| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K171373 |
05/10/2017 |
3M Bair Hugger Model 675 Total Temperature Management System |
3M Company |
Jon Platt |
| K171351 |
05/09/2017 |
Posterior Spine Truss System (PSTS) Interbody Fusion Device |
4Web, Inc. |
Jessee Hunt |
| K171411 |
05/15/2017 |
IRRIS (Infra-Red-Red Intubation System) |
A.R Guide In Medical Ltd. |
Ariel Shrem |
| K171583 |
05/31/2017 |
RhythmView Workstation |
Abbott Electrophysiology |
Dennis Pozzo |
| K171557 |
05/30/2017 |
AcQRef Introducer Sheath |
Acutus Medical, Inc. |
Brenda Clay |
| K171533 |
05/25/2017 |
Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap |
Ahlstrom Nonwovens LLC |
Gary Jackson |
| K171299 |
05/03/2017 |
Fixone Biocomposite Anchor |
AJU Pharm Co.,Ltd. |
Kim Jung Gil |
| K171581 |
05/31/2017 |
Neuro Omega System |
Alpha Omega Engineering Ltd, |
Maysana Mousa |
| K171329 |
05/05/2017 |
Altus Spine Titanium Interbody Fusion System |
Altus Partners, LLC |
Claudia Hill |
| K171265 |
05/01/2017 |
Otowave 302 Portable Tympanometer |
Amplivox Ltd |
Chris Roerig |
| K171282 |
05/01/2017 |
Fully Automatic Blood Pressure Monitor |
Andon Health Co., Ltd |
Liu Yi |
| K171375 |
05/10/2017 |
Gammex PI Breach Detect Powder Free Surgical Glove |
Ansell Healthcare Products LLC |
Robert Mahler |
| K171586 |
05/31/2017 |
Smart External Drain (SED) System |
Aqueduct Critical Care, Inc |
Thomas Clement |
| K171544 |
05/26/2017 |
Arterys Viewer |
Arterys Inc. |
Golnaz Moeini |
| K171365 |
05/09/2017 |
Arthrex Knee Systems |
Arthrex Inc. |
David L. Rogers |
| K171296 |
05/02/2017 |
SutureTape |
Arthrex, Inc. |
Ivette Galmez |
| K171482 |
05/19/2017 |
NEPHROCHECK Test System |
Astute Medical, Inc. |
Karin Hughes |
| K171528 |
05/25/2017 |
Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) |
Avantsonic Technology Co., Ltd. |
Cuiling Wu |
| K171476 |
05/19/2017 |
SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) |
Awareness Technology, Inc. |
Steve Andrus |
| K171584 |
05/31/2017 |
B. Braun Tear-Away Introducer Needle |
B. Braun Medical Inc. |
Kimberly Smith |
| K171338 |
05/08/2017 |
B R A H M S PCT sensitive KRYPTOR |
B.R.A.H.M.S GmbH |
Sascha Johannes |
| K171404 |
05/12/2017 |
BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) |
BAUSCH + LOMB Incorporated |
Glenn A. Davies |
| K171361 |
05/09/2017 |
BETTERCARE PLATFORM - ADVANCED WEB CLIENT |
Bettercare S.L. |
Bernat Sales |
| K171517 |
05/24/2017 |
Digital Electrocardiograph |
Biocare Bio-Medical Equipment Co., Ltd. |
Hongbo Zhong |
| K171540 |
05/26/2017 |
Refobacin Bone Cement R |
Biomet Inc. |
Heidi Busz |
| K171323 |
05/05/2017 |
BIOPHOTAS CELLUMA3 |
Biophotas Inc |
PATRICK JOHNSON |
| K171431 |
05/15/2017 |
HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm |
BioStable Science & Engineering, Inc. |
Julie Thomas |
| K171297 |
05/02/2017 |
AR_N Type Implant System |
Biotem Co., Ltd. |
Hong Koo Yeo |
| K171514 |
05/24/2017 |
BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set |
BIOTRONIK, Inc. |
Jon Brumbaugh |
| K171485 |
05/22/2017 |
BSD4343R Digital Flat Panel X-ray Detector |
Bontech Inc. |
Kwang S. Choi |
| K171454 |
05/17/2017 |
Interject Injection Therapy Needle Catheter |
Boston Scientific Corporation |
Tara Paul |
| K171452 |
05/17/2017 |
MAMBA and MAMBA FLEX Microcatheters |
Boston Scientific Corporation |
Sherry Kollmann |
| K171271 |
05/01/2017 |
Polyform Synthetic Mesh |
Boston Scientific Corporation |
Michelle Berry |
| K171410 |
05/15/2017 |
ePatch |
Braemar Manufacturing, LLC |
