| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K160127 |
11/10/2016 |
iCodeConnect |
3B MEDICAL, INC. |
ALEX LUCIO |
| K163207 |
11/28/2016 |
Filtek One Bulk Fill Restorative |
3M Company |
Scott Erickson |
| K161696 |
11/23/2016 |
aap LOQTEQ« Distal Lateral Humerus Plate 2.7/3.5 |
AAP IMPLANTATE AG |
RENI SCHALLER |
| K161703 |
11/04/2016 |
LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer |
AAP IMPLANTATE AG |
RENI SCHALLER |
| K161747 |
11/22/2016 |
LOQTEQ« VA Distal Tibia Plate System: LOQTEQ« VA Distal Medial Tibia Plate 3.5; LOQTEQ« VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ« VA Distal Fibula Plate 2.7/3.5 |
aap Implantate AG |
Reni Schaller |
| K162322 |
11/17/2016 |
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model |
ACCESS SCIENTIFIC, LLC |
WALTER CORDIGLIA |
| K163092 |
11/30/2016 |
TubeClear Control Box and Clearing Stem |
Actuated Medical, Inc. |
Thomas L. Cronin |
| K161011 |
11/08/2016 |
SURGISEAL Topical Skin Adhesive, SURGISEAL Stylus Topical Skin Adhesive, SURGISEAL Twist Topical Skin Adhesive |
Adhezion Biomedical, LLC |
Richard Jones |
| K162230 |
11/18/2016 |
Fully Automatic Electronic Blood Pressure Monitor |
ADON HEALTH CO., LTD. |
Liu Yi |
| K161913 |
11/04/2016 |
AOS Small Fragment Plating System |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS) |
ALEX BHASKARLA |
| K161834 |
11/30/2016 |
One Drop Blood Glucose Monitoring System |
AgaMatrix, Inc. |
David Olsen |
| K161391 |
11/30/2016 |
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives |
ALCON LABORATORIES, INC. |
Sherri Lakota |
| K161288 |
11/16/2016 |
LenSX Laser System |
ALCON LABORATORIES, INC. |
JAMES ARGANDA |
| K161457 |
11/21/2016 |
XEN Glaucoma Treatment System |
Allergan, Inc. |
Barbara A. Niksch |
| K162160 |
11/18/2016 |
Preference Elite Pedicle Screw System |
AMEDICA CORPORATION |
Shanna Ryan |
| K153021 |
11/22/2016 |
Fingertip Pulse Oximeter A310 |
AMEMO INC |
HUA XIE |
| K160924 |
11/08/2016 |
Amendia Interbody Fusion Devices |
AMENDIA, INC. |
Bruce Hooper |
| K160791 |
11/15/2016 |
AmorChem Titanium Porous Fixation Device |
AmorChem Holdings, Inc. |
KEVIN MCBRIDE |
| K162914 |
11/16/2016 |
VenaCure EVLT NeverTouch Procedure Kit |
AngioDynamics, Inc. |
Robin Fuller |
| K162316 |
11/22/2016 |
Pirouette 014 |
ArraVasc Ltd |
Aoife Donoghue |
| K161782 |
11/21/2016 |
Arthrex Univers Revers Shoulder Prosthesis System |
ARTHREX, INC. |
David L Rogers |
| K160682 |
11/17/2016 |
CONTOUR NEXT ONE Blood Glucose Monitoring System |
ASCENSIA DIABETES CARE |
Roger Sonnenburg |
| K161623 |
11/10/2016 |
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL |
B. Braun Medical Inc. |
Nancy Skocypec |
| K161819 |
11/25/2016 |
NNR06 Multi-Purpose Solution |
Bausch & Lomb Incorporated |
Glenn Davies |
| K161323 |
11/30/2016 |
Solution Set for Epidural Use |
BAXTER HEALTHCARE CORPORATION |
Tiffany Lin |
| K162414 |
11/29/2016 |
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System |
BECKMAN COULTER, INC. |
NANCY NADLER |
| K161692 |
11/16/2016 |
Diode Laser Therapy Machine |
BEIJING ADSS DEVELOPMENT CO., LTD |
GAO YURONG |
| K160508 |
11/21/2016 |
Electronic Pulse Stimulator |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
Lei Chen |
| K160558 |
11/18/2016 |
RAPIDO HOLLOW-FIBRE DIALYZERS |
BELLCO Srl |
Giuseppe Tomasini |
| K162431 |
11/17/2016 |
Luna 3D Interbody Fusion System |
Benvenue Medical, Inc. |
Jeff Emery |
| K162232 |
11/17/2016 |
MOSS 100 Pedicle Screw System |
Biedermann Motech GmbH & Co. KG |
Gerd Federle |
| K161974 |
11/01/2016 |
SLENDERTONE« Connect Abs, Type 570 |
Bio-Medical Research Ltd. |
Anne-Marie Keenan |
| K163007 |
11/23/2016 |
Biomet Microfixation SternaLock 360 Sternal Closure System |
BIOMET MICROFIXATION |
LAUREN JASPER |
| K161592 |
11/03/2016 |
Persona Partial Knee System |
BIOMET, INC. |
Nicole J. Meredith |
| K160446 |
11/07/2016 |
MCP Bone Putty |
BioStructures, LLC |
John Brunelle |
| K161670 |
11/02/2016 |
Lucid Q-PTP / HWA 55 |
BISON MEDICAL CO., LTD |
SUN WO |
| K161628 |
11/10/2016 |
JAS Pulse(TM) Ultrasonic Therapy |
Bonutti Research, Inc. |
Patrick G. Balsmann |
| K162350 |
11/04/2016 |
Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous |
Boston Scientific Corporation |
Ka Zoua Xiong |
| K160481 |
11/09/2016 |
Vivo 60 |
BREAS MEDICAL AB |
Albert Cefalo |
| K161277 |
11/22/2016 |
ConvertX Nephroureteral Stent System |
BRIGHTWATER MEDICAL |
BOB SMOUSE |
| K162769 |
11/04/2016 |
Pinpoint GT Introducer Needle |
C.R. BARD, INC. |
Jamie Howell |
| K162894 |
11/15/2016 |
AccuCath Intravascular Catheter |
C.R.BARD, INC. |
JACOB LEE |
| K161027 |
11/08/2016 |
Cadwell AmpliScan |
Cadwell Industries, Inc. |
John Cadwell |
| K162994 |
11/18/2016 |
Capillus302, Capillus312, Capillus352 |
CAPILLUS, LLC |
PATRICIA SCHNOOR |
| K162214 |
11/30/2016 |
Protek Solo 24 Fr Venous Cannula Set |
CARDIAC ASSIST, INC. |
GREG JOHNSON |
| K162440 |
11/04/2016 |
CardioInsight Cardiac Mapping System |
CARDIOINSIGHT TECHNOLOGIES, INC |
LAURIE LEWANDOWSKI |
| K160746 |
11/02/2016 |
CARDIOLINE touchECG |
CARDIOLINE S.p.A |
Emanuele Ercoli |
| K160437 |
11/03/2016 |
PleurX Peritoneal Catheter System |
CareFusion |
Tamara Brey |
| K161408 |
11/22/2016 |
Compass Cast and MAP |
CENTURION MEDICAL PRODUCTS CORPORATION |
MATTHEW K. PRICE |
| K162444 |
11/23/2016 |
Xpert MRSA NxG |
CEPHEID |
SCOTT A. CAMPBELL |
| K161905 |
11/17/2016 |
Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge |
CHANGZHOU XIN NENG YUAN MEDICAL STAPLER CO.,LTD. |
Boping Ma |
| K162103 |
11/23/2016 |
Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine Interbody Fusion System (HarrierÖ), Choice Spine Vertebral Body Replacement System (HawkeyeÖ) |
CHOICE SPINE, LP |
KIM FINCH |
| K163138 |
11/30/2016 |
Clarius Ultrasound System |
Clarius Mobile Health Corp. |
Abhijit Ahir |
| K163139 |
11/30/2016 |
PleuraFlow System with FlowGlide |
CLEARFLOW, INC. |
DOV GAL |
| K161515 |
11/15/2016 |
eUnity |
Client Outlook Inc. |
Christie Eby |
| K160800 |
11/16/2016 |
DuoCem |
COLTENE/WHALEDENT AG |
Silke Wallaschek |
| K160884 |
11/22/2016 |
CXI Support Catheter |
COOK INCORPORATED |
Daniel J. Corbin |
| K160656 |
11/21/2016 |
CorSens |
CorSens Medical Ltd. |
Yoram Levy |
| K162941 |
11/14/2016 |
Ligasure Blunt Tip, Sealer/Divider, Nano-coated |
COVIDIEN |
CELSO DURAN |
| K163102 |
11/30/2016 |
ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mm |
COVIDIEN |
KATIE BROWN |
| K160718 |
11/14/2016 |
Vital Sync Informatics Manager & Virtual Patient Monitoring Platform |
COVIDIEN |
Timothy Holwick |
| K160921 |
11/03/2016 |
CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant |
CS Medical LLC |
Kendall Ashe |
