FDA 510(k) Applications Received During August, 2015

FDA 510(k) Number Submission Date Device Name Applicant Contact
K152155 08/03/2015 ARCHITECT 2nd Generation Testosterone Abbott Laboratories Regina Xavier Kumar
K152442 08/27/2015 Freestyle Freedom Blood Glucose Monitoring Sytem ABBOTT LABORATORIES Sai Sriharshada Tatavarty
K152404 08/25/2015 Hi-Torque Command 18 Guide Wire ABBOTT VASCULAR SHU CHI HSU
K152328 08/18/2015 FreeStyle InsuLinx Blood Glucose Monotioring System ABOTT LABORATORIES SAI SRIHARSHADA TATAVARTY
K152488 08/31/2015 Onrad Treatment System ACCURAY INCORPORATED ERIN DALY
K152480 08/31/2015 Revitive Medic; Revitive MV; Revitive LV Actegy, Ltd. Angela Glover
K152417 08/26/2015 Adler MicroMed Laser Surgery Fibers ADLER MICROMED INC. BRIAN CHANDLER
K152450 08/28/2015 Esophageal Cooling Device ADVANCED COOLING THERAPY, LLC Erik Kulstad
K152189 08/05/2015 EVOTECH ECR Advanced Sterilization Products (ASP) Nazanin Yacobi
K152365 08/21/2015 AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System AgaMatrix, Inc. David Olsen
K152420 08/26/2015 AK Body Toning Device AK BEAUTY ENTERPRISES, LLC Robert Applebaum
K152455 08/28/2015 Amendia Cervical Plate System Amendia, Inc Kristen Allen
K152460 08/28/2015 Rectangular Corpectomy Cage Amendia, Inc. Bruce Hooper
K152291 08/13/2015 Sterisheet Sterilization Wrap ANDERSEN STERILIZERS, INC. WILLIAM K ANDERSEN
K152379 08/21/2015 iHealth View BP7S Wireless Blood Pressure Wrist Monitor ANDON HEALTH CO.,LTD Liu Yi
K152160 08/03/2015 Navik 3D APN Health, LLC David Geddam
K152272 08/12/2015 Arrow Endurance Extended Dwell Peripheral Catheter System ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) TRACY LARISH
K152252 08/10/2015 Arthrex iBalance TKA System ARTHREX, INC. LEON BROWN
K152382 08/24/2015 Arthrex iBalance TKA System ARTHREX, INC. LEON BROWN
K152454 08/28/2015 HemiCAP MTP Resurfacing Hemi-Arthroplasty System ARTHROSURFACE, INC. DAWN J. WILSON
K152447 08/27/2015 ASAHI Caravel ASAHI INTECC CO., LTD. YOSHIHIKO FUKUI
K152249 08/10/2015 ASAHI Corsair Armet ASAHI INTECC CO., LTD. YOSHIHIKO FUKUI
K152153 08/03/2015 MicroSpot Handpiece ASCLEPION LASER TECHNOLOGIES GMBH ANTJE KATZER
K152151 08/03/2015 ATAL 9 ATLAIM CORPORATION JOHN ROSS
K152337 08/19/2015 cryoFORM cryoICE cryoablation probe ATRICURE, INC JONATHAN MCELWEE
K152319 08/17/2015 Auris Robotic Endoscopy System (ARES) AURIS SURGICAL ROBOTICS, INC. MICHAEL A. DANIEL
K152275 08/12/2015 Pantheris System Avinger, Inc. Patty Hevey
K152474 08/31/2015 Avitus Bone Harvester Avitus Orthopaedics Inc. Maxim Budyansky
DEN150035 08/05/2015 SEEKER System Baebies, Inc. Vamsee Pamula
K152346 08/20/2015 MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) BECKMAN COULTER, INC. SHANNON POPSON
K152324 08/17/2015 YAHUA Spinal System BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD. XINJIAN LV
K152208 08/07/2015 The Belmont Hyperthermia Pump BELMONT INSTRUMENT CORPORATION URAIWAN P LABADINI
K152157 08/03/2015 LC Bead LUMI BIOCOMPATIBLES UK LTD April Kent
K152432 08/27/2015 ActiPatch(R) BIOELECTRONICS CORPORATION ANDREW WHELAN
K152185 08/05/2015 ARCHITECT SHBG BIOKIT, S.A. ANGELS ROMA
K152262 08/11/2015 Ventix Knotless Anchors BIOMET MANUFACTURING CORP. JARED COOPER
K152326 08/18/2015 Biomet Microfixation OmniMax MMF System BIOMET MICROFIXATION LAUREN JASPER
K152253 08/10/2015 Biomet Microfixation RibFix Blu Thoracic Fixation System BIOMET MICROFIXATION LAUREN JASPER
K152280 08/12/2015 BioPhotas Celluma3 BIOPHOTAS, INC PATRICK JOHNSON
K152240 08/10/2015 Passeo-14 Peripheral Dilatation Catheter BIOTRONIK, INC. JON BRUMBAUGH
K152437 08/27/2015 BiowaveHOME Neuromodulation Pain Therapy Device BIOWAVE CORPORATION BRADFORD SIFF
K152141 08/03/2015 High Pressure Tanning Lamps BLV Licht-und Vakuumtechnik GmbH Heinz-Jurgen Wesseling
K152297 08/13/2015 OBS Anchorage Screw BOMEI CO., LTD LINNEY CHIANG
K152316 08/17/2015 iLab Ultrasound Imaging System BOSTON SCIENTIFIC George J Prendergast
K152403 08/25/2015 Permanent Sled Bag BOSTON SCIENTIFIC George J. Prendergast
DEN150040 08/28/2015 WallFlex Biliary RX Fully Covered Stent System RMV BOSTON SCIENTIFIC THOMAS HIRTE
K152231 08/07/2015 Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire BOSTON SCIENTIFIC CORPORATION Nikki M Wahlberg
K152401 08/25/2015 Stingray LP Catheter BOSTON SCIENTIFIC CORPORATION KURTIS HUNSBERGER
K152140 08/03/2015 Boa Endoscopic Valve C2 THERAPEUTICS, INC. THERESA BRANDNER-ALLEN
K152329 08/18/2015 Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System C2 Therapeutics, Inc. Theresa Brandner-Allen
K152310 08/14/2015 HeartLight Deflectable Sheath CARDIOFOCUS, INC. Seema Paliwal
K152467 08/31/2015 Touch Ultrasound CARESTREAM HEALTH, INC. CAROLYN L. WAGNER
K152473 08/31/2015 CAS-One IR CAScination AG Matthias Peterehans
K152162 08/03/2015 Myray- HYPERION X5 CEFLA S.C. Silvia Sansavini
K152211 08/07/2015 PCT System CENTINEL SPINE, INC. JESSICA STAUB
K152476 08/31/2015 Exofin High Viscosity Tissue Adhesive CHEMENCE MEDICAL PRODUCTS INC. Kenneth Broadley
K152146 08/03/2015 High Speed Handpieces and Accessories CODENT TECHNICAL INDUSTRY CO., LTD. Chin-Ting Wen
K152481 08/31/2015 DURAFORM Dural Graft Implant CODMAN & SHURTLEFF, INC. JENNIFER SIU
K152243 08/10/2015 One Coat 7 Universal Coltene/Whaledent AG Silke Wallaschek
K152237 08/10/2015 The Entasis Dual-Lead Sacroiliac Implant CoreLink, LLC Dan Hoehn
K152273 08/12/2015 Cosmedico Ultraviolet Lamps of Various Models Cosmedico Light, Inc Steven Schlitt
K152284 08/12/2015 COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS COTTON HIGH TECH S.L. Anna Garcia
K152286 08/13/2015 LigaSure Curved, Small Jaw, Open Sealer/Divider COVIDIEN DAWN TINDALL
K152149 08/03/2015 VersaOne Bladed Trocar 5mm COVIDIEN Trang Huynh
K152306 08/14/2015 MotoBand? CP Implant System CROSSROADS EXTREMITY SYSTEMS, LLC VERNON HARTDEGEN
K152349 08/20/2015 Star+ VPS Scannable Impression Material DANVILLE MATERIALS LLC DONG HUA
K152246 08/10/2015 Aquarius Stoma Measuring Device DEGANIA SILICONE LTD ZOYA LEE
K152322 08/17/2015 Resolve 2.0 DENALI CORPORATION Jan G Stannard
K152188 08/05/2015 QUAD Dental Implants and Prostheses Dentack Impants Ltd David Salton
K152215 08/07/2015 DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR DENTALPLUS GMBH RALF GERSCHUETZ RUETH
K152385 08/24/2015 Zeramex P6 Dental Implant System DENTALPOINT AG Viktor Lienhard
K152247 08/10/2015 ATLANTIS Crown DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K152464 08/31/2015 ORAcollect.Dx DNA GENOTEK INC. Dan Fullerton
K152407 08/25/2015 Infinity Delta, Infinity Delta XL, Infinity Kappa Draeger Medical Sytems, Inc. Beth Zis
K152172 08/04/2015 Econsole1 DRTECH CORPORATION CHOUL-WOO SHIN
K152427 08/26/2015 PC ECG EDAN INSTRUMENTS, INC. QUEENA CHEN
K152225 08/07/2015 Edwards eSheath Introducer Set EDWARDS LIFESCIENCES KAREN REYNOLDS
K152370 08/21/2015 PRECICE Trauma Nail System Ellipse Technologies Incorporated John McIntyre
K152383 08/24/2015 Ceramill Zolid FX Emergo Europe Consulting RACHEL PAUL
K152182 08/05/2015 Fuse Gastroscopy System ENDOCHOICE INC. DANIEL HOEFER
K152435 08/27/2015 PassAssist LED Light Fiber ENTELLUS MEDICAL, INC. KAREN E. PETERSON
K152434 08/27/2015 XprESS Multi-Sinus Dilation System ENTELLUS MEDICAL, INC. KAREN E. PETERSON
K152196 08/05/2015 Erchonia EVRL ERCHONIA CORPORATION STEVEN SHANKS
K152258 08/11/2015 T3 Software ETIOMETRY, INC. DIMITAR BARONOV
K152438 08/27/2015 ETView VivaSight-SL (TVT) system ETVIEW LTD. YORAM LEVY
K152217 08/07/2015 Exactech Vantage Total Ankle System EXACTECH INC SHING JEN TAI
K152170 08/04/2015 Exactech Optetrak Logic Enhanced Assembly EXACTECH, INC. Patrick Hughes
K152183 08/05/2015 EXELINT SecureTouch Safety Hypodermic Needle EXELINT INTERNATIONAL CO. Navid Hamid
K152408 08/25/2015 Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack FOCUS DIAGNOSTICS, INC. IRENE M GUZMAN
K152406 08/25/2015 SalivaMAX FORWARD SCIENCE LLC Brian Pikkula
K152367 08/21/2015 Optiflux dialyzer FRESENIUS MEDICAL CARE NORTH AMERICA Denise Oppermann
K152374 08/21/2015 LL TENS 160A, LL TENS 160B Fuji Dynamics Ltd Man Man Chung
K152257 08/10/2015 Fujifilm Duodenoscope Model ED-530XT FUJIFILM MEDICAL SYSTEMS U.S.A., INC. AARON GE
K152209 08/07/2015 FUJIFILM SonoSite X-Porte Ultrasound System FUJIFILM SONOSITE,INC. PATRICIA LIAU
K152303 08/14/2015 CT Sim Laser System GAMMEX, INC. Kenneth Windisch
K152274 08/12/2015 MSCB-001 GC AMERICA INC. MARK HEISS
K152195 08/05/2015 LOGIQ S8 GE Healthcare Bryan Behn
K152309 08/14/2015 LOGIQ E9, LOGIQ E9 XDClear 2.0 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS BRYAN BEHN
K152352 08/20/2015 Stereo 3D option for Vision Applications GE MEDICAL SYSTEMS, SCS NING WEN
K152242 08/10/2015 G3? Active Plate« Large Fragment System GENESIS FRACTURE CARE, INC. MICHAEL BOTTLANG
K152300 08/14/2015 Glucommander GLYTEC, LLC JULIE GLENDRANGE
K152222 08/07/2015 NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs GMP MEDICARE SDN BHD (F25) MS.EVA VINONI MUSTAFA
K152483 08/31/2015 Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K152470 08/31/2015 Great Basin Staph ID/R Blood Culture Panel GREAT BASIN SCIENTIFIC, INC. Chuck Owen
K152219 08/07/2015 PK AIM GYRUS ACMI INC NEIL KELLY
K152269 08/11/2015 Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) HEALGEN SCIENTIFIC LLC Jianqiu Fang
K152186 08/05/2015 HealthMyne PACS HEALTHMYNE, INC. SIGRID SCHOEPEL
K152479 08/31/2015 HG Pro Nitrile Powder Free Examination Gloves HEALTHY GLOVE CO.,LTD TEOH CHOH SHEE
K152205 08/06/2015 Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor Heidelberg Engineering GmbH Gerhard Zinser
K152251 08/10/2015 Endobronchial Tube HENAN TUOREN MEDICAL DEVICE CO., LTD MEIZI ZHANG
K152207 08/06/2015 Extended Range Shifter for PROBEAT-V Hitachi,Ltd. , Health Care Company Naoya Nishimura
K152268 08/11/2015 VAPRO PLUS POCKET Intermittent Catheter HOLLISTER INCORPORATED JEANNE LEE
K152228 08/07/2015 Hydroven 12, Hydroven 12 Garments HUNTLEIGH HEALTHCARE LTD GREG BAILY
K152405 08/25/2015 IBL 5000 Tanning Booth IBL ACQUISITIONS LLC MICHAEL GILLEY
K152176 08/04/2015 Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation Joseph Ginete
DEN150037 08/11/2015 ImPACT Computerized Neurocognitive Concussion Management Aid IMPACT APPLICATIONS, INC. MICHAEL ZAGORSKI
K152436 08/27/2015 Suntanning Lamps Interlectric Corporation Ken C. Frazier
K152150 08/03/2015 V8 Balloon Aortic Valvuloplasty Catheter InterValve, Inc. Mark Ungs
K152156 08/03/2015 Opticage Expandable Interbody Fusion Device INTERVENTIONAL SPINE, INC. Jane Metcalf
K152448 08/27/2015 da Vinci Single-Site Instrument and Accessories INTUITIVE SURGICAL, INC. Melissa Gonzalez
K152421 08/26/2015 IS4000 Stapler 30 Instrument and Stapler 30 Reloads INTUITIVE SURGICAL, INC. MANISH PATEL
K152330 08/18/2015 Expression MR400 MRI Patient Monitoring System INVIVO CORPORATION Rusty Kelly
K152224 08/07/2015 Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) ION BEAM APPLICATION S.A. ANNE-SOPHIE GRELL
K152336 08/19/2015 HEX tanning booth J & B PRODUCTS LTD DBA HEX TANNING LINDA BOMMARITO
K152166 08/04/2015 JSM Insulin Pen Needle JEESUNG MEDICAL CO LTD CHOI YONG HYUN
K152158 08/03/2015 ARIX Ankle System Jeil Medical Corporation Jiwon KANG
K152323 08/17/2015 Disposable Infusion Needle, Safelock Disposable Infusion Needle JIANGYIN CAINA TECHNOLOGY CO., LTD JUN LU
K152281 08/12/2015 Pyrenees Cervical Plate System K2M Nancy Giezen
K152236 08/10/2015 KATOR Suture Anchor KATOR LLC Robert Hoy
K152441 08/27/2015 KIRO Set KIRO ROBOTICS S.L. Naiara Telleria
K152203 08/06/2015 UTERMOHLEN CRYO PROFESSIONAL KONINKLIJKE (ROYAL) UTERMOHLEN MR.D VAN HOOF
K152270 08/11/2015 Denture base resin KOREA ENGINEERING PLASTICS CO., LTD. SONG-YI CHONG
K152216 08/07/2015 SudoC LD TECHNOLOGY LLC Albert MAAREK
K152453 08/28/2015 LENSAR Laser System - fs 3D (LLS-fs 3D) LENSAR, Inc. Mohinder Merchea
K152175 08/04/2015 Upcera Dental Zirconia Blank for Aesthetic Restoration LIAONING UPCERA CO.,LTD Charles Shen
K152361 08/20/2015 OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension;Injector, OptiOne Base System Liebel-Flarsheim Company LLC Craig Buehler
K152282 08/12/2015 Cam Lock Plating System LIFE SPINE, INC RANDY LEWIS
K152386 08/24/2015 NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software LUMINEX MOLECULAR DIAGNOSTICS, INC. TINA IP
K152318 08/17/2015 MD-2300S Ultrasonic A/B Scanner for Ophthalmology MEDA CO.,LTD Yusheng ZHANG
K152201 08/06/2015 MedActive Oral Gel and Spray MedActive Oral Pharmaceuticals, LLC. Brian Walker
K152317 08/17/2015 Stretta Catheter MEDERI THERAPEUTICS INC. Oleg Shikhman
K152410 08/26/2015 Top Fine Pen Needle MEDEXEL CO., LTD. CHA DONG IK
K152327 08/18/2015 EasyLyte Na/K/Cl/Ca Analyzer Medica Corporation Photios Makris
K152461 08/28/2015 The Time Machine Series Lasers MEDICAL LASERS MANUFACTURER INC. BRUCE SCHOENGOOD
K152299 08/13/2015 TBS iNsight MEDIMAPS GROUP SA CHRISTOPHE LELONG
K152394 08/24/2015 Rapicide PA High-Level Disinfectant Test Strips MEDIVATORS INC. MEGAN DICKEY
K152458 08/28/2015 Gemini Bonded Sterilization Wrap MEDLINE INDUSTRIES, INC. Jennifier Mason
