FDA 510(k) Applications Received During May, 2017

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
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
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
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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact