FDA 510(k) Decisions During August, 2018  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K181041 08/08/2018 7D Surgical System Cranial Application 7D Surgical Inc. Daniel Ziskind
K180040 08/24/2018 NC TREKÖ RX Coronary Dilatation Catheter; NC TREKÖ OTW Coronary Dilatation Catheter; TREKÖ RX Coronary Dilatation Catheter; TREKÖ OTW Coronary Dilatation Catheter; MINI TREKÖ RX Coronary Dilatation Catheter; MINI TREKÖ OTW Coronary Dilatation Catheter; MI Abbott Vascular Emily Zhao
K181471 08/29/2018 ACCUFUSE Cervical System Absolute Advantage Medical, LLC J.D. Webb
K181544 08/09/2018 Anchor Bolt (as an accessory to Depth Electrodes) Ad-Tech Medical Instrument Corporation Lisa Theama
K181197 08/03/2018 PHMB Foam Wound Dressing Advanced Medical Solutions Ltd. Rose Guang
K180634 08/07/2018 Surgical Silver Post Operative Dressing Advanced Medical Solutions Ltd. Rose Guang
K181035 08/24/2018 AOS Small Fragment Plating System Lite Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla
K172508 08/08/2018 Ageless Health Medical Digital Thermometer Ageless Health Industrial Co., Ltd Victor Wan
K180647 08/01/2018 BriefCase Aidoc Medical, Ltd. Anna Kuperberg
K181482 08/31/2018 myTAP2 Airway Management, Inc. Eric Jarrett
K181796 08/03/2018 FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions Alcon Laboratories, Inc. Sherri Lakota
K181853 08/08/2018 Alere BinaxNOW Influenza A & B Card 2, Alere Reader Alere Scarborough, Inc. Angela Drysdale
K182054 08/29/2018 Natrelle 133S Tissue Expander Allergan Melissa Pathmajeyan
K181435 08/21/2018 ATEC Cervical Spacer System Alphatec Spine, Inc. Cynthia Adams
K181677 08/09/2018 Kodiak Spinal Fixation System Alphatec Spine, Inc. Cynthia Adams
K180006 08/31/2018 AmCAD-UT Detection 2.2 AmCad BioMed Corporation Jack Yang
K180185 08/31/2018 BIO-C REPAIR Angelus Industria de Produtos Odontologicos S/A Paulo Sergio Calixto de Oliveria
K173658 08/21/2018 Confidence Blood Glucose Monitoring System Applied Biomedical LLC Zakir Murtaza
K182024 08/30/2018 Dissecting Balloon System Applied Medical Resources Corp. Corinne Yestrepsky
K180539 08/13/2018 Deformity Analysis and Correction Software (DACS) and Instrumentation Arrowhead Medical Device Technologies, LLC Thomas J. Twardzik
K181513 08/30/2018 Arthrex PushLock Tenodesis Anchor Arthrex Inc. Ivette Galmez
K173845 08/06/2018 Arthrex SwiveLock Arthrex Inc. David L Rogers
K181768 08/20/2018 AssureTech Panel Dip Tests, AssureTech Quick Cup Tests Assure Tech (Hangzhou) Co., Ltd. Shisheng Ling
K180155 08/03/2018 Arm Type Blood Pressure Monitor Avita Corporation Steven Jhou
K173380 08/30/2018 b-ONE« Total Hip System b-One Ortho Corp. Clark Hutton
K173531 08/02/2018 Lockbox for Perfusor Space PCA Infusion Pump B. Braun Medical Inc. Tracy Maddock
K173257 08/17/2018 BTI Dental Implant System UnicCa B.T.I. Biotechnology Institute, S.L. Fernanda O Ros
K181627 08/10/2018 Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner Bausch & Lomb Incorporated Melissa Thomas
K181306 08/17/2018 Actifuse Flow Baxter Healthcare Corporation Daniel Davis
K181225 08/31/2018 ALTAPORE Baxter Healthcare Corporation Caitlin Ziebell
K173773 08/17/2018 MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Bayer Medical Care Inc. Lisa A Ewing
K170824 08/20/2018 BD Vacutainer Eclipse Signal Blood Collection Needle Becton, Dickinson and Company Eileen Hiller
K180417 08/09/2018 Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use BERPU MEDICAL TECHNOLOGY CO., LTD Jundong Tan
K172280 08/03/2018 BH Sterilization Pouch BH Medical Products Co., Ltd. Edward Tao
K180248 08/07/2018 VascuEase IC-1200-WH Bio Compression Systems, Inc. Barbara Whitman
K181333 08/23/2018 ADVIA Centaur Herpes-1 IgG Biokit, S.A. Joan Guixer
K181334 08/23/2018 ADVIA Centaur Herpes-2 IgG Biokit, S.A. Joan Guixe
K173623 08/30/2018 Anchor plate BioMaterials Korea, Inc Jiyea Kim