| K162231 |
11/16/2016 |
iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert |
CYDEN LIMITED |
MIKE KIERNAN |
| K160180 |
11/03/2016 |
Intermittent Pneumatic Compression system |
DaeSung Maref Co., Ltd |
Jae-wha Lee |
| K160166 |
11/15/2016 |
X-MIND trium |
DE GOTZEN S.R.L. |
Olivier Balouka |
| K163043 |
11/30/2016 |
Zeramex P6 Dental Implant System |
DENTALPOINT AG |
Viktor Lienhard |
| K160762 |
11/21/2016 |
Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set |
DIAZYME LABORATORIES |
ABHIJIT DATTA |
| K161646 |
11/04/2016 |
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set |
DIAZYME LABORATORIES |
ABHIJIT DATTA |
| K153394 |
11/18/2016 |
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator |
Diazyme Laboratories |
Abhijit Datta |
| K162220 |
11/21/2016 |
DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage |
DIO MEDICAL CO., LTD |
SUNG HEE-LEE |
| K160761 |
11/22/2016 |
DW-1C |
DONGWON MEDICAL CO., LTD. |
Gil Haeng Lee |
| K161962 |
11/28/2016 |
VAMP Venous/Arterial Blood Management Protection System |
Edwards Lifesciences LLC |
Jennifer Wilbur |
| K162024 |
11/21/2016 |
AltiVate Anatomic Shoulder System |
ENCORE MEDICAL, L.P |
DESIREE WELLS |
| K161610 |
11/09/2016 |
EXPRT Revision Hip System |
Encore Medical, L.P. |
TEFFANY HUTTO |
| K161472 |
11/18/2016 |
Walk-O2-Bout |
ESSEX INDUSTRIES, INC. |
RUSS JACOBSMEYER |
| K160447 |
11/10/2016 |
Calprest NG |
EUROSPITAL S.P.A. |
Claudia Brandolin |
| K160663 |
11/16/2016 |
Lumbar Interbody Fusion System (ALIF, PLIF, LLIF, TPLIF) |
EVOLUTION SPINE, LLC |
Ashton Kouzbari |
| K161373 |
11/03/2016 |
Nunchaku |
FCI (FRANCE CHIRURGIE INSTRUMENTATION) |
THIERRY FETICK |
| K161131 |
11/03/2016 |
FONA Pan/Ceph |
FONA SRL |
ELISA GUSBERTI |
| K162450 |
11/30/2016 |
ESPADA Acne-Clearing Blue Light Pen |
FOREO INC. |
Davor Soldo |
| K162781 |
11/09/2016 |
Magma Spark |
Formatk Systems Ltd. |
Ahava Stein |
| K162462 |
11/23/2016 |
AMICUS Separator System, AMICUS Separator System; Refurbished |
FRESENIUS KABI USA LLC |
KIM FORCH |
| K160933 |
11/18/2016 |
Discovery NM 750b Bopsy |
GE Healthcare |
Efrat Hartog-David |
| K162268 |
11/03/2016 |
Senographe Pristina |
GE HEALTHCARE |
Gregory Pessato |
| K162743 |
11/22/2016 |
ViewPoint 6 |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
TRACEY ORTIZ |
| K163077 |
11/17/2016 |
LOGIQ E9, LOGIQ E9 XDClear 2.0 |
GE Medical Systems Ultrasound and Primary Care Diagnostics, |
Bryan Behn |
| K162403 |
11/18/2016 |
HyperBand |
GE Medical Systems, LLC |
Jason Ma |
| K162990 |
11/15/2016 |
Optima XR240amx |
GE Medical Systems, LLC |
Chris Paulik |
| K161438 |
11/08/2016 |
Genesys Spine Apache« Anterior Lumbar Interbody Fusion System |
GENESYS SPINE |
BRIAN BERGERON |
| K160079 |
11/10/2016 |
rainbow Shine |
GENOSS Co. Ltd. |
Byungsun Kim |
| K160872 |
11/23/2016 |
PolyPlex Wound Dressing |
GLOBAL HEALTH SOLUTIONS, LLC |
Bradley Burnam |
| K160564 |
11/17/2016 |
TroClose1200 |
GORDIAN SURGICAL LTD. |
ZVI PEER |
| K160532 |
11/03/2016 |
Greiner Holdex |
GREINER BIO-ONE NA INC. |
MANFRED ABEL |
| K160349 |
11/03/2016 |
Electronic Sphygmomanometer |
Guangdong Biolight Meditech Co., Ltd. |
Liang Jin |
| K160132 |
11/21/2016 |
Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC |
HAGER & MEISINGER GMBH |
Melanie May |
| K160512 |
11/15/2016 |
HardyCHROM ESBL |
