wt 400g/14.1 oz Product of India, Distributed by: Chetak New York, L.L.C. Edison, NJ 08837 USA | Chetak New York, LLC | Food | Class I | 1 |
| 20 Aug 2015 | Dry Grated Romano, Tipico Item #1-00111000, Net Wt. 50 lbs. (72027) | Tipico Products Company, Inc. | Food | Class I | 1 |
| 19 Aug 2015 | MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC | Covidien LLC | Device | Class II | 3 |
| 19 Aug 2015 | Regard Custom Surgical Pack, Item Number: 800628; Sterile, CV0805 - CABG B. Used in cardiovascular surgical procedures. | Resource Optimization & Innovation Llc | Device | Class II | 2 |
| 19 Aug 2015 | ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal… | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 19 Aug 2015 | CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area. | Med Tec Inc | Device | Class II | 1 |
| 18 Aug 2015 | PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15 (72038) | Zien Medical Technologies, Inc | Device | Class II | 1 |
| 18 Aug 2015 | Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case… | Ecolab Inc | Device | Class II | 1 |
| 18 Aug 2015 | MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status. | Medtronic Perfusion Systems | Device | Class II | 2 |
| 18 Aug 2015 | Disposable Reflective Marker Spheres The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.… | Brainlab AG | Device | Class II | 1 |
| 18 Aug 2015 | Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's. | St Jude Medical Cardiac Rhythm Management Division | Device | Class II | 1 |
| 17 Aug 2015 | da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: 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 including rigid… | Intuitive Surgical, Inc. | Device | Class II | 1 |
| 17 Aug 2015 | Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5 | Apotex Inc. | Drug | Class II | 1 |
| 14 Aug 2015 | SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery. | Individual firm, name withheld | Device | Class II | 2 |
| 14 Aug 2015 | think Thin Protein & Fiber Oatmeal, Madagascar Vanilla, Almonds, Pecans; 10 g Protein, 5 g Fiber, 190 calories; Net wt 1.76 oz. (50g); (Nuts are visible in product when lid is opened. Tray - 12 x 1.76 oz cups UPC 753656711881: Individual cup UPC 753656 711874 Ingredients: Whole rolled oats, steel cut oats, almonds,… (71977) | Interpac Technologies | Food | Class II | 1 |
| 13 Aug 2015 | Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1526-11 | GlaxoSmithKline, LLC. | Drug | Class II | 4 |
| 13 Aug 2015 | Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30. | Individual firm, name withheld | Drug | Class III | 7 |
| 12 Aug 2015 | FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model number : USAR064060 Sterile, Rx only Cardiovascular: For use in cardiac electrophysiology procedures to assist in the diagnosis of complex arrhythmias that may be difficult to identify using conventional mapping systems… (71970) | Individual firm, name withheld | Device | Class III | 1 |
| 12 Aug 2015 | Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings. (71950) | Otto Bock Healthcare Product | Device | Class II | 1 |
| 12 Aug 2015 | XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile… (72019) | Revmedx Inc | Device | Class II | 1 |
| 12 Aug 2015 | Dark Chocolate with Cranberry, Roasted Nuts & Sea Salt, sold under brand Willit House. Each bar is wrapped in gold foil and then wrapped with a box. Each box contains 12 bars and each bar has a net weight 60 gram. (71954) | Willit House Chocolate Co | Food | Class II | 1 |
| 11 Aug 2015 | Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware… | GE Healthcare | Device | Class II | 2 |
| 11 Aug 2015 | Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 11 Aug 2015 | LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that… | Alcon Research, Ltd. | Device | Class II | 1 |
| 11 Aug 2015 | METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05. | Golden State Medical Supply Inc. | Drug | Class III | 1 |
| 10 Aug 2015 | CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices. | Advanced Sterilization Products | Device | Class II | 1 |
| 8 Aug 2015 | Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428050-12, 428050-13 and 428050-14; The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room… | Intuitive Surgical, Inc. | Device | Class II | 9 |
| 7 Aug 2015 | CDI 500 Blood Parameter Monitoring System. Provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. | Terumo Cardiovascular Systems Corporation | Device | Class II | 1 |
| 7 Aug 2015 | CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. | Carestream Health Inc | Device | Class II | 1 |
| 7 Aug 2015 | IQF Red Tart Cherries, 30 lbs., 2/5 lb packages/case, 4/5 lb. packages per case; packed in cartons, square plastic pails, and poly bag in cartons; Nature Blessed Red Tart Cherries, 4/40 oz. packages per case. | Coloma Frozen Foods, Inc. | Food | Class II | 3 |
| 7 Aug 2015 | Big Train Chai Tea Vanilla Chai, Naturally and Artificially Flavored Drink Mix, No Sugar Added, NET WT 56 oz (3 LB 8 OZ) 1.59kg lb), UPC 6 42628 10359 8. Case UPC code: 10642628103526 Soft sided 3.5 lb. pouch style package. Each case has 4 pouches. | Kerry Foods | Food | Class II | 1 |
| 6 Aug 2015 | 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones. | Trilliant Surgical Ltd. | Device | Class II | 1 |
| 6 Aug 2015 | Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument | Tornier, Inc | Device | Class II | 1 |
| 6 Aug 2015 | Monoject 0.9% Saline Flush Prefill Double Pouch Item Code: 8881570129 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices. | Covidien LLC | Device | Class II | 13 |
| 6 Aug 2015 | Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom… | SynCardia Systems Inc. | Device | Class I | 1 |
| 6 Aug 2015 | DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/urethane sponge and 2-count Cotton-tipped swabs per pouch, packaged in 20 pouches per case (NDC 17518-0011-08, UPC (01) 0… | 3M Company - Health Care Business | Drug | Class II | 1 |
| 5 Aug 2015 | ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. | Brainlab AG | Device | Class II | 1 |
| 5 Aug 2015 | Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440. | Biomet Spine, LLC | Device | Class II | 1 |
| 5 Aug 2015 | ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 5 Aug 2015 | The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration. | Leica Microsystems, Inc. | Device | Class III | 1 |
| 5 Aug 2015 | Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7. | Taro Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 4 Aug 2015 | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. | Bayer Healthcare | Device | Class II | 1 |
| 4 Aug 2015 | NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment. | Salter Labs | Device | Class II | 1 |
| 4 Aug 2015 | A&W Cream Soda 12 FL OZ (355 mL) (71870) | Individual firm, name withheld | Food | Class II | 1 |
| 4 Aug 2015 | Golden Seal Extract packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403. | HoneyCombs Industries, LLC | Food | Class II | 7 |
| 3 Aug 2015 | Central Line >34 Weeks Kit . Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long… | Medline Industries Inc | Device | Class II | 1 |
| 3 Aug 2015 | Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. | Medivators, Inc. | Device | Class II | 1 |
| 3 Aug 2015 | Soybean sprouts, 1, 2 & 10-lb clear plastic bags labeled GOODSEED Soy Bean Sprouts Keep Refrigerated | Good Seed, Inc. | Food | Class I | 2 |
| 3 Aug 2015 | Izzie Macs! Macadamia Nuts; Salted. Certified Organic Macadamia Nuts, 100% Big Island Grown. A Raw Food. sold in 6 oz. and 16 oz sizes. 6 oz, UPC 689076792677; 16 oz. UPC 689076792974 Mahina Mele Farm, Captain Cook, HI 96704 | Individual firm, name withheld | Food | Class I | 5 |
| 31 Jul 2015 | 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones. | Trilliant Surgical Ltd. | Device | Class II | 1 |
| 31 Jul 2015 | Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling | Covidien LLC | Device | Class II | 2 |
| 31 Jul 2015 | Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring. (71971) | Edward Lifesciences, Llc | Device | Class II | 1 |
| 31 Jul 2015 | Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm… | Applied Medical Resources Corp | Device | Class II | 1 |
| 31 Jul 2015 | Label reads in part as: "GRAVIOLA EXTRACT***1 FL Oz (30 ml)*** ORIGINAL FORMULA***Manufactured by: Majopa Industries Corp.*** PRODUCT OF PUERTO RICO,USA". Drug claims in the product label are as follows: "Researchers have found that Extracts from Graviola leaves can produce acetogenins which are extremely effective… (71918) | Majopa Industries Corporation | Food | Class I | 1 |
| 30 Jul 2015 | Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days | Arrow International Inc | Device | Class II | 1 |
| 30 Jul 2015 | Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to… (71851) | Lumenis | Device | Class II | 1 |
| 30 Jul 2015 | PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound | Arrow International Inc | Device | Class II | 1 |
| 30 Jul 2015 | Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10 | Unichem Pharmaceuticals Usa Inc | Drug | Class II | 1 |
| 30 Jul 2015 | 5 ounce containers of SUGAR FREE Milk Chocolate Caramels. The 5 oz container is a cardboard box with clear plastic window on the front. Retail packages are packed 4 per shipping case. | Kilwin's Quality Confections, Inc. | Food | Class II | 1 |
| 29 Jul 2015 | VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 29 Jul 2015 | Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult… | Synthes (USA) Products LLC | Device | Class II | 1 |
| 29 Jul 2015 | KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to… | Halyard Health, Inc | Device | Class II | 32 |
| 29 Jul 2015 | NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and… | Nico Corp. | Device | Class II | 1 |
| 29 Jul 2015 | UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. | Biomet 3i, LLC | Device | Class II | 1 |
| 29 Jul 2015 | Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811 | Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals | Drug | Class II | 1 |
| 28 Jul 2015 | Access Thyroglobulin Assay; 100 determinations, 2 packs, 50 tests/pack. For the quantitative determination of thyroglobulin levels in human serum and plasma using the Access Immunoassay Systems. | Beckman Coulter Inc. | Device | Class II | 1 |
| 28 Jul 2015 | RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. | Siemens Healthcare Diagnostics Inc | Device | Class II | 1 |
| 28 Jul 2015 | Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis. | Biomet, Inc. | Device | Class II | 1 |
| 28 Jul 2015 | 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics. | OrthoPediatrics Corp | Device | Class II | 1 |
| 28 Jul 2015 | Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540 | Novartis Pharmaceuticals Corp. | Drug | Class III | 1 |
| 28 Jul 2015 | Kariba Farms Macadamia Meal, 1 pound bags; Packed by: Kariba Farms, Denville, NJ 07834 Product of USA. www.KaribaFarms.com 1.800.442.1969. (71951) | Kariba Farms, Inc. | Food | Class I | 1 |
| 28 Jul 2015 | Valley View Orchard Pies, Raspberry Rhubarb | Valley View Orchard Pies Inc. | Food | Class II | 6 |
| 27 Jul 2015 | Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, and heart rate. | Mindray DS USA, Inc. dba Mindray North America | Device | Class II | 1 |
| 27 Jul 2015 | ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay. | Siemens Healthcare Diagnostics, Inc | Device | Class II | 1 |
| 27 Jul 2015 | The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration. | Leica Microsystems, Inc. | Device | Class II | 1 |
| 27 Jul 2015 | Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively. | Transonic Systems Inc | Device | Class II | 10 |
| 27 Jul 2015 | CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 | Advanced Sterilization Products | Device | Class II | 1 |
| 27 Jul 2015 | Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position. | Sunrise Medical (US) LLC | Device | Class II | 2 |
| 27 Jul 2015 | Doubletree Cookie Dough, item number 2603450, Contents: 106 pieces, Net Weight: approx. 15 lbs. (6.8 kg), Mfg by: The Christie Cookie Co, Nashville, TN (71916) | Christie Cookie Co Inc | Food | Class II | 1 |
| 27 Jul 2015 | THE ORIGINAL CHICKEN FRY MIX FROM THE MAKERS OF LOUISIANA BRAND HOT SAUCE, NET WT. 9 oz. (255g), BRUCE FOODS CORPORATION, EL PASO, TEXAS, UPC 1760002733 | Bruce Foods Corporation | Food | Class II | 3 |