K152428 08/26/2015 SensiCare PI Surgical Gloves MEDLINE INDUSTRIES, INC. JENNIFER MASON
K152152 08/03/2015 Codman Certas Plus Programmable Valve Medos International Sarl Jocelyn Raposo
K152452 08/28/2015 Peacock Tanning, EXPRESS TAN models 1000HT/1600HT/2000CT/2000HT/3200 MEDTEK LIGHTING CORP D/B/A PEACOCK TANNING GARY RICHARDSON
K152277 08/12/2015 PIVOX(tm) Oblique Lateral Spinal System MEDTRONIC SOFAMOR DANEK USA, INC Lila Joe
K152338 08/19/2015 VERTEX(r) Reconstruction System MEDTRONIC SOFAMOR DANEK USA, INC Victoria Scheitlin
K152248 08/10/2015 CD HORIZON Spinal System Medtronic Sofamor Danek USA, Inc. Becky Ronner
K152457 08/28/2015 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC. Laveeda Leflore
K152241 08/10/2015 Medtronic Transportation/Sterilization Cassettes Medtronic Sofamor Danek USA, Inc. Victoria Scheitlin
K152335 08/19/2015 Export Advance Aspiration Catheter Medtronic, Inc. Colleen Mullins
K152187 08/05/2015 MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws MERETE MEDICAL GMBH EMMANUEL ANAPLIOTIS
K152285 08/12/2015 illumigene Pertussis DNA Amplification Assay MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K152381 08/24/2015 Prelude SNAP Splittable Hydrophilic Sheath Introducer MERIT MEDICAL SYSTEMS, INC. Alina Stubbs
K152298 08/13/2015 EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base MICROPORT ORTHOPEDICS, INC. BYRON LEDBETTER
K152192 08/05/2015 LED Curing Light MONITEX INDUSTRIAL CO., LTD. Shu-Lung Wang
K152422 08/26/2015 FRENDÖ Free T4 Test System NANOENTEK USA INC JIMMY CHEN
K152230 08/07/2015 Ebony PTA .014 RX Pheripheral Dilatation Catheter NATEC MEDICAL XAVIER DE BUCHERE
K152301 08/14/2015 Background Pattern Classification [BPc(TM)] Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) Sanjay Mehta
K152409 08/26/2015 Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC NAVILYST MEDICAL, INC. ROBIN FULLER
K152180 08/04/2015 PEAK Neosil Co., Ltd Park Dong Min
K152289 08/13/2015 Alians Elbow Locking Plating System NEWCLIP TECHNICS Gaelle LUSSORI
K152305 08/14/2015 Nihon Kohden Afib Detection Program QP-039P NIHON KOHDEN CORPORATION TOM BENTO
K152350 08/20/2015 Regular and Special Umbilical Cord Clamp and Cutter NINGBO FEITE MEDICAL DEVICE CO., LTD CHARLES SHEN
K152142 08/03/2015 RECON system - MPJ-Plates NORMED MEDIZIN-TECHNIK GMBH ARNE BRIEST
K152256 08/10/2015 RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws NORMED MEDIZIN-TECHNIK GMBH ARNE BRIEST
K152312 08/17/2015 RECON system-V-TEK-IVP Plates and Screws NORMED MEDIZIN-TECHNIK GMBH Arne Briest
K152340 08/19/2015 NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six North American Rescue, LLC William Slevin
K152261 08/11/2015 PICC Tip Positioning Aid NOSTIX LLC Peter Nelson
K152311 08/14/2015 Pentacam AXL OCULUS OPTIKGERATE GMBH ECKHARD LOH
K152332 08/18/2015 Perfectio LED infrared device OMM IMPORTS INC DBA ZERO GRAVITY OHAD MENACHEM
K152159 08/03/2015 Oravan Herbst OravanOSA, LLC Deborah Stein
K152433 08/27/2015 VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 ORTHO CLINICAL DIAGNOSTICS Jessica Miller
K152169 08/04/2015 Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts ORTHO DEVELOPMENT CORPORATION DREW WEAVER
K152475 08/31/2015 FORZA PTC Spacer System ORTHOFIX INC. NATALIA VOLOSEN