HARDY DIAGNOSTICS |
ANDRE HSIUNG |
| K160049 |
11/15/2016 |
Charisma |
Heraeus Kulzer, LLC (Mitsui Chemicals Group) |
Jamie Cleveland |
| K162583 |
11/17/2016 |
ALOKA LISENDO 880 |
HITACHI, LTD. |
ANGELA VAN ARSDALE |
| K162085 |
11/10/2016 |
i-CAT FLX V series / KaVo 3D eXam+ V series |
IMAGING SCIENCES INTERNATIONAL |
Ruth Pui |
| K161831 |
11/15/2016 |
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set |
Immunodiagnostic Systems Ltd |
Mick Henderson |
| K162970 |
11/22/2016 |
FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction Aspirator |
Inari Medical |
Eben Gordon |
| K161013 |
11/29/2016 |
InnoSEAL Hemostatic Pad |
InnoTherapy Inc. |
Moon Sue Lee |
| K160421 |
11/02/2016 |
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
Rafal Chudzik |
| K162863 |
11/07/2016 |
dS Small Extremity 16CH 1.5T Coil |
INVIVO THERAPEUTICS CORPORATION |
Ken Revennaugh |
| K163185 |
11/21/2016 |
OptiLux LED Illuminator |
ISOLUX LLC |
NIKOLAOS ANDREOULAKIS |
| K162265 |
11/15/2016 |
CushionCast Moldable Cushions |
IZI Medical Products LLC |
Qiang Cao |
| K161378 |
11/02/2016 |
joimax Electrosurgical Instruments |
JOIMAX GMBH |
WOLFGANG RIES |
| K161768 |
11/09/2016 |
LUCAS 3 Chest Compression System |
Jolife AB |
Malin Melander |
| K162257 |
11/07/2016 |
P1145 Dental Restorative |
Kerr Corporation |
Mohammad Saad Ansari |
| K160895 |
11/01/2016 |
Initia Total Hip System & BIOCERAM AZUL(R) HEAD |
KYOCERA Medical Corporation |
Cheryl Hastings |
| K162801 |
11/03/2016 |
CastleLoc Spinal Fixation System |
L&K BIOMED CO., LTD. |
Yerim An |
| K153656 |
11/14/2016 |
PathLoc-SI Joint Fusion System |
L&K BIOMED Co., Ltd. |
Yerim An |
| K162136 |
11/03/2016 |
CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation System |
L&K BIOMED CO.,LTD. |
Yerim An |
| K161673 |
11/18/2016 |
LacriPro Punctum Plug |
LACRIMEDICS, INC. |
REBECCA C. DUTTON |
| K161776 |
11/29/2016 |
Lenstec LC Injection system |
LENSTEC INC. |
JIMMY CHACKO |
| K161636 |
11/04/2016 |
Lipogems System |
Lipogems International SpA |
CARLO RUSSO |
| K162210 |
11/16/2016 |
touchTymp |
MAICO DIAGNOSTICS GMBH |
UWE LEDWORUSKI |
| K160940 |
11/23/2016 |
Masimo Disposable Transflectance Forehead Sensor |
Masimo Corporation |
Marguerite Thomlinson |
| K162273 |
11/07/2016 |
Materialise TKA Guide System |
MATERIALISE NV |
OLIVER CLEMENS |
| K162577 |
11/18/2016 |
Dosimetry Check Version 5 Release 1 |
MATH RESOLUTIONS, LLC |
WENDEL DEAN RENNER |
| K161493 |
11/08/2016 |
YO Home Sperm Test |
MEDICAL ELECTRONIC SYSTEMS, LTD |
MARCIA DEUTSCH |
| K160642 |
11/29/2016 |
Medline ENFit Syringe |
Medline Industries, Inc. |
Stephanie Blair |
| K161638 |
11/07/2016 |
SPEEDTRAP Graft Preparation System |
MEDOS INTERNATIONAL SARL |
Jeffrey Dzialo |
| K161779 |
11/03/2016 |
MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter |
MedSource International, LLC |
Laura Riggen |
| K162892 |
11/15/2016 |
Achieve Advance Mapping Catheter |
MEDTRONIC INC. |
HEATHER TAYLOR |
| K161370 |
11/02/2016 |
Durepair Dura Regeneration Matrix |
Medtronic Neurosurgery |
Manas Lele |
| K162379 |
11/16/2016 |
CD HORIZON« Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
Nathaniel Hendricks |
| K162097 |
11/17/2016 |
InTRAkit |
Medtronic Vascular |
Nisarg Shah |
| K161921 |
11/04/2016 |
SwiftNINJA Microcatheter |
MERIT MEDICAL SYSTEMS, INC. |
LUKE MEIDELL |