K173638 08/17/2018 Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus Bionime Corporation Kay Wu
K173978 08/24/2018 CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module Biosense Webster, Inc. Phuong Chau
K173248 08/11/2018 CARDIOSKIN Bioserenity SAS Quang Tran
K180805 08/08/2018 Pure EP BioSig Technologies Tiffini Wittwer
K180943 08/17/2018 BioWaveGO Biowave Corporation Bradford Siff
K180737 08/01/2018 Ultrasound Scanner System bk2300 BK Medical ApS Susana Mogensen
K180542 08/22/2018 NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe Boston Endo Surgical Tech, James Rogers
K181439 08/23/2018 SpyGlass DS and DS II Direct Visualization System Boston Scientific Corporation Carter Navarro
DEN170078 08/17/2018 Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System Brainways Ltd. Ahava Stein
K181323 08/03/2018 Atlas Gold PTA Dilatation Catheter C. R. Bard, Inc. Aaron Conovaloff
K181804 08/02/2018 Alphenix, INFX-8000C/B, V8.0 Canon Medical Systems Corporation Paul Biggins
K181593 08/13/2018 Vantage Galan 3T, MRT-3020/A7, V5.0 Canon Medical Systems Corporation Paul Biggins
K180734 08/08/2018 SmartLinx Vitals Plus Patient Monitoring System Capsule Technologie Maylin Truesdell
K180990 08/13/2018 TirboLOX-L Lumbar IBFD Captiva Spine, Inc. Jackie Ferro
K181217 08/05/2018 VesoFlow Lite DVT Compression Device Caremed Supply, Inc. Tsung-Hsuan Liu
K173407 08/09/2018 VT - 100, VT - 200 Carilex Medical, Inc. Henry Kao
K173771 08/24/2018 IOLMaster 700 Carl Zeiss Meditec AG Christian Muenster
K181289 08/15/2018 Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System Cepheid Yi-Ping Lin
K181772 08/01/2018 NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) Ceterix Orthopaedics, Inc. Tarhan Kayihan
K181185 08/29/2018 Change Healthcare Enterprise Viewer Change Healthcare Canada Company Nadia Marchant
K180974 08/17/2018 CBit Series Digital Color Doppler Ultrasound System CHISON Medical Technologies Co., Ltd. Qifei Liu
K171245 08/09/2018 Presygen/si-1 Christie Medical Holdings, Inc. Salwa Rezk
K180764 08/01/2018 TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) Church & Dwight Co., Inc Joelle Reinson
K181007 08/02/2018 Cianna Medical SAVI Scout Reflector and SAVI Scout System Cianna Medical, Inc. Gary Mocnik
K180150 08/02/2018 PL8 Wrist Reconstruction Plate CITIEFFE S.r.l. Stefano Pullega
K182067 08/14/2018 PleuraFlow System with FlowGlide Extra Drainage Length ClearFlow, Inc. Dov Gal
K173848 08/07/2018 Model WP-3840 and WP-3040 CNMC Co., Inc. Thomas Kraus
K181500 08/15/2018 BRILLIANT Crios Coltene/Whaledent AG Daniel Meier
K181206 08/16/2018 GentleCath Glide Intermittent Urinary Catheter ConvaTec Limited Elinor Jones
K173657 08/23/2018 Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter Cook Incorporated Samuel Engelman
K181713 08/17/2018 Ultraxx Nephrostomy Balloon Catheter Set Cook Incorporated Minjin Choi
K181592 08/15/2018 RAIN Sheath Transradial Cordis Corporation Ankita Phophalia
K181836 08/08/2018 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters Cordis, a Cardinal Health Company Vidya Venkataeaghavan
K180814 08/10/2018 CoreLink« M3Ö Stand-Alone Anterior Lumbar System CoreLink, LLC Steve Mounts
K181799 08/29/2018 ResCUBEÖ Ligament Fixation System Cousin Biotech S.A.S. Mathilde Collet
K180496 08/29/2018 TruClear Elite Hysteroscope Covidien Gail Yaeker-Daunis
K181020 08/16/2018 Cytosponge Cell Collection Device Covidien llc Rachel Silva
K181219 08/03/2018 OptiPillows EPAP Mask Cpapnea Medical Supply Sal T. Hakim
K181866 08/09/2018 MotoCLIP/HiMAX Step Staple Implant System CrossRoads Extremity Systems, LLC Chad Hollis
K181562 08/02/2018 Curiteva Anterior Cervical Plate System Curiteva, LLC Eric Linder
K181549 08/03/2018 Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) Curiteva, LLC Eric Linder
K181962 08/07/2018 CubeVue CurveBeam, LLC Stuti Singh
K181582 08/27/2018 DemeTECH DemeDIOX absorbable surgical suture Demetech Corporation Linda Hernandez
