FDA 510(k) Decisions During September, 2015  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K150622 09/29/2015 3M Comply Hydrogen Peroxide Chemical Indicator 1248 3M Company Hilary B. Hovde
K151302 09/18/2015 Clinpro Varnish 3m Company Shari L. Myszka
K151144 09/14/2015 SuPro 100 3M DEUTSCHLAND GMBH DESI W. SOEGIARTO
K151822 09/04/2015 ab medica irrigation/suction gravity system AB MEDICA S.A.S. ALEXANDRE BLANC
K142928 09/30/2015 FreeStyle Precision Neo Blood Glucose Monitoring System ABBOTT DIABETES CARE INC MICHELLE RICAFORT
K151783 09/02/2015 COMPACT INTUITIV Multiple-Use Pack Abbott Medical Optics Inc. Priya Viswanathan
K152404 09/21/2015 Hi-Torque Command 18 Guide Wire ABBOTT VASCULAR SHU CHI HSU
K152328 09/17/2015 FreeStyle InsuLinx Blood Glucose Monotioring System ABOTT LABORATORIES SAI SRIHARSHADA TATAVARTY
K152488 09/28/2015 Onrad Treatment System ACCURAY INCORPORATED ERIN DALY
K143450 09/16/2015 Ackermann Intervertebral Body Fusion Device ACKERMANN INSTRUMENTE GMBH Rolf Ackermann
K151595 09/05/2015 On Call Express Pro Blood Glucose Monitoring System ACON Laboratories, Inc. Qiyi Xie
K151554 09/15/2015 Occlusion Perfusion Catheter ADVANCED CATHETER THERAPIES, INC. PAUL JOSEPH FITZPATRIC
K151809 09/25/2015 Alere Afinion HbA1c, Alere Afinion AS100 Analyzer Alere Technologies AS Kari Skinnemoen
K142557 09/21/2015 Anker Dental Implant System - SB-III, ST and AT series Alliance Global Technology Co., Ltd. Yayuan Chang
K151322 09/10/2015 Amendia Interbody Fusion Devices AMENDIA, INC. BRUCE HOOPER
K151460 09/08/2015 Fully Automatic Electronic Blood Pressure Monitor ANDON HEALTH CO., LTD. LIU YI
K152003 09/24/2015 iHealth BP3L Wireless Blood Pressure Monitor ANDON HEALTH CO.,LTD Liu Yi
K152379 09/23/2015 iHealth View BP7S Wireless Blood Pressure Wrist Monitor ANDON HEALTH CO.,LTD Liu Yi
K151112 09/10/2015 Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design ANGIOTECH HILARY WELLS
K150111 09/15/2015 Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series APEX MEDICAL CORP. Frank Lin
K150402 09/25/2015 Endoluminal Occlusion System-EOS ARTVENTIVE MEDICAL GROUP, INC Roberta Hines
K151678 09/21/2015 Chameleon PTA Balloon Catheter AV Medical Technologies Ltd Limor Sandach
K152032 09/16/2015 ELUMI 810 + 980 Soft Tissue Laser AZENA MEDICAL, LLC ALEX DI SESSA
K151742 09/23/2015 Contour Next Control Solution BAYER HEALTHCARE JENNIFER L. GREGORY
K152346 09/16/2015 MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) BECKMAN COULTER, INC. SHANNON POPSON
K151766 09/02/2015 BD Single Use, Hypodermic Syringe BECTON, DICKINSON AND COMPANY MURTAZA RANA
K151280 09/30/2015 MultiScan G-Arm System BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. June Li
K152208 09/02/2015 The Belmont Hyperthermia Pump BELMONT INSTRUMENT CORPORATION URAIWAN P LABADINI
K142657 09/14/2015 XEROSTOM SALIVA SUBSTITUTE GEL BIO COSMETICS, S.L. SUSANA SARDON
K150768 09/04/2015 JuggerKnot Soft Anchors BIOMET MANUFACTURING CORP. ADAM CARGILL
K151040 09/04/2015 Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer BIOMETRIX LTD. Zoya Lee
