| 5 Jan 2016 | InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use. | Rymed Technologies, LLC | Device | Class II | 2 |
| 5 Jan 2016 | Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 (73072) | Mayne Pharma Usa | Drug | Class II | 1 |
| 4 Jan 2016 | Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb. | Otto Bock Healthcare GmbH | Device | Class II | 1 |
| 31 Dec 2015 | The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. | Siemens Medical Solutions USA, Inc. | Device | Class II | 1 |
| 24 Dec 2015 | Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614 | Amerita Specialty Infusion Services | Drug | Class II | 2 |
| 22 Dec 2015 | InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion. | Ultradent Products, Inc. | Device | Class II | 1 |
| 22 Dec 2015 | Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine,… | Grato Holdings, Inc. | Drug | Class II | 6 |
| 21 Dec 2015 | Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients. (72953) | Fukuda Denshi USA, Inc. | Device | Class II | 1 |
| 18 Dec 2015 | VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures. | Cyberonics, Inc | Device | Class II | 1 |
| 18 Dec 2015 | Oncentra External Beam - VMAT - Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. | Elekta, Inc. | Device | Class II | 1 |
| 18 Dec 2015 | arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples. | Arkray Factory USA, Inc. | Device | Class I | 2 |
| 18 Dec 2015 | Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01 (72893) | National Vitamin Co Inc | Drug | Class III | 1 |
| 17 Dec 2015 | Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities. | Stryker Sustainability Solutions | Device | Class II | 1 |
| 16 Dec 2015 | TWININGS OF London ENGLISH BREAKFAST BLACK TEA DECAFFEINATED, 12-0.11OZ (3.2g)/ EA NET WT 1.34 oz (38g), UPC 00070177513078 (72924) | Twinings North America, Inc. | Food | Class III | 1 |
| 15 Dec 2015 | GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The devices are intended for… | GE Medical Systems, LLC | Device | Class II | 6 |
| 15 Dec 2015 | Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60 | Morton Grove Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 14 Dec 2015 | FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent. | Becton, Dickinson and Company, BD Biosciences | Device | Class III | 1 |
| 11 Dec 2015 | MED-RX Single Use REF 54-3680R, 8 FR. x 36" (91CM) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, Made in Canada, Benton, Oakville, Ontario, Canada (72851) | Benlan, Inc. | Device | Class II | 1 |
| 11 Dec 2015 | PICOSITO Jalapenos Distributed by: Sweet Superior Fruit LTD. CO. PRODUCE OF MEXICO (72844) | Sweet Superior Ltd | Food | Class I | 1 |
| 10 Dec 2015 | IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2 | Iba Dosimetry Gmbh | Device | Class II | 1 |
| 10 Dec 2015 | Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary | Boston Scientific Corporation | Device | Class II | 2 |
| 10 Dec 2015 | Crazy about Cookies 2.7lb Sugar Cookies Pre-Portion Item # 25-2004 UPC Code - 698768102120 | Pine Valley Foods Inc | Food | Class I | 8 |
| 9 Dec 2015 | Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 9 Dec 2015 | Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0) | Philips Ultrasound, Inc. | Device | Class II | 1 |
| 9 Dec 2015 | Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures. | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 9 Dec 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 |
| 9 Dec 2015 | Peanut Butter Lust Bar, Net weight 2 ounces, UPC: 1425361001 (72903) | Eaton Farm Confectionaries, Inc. | Food | Class II | 1 |
| 9 Dec 2015 | Sweet Leaf Organic Raspberry Iced Tea, 16 oz glass bottle UPC: 6-51538-06703-6 | Nestle Waters North America | Food | Class II | 6 |
| 8 Dec 2015 | AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis. | Encore Medical, Lp | Device | Class II | 1 |