K152171 08/04/2015 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 ORTHOFIX SRL GIANLUCA RICADONA
K152295 08/13/2015 Talon DistalFix Antegrade/Retrograde Femoral Nail ORTHOPEDIC DESIGNS NORTH AMERICA, INC. Robin Wilson
K152218 08/07/2015 AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System Osprey Medical Melanie Hess
K152145 08/03/2015 OsteoMed ExtremiLOCK Wrist Plating System OSTEOMED Piedad Pena
K152267 08/11/2015 Remedy« Shoulder Spacer Osteoremedies LLC Chris Hughes
K152485 08/31/2015 FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm OSTIAL CORPORATION JAKE WOLENBERG
K152339 08/19/2015 Unifine Pentips/ Unifine Pentips Plus OWEN MUMFORD LTD Patty Cronan
K152223 08/07/2015 Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System OXYHEAL MEDICAL SYSTEMS, INC. Edward J Chomas
K152416 08/26/2015 Indego PARKER HANNIFIN CORPORATION ACHILLEAS DOROTHEOU
K152364 08/21/2015 uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS PC Marketing, Inc. Michael Rolls
K152363 08/20/2015 Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M PHILIPS MEDICAL SYSTEMS MARY KRUITWAGEN
K152259 08/11/2015 InFill Interbody Fusion Device Pinnacle Spine Group, LLC Rebecca K Pine
K152463 08/28/2015 SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant PORIFEROUS LLC JERRI L. MANN
DEN150038 08/13/2015 CleanCisionTM Wound Retraction and Protection System Prescient Surgical Lisa Ruehlow
K152278 08/12/2015 ENDOFLOW II - Irrigation, Warming and Suction System PROMEPLA SAM ALEXANDRE BAREILLE
K152466 08/31/2015 Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) PROSURG, INC Ashvin Desai
K152321 08/17/2015 kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fi QFIX NADIA SOOKDEO HARHEN
K152220 08/07/2015 MH01 QUANTA SYSTEM SPA FRANCESCO DELL'ANTONIO
K152232 08/07/2015 Quest Diagnostics HairCheck-DT (Cocaine) Quest Diagnostics Incorporated Lisa Christo
K152353 08/20/2015 SeraQuest HSV Type 2 Specific IgG Quest International, Inc. David J Kiefer
K152343 08/19/2015 Direct Bilirubin RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K152344 08/19/2015 Total Bilirubin RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K152482 08/31/2015 Propeller Sensor Model 2014-R RECIPROCAL LABS DAVID HUBANKS
K152193 08/05/2015 Renovis Anterior Cervical Plate System Renovis Surgical Technologies, Inc. Anthony DeBenedictis
K152292 08/13/2015 Respire Blue Series-EF Respire Medical Holding David Walton
K152356 08/20/2015 Sapphire RESPIRONICS INC. COLLEEN WITT
K152227 08/07/2015 Elecsys Cortisol II, Cortisol II CalSet ROCHE DIAGNOSTICS KELLI TURNER
K152245 08/10/2015 ONLINE TDM Vancomycin Gen.3 ROCHE DIAGNOSTICS OPERATIONS (RDO) BARBARA MCWHORTER
K152456 08/28/2015 CenterCross Ultra Catheter ROXWOOD MEDICAL, INC. Grace Li
K152471 08/31/2015 CAPO BULK FILL SCHUETZ DENTAL GMBH Anke Puent
K152402 08/25/2015 IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) SECURUS,INC William J Gorman
K152426 08/26/2015 Wrist - Type Fully Automatic Digital Blood Pressure Monitor SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
K152308 08/14/2015 Sensor Medical Single Use Tonometer Prism SENSOR MEDICAL TECHNOLOGY, LLC Louise Culham
K152429 08/26/2015 Slit Lamp Microscope SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO., LTD. WEIDA ZHAN