K142293 09/18/2015 Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls BIOPHOR DIAGNOSTICS, INC. Nathaniel G. Butlin
K152437 09/25/2015 BiowaveHOME Neuromodulation Pain Therapy Device BIOWAVE CORPORATION BRADFORD SIFF
K152052 09/16/2015 Ultrasound Scanner System bk2300 BK MEDICAL APS Michael J. Doyle
K143267 09/02/2015 TempTraq TT-100 Blue Spark Technologies Inc. Jennifer Cartledge
K151990 09/11/2015 Tissue Removal System BOEHRINGER LABORATORIES LLC CHRIS RADL
K152316 09/18/2015 iLab Ultrasound Imaging System BOSTON SCIENTIFIC George J Prendergast
K152403 09/22/2015 Permanent Sled Bag BOSTON SCIENTIFIC George J. Prendergast
K151313 09/21/2015 ZelanteDVT Thrombectomy Set BOSTON SCIENTIFIC CORPORATION ANNE V. ROSSI
K151957 09/01/2015 BOX DICOM Viewer BOX INC. CRISPEN MAUNG
K150720 09/16/2015 XP3000 BTL Industries, Inc. Jan Zarsky
K143743 09/18/2015 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH C.R. Bard Inc. FELICIA RULEY
K151071 09/17/2015 SmartLinx Vitals Plus Patient Monitoring System CAPSULE TECHNOLOGIE SAS PETER KELLEY
K150124 09/02/2015 Cardinal Health NPWT PRO HC CARDINAL HEALTH TATYANA BOGDAN
K141488 09/08/2015 CAREVIEW 1800R CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. JAMIE KU
K151774 09/21/2015 CARESTREAM Vue Motion CARESTREAM HEALTH, INC. CAROLYN L WAGNER
K150977 09/01/2015 Optical Coherence Tomography CARL ZEISS MEDITEC INC MANDY AMBRECHT
K142982 09/03/2015 OPUS 5100 Diagnostic Doppler Ultrasound System Chang Gung Medical Technology Co., Ltd. CHENG MING CHEN
K150265 09/03/2015 Model 206 Electrometer/Dosimeter CNMC COMPANY INCORPORATED THOMAS KRAUS
K140310 09/03/2015 Peristeen Anal Irrigation System COLOPLAST A/S MEG DANIEL
K151306 09/23/2015 Solea CONVERGENT DENTAL, INC Mike Manor
K150594 09/16/2015 Biodesign Otologic Repair Graft COOK BIOTECH INCORPRATED PERRY W. GUINN
K152524 09/30/2015 Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set COOK INCORPORATED ERUM B. NASIR
K150852 09/03/2015 SIC 8000 COSMO TECHNOLOGIES, LTD. RICHARD JONES
K152286 09/08/2015 LigaSure Curved, Small Jaw, Open Sealer/Divider COVIDIEN DAWN TINDALL
K143644 09/14/2015 Premium Surgiclip?; Endo Clip?; AcuClip? COVIDIEN Michael Koczocik
K151649 09/10/2015 Valleylab FT10 Electrosurgical Platform COVIDIEN Sharon McDermott
K151270 09/04/2015 CrossTIE Intraosseous Fixation System CrossRoads Extremity Systems LLC Vernon Hartdegen
K152072 09/23/2015 CrossRoads Screw System CrossRoads Extremity Systems, LLC Vernon Hartgegen
K151795 09/10/2015 ML24000 UVA-1 Phototherapy Cabinet DAAVLIN DISTRIBUTING CO. MICHELE THIEL
K151514 09/21/2015 Prestige DANVILLE MATERIALS LLC DONG HUA
K151149 09/30/2015 Ready-Fit DENTEK ORAL CARE, INC. LINDA GILES
K150862 09/25/2015 DePuy Actis Duofox Hip Prosthesis DEPUY ORTHOPAEDICS, INC. CORRENE RAMY
K151885 09/03/2015 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System DEPUY SYNTHES, Inc. Karen K Sylvia
K143677 09/18/2015 DeVilbiss Intellipap2/DeVilbiss BLUE DeVilbiss Healthcare, LLC Betty Miller