Kent Sayler |
| K171414 |
05/15/2017 |
qEEG-Pro |
Brainmaster Technologies, Inc. |
Tom Collura |
| K171348 |
05/08/2017 |
Pinpoint GT Needle Guide Kits |
C.R. Bard, Inc. |
Christopher M. Phillips |
| K171487 |
05/22/2017 |
Sirius MRI Marker NS |
C4 Imaging, LLC |
Andrew Bright |
| DEN170028 |
05/17/2017 |
Cala ONE |
Cala Health, Inc. |
Scott A. Wilson |
| K171270 |
05/01/2017 |
DIGITAL RADIOGRAPHY CXDI-410C WIRELESS |
Canon, Inc |
SHINJI MORI |
| K171493 |
05/22/2017 |
MegaVac Mechanical Thrombectomy System |
Capture Vascular, Inc. |
Aaron Call |
| K171499 |
05/23/2017 |
Occlusion Detection Dressing Kit |
Cardinal Health |
Beth Foster |
| K171531 |
05/25/2017 |
Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle |
CareFusion |
Tamara Brey |
| K171588 |
05/31/2017 |
NuBODY Skin Toning Device |
Carol Cole Company dba NuFACE |
Donald Ellis |
| K171408 |
05/12/2017 |
Carbon Monoxide Breath Sensor System (COBSS) |
Carrot Sense, Inc. |
Daniel J. Balbierz |
| K171356 |
05/09/2017 |
Clarity Reveal |
Ceevra, Inc. |
Russ Yoshinaka |
| K171446 |
05/16/2017 |
Cefaly Acute |
CEFALY Technology |
Jean-Yves Mignolet |
| K171315 |
05/04/2017 |
Advanced RBC Application |
Cella Vision AB |
Cella Vision AB |
| K171552 |
05/26/2017 |
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV |
Cepheid |
Yi-Ping Lin |
| K171459 |
05/18/2017 |
Ceribell Instant EEG Headband |
Ceribell, Inc. |
Josef Parvizi |
| K171442 |
05/16/2017 |
Exofin Fusion Skin Closure System |
Chemence Medical, Inc. |
Kenneth Broadley |
| K171456 |
05/17/2017 |
ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems |
Choice Spine |
Kim Finch |
| K171489 |
05/22/2017 |
Acapella Cervical Spacer System |
Choice Spine, LP. |
Kim Finch |
| K171328 |
05/05/2017 |
cNeuro cMRI |
Combinostics Oy |
Lennart Thurfjell |
| K171541 |
05/26/2017 |
Powder Free Nitrile Examination Gloves (Orange) |
Comfort Rubber Gloves Industries Sdn. Bhd. |
Chan Yew Men |
| K171592 |
05/31/2017 |
CrossFTÖ Knotless Biocomposite Suture Anchor with Disposable Driver |
ConMed Corporation |
Diana L. Nader-Martone |
| K171575 |
05/30/2017 |
ENFLU 18 (enflufocon A) Daily Wear Contact Lens |
CONTAMAC Ltd. |
Rob Mcgregor |
| K171360 |
05/09/2017 |
CONTECÖ Electrocardiograph |
Contec Medical Systems Co., LTD. |
Xueyong Li |
| K171445 |
05/16/2017 |
Amplatz Support Wire Guide with Apex Curve |
Cook Incorporated |
Jennifer Allman |
| K171272 |
05/01/2017 |
Cook-Swartz Doppler Flow Probe |
Cook Incorporated |
Tom Kardos |
| K171275 |
05/01/2017 |
Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design |
Cook Incorporated |
Daniel J. Corbin |
| K171264 |
05/01/2017 |
Royal Flush Catheter |
Cook Incorporated |
Jessica Swafford |
| K171358 |
05/09/2017 |
Emprint SX Ablation Platform and Accessories |
Coviden llc |
Patti Arndt |
| K171522 |
05/25/2017 |
truFreeze Rapid AV Spray Kit |
CSA Medical, Inc. |
Sherrie Coval-Goldsmith |
| K171290 |
05/02/2017 |
Vela RX PTA Balloon Dilatation Catheter |
Curatia Medical |
Jessica Chiu |
| K171262 |
05/01/2017 |
TempSure |
Cynosure, Inc |
Amy Tannenbaum |
| K171473 |
05/19/2017 |
CompressynÖ Staple |
Dallen Medical, Inc. |
Al Memmolo |
| K171530 |
05/25/2017 |
Deltaven XiV Max, Deltaven XiV Max FF |
Delta Med SpA |
Raschi Olga |
| K171585 |
05/31/2017 |
LUXEN Zr, LUXEN Smile |
Dentalmax Co., Ltd |
Jindong Kim |
| K171475 |
05/19/2017 |
DeRoyal Laprador Specimen Retrieval System |
DeRoyal Industries, Inc. |
Sarah Bennett |
| K171561 |
05/30/2017 |
Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload |
Dextera Surgical Inc. |
Greg Watson |
| K171521 |
05/24/2017 |
DUS R-50S (Urine Chemistry system) |
DFI Co., Ltd. |
Bella Cho |
| K171301 |
05/03/2017 |
Scanmate Flex |
DGH Technology, Inc. |
David Henderson |
| K171505 |
05/23/2017 |
Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) |
Dimesol, Inc. |
Stephen P. Callaghan |
| K171542 |
05/26/2017 |
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges |
Dr. Harold Katz, LLC (dba TheraBreath |
Harold Katz |
| K171562 |
05/30/2017 |
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono |
Dreve Dentamid GmbH |
Reiner Altmann |
| K171539 |
05/26/2017 |
Contact Lens Case |
E-Link Plastic & Metal Industrial Co.,Ltd |
Marvis Lee |
| K171577 |
05/30/2017 |
Smartcord, Smartcord X |
EASTDENT Co., Ltd |
Hyonsu Kim |
| K171339 |
05/08/2017 |
EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs |
ECO MEDI GLOVE SDN. BHD |
Suresh Kumar |
| K171306 |
05/03/2017 |
gammaCore-S |
electroCore, LLC |
Mike Romaniw |
| K171387 |
05/11/2017 |
EMS100 Tri-Wave Combination Stimulator |
Elite Medical Supply of New York, LLC |
John McGrady |
| K171401 |
05/12/2017 |
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1 |
ELITechGroup |
Valerie Gourdon |
| K171397 |
05/11/2017 |
Sienna Ultimate Wireless Amplifier |
EMS Handels Gesellschaft m.b.H. |
Ruzena Ortnerova |
| K171534 |
05/25/2017 |
SurgicalPreview |
Endo Vantage, LLC |
Robert S. Green |
| K171307 |
05/03/2017 |
EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with SerosaFuse Fasteners and Accessories |
EndoGastric Solutions, Inc. |
Steve Hoffman |
| K171422 |
05/15/2017 |
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color |
Ever Global (Vietnam) Enterprise Corp |
Jerry Lin |
| K171519 |
05/24/2017 |
FLXfitÖ |
Expanding Orthopedics, Inc. |
Ofer Bokobza |
| K171407 |
05/12/2017 |
ExsoMed ArcPhix and ExsoMed ArrowPhix |
ExsoMed Holding Company, LLC |
Richard L. Kovach |
| K171558 |
05/30/2017 |
ExsoMed ITN Cannulated Screw System |
Exsomed Holdings Company, LLC |
Richard Kovach |
| K171507 |
05/23/2017 |
CustomizedBone Service |
Fin-ceramica faenza spa |
Marina Monticelli |
| K171467 |
05/18/2017 |
BioZorb Marker GOLD / LP Marker GOLD |
Focal Therapeutics |
George Hermann |
| K171463 |
05/18/2017 |
ASPIRE Bellus II |
FUJIFILM Medical Systems U.S.A., Inc. |
Jyh-Shyan Lin |
| K171291 |
05/02/2017 |
FUJIFILM Bronchoscope Model EB-530P |
FUJIFILM Medical Systems U.S.A., Inc. |
Shraddha S. More |
| K171437 |
05/16/2017 |
SonoSite X-Porte Ultrasound System |
FujiFilm SonoSite, Inc. |
Jordan Lydia Grimmer |
| K171580 |
05/31/2017 |
Monitor B125, Monitor B105 |
GE MEDICAL SYSTEMS (CHINA) CO., LTD. |
Sun YanLi |
| K171565 |
05/30/2017 |
OEC Elite |
GE OEC Medical Systems, Inc. |
Rachel Schandel |
| K171293 |
05/02/2017 |
G3Ö Active Plate« Miniature System |
Genesis Fracture Care, Inc. |
Michael Bottlang |
| K171523 |
05/25/2017 |
Monopolar Single Use Laparoscopic Instrument |
Getsch+Hiller Medizintechnik GmbH |
Werner Hiller |
| K171413 |
05/15/2017 |
HAVENÖ Laminoplasty System, CANOPY« Laminoplasty Fixation System |
Globus Medical Inc. |
Kelly J. Baker |
| K171450 |
05/17/2017 |
Glooko Mobile Insulin Dosing System |
Glooko, Inc |
Tejasvi Pasi |
| K171494 |
05/22/2017 |
TroClose1200, TroClose1200 Cannula |
Gordian Surgical Ltd. |
Amir Schvartzer |
| K171379 |
05/11/2017 |
Digital Automatic Wrist Blood Pressure Monitor MD4300 |
Grandway Technology (Shenzhen) Limited |
Patrick Chow |
| K171440 |
05/16/2017 |
Berkeley VC-10 Vacuum Curettage System |
Gyrus ACMI |
