| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| DEN160026 |
04/06/2017 |
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia |
23andMe, Inc. |
Lisa Charter |
| K163677 |
04/20/2017 |
Ortho System |
3Shape A/S |
Hanne Nielsen |
| K161884 |
04/19/2017 |
Ortho System |
3Shape A/S |
Hanne Nielsen |
| K163271 |
04/10/2017 |
i-Stat Alinity System with i-Stat Glucose test |
Abbott Point of Care, Inc. |
Maria L Figueroa |
| K170788 |
04/11/2017 |
CyberKnife Treatment Delivery System |
Accuray Incorportaed |
Jyoti Singh |
| K170300 |
04/26/2017 |
Restrata Wound Matrix |
Acera Surgical, Inc. |
Tamas Kovacs |
| K162925 |
04/06/2017 |
AcQGuide Steerable Sheath |
ACUTUS MEDICAL, INC. |
Brenda Clay |
| K163355 |
04/12/2017 |
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes |
Ad-Tech Medical Instrument Corporation |
Lisa Theama |
| K170214 |
04/13/2017 |
Additive Orthopaedics Locking Lattice Plate |
Additive Orthopaedics, LLC |
Greg Kowalczyk |
| K170951 |
04/28/2017 |
CardioCel 3D |
Admedus Regen Pty Ltd |
Mary E. Donlin |
| K163274 |
04/05/2017 |
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument |
Aggredyne, Inc. |
Philip C. Speros |
| K161179 |
04/13/2017 |
Intelli-Ox |
AIR LIQUIDE HEALTHCARE AMERICA CORPORATION |
Steve Miller |
| K170075 |
04/03/2017 |
AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) |
AirXpanders, Inc. |
Belinda Pinedo |
| K161794 |
04/14/2017 |
CENTURION Vision System (Active SentryTM) |
Alcon Research, Ltd. |
Paul Swift |
| K162642 |
04/10/2017 |
Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit |
ALERE SCARBOROUGH, INC. |
SARA HALLOWELL |
| K163192 |
04/10/2017 |
Comfort EC710 |
ALLTECH MEDICAL SYSTEMS AMERICA, INC. |
MICHAELEEN DOM |
| K170069 |
04/26/2017 |
AmCAD-UV |
AmCad BioMed Corporation |
Jack Yang |
| K161596 |
04/28/2017 |
Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters |
AngioDynamics, Inc. |
Teri Juckett |
| K160730 |
04/27/2017 |
Instrument kits |
ANTHOGYR |
Therese CANDAU |
| K170719 |
04/05/2017 |
Anzai Respiratory Gating System |
Anzai Medical Co., Ltd. |
Naoya Iwasaki |
| K170536 |
04/24/2017 |
ECG Disposable Lead Wire |
APK Technology Co., Ltd. |
Caifang Wang |
| K163426 |
04/03/2017 |
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension |
ASAHI INTECC CO., LTD. |
Yasuyuki Kawahara |
| K163358 |
04/28/2017 |
Introcan Safety 3 Closed IV Catheter |
B.BRAUN MELSUNGEN AG |
ULRICH JEDELHAUSER |
| K170537 |
04/21/2017 |
Nexxis OR, Nexxis |
Barco n.v. |
Eric Caus |
| K170837 |
04/05/2017 |
Nio Color 3MP (MDNC-3421) |
Barco NV |
Helena Soenen |
| K170483 |
04/11/2017 |
Bausch + Lomb Sensitive Eyes Plus Saline Solution |
Bausch & Lomb Incorporated |
Melissa Thomas |
| K170052 |
04/19/2017 |
Stellaris Elite vision enhancement system |
Bausch + Lomb |
Dan Regan |
| K170386 |
04/12/2017 |
BD Ultra-FineÖ Insulin Syringe, BD Ultra-FineÖ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-FineÖ needle and BD Insulin Syringes with Micro-FineÖ IV Needle |
Becton, Dickinson & Company |
Riddhish Patel |
| K162385 |
04/27/2017 |
RAPIDEC CARBA NP |
BIOMERIEUX SA |
ASA KARLSSON |
| K162017 |
04/20/2017 |
Ross Ru Wound Dressing Gel |
BIOTD, S.A. |
Lawrence Pratt |
| K163171 |
04/14/2017 |
CeraClean |
Bisco, Inc. |
Ryan Hobson |
| K162567 |
04/05/2017 |
ExactechGPS Total Shoulder Application, Equinoxe Planning Software |
Blue Ortho |
Anthony Boyer |
| K162294 |
04/21/2017 |
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12ö, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
BRIGHTWAY HOLDINGS SDN BHD. |
G. BASKARAN |
| K163458 |
04/04/2017 |
Zenysis Short-Term Dialysis Catheter |
C.R BARD. INC. |
SILVIA DE LA BARRA |
| K163698 |
04/11/2017 |
OptiFix Open Absorbable Fixation System - 20 absorbable fasteners |
C.R. BARD INC, |
KATHERINE EARLE |
| K162441 |
04/24/2017 |
PowerPICC Provena Catheters with SOLO Valve Technology |
C.R. BARD, INC |
BRYAN STONE |
| K163001 |
04/17/2017 |
PowerFlow Apheresis I.V. Port |
C.R. BARD, INC. |
Christoph Wagner von Hoff |
| K161910 |
04/20/2017 |
Cardinal Health Sterilization Wrap |
CARDINAL HEALTH 200, LLC |
MEGAN MIDDAUGH |
| K170580 |
04/11/2017 |
Carestream Vue PACS |
Carestream Health, Inc. |
Diane Koetter |
| K163255 |
04/21/2017 |
CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor |
Caretaker Medical, LLC |
Jeff Pompeo |
| K170171 |
04/06/2017 |
IOLMaster 700 |
Carl Zeiss Meditec AG |
Christian Muenster |
| K170942 |
04/26/2017 |
The ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
Choice Spine, LP |
Kim Finch |
| K170953 |
04/21/2017 |
Tomcat Cervical Spinal System |
Choice Spine, LP |
Kim Finch |
| K162891 |
04/14/2017 |
Complete Control System |
COAPT, LLC |
Blair Lock |
| K170945 |
04/28/2017 |
Biodesign Staple Line Reinforcement |
Cook Biotech Incorporated |
Perry W. Guinn |
| K162104 |
04/24/2017 |
C-Flex Ureteral Stent Set |
COOK INCORPORATED |
MINJIN CHOI |
| K170616 |
04/28/2017 |
van Andel Dilatation Catheter |
Cook Incorporated |
Daniel J. Corbin |
| K170560 |
04/04/2017 |
SAGE Vitrification Kit and SAGE Vitrification Warming Kit |
CooperSurgical Inc |
Tove Kjµr |
| K170869 |
04/21/2017 |
LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated |
Covidien |
Celso Duran |
| K163537 |
04/21/2017 |
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga |
Covidien llc |
LeeAnne Swiridow |
| K170833 |
04/17/2017 |
EndoFLIP« System with FLIP Topography module |
Crospon Ltd. |
John OÆDea |
| K162120 |
04/28/2017 |
Scope-Assist Flushing Sink |
Custom Ultrasonics Inc. |
Elizabeth Lazaro |
| K170936 |
04/25/2017 |
Cutera enlighten III Laser System |
Cutera, Inc. |
Bradley Renton |
| K161919 |
04/05/2017 |
UltraScan 650 |
CyberLogic, Inc. |
Jonathan J. Kaufman |
| K170220 |
04/27/2017 |
OneQ-SL s-Clean Implant System |
DENTIS CO., LTD. |
SUN CHU SHIN |
| K162297 |
04/18/2017 |
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set |
Diazyme Laboratories |
Abhijit Datta |
| K160323 |
04/06/2017 |
FlowKeepers |
DK ELECTRONICS, LLC |
AVERY HUFF |
| K170930 |
04/27/2017 |
RSM 2430C |
DRTECH Corporation |
Choul-Woo Shin |
| K163381 |
04/14/2017 |
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable |
Edwards Lifesciences, LLC |
Chirag Shah |
| K170949 |
04/27/2017 |
RadiForce MX315W |
EIZO Corporation |
Hiroaki Hashimoto |
| DEN150048 |
04/14/2017 |
gammaCore Non-invasive Vagus Nerve Stimulator |
electroCore, LLC |
Mike Romaniw |
| K163617 |
04/11/2017 |
REMbrandt |
Embla Systems |
Shane T Sawall |
| K163435 |
04/05/2017 |