K151189 09/18/2015 Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System Devon Medical Products ROCCO BRAVOCO
K143586 09/02/2015 FACT Medical Imaging Sysytem Dexin Medical Imaging Technology Co., Ltd. Wang Yu
K151860 09/02/2015 Infinity CentralStation Wide Draeger Medical Systems, Inc. Thomas Ostrowski
K152407 09/23/2015 Infinity Delta, Infinity Delta XL, Infinity Kappa Draeger Medical Sytems, Inc. Beth Zis
K151575 09/01/2015 Dynarex Eye Cups DYNAREX CORPORATION JAMES HURLMAN
DEN150002 09/29/2015 EarLens Contact Hearing Device EARLENS CORPORATION SUZANNE LEVY
K150239 09/01/2015 FibroScan Echosens Celine Fournier
K151666 09/03/2015 Leksell GammaPlan ELEKTA INSTRUMENT AB MATILDA FORSBERG
K152383 09/21/2015 Ceramill Zolid FX Emergo Europe Consulting RACHEL PAUL
K151668 09/08/2015 S-scan ESAOTE S.P.A. DONATELLA RAGGHIANTI
K150840 09/10/2015 Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier ETHICON ENDO-SURGERY, LLC Marjorie Medina
K143557 09/16/2015 SupaScoota Motorized vehicle EUROGREEN INTERNATIONAL INC DAVID HSIEH
K152170 09/03/2015 Exactech Optetrak Logic Enhanced Assembly EXACTECH, INC. Patrick Hughes
K141960 09/03/2015 Exactech« Novation« Crown Cup« EXACTECH, INC. THOMAS MCNAMARA
K150883 09/01/2015 HyaloGYN Vaginal Hydrating Gel FIDIA FARMACEUTICI SPA Dr. Giuseppina Lo Castro
K152408 09/21/2015 Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack FOCUS DIAGNOSTICS, INC. IRENE M GUZMAN
K151473 09/01/2015 NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and Pulse Slicing Module FOCUS MEDICAL, LLC. John B Lee
K151944 09/10/2015 Luggie Super Freerider Corporation Arthur Wang
K152303 09/11/2015 CT Sim Laser System GAMMEX, INC. Kenneth Windisch
K152195 09/29/2015 LOGIQ S8 GE Healthcare Bryan Behn
K152309 09/14/2015 LOGIQ E9, LOGIQ E9 XDClear 2.0 GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS BRYAN BEHN
K150812 09/03/2015 Genesys Spine Apache Cervical Interbody Fusion System Genesys Spine Dave Lamb
K143245 09/30/2015 GPC Intramedullary Nailing Systems GPC MEDICAL LIMITED Vikas Narang
K152483 09/29/2015 Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K140939 09/02/2015 HAMILTON-T1,HAMILTON-C1 HAMILTON MEDICAL AG FREDERIKE BRUEHSCHWEIN
K151684 09/18/2015 Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim(Blue) HARTALEGA NGC SDN. BHD. KUAN MUN LEONG
K151339 09/10/2015 SONON Ultrasound Imaging System (Model: SONON 300C) HEALCERION CO., LTD. JAEYEOB JUNG
K152269 09/09/2015 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
K151968 09/09/2015 Cryocare CS-3 Surgical System version 5 HEALTHTRONICS SCOTT EDEN
K150998 09/29/2015 HEARTWAY Power Mobility Scooter HEARTWAY Medical Products Co., Ltd. JEN KE-MIN
K150987 09/22/2015 HEARTWAY Power Mobility Scooter, BRIO S19 HEARTWAY Medical Products Co., Ltd. JEN KE-MIN
K150565 09/30/2015 Supria Whole-body X-ray CT System HITACHI MEDICAL SYSTEMS AMERICA, INC. Doug Thistlethwaite
K152268 09/09/2015 VAPRO PLUS POCKET Intermittent Catheter HOLLISTER INCORPORATED JEANNE LEE
K150112 09/10/2015 HS AMICA DEVICES FAMILY HS HOSPITAL SERVICE SPA Laura Lenzi
K143736 09/23/2015 ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA IMMCO DIAGNOSTICS, INC. Kevin Lawson
K152176 09/04/2015 Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators Immunalysis Corporation Joseph Ginete
K151576 09/29/2015 Neon EEG Incereb Ltd PAUL PHILLIPS
K143754 09/21/2015 QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 INOVA DIAGNOSTICS, INC. Gabriella Lakos
K151564 09/21/2015 Telio CAD Abutment Solutions IVOCLAR VIVADENT AG SANDRA CAKEBREAD
K152158 09/28/2015 ARIX Ankle System Jeil Medical Corporation Jiwon KANG
K150965 09/17/2015 LeForte System II Jeil Medical Corporation Jieun KIM
K151400 09/16/2015 Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products JK HOLDING GmbH JUERGEN GERSTENMEIER
K152281 09/24/2015 Pyrenees Cervical Plate System K2M Nancy Giezen
K151727 09/17/2015 Everest Spinal System K2M, INC NANCY GIEZEN
K152015 09/04/2015 Pyrenees Cervical Plate System K2M, INC. NANCY GIEZEN
K152080 09/24/2015 Metacross OTW PTA Balloon Dilatation Catheter Kaneka Corporation Toshihiko Motomine
K143640 09/17/2015 KSEA CMOS Camera System (C-cam) KARL STORZ ENDOSCOPY-AMERICA, INC. Susie S Chen
K151394 09/10/2015 Keeler Slit Lamp KEELER LIMITED IRINA PROUTSKI
K150532 09/22/2015 Universal Light Handle Cover, Light Handle Cover Key Surgical, Inc. Amy Yanta
K152098 09/17/2015 ODALYS Pedicle Screw System Kisco International Hiroko Ito
K143177 09/14/2015 KleenGel Dispenser KleenGel, LLC Suzanne Mair
K152216 09/24/2015 SudoC LD TECHNOLOGY LLC Albert MAAREK
K150765 09/17/2015 LDR Spine ROI-C Cervical Cage System LDR SPINE USA Brad Strasser
K143359 09/11/2015 CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector LifeWatch Technologies Ltd. Asher Kassel
K142530 09/16/2015 Partial Knee Application (PKA) MAKO SURGICAL CORPORATION Jonathan Reeves
K151248 09/04/2015 PIEZOSURGERY WHITE MECTRON SPA MR. FRANCO ZUNINO
K152317 09/23/2015 Stretta Catheter MEDERI THERAPEUTICS INC. Oleg Shikhman
K151522 09/17/2015 DEFENDO Bronchoscopy Suction Valve MEDIVATORS, INC. Jeff Kasoff
K152335 09/18/2015 Export Advance Aspiration Catheter Medtronic, Inc. Colleen Mullins
K150657 09/21/2015 Phoenix XL Dialysate Meter Mesa Laboratories, Inc. Jamie Louie
K151358 09/25/2015 AZUR CX Detachable 35 Coils Micro Vention, Inc. Cynthia Valenzuela
K151869 09/02/2015 Microlife Upper Arm Automatic Digital Blood Pressure Monitor MICROLIFE INTELLECTUAL PROPERTY GMBH, SWITZERLAND GERHARD FRICK
K150958 09/17/2015 LifePearl Microshperes MicroVention, Inc. Naomi Gong
K151861 09/10/2015 JUSHA-C23C LCD Monitor NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD MA JING
K151972 09/10/2015 JUSHA-C43 LCD Monitor Nanjing Jusha Display Technology Co., Ltd Ma Jing
K143653 09/04/2015 Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) NANOSPHERE, INC Noah Lermer
K152230 09/03/2015 Ebony PTA .014 RX Pheripheral Dilatation Catheter NATEC MEDICAL XAVIER DE BUCHERE
K152069 09/24/2015 Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter NAVILYST MEDICAL, INC. MICHAEL P. HANLEY