| K161649 |
11/09/2016 |
Virtu C Spinal Implant System |
Met 1 Technologies, LLC |
Dan Gerbec |
| K162539 |
11/10/2016 |
Solitaire 2 Revascularization Device |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
JENNIFER CORREA |
| K162466 |
11/29/2016 |
LuminScan (TM) Imaging System |
MICRO-TECH (NANJING) CO.,LTD. |
Becky Li |
| K161624 |
11/07/2016 |
MicrO2 OSA Device with Micro-Recorder |
MICRODENTAL, Inc. |
David Kuhns |
| K161909 |
11/17/2016 |
IQvitals Zone |
Midmark Corporation |
Asad Abu-Tarif |
| K161939 |
11/17/2016 |
Avance Abdominal Dressing Kit |
Molnlycke Health Care US, LLC |
Megan Bevill |
| K161935 |
11/04/2016 |
Avance Foam Dressing Kit - XL |
MOLNLYCKE HEALTH CARE, US LLC |
MEGAN BEVILL |
| K161948 |
11/03/2016 |
Avance Gauze Dressing Kits |
MOLNLYCKE HEALTH CARE, US LLC |
MEGAN BEVILL |
| K162113 |
11/07/2016 |
Powder Free Nitrile Examination Gloves (Blue) |
NAM VIET GLOVE JOINT STOCK COMPANY |
OOI LOON SENG |
| K160594 |
11/22/2016 |
MRWire Guide Wire |
NANO4IMAGING GMBH |
CHRISTOPH R. MANEGOLD |
| K161174 |
11/03/2016 |
Nanova Interference Screw |
NANOVA BIOMATERIALS INC. |
ANDREW RITTS |
| K161431 |
11/30/2016 |
SimplECG |
Nanowear Inc. |
Venkatesh Varadan |
| K162595 |
11/04/2016 |
Trex_HD |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Sanjay Mehta |
| K161634 |
11/10/2016 |
IPS CaseDesigner |
NOBEL BIOCARE AB |
CHARLEMAGNE CHUA |
| K162043 |
11/22/2016 |
NobelProcera HT ML FCZ Bridge |
Nobel Biocare AB |
Charlemagne Chua |
| K161435 |
11/22/2016 |
Temporary Snap Abutment |
Nobel Biocare AB |
Charlemagne Chua |
| K161856 |
11/15/2016 |
StatStrip Xpress Glucose Hospital Meter System |
Nova Biomedical Corporation |
Paul W. MacDonald |
| K162218 |
11/22/2016 |
Pain FreezeÖ, Medium Stream Spray, Model #2101; Pain FreezeÖ, Mist Spray, Model #2102 |
NUANCE MEDICAL, LLC |
MARC LIEBERMAN |
| K162191 |
11/22/2016 |
NAVILAS Laser System |
OD-OS GMBH |
WINFRIED TEIWES |
| K153773 |
11/22/2016 |
Disposal Lens Cleaning Sheath |
OLYMPUS MEDICAL SYSTEMS CORP. |
TOSHIYUKI NAKAJIMA |
| K162092 |
11/22/2016 |
Evolv Model BP7000 Upper Arm Blood Pressure Monitor |
OMRON HEALTHCARE, INC. |
RENEE THORNBOROUGH |
| K162862 |
11/09/2016 |
Raycast High Precision Lung Board Solution |
Orfit Industries NV |
Raymond Kelly |
| K162355 |
11/22/2016 |
Raycast MammoRx Carbon Fibre Breast Board |
Orfit Industries NV |
Eddy Marivoet |
| K160720 |
11/28/2016 |
Carriere Motion Clear Class II |
ORTHO ORGANIZERS, INC. |
COLLEEN BOSWELL |
| K153317 |
11/30/2016 |
HEMASORBPLUS Resorbable Hemostatic Bone Putty |
ORTHOCON, INC. |
HOWARD L. SCHRAYER |
| K162576 |
11/10/2016 |
FORTEZZA Spinal Stabilization System |
OSSO SURGICAL |
Basheer Hassan |
| K160881 |
11/15/2016 |
Tablo Console |
OUTSET MEDICAL, INC. |
LESLIE TRIGG |
| K162453 |
11/01/2016 |
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) |
Pan Medical Ltd. |
Jennie Budding |
| K162198 |
11/18/2016 |
GFS Ultimate |
PARCUS MEDICAL, LLC |
PAUL VAGTS |
| K160545 |
11/23/2016 |
GAP ENDO-EXO MEDULLARY SYSTEM |
PEGA MEDICAL INC. |
Ariel R. Dujovne |
| K163020 |
11/16/2016 |
Xperius Ultrasound System |
PHILIPS HEALTHCARE |
SCOTT ZHANG |
| K162148 |
11/23/2016 |
Allura Xper R9 |
PHILIPS MEDICAL SYSTEMS NETHRLANDS BV |
Jeanette Becker |
| K160595 |
11/18/2016 |
PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator |
PMS Medikal Ambalaj Sanayi ve Ticaret LTD STI |
Derya Dikici |
| K162211 |
11/28/2016 |
AccuFit Lateral Plate System |
PRECISION SPINE, INC. |
Michael C. Dawson |
| K162300 |
11/22/2016 |
Reform« POCT System |
PRECISION SPINE, INC. |
MICHAEL C. DAWSON |
| K160361 |
11/04/2016 |
PRIMAGARD Isolation Gown (AAMI PB70 Level 3) |
PRIMED MEDICAL PRODUCTS INC. |
RICHARD R ROY |
| K162537 |
11/16/2016 |
CAD/CAMouflage Milling Block |
PRISMATIK DENTALCRAFT, INC. |
ALIVA DAS |
| K160979 |
11/04/2016 |
Inclusive Abutments |
PRISMATIK DENTALCRAFT, INC. |
SHELLY HARRIS |
| K162240 |
11/17/2016 |
ProMedTek Model C1400 Shortwave Diathermy Device |
PROMEDTEK INC. |
Dan Puchek |
| K153409 |
11/15/2016 |
Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) |
PROTECT U GUARD, LLC |
Brent W. Laartz |
| K162284 |
11/04/2016 |
Puritan Fecal Opti-Swab Collection and Transport System |
PURITAN MEDICAL PRODUCTS LLC |
MEHDI KARAMCHI |
| K162966 |
11/30/2016 |
TxRx Knee 15 Flare MR Coil 1.5T |
Quality Electrodynamics, LLC |
Kathleen Aras |
| K163066 |
11/29/2016 |
TxRx Knee 15 Flare MR Coil 3.0T |
QUALITY ELECTRODYNAMICS, LLC |
Kathleen Aras |
| K152232 |
11/18/2016 |
Quest Diagnostics HairCheck-DT (Cocaine) |
Quest Diagnostics Incorporated |
Lisa Christo |
| K162451 |
11/28/2016 |
Solana HSV 1+2/VZV Assay |
QUIDEL CORPORATION |
Ronald H. Lollar |
| K160561 |
11/02/2016 |
Boosting Catheter |
QXMEDICAL, LLC |
FERNANDO DI CAPRIO |
| K160153 |
11/04/2016 |
ABL90 FLEX PLUS |
RADIOMETER MEDICAL APS |
SOEREN BOEGESTRAND |
| K161454 |
11/01/2016 |
Propeller Sensor Model 2015-E |
Reciprocal Labs Corporation |
Taylor Mahan-Rudolph |
| K161254 |
11/07/2016 |
Renovo Life Small Bone IM Nail System |
Renovo Life LLC |
Harold Crowder |
| K161978 |
11/17/2016 |
AirFit N20 |
ResMed Ltd |
Kim Kuan Lee |
| K161778 |
11/22/2016 |
ToeTacÖ 10░ Hammertoe Fixation System |
RESTORE SURGICAL LLC DBA INSTRATEK |
JEFF SEAVEY |
| K162457 |
11/14/2016 |
Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit |
Rocket Medical Plc |
Tracy Charlton |
| K160786 |
11/21/2016 |
RODO Abutment System |
RODO MEDICAL, INC |
Michael Parsons |
| K162278 |
11/15/2016 |
Digital Diagnostic Mobile X-ray System |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K161944 |
11/21/2016 |
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs |
SHANDONG BAISHENG MEDICAL PRODUCTS CO., LTD. |
CECILY SHENG |
| K161074 |
11/17/2016 |
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color |
SHEN WEI (USA), INC. |
CHERYL BAILEY-KROLL |
| K161735 |
11/17/2016 |
Non-contact Forehead Thermometer |
Shenzhen Dongdixin Technology Co., Ltd. |
Siping Yuan |
| K160530 |
11/28/2016 |
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff |
SHENZHEN MED-LINK ELECTRONICS TECH CO., LTD. |
Mina Cheng |
| K161708 |
11/22/2016 |
Arm automatic blood pressure monitor |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD |
XIE QIONGYU |
| K161891 |
11/21/2016 |
HC Primer |
Shofu Dental Corporation |
Mauro Malzyner |
| K162538 |
11/17/2016 |
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator |
SIEMENS HEALTHCARE DIAGNOSTICS |
SUSAN FERRIN |
| K161494 |
11/15/2016 |
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) |
Siemens Healthcare Diagnostics, Inc. |
Laura J. Duggan |
| K162541 |
11/16/2016 |
syngo Application Software |