K152384 08/24/2015 Digital Electrocardiograph SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. Hongbo Zhong
K152390 08/24/2015 Medke Oximetry Finger Sensor Shenzhen Medke Technology Co., LTD Lao Chengxin
K152465 08/31/2015 Disposable Blood Pressure Cuff Shenzhen Vistar Medical Supplies Co., Ltd. Zhenxun Chen
K152468 08/31/2015 Reusable Blood Pressure Cuff Shenzhen Vistar Medical Supplies Co., Ltd. Zhenxun Chen
K152294 08/13/2015 FDR Visionary Suite SHIMADZU CORPORATION TOSHIO KADOWAKI
K152244 08/10/2015 RADspeed Pro SHIMADZU CORPORATION Toshio Kadowaki
K152451 08/28/2015 VINTAGE Art LF SHOFU DENTAL CORPORATION MAURO MALZYNER
K152392 08/24/2015 VINTAGE LD SHOFU DENTAL CORPORATION Mauro Malzyner
K152283 08/12/2015 MAGNETOM Amira SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L FIELDS
K152469 08/31/2015 ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System SIEMENS MEDICAL SOLUTIONS, INC., ULTRASOUND DIVISION SHELLY PEARCE
K152369 08/21/2015 ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System SIEMENS MEDICAL SOLUTIONS, USA, INC. ULTRASOUND GROUP Nancy Burke
K152250 08/10/2015 SpeqRT Signostics Limited Stewart Bartlett
K152197 08/05/2015 Skypro, SP01 Mask Skypro Medical Supplies Company Cyrus Wong
K152315 08/17/2015 JOURNEY II Uni Tibial Base and Insert Smith & Nephew, Inc. Brad Sheals
K152163 08/03/2015 RENASYS GO SMITH & NEPHEW, INC. Laura Reynolds
K152143 08/03/2015 TRUCLEAR Operative Hysteroscope 5C and Sheath 5C SMITH & NEPHEW, INC. Bradley Heil
K152396 08/24/2015 S12 Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K152164 08/03/2015 S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K152165 08/03/2015 S9 Portable Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K152177 08/04/2015 SonoStik IV Guide Wire Introducer SONOSTIK, LLC RICHARD FOGEL
K152400 08/25/2015 General & Plastic Surgery Instruments Sontec Instruments Inc. Stefan M. Scanlan
K152341 08/19/2015 ViSi Mobile Monitoring System SOTERA WIRELESS, INC Carson Krupp
K152276 08/12/2015 Wing Smart FEVI and Peak Flow Meter Sparo Inc. Mona Dean
K152181 08/04/2015 Turbo-Power Laser Atherectomy Catheter SPECTRANETICS, INC. Priscila Tapia
K152174 08/04/2015 Sniper Spine System SPINE WAVE, INC. Sanja Jahr
K152148 08/03/2015 Fortress Pedicular Fixation System SPINEOLOGY, INC. Karen Roche
K152355 08/20/2015 Twin Peaks Lumbar Interbody Fusion System SPINEWAY Julien Thao my
K152233 08/07/2015 BPhase, HPO Exotic, LPI, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux Sportarredo Group S.C. Stefano Iridio
K152342 08/19/2015 Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover ST. JUDE MEDICAL PARITA MEHTA
K152357 08/20/2015 MicroSTAAR Injector System Cartridges STAAR Surgical Company Jack Coggan
K152178 08/04/2015 StimQ Peripheral Nerve Stimulator (PNS) System STIMQ LLC ELIZABETH GREENE
K152304 08/14/2015 Tritanium PL Cage Stryker SIMONA VOIC
K152266 08/11/2015 Altrix Precision Temperature Management System STRYKER MEDICAL BRIAN ORWAT
K152238 08/10/2015 Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/ SUN CAPSULE, INC. THOMAS P. HOLLAND
K152423 08/26/2015 Sunfire 32 Tanning Bed; Sunfire 24 Tanning Bed; Sunfire 16 Tanning Canopy; Sunfire 12R Tanning Canopy Sunfire Industries Inc. Doug Tyler