K152409 09/24/2015 Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC NAVILYST MEDICAL, INC. ROBIN FULLER
K152031 09/17/2015 New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with NEW DEANTRONICS TAIWAN, LTD. JANE LIU
K151160 09/04/2015 Arcus Staple System NEXTREMITY SOLUTIONS, INC. Ryan Schlotterback
K143507 09/09/2015 NFANT Feeding Solution NFANT Labs, LLC Lou Malice
K152142 09/16/2015 RECON system - MPJ-Plates NORMED MEDIZIN-TECHNIK GMBH ARNE BRIEST
K151982 09/10/2015 Stat Profile Prime ABG Analyzer System NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K151095 09/18/2015 Circumplast Circumcision Device Novadien Healthcare Milad Melhem
K151472 09/10/2015 NuVasive CoRoent Lumbar System NuVasive, Incorporated Martin A Yahiro
K151538 09/04/2015 NuVasive PEEK Corpectomy Railed System NuVasive, Incorporated Olga Lewis
K151167 09/03/2015 NuVasive PEEK Corpectomy System NUVASIVE, INCORPORATED OLGA LEWIS
K151651 09/25/2015 NuVasive X-CORE Mini Cervical Expandable VBR System NUVASIVE, INCORPORATED Olga Lewis
K152433 09/24/2015 VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 ORTHO CLINICAL DIAGNOSTICS Jessica Miller
K150619 09/11/2015 CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System Orthofix Inc. Natalia Volosen
K152171 09/28/2015 Orthofix TL-HEX True Lok Hexapod System (TL-HEX) V1.4 ORTHOFIX SRL GIANLUCA RICADONA
K150064 09/04/2015 Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15) ORTHOGEM LTD PAUL Z MARKGRAF
K151979 09/18/2015 STARband, STARlight ORTHOMERICA PRODUCTS, INC. DAVID C. KERR
K151951 09/22/2015 Destino Reach Oscor Inc. Jan Flegeau
K152218 09/21/2015 AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast Modulation System Osprey Medical Melanie Hess
K151262 09/21/2015 Hyflex Heavy, Hyflex Mono, Hyflex Light Osstem Implant Co., Ltd Heekwon Son
K141177 09/15/2015 VITALA PORCINE DERIVED COLLAGEN MEMBRANE OSTEOGENICS BIOMEDICAL, INC. (FORMERLY OBI BIOLOGI SHANE SHUTTLESWORTH
K151195 09/21/2015 OsteoMed IMF Screw OSTEOMED Piedad Pena
K150067 09/16/2015 OTSC Proctology OVESCO ENDOSCOPY AG Marc O Schurr
K151518 09/18/2015 BRUSH&BOND PLUS Parkell, Inc. David Mott
K143696 09/18/2015 Spirit PELTON & CRANE Frank Ray
K151604 09/11/2015 23ga Chandelier Illuminator, 25ga Chandelier Illuminator PEREGRINE SURGICAL LTD. RYAN O'LEARY
K151761 09/29/2015 SureSigns VS3, SureSigns VS4 PHILLIPS MEDICAL SYSTEMS Greg Li
K151521 09/04/2015 Phoenix Thera-Lase System PHOENIX THERA-LASE SYSTEMS, LLC GARY BELLINGER
K151630 09/15/2015 G.o.c.c.l.e.s. PIERREL PHARMA S.R.L. FABIO VELOTTI
K143349 09/16/2015 Gynomunal POLICHEM S.A. Daria Mari
K142821 09/09/2015 PAXgene Blood DNA Tube PREANALYTIX GMBH Pasquale Amato
K151830 09/21/2015 Hummingbird Tympanostomy Tube PRECEPTIS MEDICAL Keith Leland
K151728 09/18/2015 CoStorSol plus G PRESERVATION SOLUTIONS, INC. GARY SWANSON
K151188 09/17/2015 BodyGuardian Remote Monitoring System PREVENTICE CHARLIE RECTOR
K150392 09/18/2015 PROPEL device PROPEL ORTHODONTICS LLC. BRYCE WAY