| 8 Dec 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 |
| 8 Dec 2015 | Simply Enjoy Shrimp and Lobster Ravioli, 9 oz, refrigerated packaged in plastic tray. Distributed by Foodhold USA, Landover, MD. UPC Code: 68826743926 (72839) | Nuovo Pasta Productions, Ltd | Food | Class II | 1 |
| 7 Dec 2015 | Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine. | Innovasis, Inc | Device | Class II | 1 |
| 7 Dec 2015 | Roasted pumpkin seeds with salt in a clear plastic bag with a yellow and red label attatched. (72930) | Yoli Inc. | Food | Class II | 1 |
| 4 Dec 2015 | Model NuCARTGN. The NuCART is a mobile display and image management platform used in Minimally Invasive Surgery (MIS) environments to facilitate the routing and ergonomic display of video signals from source devices to flat-panel monitors. It is tailored for use with an OEC C-arm and Endo-Cam in MIS surgery suites,… (72915) | CompView Medical, LLC | Device | Class II | 1 |
| 3 Dec 2015 | Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE¿ III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign… | Ethicon, Inc. | Device | Class II | 1 |
| 3 Dec 2015 | BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer¿ Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting,… | Becton Dickinson & Company | Device | Class II | 5 |
| 3 Dec 2015 | NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component Option CR/PS/LPS Size Stemmed 3. Tibial component of implanted knee prosthesis. | Zimmer Manufacturing B.V. | Device | Class II | 1 |
| 2 Dec 2015 | Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms | Skytron, Div. The KMW Group, Inc | Device | Class II | 1 |
| 1 Dec 2015 | SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures. | Synthes (USA) Products LLC | Device | Class II | 1 |
| 1 Dec 2015 | 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM. | 3M Company - Health Care Business | Device | Class II | 1 |
| 1 Dec 2015 | CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and… (72710) | Partners In Medicine Llc | Device | Class II | 1 |
| 1 Dec 2015 | MicroScan Pos Combo Panel Type 21, Part No. B1017-201 MicroScan Pos (Positive) panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and… | Beckman Coulter Inc. | Device | Class II | 5 |
| 30 Nov 2015 | Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device. | Baxter Healthcare Corp. | Device | Class II | 3 |
| 30 Nov 2015 | Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures. | Bayer Healthcare | Device | Class II | 1 |
| 25 Nov 2015 | ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the… | KCI USA, INC. | Device | Class II | 1 |
| 25 Nov 2015 | Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery System is designed for venous use to aid in the selective placement of cardiac resynchronization therapy (CRT)… | Boston Scientific Corporation | Device | Class II | 1 |
| 25 Nov 2015 | RenovoCath RC 120; Temporary Intravascular Occluding Catheter Model number: MMRC120-DB-1111; Rx only. Cardiovascular: The RenovoCath RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. (72810) | RenovoRx, Inc. | Device | Class II | 1 |
| 25 Nov 2015 | TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface. | Abeon Medical Corporation | Device | Class II | 3 |
| 23 Nov 2015 | Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens. | Biomerieux Inc | Device | Class II | 1 |
| 23 Nov 2015 | 0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General and Plastic Surgery: The da Vinci Xi endoscope produces high definition (HD), visible light (VIS). The HD video is processed by the system electronics in the Vision Cart and displayed on the Surgeon Console 3D viewer and Vision Cart… | Intuitive Surgical, Inc. | Device | Class II | 2 |
| 23 Nov 2015 | Nicomex Velitas Candies Candles Net. Wt. 2 oz (56.7 gms) Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 | Nicomex Inc. | Food | Class II | 1 |