K152334 08/19/2015 Sungshim Insulin Pen Needle SUNGSHIM MEDICARE CO., LTD. KIM YOUNG KWAN
K152271 08/12/2015 Powder Free Nitrile Patient Examination Gloves, Black color SUQIAN XINGYE GLOVE CO,LTD JIAN ZHANG DENG
K152313 08/17/2015 Medline ReNewal Reprocessed Endopath Endoscopic Instruments Surgical Instrument Services and Savings, Inc Brandi J Panteleon
K152200 08/06/2015 SurgTech Interbody System SURGTECH INC XUEGONG YU
K152415 08/26/2015 Digital Blood Pressure Monitor SUZHOU SUNSPIRIT CO., LTD. Jing Zhang
K152239 08/10/2015 Zero-P Natural Plate System Synthes (USA), LLC Beth Becotte
K152412 08/26/2015 T-32;T-40;T-44;T-52;T-72;TT-50 Tanses Technologies inc. Kirk Kiremitci
K152362 08/20/2015 Terumo SurGuard 3 Safety Hypodermic Needle TERUMO (PHILIPPINES) CORPORATION PHEBE VARGHESE
K152173 08/04/2015 Glidesheath TERUMO MEDICAL CORPORATION ERIN DOYLE
K152389 08/24/2015 Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit THE BINDING SITE GROUP LTD STEPHANIE THOULESS
K152168 08/04/2015 Love Liquid Personal Lubricant The Kama Sutra Company Marla Lee
K152190 08/05/2015 Thoratec CentriMag Drainage (Venous) Cannula Kit THORATEC CORPORATION Lori DonDiego
K152161 08/03/2015 Thoratec CentriMag Return (Arterial) Cannula Kit Thoratec Corporation Lori DonDiego
K152206 08/06/2015 SurgiPure XD Reconstructive Tissue Matrix TISSUE REGENIX GROUP PLC MIKE IZON
K152202 08/06/2015 Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate Catheter , 125cm TNI Manufacturing, Inc. Daniel Sablyak
K152371 08/21/2015 Vantage Titan 3T Toshiba Medical Systems Corporation Janine Reyes
K152194 08/05/2015 transGlide Expandable Introducer TRANSAORTIC MEDICAL, INC. RICHARD GINN
K152184 08/05/2015 MagView BIOMAGNETOMETER SYSTEM TRISTAN TECHNOLOGIES, INC KEVIN PRATT
K152199 08/06/2015 RejuvatoneMD TROPHY SKIN, INC. IMRAN KARIM
K152430 08/26/2015 All Poly Tibial Component UNITED ORTHOPEDIC CORPORATION KAREN HO
K152439 08/27/2015 U2 Bipolar Implant and 22mm Femoral Head UNITED ORTHOPEDIC CORPORATION Karen Ho
K152255 08/10/2015 BoneCam Suture Anchors VALERIS MEDICAL DANIEL LANOIS
K152393 08/24/2015 Eclipse Treatment Planning System VARIAN MEDICAL SYSTEMS, INC. PETER J. CORONADO
K152387 08/24/2015 Fluent Inflation Device VASCULAR SOLUTIONS, INC. BEKA VITE
K152204 08/06/2015 VS3-IR system VISIONSENSE LTD ALEX CHANIN
K152373 08/21/2015 VITA VM LC Flow VITA ZAHNFABRIK H. RAUTER GMBH & CO. Bernd Walker
K152139 08/03/2015 Vital Connect Platform, HealthPatch MD, VitalPatch VITAL CONNECT, INC. BONNIE WU
K152279 08/12/2015 ViZion DR + Wireless VIZTEK LLC BRUCE ASHBY
K152431 08/26/2015 LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating WALDEMAR LINK GMBH & CO. KG HELMUT D. LINK
K152443 08/27/2015 Vericore Gradient Temporary Disc WHIP MIX CORPORATION JOHN WATERS
K152440 08/27/2015 Sydney IVF PVP WILLAM A. COOK AUSTRALIA PTY LTD GORDANA POZVEK
K152167 08/04/2015 BIJOU Orthodontic Ceramic Bracket WORLD BIO TECH CO., LTD JIN-KYU PARK
K152302 08/14/2015 Xenco Medical Cervical Interbody System (Argus) Xenco Medical, LLC Gustavo Prado
K152472 08/31/2015 Disposable Pressure Transducer ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. Junbin Hu
K152484 08/31/2015 FastFrame External Fixation System - Distal Radius ZIMMER, INC. DOROTHY SNYDER


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