| 25 Jul 2015 | Kroger Ground Cinnamon UPC 11110 70034 NEW WT. 18.3 oz Plastic container | The Kroger Co | Food | Class I | 4 |
| 24 Jul 2015 | cobas Liat Analyzer, for in vitro diagnostic use. | Roche Molecular Systems, Inc. | Device | Class II | 1 |
| 24 Jul 2015 | ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five). | Teva Pharmaceuticals USA | Drug | Class I | 1 |
| 23 Jul 2015 | Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems | Philips Medical Systems (Cleveland) Inc | Device | Class II | 1 |
| 23 Jul 2015 | Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the… | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 22 Jul 2015 | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. | Volcano Corporation | Device | Class II | 1 |
| 22 Jul 2015 | Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs,… | Biomet Spine, LLC | Device | Class II | 1 |
| 22 Jul 2015 | COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets. | Beckman Coulter Inc. | Device | Class II | 2 |
| 22 Jul 2015 | Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management. | Medtronic MiniMed Inc. | Device | Class II | 1 |
| 22 Jul 2015 | Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion | Synthes (USA) Products LLC | Device | Class II | 1 |
| 21 Jul 2015 | CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x 24 mm, REF CCP-L3024; 3.0 x 26 mm, REF… | Wright Medical Technology, Inc. | Device | Class II | 2 |
| 21 Jul 2015 | Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be… | Neuro Kinetics, Inc. | Device | Class II | 1 |
| 21 Jul 2015 | Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48 | Pharmedium Services, LLC | Drug | Class II | 1 |
| 21 Jul 2015 | KellBran" CANDIES, INC. creamy rich caramel popcorn Net Wt. 8 oz. (226.64 Grams) ALLERGY INFO: Manufactured in a facility that processes peanuts, nuts, soy and milk. UPC 0 96637 50153 9 kellbrancandies.com KellBran Candies, Inc. Akron, Ohio 44312 (71753) | Kellbran Candies and Snacks Inc | Food | Class II | 1 |
| 20 Jul 2015 | Marketing brochures for the PowerPICC and PowerPICC SOLO catheters | Bard Access Systems | Device | Class II | 1 |
| 20 Jul 2015 | Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker) is a component of the Neptune 2 Waste Management System. The Stryker Rover, another component of the system, is a mobile unit used to suction and collect fluid waste and surgical… | Stryker Instruments Div. of Stryker Corporation | Device | Class II | 1 |
| 20 Jul 2015 | 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. | Trilliant Surgical Ltd. | Device | Class II | 1 |
| 20 Jul 2015 | Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones. | Trilliant Surgical Ltd. | Device | Class II | 1 |
| 20 Jul 2015 | Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless Cannulated Screw Fixation… | Trilliant Surgical Ltd. | Device | Class II | 1 |
| 20 Jul 2015 | ALLOPURINOL TABLETS, USP, 300 mg, 500 count bottle, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811 --- NDC 0603-2116-28 | Qualitest Pharmaceuticals | Drug | Class III | 1 |
| 19 Jul 2015 | Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20. | Elcam Medical, Inc. | Device | Class II | 2 |
| 17 Jul 2015 | MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Catalog No. 10714149, 10714150. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST). | Beckman Coulter Inc. | Device | Class II | 1 |
| 17 Jul 2015 | BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells. | Becton, Dickinson and Company, BD Biosciences | Device | Class II | 1 |
| 17 Jul 2015 | Lightspeed 16 CT | GE Healthcare | Device | Class II | 3 |
| 17 Jul 2015 | Vic's All Natural Original White Popcorn, Net Wt. 1-1/8 oz (32g), UPC 46555-00062 (71761) | Barrel O' Fun Snack Foods, Inc. | Food | Class I | 1 |
| 17 Jul 2015 | Kale Crisps Zen Nori product is seaweed flavored dehydrated kale chip, sold under brand Veggie Evolution, each poly pouch has a net weight 1.5 oz. There are six packages per case. UPC is 7 13757 57480 8. The product's label is read in part: "***VEGGIE EVOLUTION***KALE CRISPS***ZEN NORI***NET WT 1.5 OZ… | It Takes A Village Foods, LLC | Food | Class I | 3 |