| 20 Nov 2015 | FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures. | DePuy Mitek, Inc., a Johnson & Johnson Co. | Device | Class II | 3 |
| 20 Nov 2015 | AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications. | Steris Corporation | Device | Class II | 1 |
| 20 Nov 2015 | Made In Nature Sriracha Chili Kale Chips, 2.2oz or 62g, In a clamshell container with a paper sleeve, 8 packages per case | Made In Nature, LLC | Food | Class II | 2 |
| 20 Nov 2015 | Mi Tienda Masa Preparada By the Pound packaged in bag | HEB Retail Support Center | Food | Class II | 3 |
| 19 Nov 2015 | MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient monitoring capabilities. The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults… | Thornhill Research Inc | Device | Class I | 2 |
| 18 Nov 2015 | Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 | Cyberonics, Inc | Device | Class II | 1 |
| 18 Nov 2015 | Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. | Siemens Medical Solutions USA, Inc | Device | Class II | 1 |
| 17 Nov 2015 | Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm | Biomet, Inc. | Device | Class II | 1 |
| 17 Nov 2015 | Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery. | Aesculap, Inc. | Device | Class II | 1 |
| 17 Nov 2015 | Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952 | Zimmer Biomet, Inc. | Device | Class II | 1 |
| 17 Nov 2015 | The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock. | Stryker Sustainability Solutions | Device | Class I | 1 |
| 17 Nov 2015 | Raley's Sweet Pumpkin Ravioli; Fresh egg pasta with a pumpkin & Amaretti Biscuits filling. Net Wt. 10 oz. (284 g); Ingredients: Filling- pumpkin, bread crumbs (wheat flour, natural yeast, salt), Butter Amaretti Biscuits (sugar, apricot kernels, egg whites, lactose, milk protein, leavening- sodium hydrogen carbonate(,… (72728) | Individual firm, name withheld | Food | Class I | 1 |
| 17 Nov 2015 | Casey's Bakery, 8X8 Snickers cake, www.caseysbakery.com, Sioux Center, IA (72657) | Casey's Bakery, Inc | Food | Class I | 1 |
| 16 Nov 2015 | BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HEAD 38 MM -8MM 74121242, MODULAR HEAD 42 MM -8MM 74121246, MODULAR HEAD 46 MM -8MM 74121250, MODULAR HEAD 50 MM -8MM 74121254, MODULAR HEAD 54 MM -8MM 74121258, MODULAR HEAD 58 MM -8MM 74121338, MODULAR HEAD 3 8MM -4 (SHORT) 74121342, MODULAR… | Smith & Nephew, Inc. | Device | Class II | 1 |
| 16 Nov 2015 | Radiographic Transparency for Certain and External Connection Tapered Implants. Images that assist with measurements for dental implants. | Biomet 3i, LLC | Device | Class II | 1 |
| 16 Nov 2015 | BAKERY FRESH GOODNESS Chocolate Brownie NET WT 16 OZ (1 LB) 453 g CONTAINS: MILK, EGGS, WHEAT, SOY. MAY CONTAIN: ALMONDS, PECANS, WALNUTS, CASHEWS, COCONUT. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 09172 7 | The Kroger Co | Food | Class I | 1 |
| 13 Nov 2015 | Maquet HCU 30 Coolant Type R134A Filling weight 250 g 120 V 50-60 Hz 1920 W Product Usage: The Heater Cooler Unit (HCU) 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less. | Maquet Cardiovascular Us Sales, Llc | Device | Class II | 1 |
| 13 Nov 2015 | Friendly Farms Greek Peach Parfait Nonfat Yogurt net wt. 5.3 oz (150g) Distributed by ALDI Inc., Batavia, IL 60510 (72668) | Ehrmann Arizona Dairy Llc | Food | Class II | 1 |
| 12 Nov 2015 | Corflex Contender Post-Op Knee Brace Lite Model: 75-7500-000 Post-Operative Knee Brace is indicated for range of motion control at the knee joint following ACL, PCL, MCL, and LCL surgeries, meniscal repairs, patella realignment, regenerative chondroplasty, stable femoral fractures, total knee replacements, and high… | Corflex | Device | Class II | 7 |
| 12 Nov 2015 | DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0972-02, UPC 3 0555-0972-02 0. | Teva Pharmaceuticals USA | Drug | Class II | 1 |
| 11 Nov 2015 | Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks /SleepWorks software to… | Natus Neurology DBA Excel Tech., Ltd. (XLTEK) | Device | Class II | 1 |