Entellus Medical Reinforced Anesthesia Needle |
Entellus Medical Inc. |
Megan Bernier |
| K163509 |
04/05/2017 |
XprESS ENT Dilation System |
Entellus Medical, Inc. |
Karen E. Peterson |
| K161743 |
04/14/2017 |
Etgar Dental Implant System |
ETGAR MEDICAL INSTRUMENTS, LTD |
Yehudit PeÆer |
| K163523 |
04/18/2017 |
ECHELON CIRCULAR Powered Stapler |
Ethicon Endo-Surgery, LLC |
Carmen Ortiz |
| K163645 |
04/21/2017 |
DERMABOND PRINEO Skin Closure System |
Ethicon, LLC |
Joice Pappan |
| K162732 |
04/26/2017 |
Exactech« Alteon« HA Femoral Stem |
EXACTECH INC |
Thomas McNamara |
| K171045 |
04/28/2017 |
Exactech« TruliantÖ Line Extensions |
Exactech, Inc. |
Patrick Hughes |
| K162319 |
04/28/2017 |
BabyDance Fertility Lubricant |
Fairhaven Health, LLC |
Suzanne Munson |
| K160967 |
04/18/2017 |
Finapres Nova Noninvasive Hemodynamic Monitor |
FINAPRES MEDICAL SYSTEMS BV |
IR. IRIS VAN UITERT |
| K163125 |
04/10/2017 |
gekoÖ T-2 and gekoÖ Plus R-2 Neuromuscular Stimulators |
FIRSTKIND LIMITED |
NEIL BUCKLEY |
| K170502 |
04/13/2017 |
Patient Positioning System |
Forte Automation Systems, Inc. |
Phil Reece |
| K162068 |
04/10/2017 |
ARROW Anatomical Porous glenoid |
Fournitures Hospitalieres Industrie |
Patricia Donnard |
| K170040 |
04/04/2017 |
BePOD Cannulated Arthrodesis Screws |
Fournitures Hospitalieres Industrie |
PATRICIA DONNARD |
| K162488 |
04/06/2017 |
Optiflux dialyzer |
FRESENIUS MEDICAL CARE NORTH AMERICA |
DENISE OPPERMANN |
| K163675 |
04/25/2017 |
Processor VP-7000, Light Source BL-7000 |
FUJIFILM Medical System U.S.A., Inc. |
Shraddha S More |
| K170858 |
04/24/2017 |
FDR AQRO (DR-XD 1000) |
FUJIFILM Medical Systems U.S.A., Inc. |
Peter Altman |
| K162287 |
04/06/2017 |
Synapse 3D Perfusion Analysis |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
Jyh-Shyan Lin |
| K163507 |
04/25/2017 |
Triton Sponge System |
Gauss Surgical, Inc. |
Artie Kaushik |
| K170445 |
04/11/2017 |
LOGIQ S8 |
GE Healthcare |
Bryan Behn |
| K162722 |
04/20/2017 |
HyperSense |
GE MEDICAL SYSTEMS, LLC |
GLEN SABIN |
| K161599 |
04/06/2017 |
UNO Negative Pressure Wound Therapy System |
GENADYNE BIOTECHNOLOGIES, INC. |
Chien Ming GOH |
| K163144 |
04/07/2017 |
gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) |
GKE-GMBH |
Ulrich Kaiser |
| K163361 |
04/07/2017 |
ANTHEMÖ Fracture System |
Globus Medical Inc. |
Kelly J. Baker |
| K163383 |
04/19/2017 |
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System |
GREENS SURGICALS PVT. LTD. |
Vinay Kumar |
| K160502 |
04/19/2017 |
TEG 6s Hemostasis System |
Haemonetics Corporation |
Paige Sweeney |
| K162930 |
04/21/2017 |
Aero Chrome* Select Breathable Performance Surgical Gowns |
Halyard Health, Inc. |
David M. Lee |
| K163461 |
04/13/2017 |
Coolief* Cooled RF Probe |
Halyard Health, Inc. |
Monica King |
| K161450 |
04/27/2017 |
HAMILTON-C3 |
HAMILTON MEDICAL AG |
Katrin Vogt |
| K163667 |
04/28/2017 |
RFID Localization System- Localizer Reader, RFID Localization System- Localizer Surgical Probe, RFID Localization System- Localizer Surgical Probe (5 pack), RFID Localization System- Tag Applicator, RFID Localization System -Tag Applicator (10 pack) |
HEALTH BEACONS, INC. |
NANCY CONFREY |
| K170511 |
04/25/2017 |
NeoFuse HA Enhanced PLIF/TLIF |
HT Medical, LLC |
Robert Compton |
| K161829 |
04/06/2017 |
Huvitz Imaging System |
HUVITZ CO., LTD. |
KIM EUN-JO |
| K162236 |
04/20/2017 |
Ax Stand-Alone ALIF System |
INNOVASIS, INC. |
Marshall McCarty |
| K170211 |
04/27/2017 |
Insight Dental System |
Insight Dental System |
Matthew Kaupp |
| K162296 |
04/18/2017 |
OmniPod Insulin Management System |
INSULET CORPORATION |
MATTHEW KING |
| K163256 |
04/06/2017 |
Dual Mode Infrared Thermometer |
Intelliworks LLC |
Dr. Jessica Leonardi |
| K163149 |
04/26/2017 |
VisualEyes |
Interacoustics A/S |
Erik Nielsen |
| K170120 |
04/18/2017 |
EndoRotor |
Interscope, Inc |
Jeffrey Ryan |
| K163443 |
04/13/2017 |
Interson USB Ultrasound System |
Interson Corporation |
David Asarnow |
| K170865 |
04/21/2017 |
EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories |
Intuitive Surgical, Inc. |
Cheryl Wu |
| K162203 |
04/06/2017 |
POGO Automatic Blood Glucose Monitoring System |
Intuity Medical, Inc. |
Robb Hesley |
| K162621 |
04/17/2017 |
Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair |
Invacare Corporation |
Elijah N. Wreh |
| K162679 |
04/28/2017 |
IOB Temperature Management System |
IOB MEDICAL INC |
JIULIN XIA |
| K163613 |
04/04/2017 |
Bluephase Style 20i |
IVOCLAR VIVADENT, AG |
SANDRA CAKEBREAD |
| K170926 |
04/28/2017 |
BrainPulse 1100 |
Jan Medical, Inc. |
Prabhu Raghavan |
| K163160 |
04/20/2017 |
Sterile Single-use Infusion Set |
JiangXi HongDa Medical Equipment Group Ltd. |
Xiaohua Yang |
| K162517 |
04/14/2017 |
Electronic Pulse Stimulator Model: PL-029K12 and PL-029K13 |
JKH Health Co., Ltd. |
Pu Jiang |
| K170358 |
04/21/2017 |
joimax Endovapor 2 |
joimax GmbH |
Wolfgang Ries |
| K170055 |
04/13/2017 |
CAPRI Corpectomy Cage System |
K2M |
Nancy Giezen |
| K161332 |
04/05/2017 |
NILE Proximal Fixation Spinal System |
K2M, INC. |
NANCY GIEZEN |
| K163372 |
04/07/2017 |
RX Takeru Balloon Dilatation Catheter |
KANEKA CORPORATION |
Toshihiko Motomine |
| K170247 |
04/18/2017 |
Lacriflow CL |
KANEKA PHARMA AMERICA LLC |
Masaaki Fukunishi |
| K163516 |
04/21/2017 |
Braun No Touch + Forehead NTF3000 Thermometer |
Kaz USA, Inc., a Helen of Troy Company |
Rajesh Kasbekar |
| K163386 |
04/10/2017 |
Keos Lumbar IBFD |
Keos |
Mark F Schenk |
| K161341 |
04/05/2017 |
LIFESYS PACS |
LIFETRACK MEDICAL SYSTEMS, INC. |
ERIC SCHULZE |
| K162067 |
04/24/2017 |
VX130 Ophthalmic Diagnostic Device |
LUNEAU SAS |
ISABELLE DURAND |
| K170593 |
04/18/2017 |
Mako Total Hip Application |
MAKO Surgical Corp. |
Shikha Khandelwal |
| K163221 |
04/04/2017 |
Mazor X |
Mazor Robotics Ltd. |
Ayelet Matia |
| K161741 |
04/14/2017 |
GMK UNI |
MEDACTA INTERNATIONAL SA |
Stefano Baj |
| K162271 |
04/26/2017 |
Pro-Lock CT Safety Infusion Set |
MEDCOMP (MEDICAL COMPONENTS, INC.) |
COURTNEY NIX |
| K170088 |
04/06/2017 |
Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film |
MEDELA, AG |
Markus Butler |
| K170610 |
04/13/2017 |
PlasmaBlade T |
Medtronic Advanced Energy |
Lydia Sakakeeny |
| K162655 |
04/21/2017 |
StealthConnect Remote Viewing, Planning and Collaboration System |
MEDTRONIC NAVIGATION, INC. |
MONICA R. MONTANEZ |
| K170347 |
04/04/2017 |
CD HORIZONÖ Fenestrated Screw Set |
Medtronic Sofamor Danek USA |
Lee Grant |
| K163581 |