Christina Flores |
| K171568 |
05/30/2017 |
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty |
Hans Biomed Corporation |
Lucy Choi |
| K171336 |
05/08/2017 |
Cystoscope 4.0mm autoclavable 0? WL 302mm; Hysteroscope 4.0mm autoclavable 0? WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath |
Henke-Sass, Wolf GmbH |
Anna Reifschneider |
| K171433 |
05/15/2017 |
Silk'n Infinity |
Home Skinovations Ltd. |
Amit Goren |
| K171480 |
05/19/2017 |
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System |
i-SENS, Inc. |
Joon Ho Jung |
| K171346 |
05/08/2017 |
Sapphire Sets |
ICU Medical |
Andrea Doyle |
| K171484 |
05/22/2017 |
hema-screen SPECIFIC Gold |
Immunostics, Inc. |
Elizabeth Galella |
| K171516 |
05/24/2017 |
Flip Lube |
Imquest Biosciences Inc. |
Karen W. Buckheit |
| K171593 |
05/31/2017 |
InMode RF System |
InMode MD Ltd. |
Amit Goren |
| K171503 |
05/23/2017 |
Reprocessed CristaCath Diagnostic Electrophysiology Catheter |
Innovative Health, LLC. |
Amy Stoklas-Oakes |
| K171277 |
05/01/2017 |
Reprocessed Inquiry Steerable Diagnostic EP Catheter |
Innovative Health, LLC. |
Amy Stoklas-Oakes |
| K171559 |
05/30/2017 |
True Spinal Fixation System |
Innovative Surgical Designs, Inc. |
Jon Rinehart |
| K171357 |
05/09/2017 |
SurgiMend PRS Meshed, Revize-X |
Integra LifeSciences Corporation (Owner of TEI Biosciences) |
Kavita Amin |
| K171525 |
05/25/2017 |
Intellijoint HIP Generation 2B System |
Intellijoint Surgical Inc. |
Brandon Gingrich |
| K171294 |
05/02/2017 |
da Vinci X Surgical System |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K171426 |
05/15/2017 |
da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree |
Intuitive Surgical, Inc. |
Brittany Cunningham |
| K171388 |
05/11/2017 |
EndoWrist Stapler 45 System and Stapler 45 Reloads |
Intuitive Surgical, Inc. |
Doreen Nakamura |
| K171285 |
05/01/2017 |
ARIX Diaphysis System |
Jeil Medical Corporation |
Yein Han |
| K171535 |
05/25/2017 |
SURGICAL ISOLATION GOWN |
Jingzhou Haixin Green Cross Medical Products Co., Ltd |
Rarda L |
| K171321 |
05/04/2017 |
K2M Navigation Instruments |
K2M |
Nancy Giezen |
| K171556 |
05/30/2017 |
K2M Navigation Instruments |
K2M |
Nancy Giezen |
| K171444 |
05/16/2017 |
YUKON OCT Spinal System |
K2M, Inc. |
Nancy Giezen |
| K171402 |
05/12/2017 |
KARL STORZ Slim Nasopharyngolaryngoscope |
KARL STORZ Endoscopy-America, Inc. |
AnnaLisa Smullin |
| K171563 |
05/30/2017 |
MagnetOs Putty |
Kuros Biosciences B.V. |
Yvonne P. Bovell |
| K171390 |
05/11/2017 |
dpl II Panel |
LED Technologies, Inc. |
Lloyd Nelson |
| K171386 |
05/11/2017 |
dpl SpectraLite |
LED Technologies, Inc. |
Lloyd Nelson |
| K171337 |
05/08/2017 |
LENSAR Laser System û fs 3D (LLS-fs 3D) |
LENSAR, Inc. |
Keith Peck |
| K171429 |
05/15/2017 |
Magnetic Surgical System |
Levita Magnetics International Corp. |
Alberto Rodrigues-Navarro |
| K171589 |
05/31/2017 |
AEON Endoscopic Stapler |
Lexington Medical Inc. |
Donna Gasper |
| K171448 |
05/17/2017 |
Hammertoe Correction System |
Life Spine Inc. |
Randy Lewis |
| K171515 |
05/24/2017 |
NHAC 16 |
LMT Medical Systems GmbH |
Thomas Plein |
| DEN170029 |
05/24/2017 |
PrimeStore MTM |
Longhorn Vaccines and Diagnostics LLC |
Jeff Fischer |
| K171441 |
05/16/2017 |
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit |
Luminex Corporation |
Wendy Ricker |
| K171506 |
05/23/2017 |
Easyscreen |
Maico Diagnostics GmbH |
Amy Yanta |
| K171571 |
05/30/2017 |
NexSite HD, Hemodialysis Step Tip Catheter (60cm) |
Marvao Medical Devices, Ltd. |
Christopher Davey |
