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 |
CIRRUS HD-OCT |
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 |
K152018 |
09/11/2015 |
Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets |
VARIAN MEDICAL SYSTEMS, INC. |
Peter J. Coronado |
K143685 |
09/23/2015 |
Hedgehog Cervical Interbody Fusion Device |
Vertera, Inc. |
Stephen Laffoon |
K152279 |
09/10/2015 |
ViZion DR + Wireless |
VIZTEK LLC |
BRUCE ASHBY |
K150442 |
09/04/2015 |
Volcano Visions PV .018 Digital IVUS Catheter |
Volcano Corporation |
Mary Stanners |
K151208 |
09/14/2015 |
Powder Free Nitrile Examination Glove |
VRG KHAI HOAN JOINT STOCK COMPANY |
PHAM NGOC THANH |
K151777 |
09/29/2015 |
Intradermal Adapter |
WEST PHARMACEUTICAL SERVICES INC. |
JEFFREY RAVEL |
K152440 |
09/23/2015 |
Sydney IVF PVP |
WILLAM A. COOK AUSTRALIA PTY LTD |
GORDANA POZVEK |
K151838 |
09/04/2015 |
PRO-TOE Hammertoe Fixation System |
Wright Medical Technology, Inc. |
Michael Mullins |
K151442 |
09/04/2015 |
TOTAL COMPRESSION PLATING (TCP) SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Val Myles |
K152132 |
09/25/2015 |
X-spine Pedicle Screw System |
X-spine Systems, Inc. |
David Kirschman |
K152302 |
09/10/2015 |
Xenco Medical Cervical Interbody System (Argus) |
Xenco Medical, LLC |
Gustavo Prado |
K151733 |
09/04/2015 |
Xenco Medical Pedicle Screw System |
Xenco Medical, LLC |
GUSTAVO PRADO |
K151601 |
09/09/2015 |
SECURE-LOOP |
XIROS LTD |
STEPHEN SEED |
K143413 |
09/11/2015 |
J+PRAS YOUNG'S Thread |
Y. Jacobs Medical, Inc. |
Joo Hwan Jeon |
K151179 |
09/22/2015 |
ZELTIQ CoolSculpting System |
ZELTIQ AESTHETICS, INC. |
SHRUTI JAYAKUMAR |