04/14/2017 |
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments |
MEDTRONIC SOFAMOR DANEK USA, INC |
LAVEEDA LEFLORE |
| K163076 |
04/05/2017 |
Segment CMR |
MEDVISO AB |
Einar Heiberg |
| K170964 |
04/26/2017 |
Zenius Spinal System |
Medyssey USA, Inc. |
Shawn Kim |
| K170700 |
04/06/2017 |
Inqwire Diagnostic Guide Wire |
Merit Medical Systems Inc. |
Mark Mullaney |
| K170668 |
04/05/2017 |
HeartSpan Steerable Sheath Introducer |
Merit Medical Systems, Inc. |
Alina Stubbs |
| K163101 |
04/06/2017 |
CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set |
MICROGENICS CORPORATION |
MINOTI PATEL |
| K162748 |
04/24/2017 |
MindMotionPRO |
MindMaze SA |
SYLVAIN BOURRIQUET |
| K163233 |
04/06/2017 |
MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter |
MIVI NEUROSCIENCE, INC |
Randy LaBounty |
| K152192 |
04/07/2017 |
LED Curing Light |
MONITEX INDUSTRIAL CO., LTD. |
Shu-Lung Wang |
| K170724 |
04/07/2017 |
NeuroBlate System |
Monteris Medical |
David H. Mueller |
| K170132 |
04/25/2017 |
MyoCycle Home, MyoCycle Pro |
MYOLYN, LLC |
Matthew Bellman |
| K170598 |
04/07/2017 |
ZeroWire Mobile |
NDS Surgical Imaging, LLC. |
Shala Famil |
| K163547 |
04/11/2017 |
MaxxiGold Electrode 48, MaxxiGold Electrode 60, MaxxiGold Electrode 96 |
NEUROVIRTUAL USA, INC. |
Eduardo Faria |
| K170677 |
04/05/2017 |
Neurovision Nerve Locator Monitor (Nerveana), EMGView Software |
Neurovision Medical Product Inc. |
Christine Vergely |
| K170012 |
04/24/2017 |
Foot and Hand Motion |
NEWCLIP TECHNICS |
Celine CHEVRIER |
| K163459 |
04/04/2017 |
Nihon Kohden Vital Sign Telemeter |
Nihon Kohden Corporation |
Tom Bento |
| K162617 |
04/06/2017 |
NobleStitch EL |
NOBLES MEDICAL TECHNOLOGIES II, INC. |
FAYE DUNN |
| K160990 |
04/11/2017 |
Nova Max Uric Acid Monitoring System |
NOVA BIOMEDICAL CORPORATION |
ELIZA WANG |
| K162927 |
04/06/2017 |
PRECICE UNYTE CoCr System |
NuVasive Specialized Orthopedics, Inc. |
Cora Sim |
| K170592 |
04/26/2017 |
NuVasive BASE Interfixated Titanium System |
NuVasive, Incorporated |
Cynthia Adams |
| K162361 |
04/17/2017 |
Soft Plug Extended Duration 180 Canalicular Plug |
OASIS MEDICAL, INC. |
JAMES CHRISTENSEN |
| DEN160030 |
04/24/2017 |
Oculeve Intranasal Tear Neurostimulator Device |
OCULEVE, INC. |
ANDY DORAISWAMY |
| K163469 |
04/06/2017 |
ViziShot 2 FLEX |
Olympus Surgical Technologies America |
Mary Anne Patella |
| K163332 |
04/26/2017 |
Apex Revision Knee System |
OMNIlife science |
Christina Rovaldi |
| K163235 |
04/20/2017 |
HEM-9210T |
Omron Healthcare, Inc. |
Renee Thornborough |
| K163021 |
04/11/2017 |
HAAG-STREIT FUNDUS MODULE 300 |
OPTOMED OY |
Jyri Leskela |
| K163265 |
04/07/2017 |
Kepler II |
Orbbo Surgical, LLC |
Eric Garofano |
| K170260 |
04/25/2017 |
BC-001+ Acne Purifier |
Oriental Inspiration Limited |
Andy Wu |
| K160670 |
04/25/2017 |
ET US SS Prosthetic system |
OSSTEM IMPLANT CO., LTD. |
HEE KWON |
| K163088 |
04/21/2017 |
TSIII BA Fixture |
OSSTEM IMPLANT Co., Ltd. |
Hee Kwon |
| K152830 |
04/20/2017 |
K3 |
OSSTEM IMPLANT CO.,LTD. |
BYEUNGHUN KIM |
| K162544 |
04/04/2017 |
OsteoMed PINNACLE Driver |
OSTEOMED |
KATHRYN A. JAYNE |
| K163303 |
04/04/2017 |
OsteoMed ExtremiFix Mid and Large Screw System |
OsteoMed LLC |
Ellen Hong |
| K162087 |
04/18/2017 |
NovoGro |
OsteoNovus, Inc. |
Brian M. Schlossberg |
| K162799 |
04/25/2017 |
Cliniview |
Palodex Group Oy |
Jouni Karkinen |
| K170813 |
04/07/2017 |
ORTHOPANTOMOGRAPH OP 3D |
PaloDEx Group Oy |
Terho Turkumaki |
| K162154 |
04/24/2017 |
Pantheon Medical Balanced Plating System |
PANTHEON MEDICAL |
TRAVID BIRD |
| K162241 |
04/03/2017 |
TITAN 3-DÖ Wedge System |
PARAGON 28 |
Frank S. Bono |
| K162785 |
04/14/2017 |
Velox Nebulizer System |
PARI Respiratory Equipment, Inc. |
Michael Judge |
| K170215 |
04/19/2017 |
LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock |
Patient Pocket LLC |
Allen D. Seftel |
| K163484 |
04/17/2017 |
Paxman Scalp Cooler |
Paxman Coolers Limited |
Richard PAXMAN |
| K162447 |
04/13/2017 |
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner |
PENTAX of America, Inc. |
Krishna Govindarajan |
| K162151 |
04/20/2017 |
PENTAX Medical ENT Video Imaging System |
PENTAX OF AMERICA, INC. |
Krishna Govindarajan |
| K162901 |
04/20/2017 |
Penumbra 3D Revascularization Device |
Penumbra, Inc. |
Michaela Mahl |
| K163711 |
04/05/2017 |
IQon Spectral CT |
Philips Medical Systems (Cleveland), Inc. |
Steven Goldberg |
| K162838 |
04/07/2017 |
Philips iCT CT System |
Philips Medical Systems (Cleveland), Inc. |
Christine Anderson |
| DEN160056 |
04/12/2017 |
Philips IntelliSite Pathology Solution |
Philips Medical Systems Nederland B.V. |
Esther Abels |
| K170716 |
04/21/2017 |
PercuNav Image Fusion and Interventional Navigation |
Philips Ultrasound Inc. |
Peng Cui |
| K170721 |
04/21/2017 |
Cut-Vac Lighted Smoke Evacuation Electrosurgical Pencil |
Precision Surgical, LLC |
Prash Jayaraj |
| K170411 |
04/04/2017 |
ER-REBOA Catheter |
Prytime Medical Devices, Inc |
Brian Young |
| K163329 |
04/14/2017 |
Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 |
PULSADERM LLC |
Gloria Avendano |
| K163708 |
04/20/2017 |
QiF Blood and Fluid Warmer |
Quality In Flow Ltd. |
Neta Sherman |
| K162438 |
04/14/2017 |
Sofia Influenza A+B FIA on Sofia 2 |
Quidel Corporation |
Jennifer S. Rial |
| K161724 |
04/28/2017 |
Visicoil MR Marker (User Loaded), Visicoil MR Marker (Pre-Loaded) |
RadioMed Corporation |
Leah Easley |
| K170882 |
04/28/2017 |
ABL90 FLEX, ABL90 FLEX PLUS |
Radiometer Medical ApS |
Soren Boegestrand |
| K162275 |
04/21/2017 |
Randox RX Daytona Plus Alkaline Phosphatase (ALP) |
RANDOX LABORATORIES LIMITED |
Pauline Armstrong |
| K162200 |
04/28/2017 |
Randox RX Daytona Plus Magnesium (MG) |
RANDOX LABORATORIES LTD |
PAULINE 0 ARMSTRONG |
| K170377 |
04/05/2017 |
TipControl RF INSTRUMENT BIPO ╪ 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO ╪ 2.5MM WL 350MM |
Richard Wolf Medical Instruments Corporation |
Mike Loiterman |
| K170678 |
04/04/2017 |
Beta-CrossLaps CalCheck 5 |
Roche Diagnostics |
Edie Brunt |
| K170938 |
04/26/2017 |
CalSet IGF-1 |
Roche Diagnostics |
Lisa K. Klinedinst |
| K170643 |
04/14/2017 |
Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System |
RTI Surgical, Inc. dba RTI Biologics |
Jennifer Bonacci |
| K161857 |
04/28/2017 |
Salvin Tenting Screw System |
Salvin Dental Specialties |
Jennifer Singer |
| K170406 |
04/18/2017 |
Plato MICROCATH 27B Microcatheter |
Scientia Vascular LLC |
David Sabodski |