| K171345 |
05/08/2017 |
Cellvizio 100 Series Systems with Confocal Miniprobes |
Mauna Kea Technologies |
Veronique Dentan |
| K171591 |
05/31/2017 |
CUBEScanÖ BioCon-900 (Bladder Volume Measurement System) |
Mcube Technology Co., Ltd. |
Changhyun Kim |
| K171326 |
05/05/2017 |
Piezosurgery White |
Mectron S.p.a |
Franco Zunino |
| K171369 |
05/10/2017 |
M.U.S.T. MINI Posterior Cervical Screws System |
Medacta International SA |
Stefano Baj |
| K171595 |
05/31/2017 |
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System |
Medacta International SA |
Stefano Baj |
| K171333 |
05/08/2017 |
20G x 5/8 Pro-Lock CT Safety Infusion Set |
Medcomp (dba Medical Components, Inc.) |
Courtney Nix |
| K171483 |
05/22/2017 |
ArchFlo CT Midline |
Medcomp (dba Medical Components, Inc.) |
Courtney Nix |
| K171538 |
05/26/2017 |
CureÖ Lumbar Plate System |
Meditech Spine, LLC |
Bruce Dunaway |
| K171439 |
05/16/2017 |
EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, U |
Medos International SARL |
Catherine Kilshaw |
| K171570 |
05/30/2017 |
Additional VIPER PRIMEÖ screws with fenestrations |
Medos International, SARL |
Karen Sylvia |
| K171425 |
05/15/2017 |
CONCORDE LIFT |
Medos International, SARL |
Karen Sylvia |
| K171376 |
05/10/2017 |
DynaNail TTC Fusion System |
MedShape, Inc. |
Courtney Kline |
| K171267 |
05/01/2017 |
NavLock Trackers |
Medtronic Navigation |
Nicole Zimmerman |
| K171468 |
05/18/2017 |
FUSE Spinal System |
Medtronic Sofamor Danek |
Ankit K. Shah |
| K171427 |
05/15/2017 |
Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassette |
Medtronic Vascular, Inc. |
Burt Goodson |
| K171308 |
05/03/2017 |
Tubing Pack |
Medtronic, Inc. |
Renee Cveykus |
| K171509 |
05/23/2017 |
Iliad« Pedicle Screw System and Zenius« Pedicle Screw System |
Medyssey USA, Inc. |
Shawn Kim |
| K171526 |
05/25/2017 |
ZeniusÖ, lliadÖ and KoraÖ Spinal Fixation Systems |
Medyssey USA, Inc. |
Shawn Kim |
| K171320 |
05/04/2017 |
ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, AR |
Meril Healthcare Pvt. Ltd. |
Umesh Sharma |
| K171362 |
05/09/2017 |
Merit Syringe |
Merit Medical Systems, Inc. |
Cory Marsh |
| K171498 |
05/23/2017 |
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument |
Meso Scale Diagnostics, LLC |
Lillian Quintero |
| K171449 |
05/17/2017 |
Metacem |
Meta Biomed Co., Ltd |
Suk Song Oh |
| K171286 |
05/01/2017 |
PAL Multi-Use Cannulas and PAL Manual Wand |
MicroAire Surgical Instruments, LLC |
Glenn Gerstenfeld |
| K171384 |
05/11/2017 |
Micromed BRAIN QUICK system |
Micromed S.P.A |
Monica Camillo |
| K171389 |
05/11/2017 |
EVOLUTION Revision CCK System |
MicroPort Orthopedics Inc. |
Matt Paul |
| K171268 |
05/01/2017 |
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter |
MicroTherapeutics, Inc. d/b/a ev3 Neurovascular |
Eric Elliott |
| K171497 |
05/22/2017 |
Mikron Spinal Fixation System |
Mikron Makina Sanayi Ticaret Co. Ltd. |
Mesut KOSE |
| K171353 |
05/09/2017 |
CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris |
MinXray, Inc. |
Keith Kretchmer |
| K171354 |
05/09/2017 |
MR4 Laser |
Multi Radiance Medical |
Andrey Godes |
| K171330 |
05/05/2017 |
Nanova Sealant |
Nanova Biomaterials Inc |
Andrew C. Ritts |
| K171312 |
05/04/2017 |
FortiCore« |
Nanovis LLC |
Matthew Hedrick |
| K171582 |
05/31/2017 |
NEO Pedicle Screw SystemÖ |
Neo Medical S.A. |
Jonas Larsson |
| K171304 |
05/03/2017 |
Maxxi Rip Sensor |
Neurovirtual USA, INC. |
Eduardo Faria |
| K171451 |
05/17/2017 |
Ahmed Glaucoma Valve Model FP8 |