| 16 Jul 2015 | Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01 | Mutual Pharmaceutical Company, Inc. | Drug | Class III | 6 |
| 15 Jul 2015 | iChemVELOCITY 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. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. | Iris Diagnostics | Device | Class II | 1 |
| 15 Jul 2015 | Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CREA method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatinine in human serum, plasma and urine. | Siemens Healthcare Diagnostics, Inc. | Device | Class II | 1 |
| 14 Jul 2015 | cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb,… | Roche Diagnostics Operations, Inc. | Device | Class II | 2 |
| 14 Jul 2015 | Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA | KVK-Tech, Inc. | Drug | Class III | 1 |
| 13 Jul 2015 | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. | Insulet Corporation | Device | Class I | 2 |
| 10 Jul 2015 | Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH¿ XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent… | Stryker Sustainability Solutions | Device | Class II | 1 |
| 10 Jul 2015 | ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. | Customed, Inc | Device | Class II | 170 |
| 9 Jul 2015 | HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In vitro diagnostic www.HardyDiagnostics.com | Hardy Diagnostics | Device | Class II | 1 |
| 9 Jul 2015 | CocoNoNut CACAO-NECTAR BAR, Honey Mama's brand, Net wt. 2.5 oz. (70.8 g), UPC 8 54835 00406 7 Square in size, 3"X3" with a bright orange label around a butcher paper wrapper. 12 bars/case (71679) | Nectar Foods LLC | Food | Class I | 1 |
| 8 Jul 2015 | Caesar Salad, #5.56 (2,522g) "INGREDIENTS: Romaine Lettuce, Caesar Dressing (Soybean oil, water, distilled vinegar, Romano cheese (pasteurized part skim milk, cheese culture, salt, enzymes),*****" *ALLERGENS** Fish, Milk, Wheat | Fresh Unlimited Inc | Food | Class I | 3 |
| 7 Jul 2015 | WESTBROOK'S CANNERY DILL PICKLES, 16 oz (453.592g) glass jars, Ingredients: White Distilled Vinegar, Water, Cucumbers, Alum, Pickling Salt, Spices 206 Dueber Ave SW Canton, OH 44706 234-214-8215 www.wesbrookscannery.com UPC 8 53238 00406 3 | Individual firm, name withheld | Food | Class II | 6 |
| 6 Jul 2015 | Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning.… | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 2 Jul 2015 | 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution. | MRP, LLC dba AMUSA | Device | Class II | 1 |
| 2 Jul 2015 | CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895. (72069) | Bestco, Inc. | Drug | Class III | 1 |
| 30 Jun 2015 | VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644, IVD --- Ortho Clinical Diagnostics Inc. The VITROS 5,1 FS Chemistry System… | Ortho-Clinical Diagnostics | Device | Class II | 1 |
| 30 Jun 2015 | Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic procedures. | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 2 |
| 30 Jun 2015 | Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals. | Fujifilm Medical Systems U.S.A., Inc. | Device | Class II | 1 |
| 25 Jun 2015 | Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component | Stryker Howmedica Osteonics Corp. | Device | Class II | 1 |
| 22 Jun 2015 | Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples. | Bayer Healthcare, LLC | Device | Class II | 1 |
| 15 Jun 2015 | OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution… | Nidek Inc | Device | Class II | 1 |
| 15 Jun 2015 | Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. | Liberty Drug & Surgical | Drug | Class II | 25 |
| 10 Jun 2015 | Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes | ASO, LLC | Device | Class II | 1 |
| 9 Jun 2015 | Offset Femoral Alignment Guide, 2mm x 6¿; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems | Omnilife Science Inc. | Device | Class II | 2 |
| 4 Jun 2015 | Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images. | Panoramic Rental Corp. | Device | Class II | 1 |