| 11 Nov 2015 | Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma Catalog Number: CCTNI SMN: 10445071 | Siemens Healthcare Diagnostics Inc | Device | Class II | 11 |
| 10 Nov 2015 | UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of… | OrthoPediatrics Corp | Device | Class II | 1 |
| 10 Nov 2015 | Pedi MVI a) 5 mL, b) 10 mL syringe, Rx Only, Compounded by Option Care 148, San Antonio, TX 78232-5045 | Walgreens Infusion Services | Drug | Class II | 33 |
| 10 Nov 2015 | Pasteurized Donor Human Milk, Frozen then thawed. Product is packaged in 4 oz. glass bottle with metal lid and plastic seal. A bar code is present on each label but there is NO UPC codes. (72730) | Northwest Mothers Milk Bank | Food | Class II | 1 |
| 9 Nov 2015 | Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant. | Smith & Nephew, Inc. | Device | Class II | 1 |
| 9 Nov 2015 | Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10. | Freedom Pharmaceuticals Inc | Drug | Class II | 1 |
| 8 Nov 2015 | Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-down… (72794) | Vidco, Inc. | Device | Class II | 1 |
| 5 Nov 2015 | RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. The simulated plan is intended for treatment evaluation for example in tumor board meetings or operating rooms | Brainlab AG | Device | Class II | 2 |
| 4 Nov 2015 | Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150. | Pine Pharmaceuticals, LLC | Drug | Class II | 4 |
| 4 Nov 2015 | TATE'S BAKE SHOP CHOCOLATE CHIP COOKIES, NET WT. 7 OZ (198 G), UPC Code 810291001002, product is packed in plastic which is inserted into green paper wrapping, DISTRIBUTED BY: TATE'S BAKE SHOP 43 NORTH SEA RD. SOUTHAMPTON NY 11968 631-780-6511, WWW.TATEBAKESHOP.COM, MADE IN THE U.S.A. | Tate's Wholesale, Llc. | Food | Class I | 2 |
| 3 Nov 2015 | Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD). | St Jude Medical Cardiac Rhythm Management Division | Device | Class I | 1 |
| 3 Nov 2015 | VITROS 3600 Chemistry System, Catalog Number 6802783, Unique Device Identifier Number 10758750009930, Software Product Code 6802866, Software Version 3.2 and below; IVD. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest,… | Ortho-Clinical Diagnostics | Device | Class II | 4 |
| 2 Nov 2015 | Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5 | Trumpf Medical Systems, Inc. | Device | Class II | 1 |
| 30 Oct 2015 | Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600. (72818) | Avantor Performance Materials Inc | Drug | Class III | 1 |
| 29 Oct 2015 | EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482. (72639) | PQ Corporation | Drug | Class III | 1 |
| 29 Oct 2015 | HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01 | Amerisource Health Services | Drug | Class II | 1 |
| 27 Oct 2015 | Helados La Tapatia Creamy Fruit Bars; Strawberry Cream flavor; Net Wt. 3 FL oz; UPC 6 34242 20001 2; INGREDIENTS FOR MILK BARS: ICE CREAM MIX (MILK FAT AND NON FAT MILK, SUGAR, CORN SYRUP, MONO AND DIGLYCERIDES, CELLULOSE GUM, GUAR GUM, POLYSORBATE 80, CARRAGEENAN), STABILIZER (XANTHAN GUM, GUAR GUM, STANDARDIZED… | Helados La Tapatia, Inc. | Food | Class I | 13 |
| 26 Oct 2015 | Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures. | ArthroCare Corporation | Device | Class II | 1 |
| 26 Oct 2015 | Merge Hemo with software versions 10.0 LA. Merge Hemo (formerly named HeartSuite Hemodynamics) monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. | Merge Healthcare, Inc. | Device | Class II | 2 |
| 24 Oct 2015 | David Trail Mix Sweet & Salty individual plastic bags net wt. 5 oz. (142 g) UPC 00 26200 23885 2 shipped in the following configurations: 1) cases of eight (8) with UPC 20-0-26200-23885-6; 2) 36-count multi-pack shipper case UPC 00-0-26200-23890-6 which contains 16 individual 5.25 oz. bags of Classic flavor and 20… | ConAgra Foods Inc | Food | Class I | 1 |
| 22 Oct 2015 | Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with neonates and infants weighing… | Mercury Enterprises, Inc. dba Mercury Medical | Device | Class II | 1 |
| 20 Oct 2015 | Roasted Seasoned Himego Fish Product is packaged in a 240 KG cardboard master carton and individual fish fillets are further packaged in a clear plastic bag. | SNACK DEPOT, INC. | Food | Class III | 2 |
| 9 Oct 2015 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01 | Mutual Pharmaceutical Company, Inc. | Drug | Class II | 1 |
| 3 Oct 2015 | Skinny Latina Million Dollar Marinade, 12 oz, shelf stable, dry storage. (72508) | Skinny Latina LLC | Food | Class I | 1 |
| 1 Oct 2015 | CPT05 5 Ounce Pizza Dough Ball, 112 - 5 Ounce Dough Balls, Net Weight 35.0 Pounds, UPC 1 081267 0012644 4.. (72339) | The Dough Shop Pizza Dough Shop, Inc. | Food | Class II | 1 |
| 27 Sep 2015 | Fancy Chinook (salmon), Sockeye Suzy Fish brand, metal can with a net weight of 6 oz. UPC 7 48252 67292 6 | Sockeye Suzys Fish LLC | Food | Class II | 20 |
| 25 Sep 2015 | Baker's Best Maximum Mind & Memory Formula, 60 capsules, Vitamin B6 75 mg. Distributed by Baker's Best Health Products, Inc. Wixom, MI (72349) | Pure Source, Inc. | Food | Class II | 1 |
| 21 Sep 2015 | Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol. | Valeant Pharmacueticals International | Device | Class II | 1 |
| 21 Sep 2015 | BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to… | Biomet 3i, LLC | Device | Class II | 4 |
| 10 Sep 2015 | Cross Valley Farms cucumbers, 24 count corrugated carton (72173) | Del Monte Fresh Produce N A Inc | Food | Class I | 1 |
| 4 Sep 2015 | Bulk refined sugar. CON AA in 50lb paper bags, 2000 and 2200 poly super totes | Amcane Sugar Llc | Food | Class II | 3 |
| 12 Aug 2015 | A BIT OF A BITE SALSA HEINEY HOT SALSA NET WT. 128 OZ INGREDIENTS: DICED TOMATOES***FRESH ZUCCHINI, FRESH ONIONS***FRESH JALAPENO PEPPERS***FRESH HABANERO PEPPERS. A Bit of Bite Salsa 1243 Nouvelle Drive Miamisburg, OH 45342 UPC 6 42125 95415 0 | Garden Harvest | Food | Class II | 32 |
| 21 Jul 2015 | Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC… | PD-Rx Pharmaceuticals, Inc. | Drug | Class III | 1 |
| 10 Jul 2015 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01 | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 1 |
| 2 Jul 2015 | Barilla MEDIUM SHELLS, 1 LB (454 g), GTIN 00076808002881, packed as twelve boxes in 1 case | Barilla America NY, Inc. | Food | Class II | 4 |
| 29 Apr 2015 | Azithromycin Tablets, USP, 250 mg, Rx Only, packaged in a) 2 count and b) 4 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK, 73127, Mfg: Wockhardt Ltd., Mumbai, India, NDC: a) 55289-964-02, b) 55289-964-04. | PD-Rx Pharmaceuticals, Inc. | Drug | Class II | 2 |
| 30 Mar 2015 | NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines. | Nipro Medical Corporation | Device | Class II | 1 |
| 10 Mar 2015 | Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011. | Freedom Pharmaceuticals Inc | Drug | Class II | 1 |
| 8 Jan 2015 | 5-methyltetrahydrofolate Calcium (L) (a) 1 gm in 2 oz container NDC: 52372-0855-04; (b) 5 gm in 2 oz container NDC: 52372-0855-02; (c) 25 gm in 4 oz container NDC: 52372-0855-02, Rx only; Manufactured by: Hangzhou Dayangchem Co., Ltd. 328 Wener Rd, Xihu, Hangzhou, Zhejiang, China | Freedom Pharmaceuticals Inc | Drug | Class III | 1 |
| 8 Dec 2014 | iChem 10 SG Urine Chemistry Strips, PN 800-7005. Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color. | Beckman Coulter Inc. | Device | Class II | 1 |
| 6 Oct 2014 | Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | MWT Materials, Inc. | Device | Class II | 11 |
| 1 Apr 2014 | NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC. | Nipro Medical Corporation | Device | Class III | 1 |
| 22 Apr 2013 | Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery. | Brainlab AG | Device | Class I | 1 |