K151249 09/04/2015 PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON PUREWAY COMPLIANCE, INC JEFFERY MIGLICCO
K152030 09/16/2015 Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) Qingdao Hisense Medical Equipment Co., Ltd. Liu Zhitang
K150381 09/11/2015 AQUA CLEANSE QUALITY MEDICAL SUPPLY, INC JULIE SOLOMON
K152220 09/03/2015 MH01 QUANTA SYSTEM SPA FRANCESCO DELL'ANTONIO
K151079 09/30/2015 Q2 Intravenous Adminstration Sets and Extension Sets QUEST MEDICAL, INC. AMY CLENDENING-WHEELER
K150382 09/16/2015 Radio Therapy Treatment Chair RADIATION PRODUCTS DESIGN, INC. Howard Larson
K150654 09/29/2015 Cholesterol RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K151446 09/18/2015 Recovr Rehabilitation System Recovr,Inc Austen Hayes
K152131 09/17/2015 Reliance Spinal Screw System Reliance Medical Systems, LLC BRET M BERRY
K152193 09/25/2015 Renovis Anterior Cervical Plate System Renovis Surgical Technologies, Inc. Anthony DeBenedictis
K150639 09/18/2015 AF541 EE Full Face Mask RESPIRONICS, INC. Shaylee Masilunas
K150638 09/18/2015 AF541 SE Full Face Mask Respironics, Inc. Shaylee Masilunas
K151786 09/24/2015 Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet Roche Diagnostics Kelli Turner
K151171 09/01/2015 TRAUS SUS10 SAESHIN PRECISION CO., LTD. SAE KWAN CHOI
K140827 09/30/2015 SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set SD Biosensor, Inc. Yeon Park
K151849 09/30/2015 Seneka I Polyscrew Pedicle Fixation System Senecka Spine Khalid Sethi
K150082 09/02/2015 Panorama Patient Monitoring Network SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD Yanhong Bai
K150352 09/02/2015 V Series Monitoring System (including V12 and V21 Monitors) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANHONG BAI
K143720 09/18/2015 Dimension Vista MMB Assay Siemens Healthcare Diagnostics Kathleen Dray-Lyons
K151579 09/29/2015 MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L. FIELDS
K151645 09/14/2015 MAMMOMAT Fusion Siemens Medical Solutions USA, Inc. Darren Dorman
K151887 09/16/2015 syngo VSim SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K152469 09/21/2015 ACUSON NX3 Elite / NX3 Diagnostic Ultrasound System SIEMENS MEDICAL SOLUTIONS, INC., ULTRASOUND DIVISION SHELLY PEARCE
K152250 09/03/2015 SpeqRT Signostics Limited Stewart Bartlett
K142592 09/02/2015 CleanSmart Wound Cleanser SIMPLE SCIENCE, LLC Justin Scanlan
K151560 09/11/2015 QuickPlan Siris Medical Colin M Carpenter
K150078 09/30/2015 PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application) Smartmissimo Technologies Pte Ltd Alexey Pisarev
K151902 09/03/2015 REDAPT? Revision Femoral System SMITH & NEPHEW, INC. Natalie P. Williams
K152143 09/02/2015 TRUCLEAR Operative Hysteroscope 5C and Sheath 5C SMITH & NEPHEW, INC. Bradley Heil
K152396 09/03/2015 S12 Digital Color Doppler Ultrasound System SONOSCAPE MEDICAL CORP. Toki Wu
K151637 09/23/2015 UPT Series Medical RO Water System Specialty Water Technologies Alex Clark
K151705 09/03/2015 Lotus Posterior Cervical/Thoracic Spinal System SPINAL ELEMENTS, INC. CECILIA SILVA