SIEMENS MEDICAL SOLUTIONS USA, INC |
PATRICIA D. JONES |
| K161795 |
11/18/2016 |
MAGNETOM ESSENZA |
Siemens Medical Solutions USA, Inc. |
Cordell L. Fields |
| K162971 |
11/22/2016 |
Multix Fusion Max |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
DENISE ADAMS |
| K162102 |
11/22/2016 |
MAGNETOM Avantofit, MAGNETOM Skyrafit |
SIEMENS MEDICAL SOLUTIONS, INC. |
JOHN URTZ |
| K162078 |
11/18/2016 |
EVOS Small Fragment Plating System |
SMITH & NEPHEW, INC. |
SAMANTHA STAUBACH |
| K160923 |
11/17/2016 |
REDAPT Anteverted Cemented Liner |
SMITH & NEPHEW, INC. |
KIM PHAN |
| K161763 |
11/22/2016 |
Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device |
Smith & Nephew, Inc. |
Bradley Heil |
| K161264 |
11/23/2016 |
TRIGEN Low Profile Bone Screws |
SMITH & NEPHEW, INC. |
ALLISON CHAN |
| K161665 |
11/15/2016 |
VLP Wrist Fracture System |
SMITH & NEPHEW, INC. |
SAMANTHA STAUBACH |
| K152660 |
11/09/2016 |
HYPNOSPAD |
Somnics Inc. |
TSUNG-MIN HSIEH |
| K162573 |
11/04/2016 |
Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source |
SOURCE PRODUCTION AND EQUIPMENT CO., INC. |
KELLEY RICHARDT |
| K161740 |
11/04/2016 |
D-SPECT Scanner, D-SPECT L Scanner |
Spectrum Dynamics Medical Ltd |
Igor Naroditsky |
| K160278 |
11/04/2016 |
VSTAAR AdjusteR |
SPINAL ACOUSTICS, LLC |
ALBERT A. TORRENCE |
| K161993 |
11/22/2016 |
Leva« Anterior Interbody System |
Spine Wave, Inc. |
Sanja Jahr |
| K161873 |
11/22/2016 |
Pacel Flow Directed Pacing Catheter |
St. Jude Medical |
Blair Schwartz |
| K162162 |
11/04/2016 |
Barrier Supreme Sterilization Wrapper |
Standard Textile Co., Inc. |
Bradley J. Bushman |
| K161700 |
11/21/2016 |
SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters |
STERILMED, INC. |
Reuben Lawson |
| K162262 |
11/09/2016 |
Tritanium« PL Cage |
STRYKER |
Deirdre Jayko |
| K162310 |
11/10/2016 |
XBraid TT Suture Tape |
Stryker |
Taylor White |
| K162062 |
11/01/2016 |
AVAmax Vertebral Balloon, AVAflex Vertebral Balloon |
STRYKER CORPORATION |
BECKY DITTY |
| K161753 |
11/15/2016 |
Hoffman LRF System |
STRYKER GMBH |
PAUL NELSON |
| K161863 |
11/23/2016 |
ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA), ReUnion Total Shoulder Arthroplasty (TSA) |
Stryker GmbH |
Saad Attiyah |
| K162585 |
11/04/2016 |
SuniIQ Digital Radiography System |
Suni Medical Imaging, Inc |
Al Bettencourt |
| K160190 |
11/10/2016 |
Sunmed Control Syringes |
Sunny Medical Device (Shenzhen) Co.,Ltd. |
James Qi Zhang |
| K161999 |
11/16/2016 |
Aixplorer |
SUPERSONIC IMAGINE |
LAURENCE HERMITTE |
| K153714 |
11/15/2016 |
SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petr |
Synergeyes, Inc. |
Karen Kincade |
| K162163 |
11/17/2016 |
UltraShape System |
SYNERON MEDICAL LTD |
Ruthie Amir |
| K161952 |
11/07/2016 |
UltraShape System |
Syneron Medical Ltd. |
Ruthie Amir |
| K161590 |
11/03/2016 |
MatrixRIB Fixation System |
SYNTHES (USA) PRODUCTS LLC |
THOMAS SHEA |
| K162358 |
11/01/2016 |
T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System |
SYNTHES USA PRODUCTS LLC |
Eugene Bang |
| K161417 |
11/10/2016 |
DePuy Synthes MAXFRAME Multi-Axial Correction System |
SYNTHES USA, LLC |
STACEY BONNELL |
| K161738 |
11/10/2016 |
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ▀-Ketone Monitoring Systems |
TAIDOC TECHNOLOGY CORPORATION |
PAUL LIU |
| K161357 |
11/04/2016 |