New World Medical, Inc. |
Cristina Avalos |
| K171372 |
05/10/2017 |
Alians Elbow Locking Plating System |
Newclip Technics |
Gaelle Lussori |
| K171510 |
05/24/2017 |
Footmotion Plating System |
Newclip Technics |
Gaelle Lussori |
| K171466 |
05/18/2017 |
NobelDesign, DTX Studio Design |
Nobel Biocare AB |
Charlemagne Chua |
| K171331 |
05/08/2017 |
NxStage System One |
NxStage Medical, Inc. |
Paul Kravitz |
| K171435 |
05/15/2017 |
VirtuOst Vertebral Fracture Assessment |
O.N. Diagnostics, LLC. |
David Kopperdahl |
| K171396 |
05/11/2017 |
ODFS Pace XL |
Odstock Medical Ltd |
Steven Crook |
| K171269 |
05/01/2017 |
X-PSI Knee System |
Orthosoft Inc. (d/b/a Zimmer CAS) |
Guylaine Roy |
| K171316 |
05/04/2017 |
O2Vent W |
Oventus Manufacturing Pty Ltd |
Hemangi Malde |
| K171576 |
05/30/2017 |
The Panthera Anti-Snoring X3 Device |
Panthera Dental Inc. |
Martine Fortin |
| K171334 |
05/08/2017 |
Indego |
Parker Hannifin Corporation |
Achilleas Dorotheou |
| K171332 |
05/08/2017 |
Artemis Neuro Evacuation Device |
Penumbra, Inc. |
Mary Rose |
| K171560 |
05/30/2017 |
OTIS Optical Coherence Tomography System |
Perimeter Medical Imaging, Inc. |
Elizabeth Munro |
| K171314 |
05/04/2017 |
QLAB Advanced Quantification Software |
Philips Healthcare |
Penny Greco |
| K171461 |
05/18/2017 |
SkyPlate Detector for Philips Radiography/Fluoroscopy Systems |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K171385 |
05/11/2017 |
Planmeca Romexis |
Planmeca Oy |
Lars Moring |
| K171359 |
05/09/2017 |
Pollogen Legend+ System |
Pollogen Ltd. |
Ilana Dessow Lironne |
| K171403 |
05/12/2017 |
OralTox Oral Fluid Drug Test |
Premier Biotech Inc |
Jacqueline Gale |
| K171284 |
05/01/2017 |
FIBERGRAFT BG Matrix Bone Graft Substitute |
Prosidyan, Inc |
Charanpreet S. Bagga |
| K171549 |
05/26/2017 |
Intelligent Mesh Nebulizer |
Qingdao Future Medical Technology Co., Ltd. |
Wang WeiLai |
| K171547 |
05/26/2017 |
Qualisys Clinical System |
Qualisys AB |
Henrik Wiberg |
| K171511 |
05/24/2017 |
RIDA GENE Norovirus GI/GII |
R-Biopharm AG |
Andreas Simons |
| K171398 |
05/12/2017 |
Dermal Cooling System |
R2 Dermatology ,Inc |
Kristine Tatsutani |
| K171350 |
05/09/2017 |
Collision Check |
Radformation, Inc. |
Kurt Sysock |
| K171352 |
05/09/2017 |
EZFluence |
Radformation, Inc. |
Kurt Sysock |
| K171418 |
05/15/2017 |
1417WCC_127um and1417WCC_140um |
Rayence Co., Ltd |
Kevin Kim |
| K171417 |
05/15/2017 |
1417WGC_127um and 1417WGC_140um |
Rayence Co., Ltd |
Kevin Kim |
| K171420 |
05/15/2017 |
1717SCC_127um and 1717SCC_140um |
Rayence Co., Ltd |
Kevin Kim |
| K171419 |
05/15/2017 |
1717SGC_127um and 1717SGC_140um |
Rayence Co., Ltd |
Kevin Kim |
| K171536 |
05/25/2017 |
RayStation |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K171543 |
05/26/2017 |
Renovis Surgical Hip Replacement System |
Renovis Surgical Technologies |
Anthony DeBenedictis |
| K171409 |
05/15/2017 |
OT EQUATOR |
Rhein'83 SRL |
Claudia Nardi |
| K171261 |
05/01/2017 |
ScannerSide DoseCheck |
Right Dose Inc. |
William Moore |
| K171594 |
05/31/2017 |
Accuro |
Rivanna Medical, LLC |
William Mauldin |
| K171436 |
05/16/2017 |
STRONG Dental Handpieces |
Saeshin Precision Co., Ltd. |
Choi Jong Woo |
| K171367 |
05/09/2017 |
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) |
Sanrea Healthcare Products Pvt Ltd |
Jose Paul M |
| K171550 |
05/26/2017 |
Sterile Latex Surgical Gloves, Powder Free |
Sanrea Healthcare Products Pvt Ltd |
Jose Paul M |
| K171529 |
05/25/2017 |
Snorer's Friend |
Scope Healthcare Technologies Pty Ltd |
Ben Olsen |
| K171537 |
05/25/2017 |
CAPI 3 Hb A1c |
Sebia |
Karen Aderson |
| K171378 |
05/10/2017 |
Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs |
SEMPERIT INVESTMENTS ASIA PTE. LTD. |
Clemens Eichler |
| K171317 |
05/04/2017 |
Clear Vinyl Powder-free Patient Examination Gloves |
Shandong Zhi Hong Medical Products, Co. Ltd. |
Jennifer Guo |
| K171460 |
05/18/2017 |
Powder-free Clear Vinyl Patient Examination Gloves |
Shandong Zhiwei Medical Products, Co. Ltd. |
Carrie Wu |
| K171578 |
05/31/2017 |
Infrared thermometer |
Shenzhen Aeon Technology Co.,Ltd. |
Applicant Wendy |
| K171430 |
05/15/2017 |
Incontinence Treatment Device, Model LT2061 |
Shenzhen Dongdixin Technology Co., Ltd |
Truman Shen |
| K171579 |
05/31/2017 |
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Yang ZhaoHui |
| K171311 |
05/02/2017 |
A5 Anesthesia System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Yanhong Bai |
| K171292 |
05/02/2017 |
A7 Anesthesia System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Yanhong Bai |
| K171381 |
05/11/2017 |
Adhesive Electrodes |
ShenZhen Quality Medical Technology Co.,Ltd |
Grace Zhao |
| K171274 |
05/01/2017 |
ADVIA Centaur High-Sensitivity Troponin I (TNIH) |
Siemens Healthcare Diagnostics Inc. |
Matthew Gee |
| K171566 |
05/30/2017 |
Atellica IM High-Sensitivity Troponin I (TNIH) |
Siemens Healthcare Diagnostics Inc. |
Matthew Gee |
| K171434 |
05/15/2017 |
ROCCIA« MultiLIF |
Silony Medical GmbH |
Bircan Yilmaz |
| K171421 |
05/15/2017 |
VERTICALE« Posterior Spinal Fixation System/VERTICALE« System |
Silony Medical GmbH |
Bircan Yilmaz |
| K171590 |
05/31/2017 |
Distal Elbow Plating System |
Skeletal Dynamics, LLC |
Ana M. Escagedo |
| K171438 |
05/16/2017 |
PalisadeÖ Pedicular Fixation System |
Spineology Inc. |
Jacqueline A. Hauge |
| K171492 |
05/22/2017 |
B7 2C Occlusion Balloon |
Spiration, Inc. |
Cheryl Frederick |
| K171287 |
05/01/2017 |
Sporview VH202 BI |
SPSmedical Supply Corp. A Division of Cantel Medical |
Brent Geiger |
| K171504 |
05/23/2017 |
VERIFY Assert VH2O2 Self-Contained Biological Indicator |
STERIS Corporation |
Anthony Piotrkowski |
| K171587 |
05/31/2017 |
VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator |
Steris Corporation |
Anthony Piotrkowski |
| K171520 |
05/24/2017 |
SteriZign Signatur Device Protection System |
SteriZign Precision Technologies, LLC |
Sonia Lutarewych |
| K171366 |
05/09/2017 |
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit |
Stimwave Technologies Inc.,DBA StimQ LLC |
Elizabeth Greene |
| K171364 |
05/09/2017 |
MP LeFort I Plates |
Stryker |
Gregory Gohl |
| K171391 |
05/11/2017 |
Stryker 90-S Max SERFAS Energy Probe |
Stryker |
Ben Krebs |
| K171465 |
05/18/2017 |
Stryker Self-Punching ICONIX |
Stryker |
Katie Farraro |
| K171496 |
05/22/2017 |
Tritanium C Anterior Cervical Cage |
STRYKER SPINE |
Deborah Cynamon |
| K171355 |
05/09/2017 |
Surefire Precision Infusion System |
Surefire Medical, Inc. |
Lynne Aronson |
| K171324 |
05/05/2017 |
Medline ReNewal Reprocessed ArthroCare ArthroWands and Smith & Nephew Dyonics |
Surgical Instrument Service and Savings Inc |
Brandi J. Panteleon |
| K171309 |
05/03/2017 |
BR-FHUS Navigation 1.0 |
TaiHao Medical Inc. |
Hsin Hung Lai |
| K171491 |
05/22/2017 |
R2P Destination Slender Guiding Sheath |
Terumo Medical Corporation |
Liang Lu |
| K171276 |
05/01/2017 |
Sterile Polyisoprene Surgical Powder Free Glove Tested for Use with Chemotherapy Drugs |
TG Medical SDN. BHD. |
Fatima Wati BT Mohamad |
| K171313 |