K151695 09/10/2015 Romeo posterior osteosynthesis system SPINEART FRANCK PENNESI
K152148 09/02/2015 Fortress Pedicular Fixation System SPINEOLOGY, INC. Karen Roche
K150899 09/16/2015 Straumann CARES Titanium Alloy (TAN) Abutment STRAUMANN USA, LLC Christopher Klaczyk
K151324 09/11/2015 Straumann Variobase for CEREC STRAUMANN USA, LLC Christopher Klaczyk
K143661 09/02/2015 DirectInject STRYKER Nathan VanSweden
K143597 09/04/2015 Navigated XIA 4.5 Polyaxial Screwdriver STRYKER CORPORATE BECKY DITTY
K150959 09/10/2015 Sutter Bipolar Forceps-Calvian SUTTER MEDIZINTECHNIK GMBH BERT SUTTER
K151592 09/24/2015 Gemmed pedicle screw spinal system SUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD. Xue Fang Zhou
K151526 09/10/2015 Zone, ZoneFree, Zone A1 SYBRON DENTAL SPECIALTIES COURTNEY CLARK
K151655 09/15/2015 CO2RE System SYNERON MEDICAL LTD. Ruthie Amir
K151100 09/29/2015 U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System TAIDOC TECHNOLOGY CORPORATION C.W. CHEN
K142349 09/21/2015 TM eCloud ECG Analysis System Telemed Solutions, Inc. Ken Burns
K151392 09/18/2015 Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content Labeling Claim with 50ug/dm2 or less TERANG NUSA SDN BHD ROBERT HILL
K151368 09/11/2015 Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter TERUMO BCT Nicholas Wong
K151471 09/17/2015 Radifocus Glidewire Endoscopic Wire Terumo Medical Corporation Phebe Varghese
K150576 09/09/2015 TGM Biolox delta Ceramic Heads TGM MEDICAL, INC. Gordon Smith
K143051 09/16/2015 ArgenIS Titanium Abutments THE ARGEN CORPORATION Maria Rao
K152190 09/18/2015 Thoratec CentriMag Drainage (Venous) Cannula Kit THORATEC CORPORATION Lori DonDiego
K152161 09/18/2015 Thoratec CentriMag Return (Arterial) Cannula Kit Thoratec Corporation Lori DonDiego
K143479 09/25/2015 Bluefin Interbody System Tides Medical J. Doug Payne
K151245 09/15/2015 Rhythm View Workstation (non-streaming, steaming option) TOPERA, INC. Dennis Pozzo
K151293 09/24/2015 Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis Tornier SAS Severine Bonneton
K151440 09/03/2015 Klassic HD Hip System TOTAL JOINT ORTHOPEDICS, INC. CHRIS WEABER
K143631 09/03/2015 Benefix Interspinous Fixation System U & I Corporation Young-Geun Kim
K151151 09/24/2015 U & U Intravascular Administration Set U & U Medical Technology Co., Ltd Xuebo Wang
K143637 09/09/2015 U&U Sterilization Pouch and Roll U&U Medical Technology Co.,Ltd Garfield Wang
K151647 09/23/2015 Uberlube UBERLUBE LLC JACK MAGNUSEN
K150650 09/24/2015 neon3 ULRICH GMBH & CO. KG Christoph Ulrich
K152064 09/24/2015 Astringedent Clear ULTRADENT PRODUCTS, INC. COREY JASEPH
K150832 09/25/2015 U2 Femoral Component, CR, Porous Coated, Additional Sizes UNITED ORTHOPEDIC CORPORATION FANG-YUAN HO
K150829 09/25/2015 U2 Total Knee System- Additional Sizes UNITED ORTHOPEDIC CORPORATION Fang-Yuan Ho
K152393 09/18/2015 Eclipse Treatment Planning System VARIAN MEDICAL SYSTEMS, INC. PETER J. CORONADO
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