| K170905 |
04/27/2017 |
Star Tissue Marker |
Scion Medical Technologies, LLC |
Louis Li |
| K170145 |
04/29/2017 |
Digital TENS Unit |
SHENZHEN EAPPLY TECHNOLOGY CO., LTD |
LISA HUANG |
| K162607 |
04/20/2017 |
BeneVision Central Monitoring System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Yanhong Bai |
| K163690 |
04/20/2017 |
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Yang Zhaohui |
| K161712 |
04/05/2017 |
Arm automatic blood pressure monitor |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
XIE QIONGYU |
| K163220 |
04/06/2017 |
Atellica CH Phencyclidine (Pcp) |
Siemens Healthcare Diagnostics, Inc. |
Laura J. Duggan |
| K170221 |
04/21/2017 |
syngo.CT Cardiac Planning |
Siemens Healthcare GmbH |
Martin Knoppik |
| K170315 |
04/04/2017 |
Acuson SC2000 Diagnostic Ultrasound System |
Siemens Medical Solutions Inc. |
Kevin Kong |
| K170952 |
04/28/2017 |
syngo.CT View&GO |
Siemens Medical Solutions USA, Inc. |
Kimberly Mangum |
| K162782 |
04/04/2017 |
iHelmet Hair Growth System |
Slinph Technologies Co., LTD |
Zou Jian |
| K163387 |
04/18/2017 |
PICO Single Use Negative Pressure Wound Therapy System |
Smith & Nephew Medical Limited |
Samantha Neilson |
| K170887 |
04/24/2017 |
EVOS Small Fragment Plating System |
Smith & Nephew, Inc. |
Samantha Staubach |
| K170280 |
04/28/2017 |
Smith & Nephew SURESHOT Distal Targeting System V4.0 |
Smith & Nephew, Inc. |
Allison Chan |
| K162108 |
04/17/2017 |
Pressio 2 ICP Monitoring System |
SOPHYSA, SA |
Jean-Christophe Audras |
| K170059 |
04/07/2017 |
Spectranetics Turbo-Elite Laser Atherectomy Catheters |
Spectranetics, Inc. |
Rebecca Spelich |
| K163246 |
04/06/2017 |
Leva Anterior Expandable Spacer System |
SPINE WAVE, INC. |
AMY NOCCIOLI |
| K170268 |
04/14/2017 |
FortressÖ Pedicular Fixation System |
Spineology Inc. |
Jacqueline Hauge |
| K170266 |
04/14/2017 |
PalisadeÖ Pedicular Fixation System |
Spineology Inc. |
Jacqueline Hauge |
| K170251 |
04/14/2017 |
ThresholdÖ Pedicular Fixation System |
SPINEOLOGY INC. |
JACQUELINE HAUGE |
| K170255 |
04/14/2017 |
ThresholdÖ V2 Pedicular Fixation System |
SPINEOLOGY INC. |
JACQUELINE HAUGE |
| K162945 |
04/28/2017 |
VERIFY ASSERT STEAM Process Challenge Device |
STERIS Corporation |
Ganga Kolli |
| K170070 |
04/28/2017 |
VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles |
STERIS Corporation |
Anthony Piotrkowski |
| K163656 |
04/14/2017 |
Hoffmann LRF System |
Stryker GmbH |
Paul Nelson |
| K170456 |
04/05/2017 |
Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology |
Stryker Sustainability Solutions |
Chelsea Cullen |
| K162046 |
04/11/2017 |
MINNE TIES MMF Suture System |
SUMMIT MEDICAL, INC. |
Nicole Dove |
| K170572 |
04/26/2017 |
Summit Spine Yellowstone Lumbar Interbody Fusion System |
Summit Spine |
Eric Buescher |
| K170582 |
04/14/2017 |
Saf-T-Vac Smoke and Fluid Evacuator |
Surgical Technology Laboratories, Inc |
Mathew Fairfax |
| K163363 |
04/05/2017 |
SurgTech Thoracolumbosacral (TLS) Posterior Fixation System |
SurgTech Inc. |
Xuegong Yu |
| K162063 |
04/21/2017 |
Steri-Cassette and Steri-Cage Sterilization Packaging System |
Sybron Dental Specialties |
Jennifer Dzidrums |
| K163415 |
04/20/2017 |
SlimShape System |
Syneron Medical Ltd. |