LipiFlow Thermal Pulsation System |
TEARSCIENCE, INC. |
Christy Coleman |
| K162396 |
11/23/2016 |
SILK Surgical Suture |
TELEFLEX MEDICAL, INC |
NATALIE HICHAK |
| K161968 |
11/03/2016 |
MicrUs |
TELEMED |
Yury Sokolov |
| K161932 |
11/28/2016 |
Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink |
Terang Nusa Sdn Bhd |
Robert Hill |
| K162843 |
11/17/2016 |
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 |
Terumo Cardiovascular Systems Corporation |
Bryan Hann |
| K161742 |
11/15/2016 |
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid |
Tornier, Inc. |
Laurie Lewandowski |
| K162183 |
11/25/2016 |
Vantage Galan 3T, MRT-3020, V4.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K162155 |
11/01/2016 |
Xario 200 Diagnostic Ultrasound System V5.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K162619 |
11/04/2016 |
I View and Imagen Sensor |
TRIDENT S.R.L. |
GIORGIO RIZZO |
| K162656 |
11/10/2016 |
ESU-1 Electrosurgical Generator |
TVA Medical, Inc. |
Katherine Kumar |
| K161597 |
11/16/2016 |
Tyber Medical BioTy« Nanotopography Trauma Screw |
TYBER MEDICAL LLC |
MARK F. SCHENK |
| K160855 |
11/22/2016 |
U&U Enteral Syringe |
U&U MEDICAL TECHNOLOGY CO.,LTD |
BLACK WANG |
| K160045 |
11/17/2016 |
Heyman Packing Applicator Set |
VARIAN MEDICAL SYSTEMS, INC |
PETER J. CORONADO |
| K152615 |
11/03/2016 |
Vonflex S |
VERICOM CO., LTD. |
Myung-Hwan Oh |
| K162252 |
11/14/2016 |
FasTouch Fixation System |
VIA SURGICAL LTD. |
OFEK LEVIN |
| K162175 |
11/21/2016 |
Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or less |
Viet Glove Corporation |
PHAM NGOC THANH |
| K162363 |
11/18/2016 |
V30 system, V-Form Handpiece BC Medium applicator |
Viora Ltd. |
Stella Raizelman Perry |
| K161157 |
11/03/2016 |
Vitrea CT Dual Energy Image View |
VITAL IMAGES, INC. |
Alexis Erazo |
| K161433 |
11/09/2016 |
Insulia Diabetes Management Companion |
VOLUNTIS S.A. |
RAFFI KRIKORIAN |
| K161957 |
11/23/2016 |
W&H Implantmed SI-1015 incl. Accessories |
W&H DENTALWERK BURMOOS GMBH |
ANJA LINDNER |
| K160801 |
11/29/2016 |
Well Lead Extraction Bag |
WELL LEAD MEDICAL CO., LTD. |
HAN GUANG YUAN |
| K162225 |
11/22/2016 |
WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System |
WellDoc, Inc |
Michele Livingston |
| K152906 |
11/22/2016 |
Disposable High Pressure Injector Syringe |
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD |
Wu Feng |
| K162944 |
11/07/2016 |
Irix-C Cervical Integrated Fusion System |
X-SPINE SYSTEMS, INC. |
KRISS ANDERSSON |
| K160959 |
11/17/2016 |
Xsert Lumbar Expandable Interbody System |
X-SPINE SYSTEMS, INC. |
KRISS ANDERSON |
| K160705 |
11/23/2016 |
Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, |
Y. JACOBS MEDICAL, INC |
HUI JUN PARK |
| K162095 |
11/02/2016 |
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) |
YTY INDUSTRY (MANJUNG) SDN. BHD., |
Punitha Samy |
| K162002 |
11/01/2016 |
Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam, Z-Bar Index Bar, Z-Pulls Patient Hand Grip Overlay |
ZDi, Solutions, LLC |
Zachary A. Dutton |
| K162050 |
11/21/2016 |
ZELTIQ CoolSculpting System |
ZELTIQ Aesthetics, Inc |
Shruti Jayakumar |
| K161620 |
11/01/2016 |
Anatomical Shoulder Domelock Dome centric |
ZIMMER GMBH |
ROBERTO TOMMASINI |
| K161862 |
11/14/2016 |
ThermoPro |
Zimmer MedizinSysteme GmbH |
Armin Petraschka |