| 4 Jun 2015 | APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. | Omnilife Science Inc. | Device | Class II | 1 |
| 3 Jun 2015 | Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis | Smith & Nephew, Inc. | Device | Class II | 3 |
| 2 Jun 2015 | 5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN | The Compounding Pharmacy of America | Drug | Class II | 382 |
| 1 Jun 2015 | Rato Bhale Nepali Finger Chips Product of Nepal Weight: 200g (7.05 OZ) Imported by: Balajee Trade Link, LLC, PA USA Batch No. 01-15 (71413) | Balajee Trade Link LLC | Food | Class II | 1 |
| 29 May 2015 | Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer… | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 27 May 2015 | RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy. | RAYSEARCH LABORATORIES AB | Device | Class II | 1 |
| 27 May 2015 | PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics. | PTW-Freiburg | Device | Class II | 1 |
| 19 May 2015 | Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). Also sold as individual vials Bottle: Clear glass vials Cap: Rubber seal with colored aluminum seals Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative… | Pointe Scientific, Inc. | Device | Class II | 1 |
| 15 May 2015 | MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic. (71993) | MedtestDx, Inc. | Device | Class II | 1 |
| 13 May 2015 | SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy… | Ethicon Endo-Surgery Inc | Device | Class I | 1 |
| 1 May 2015 | Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport. | Ferno-Washington Inc | Device | Class II | 1 |
| 1 May 2015 | Fisher Brand chopped walnuts, packaged in 10 ounce, polyethylene stand-up bag with zipper. The bag is blue with white lettering. | John B. Sanfilippo & Son Inc. | Food | Class I | 1 |
| 23 Apr 2015 | Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA | South Coast Specialty Compounding, Inc. | Drug | Class II | 15 |
| 22 Apr 2015 | Black Currant Huckleberry, Brioche and Jam Ice Cream Bucket, 313, Jeni's Splendid Ice Creams, LLC, 3 gallons, plastic bucket, individually packed, frozen. Black Currant Huckleberry, Brioche and Jam Pint Case, 215, Jeni's Splendid Ice Creams, LLC, pint size, plastic container, 8 pints per case, frozen. Black Currant… | Jeni's Splendid Ice Creams LLC | Food | Class I | 134 |
| 20 Apr 2015 | IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by:… | Akorn, Inc. | Drug | Class III | 1 |
| 15 Apr 2015 | Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India,… | Reckitt Benckiser LLC | Drug | Class I | 7 |
| 13 Apr 2015 | oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02. | Pharmedium Services, LLC | Drug | Class I | 6 |
| 26 Mar 2015 | EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the… | Olympus America Inc. | Device | Class II | 1 |
| 23 Mar 2015 | Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians. | Philips Electronics North America Corporation | Device | Class II | 1 |
| 13 Mar 2015 | Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE… | Pointe Scientific, Inc. | Device | Class III | 1 |
| 5 Feb 2015 | DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box. (71149) | Derma Pen, LLC | Device | Class II | 1 |
| 28 Jan 2015 | PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (200 mcg per mL), packaged in 250 ml bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd., Sugar Land, TX 77478, NDC# 61553-171-50 | Pharmedium Services, LLC | Drug | Class I | 8 |
| 13 Jan 2015 | Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology. (71657) | Sony Medical Systems | Device | Class II | 1 |
| 12 Dec 2014 | Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill. | Pointe Scientific, Inc. | Device | Class III | 1 |
| 16 Oct 2014 | MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic. | Diagnostic Hybrids Inc | Device | Class II | 1 |
| 31 Aug 2013 | Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60 (71803) | Physician Engineered Products, Inc. | Device | Class II | 1 |
| 25 Feb 2013 | MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer… | Baxter Healthcare Corp. | Device | Class II | 4 |