05/04/2017 |
EM-4000 Specular Microscope |
Tomey Corporation |
Tomoko Watanabe |
| K171481 |
05/19/2017 |
MagVita TMS Therapy System |
Tonica Elektronik A/S |
Lise Terkelsen |
| K171279 |
05/01/2017 |
Sterile Nitrile Surgical Powder Free Gloves Tested for Use with Chemotherapy Drugs and Sterile Latex Surgical Powder Free Gloves |
Top Glove SDN BHD |
Noor Akilah Bt Saidin |
| K171370 |
05/10/2017 |
IMAGEnet 6 Ophthalmic Data System |
Topcon Corporation |
James Lorkowski |
| K171488 |
05/22/2017 |
PSLT for PASCAL Streamline |
Topcon Medical Laser Systems, Inc. |
Sweta Srivastava |
| K171597 |
05/31/2017 |
Vantage Elan 1.5T, V4.0 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K171532 |
05/25/2017 |
TruBase S |
TruAbutment Inc. |
Brandon Kim |
| K171327 |
05/05/2017 |
Tyber Medical Wedge System |
Tyber Medical LLC |
Mark F. Schenk |
| K171295 |
05/02/2017 |
ULab Systems Treatment Planning Software |
ULab Systems, Inc. |
Charlie Wen |
| K171392 |
05/11/2017 |
ulrichINJECT CT motion |
ulrich GmbH & Co. KG |
Sven Erdmann |
| K171406 |
05/12/2017 |
Optum TeleHealth Application |
United Health Group Inc. |
Donald J. Matthews |
| K171303 |
05/03/2017 |
Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664 |
University of Texas Medical School at Houston, Texas |
K. Lance Gould |
| K171500 |
05/23/2017 |
Uro-V Cystoscope |
UroViu Corporation |
Thomas Lawson |
| K171335 |
05/08/2017 |
Venture 038 catheter |
Vascular Solutions, Inc. |
Beka Vite |
| DEN170030 |
05/30/2017 |
VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA a |
Ventana Medical Systems |
Carol "Penny" Houston |
| K171447 |
05/16/2017 |
OxyPure Color Silicone Hydrogel Soft Contact Lenses |
Visco Vision Inc |
Evan Huang |
| K171322 |
05/05/2017 |
eCareManager 4.1 |
Visicu, Inc. |
Daniel R. Plonski |
| K171443 |
05/16/2017 |
Etherea MX |
Vydence Medical Industria E Comercio Ltda |
Kathy Maynor |
| K171553 |
05/30/2017 |
W&H Assistina Twin |
W & H Dentalwerk Buermoos GmbH |
Mag. Anja Lindner |
| K171273 |
05/01/2017 |
LINK« BiMobile(TM) Dual Mobility System |
Waldemar Link Gmbh & Co. KG |
Stefanie Reimers |
| K171513 |
05/24/2017 |
Lunderquist Extra Stiff Wire Guide |
William Cook Europe ApS |
Henriette Stordal Christiansen |
| K171596 |
05/31/2017 |
ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle |
Wilson-Cook Medical Inc. |
Tiffanny A. Thomas |
| K171548 |
05/26/2017 |
Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter |
Wilson-Cook Medical, Inc. |
Sierra Lowe |
| K171573 |
05/30/2017 |
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush |
Wilson-Cook Medical, Inc. |
Sierra Lowe |
| K171567 |
05/30/2017 |
IRIX-A Lumbar Integrated Fusion System |
X-Spine Systems, Inc. |
Kriss Andersson |
| K171344 |
05/08/2017 |
Xenocor Xenoscope Laparoscopic System |
Xenocor, Inc |
Spencer Walker |
| K171347 |
05/08/2017 |
Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection |
Xeridiem Medical Devices |
Steve Murray |
| K171423 |
05/15/2017 |
Nasal Alar SpO2 Sensor |
Xhale, Inc |
Jeffrey Hoebelheinrich |
| K171455 |
05/17/2017 |
AT-6XX Series Infrared Thermometer |
Xiamen Acurio Instruments Co., Ltd |
Angel Liu |
| K171377 |
05/10/2017 |
Young INFINITY Cordless Handpiece System |
Young Dental Manufacturing Co 1, LLC |
Brian Prange |
| K171518 |
05/24/2017 |
Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles |
Zhejiang kindly Medical Devices Co., Ltd |
Zenghua Zhang |
| K171495 |
05/22/2017 |
Zyston Strut Open Titanium Spacer System |
Zimmer Biomet Spine Inc. |
Megan Fessenden |