Ruthie Amir |
| K162382 |
04/14/2017 |
Smart Dongle Blood Glucose Monitoring System |
TaiDoc Technology Corporation |
Paul Liu |
| K162636 |
04/14/2017 |
Marco Ultra M3, Marco Ultra M4 |
TAKAGI SEIKO CO.LTD. |
HAGIWARA TORU |
| K160680 |
04/19/2017 |
VisioFocus Mini, VisioFocus Smart |
TECNIMED S.R.L. |
Cinzia Bellifemine |
| K161114 |
04/12/2017 |
HIGH V+ |
Teknimed, SAS |
J.D. Webb |
| K161982 |
04/05/2017 |
C-Reactive Protein Kit for use on SPAPLUS |
THE BINDING SITE GROUP |
KIRSTY SAMUELS |
| K162258 |
04/28/2017 |
Self Sealing Sterilization Pouches |
Tianchang Jiarui Packaging Material Co., Ltd. |
Zhang Ruiqing |
| K160694 |
04/07/2017 |
Disposable Endotracheal tube, sterile, AccuCuff |
TIANJIN MEDIS MEDICAL DEVICE CO., LTD. |
ZHENCHUANG YANG |
| K163269 |
04/13/2017 |
Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device |
TITAN SPINE, LLC |
JANE RODD |
| K161353 |
04/03/2017 |
ESTELITE BULK FILL Flow |
TOKUYAMA DENTAL CORPORATION |
KEITH A. BARRITT |
| K162354 |
04/20/2017 |
Sniper Staple System |
TRILLIANT SURGICAL LTD |
Jon Olson |
| K162661 |
04/25/2017 |
SavDenTM MTA Root Canal Filling Materials |
tYDS Biotech Incorporation |
Liang-Yu Chang |
| K162334 |
04/27/2017 |
U.S. Laser Worx Patriot 1 family of lasers |
U.S. Laser Worx |
Frank Ford |
| K170731 |
04/04/2017 |
System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight |
Vatech Co., Ltd |
Daniel Kim |
| K162877 |
04/07/2017 |
VOCSN Unified Respiratory System |
VENTEC LIFE SYSTEMS, INC |
Joseph Cipollone |
| K160179 |
04/21/2017 |
VivaChek Ino Blood Glucose Monitoring System |
VIVACHEK LABORATORIES, INC. |
Julie Zhou |
| K170385 |
04/06/2017 |
CORE M2 Vascular System |
Volcano Corporation |
Courtney Moore |
| K162968 |
04/10/2017 |
VORTRAN GO2VENT |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
James Lee |
| K162159 |
04/28/2017 |
VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing |
VR Medical Technologies, LLC |
Lee Pan |
| K160499 |
04/24/2017 |
Apnea Risk Evaluation System (ARES), Model 620 |
Watermark Medical |
Frank Katarow |
| K162460 |
04/28/2017 |
WAViÖ Headset and WAViÖ eSocÖ Single Use Electrode Contacts |
WAVI, CO |
ALEXIS VERACRUZ |
| K170781 |
04/04/2017 |
MX50N(MX50YQS) |
WIDE Corporation |
YeoJin Yun |
| K162142 |
04/27/2017 |
Accessory Irrigation Adapter |
WILSON-COOK MEDICAL, INC. |
THERESA DE PRAT |
| K153763 |
04/06/2017 |
Howell Biliary Aspiration Needle |
WILSON-COOK MEDICAL, INC. |
Jennifer McMahan |
| K170889 |
04/26/2017 |
HV Screw System |
Wright Medical Technology, Inc. |
Tara Conrad |
| K162353 |
04/13/2017 |
MICATM Screw System |
WRIGHT MEDICAL TECHNOLOGY, INC. |
TARA CONRAD |
| K163650 |
04/24/2017 |
ORTHOLOC« 3Di Ankle Fusion Plating System Line Extension |
Wright Medical Technology, Inc. |
Rachel Roberts |
| K160549 |
04/07/2017 |
MEDICAL DIODE LASER SYSTEMS |
WUHAN GIGAA OPTRONICS TECHNOLOGY CO., LTD |
NIE XINXING |
| K162237 |
04/25/2017 |
XO1 Knee Balancing System |
XPANDORTHO, INC. |
REBECCA K PINE |
| K162206 |
04/04/2017 |
Zavation IBF |
Zavation, LLC |
Lawrence Walker |
| K170273 |
04/28/2017 |
Z-DOSE29 |
ZETTA MEDICAL TECHNOLOGIES, LLC. |
MAIN M. GHAZAL |
| K170533 |
04/18/2017 |
Model 330 Multifunction Aspirator |
ZOLL Medical Corporation |
Pooja Dalvi |