K181464 08/31/2018 LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set DiaSorin Inc. John C. Walter
K173498 08/13/2018 Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack DiaSorin Molecular LLC Sharon Young
K181891 08/10/2018 Portable X-ray System (Model: MiniX-V, Mini X-S) Digimed Co., LTD. Youngbae Kwon
K181318 08/13/2018 ONIS-PACS DigitalCore Co., Ltd Lemoigne Cedric
K181234 08/07/2018 Self-adhesive Electrode Dong Guan Ou Kang Electronics CO., LTD Nianjun Liu
K172830 08/24/2018 Double Medical Femoral Nail System Double Medical Technology Inc. Yan Zuo
K181432 08/02/2018 ProVectra 3D Prime with VistaSoft Durr Dental SE Oliver Lange
K173042 08/30/2018 Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 Edan Instruments, Inc Alice Yang
K181609 08/24/2018 RadiForce GX560, GX560-AR EIZO Corporation Hiroaki Hashimoto
K181486 08/30/2018 DEKA Motus AY Elen Electronic Engineering Spa Paolo Peruzzi
K180853 08/06/2018 EP GranulesÖ BVF Elute, Inc. Kirk Andriano
K181346 08/06/2018 CystoSure Plus Catheter Emmy Medical, LLC. Ronald Adams
K181997 08/30/2018 Swiss LithoClast Trilogy EMS Electro Medical Systems SA Sonia Callegaro
K182057 08/24/2018 EasyMax BT Self-Monitoring Blood Glucose System EPS Bio Technology Corp. Cynthia Hung
K182107 08/31/2018 CarriGen PF ETEX Corporation Stacy Hutchens
K181151 08/10/2018 GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System Ethicon Inc Debbie Fazen
K173923 08/02/2018 Temporary Cardiac Pacing Wire Ethicon, Inc. Joice Pappan
K181849 08/10/2018 iStim S2 OTC Pain Relief TENS Everyway Medical Instruments CO., LDT. Paul Hung
K173193 08/08/2018 F&P SleepStyle Fisher & Paykel Healthcare Ltd Jayanti Karandikar
K173505 08/09/2018 FORA GTel Blood Glucose Monitoring System ForaCare Inc. Anne Kuo
K173608 08/17/2018 Forest Dental Unit Forest Dental Products, Inc. Erin-Kate Barton
K180341 08/03/2018 FUJIFILM 600 Series Endoscope EG-600WR v2 FUJIFILM Corporation Randy Vader
K180610 08/29/2018 Geister retractor for neuro - and spine surgery Geister Medizintechnik GmbH Christian Grotzinger
K181295 08/29/2018 Genesys Spine AIS-C Cervical Stand-Alone System Genesys Spine Benjamin V. Keller
K181791 08/21/2018 SIMPLYSTRONG, SIMPLYEZEE Genicon, Inc Katlyn Kachman
K181943 08/17/2018 OSCAR (OSCAR Prime, OSCAR Classic) Genoray Co., Ltd. Jeff Hwang
K173703 08/15/2018 Sonata Sonography-Guided Transcervical Fibroid Ablation System Gynesonics, Inc. Diane King
K173819 08/09/2018 MyPlant II Implant System Hager & Meisinger GmbH Adam Tomczak
K180644 08/10/2018 Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green Hartalega Sdn Bhd Mr. Kuan Kam Hon
K173509 08/17/2018 Biodegradable Nitrile Powder Free Examination Glove (Blue) Hartalega Sdn. Bhd. Kuan Kam Hon
K181130 08/10/2018 Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs Hebei Titans Hongsen Medical Technology Co., LTD. Shaozhang Nan
K173648 08/30/2018 Spectralis HRA + OCT and variants Heidelberg Engineering GmbH Christoph Schoess
K171977 08/02/2018 miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer Hinacom Software and Technology, Ltd Yi Isabelle Sun
K172492 08/17/2018 Optical Topography System ETG-4100 Hitachi Healthcare Americas Doug Thistlethwaite
K181676 08/15/2018 Mini Ridge Filter and auxiliary functions for PROBEAT-V Hitachi Ltd. Healthcare Hitachi Works Tomoyuki Seino
K181974 08/23/2018 MyoSure XL Tissue Removal Device for Fluent Hologic, Inc Rachelle D. Fitzgerald
K180825 08/03/2018 Fluent Fluid Management System Hologic, Inc. Christine Cameron
K180866 08/31/2018 CareSens S Fit Blood Glucose Monitoring System i-SENS, Inc. Joon Ho Jung
K181680 08/09/2018 ICONN Answer II Suture Anchor ICONN Orthopedics, LLC Whitt Israel
K170110 08/10/2018 Diana Medication Transfer Set ICU MEDICAL INC Jason Ma
K173477 08/31/2018 ChemoCLAVE Cytotoxic Medication Preparation and Delivery System ICU Medical, Inc. Catherine E. Kang
K180522 08/16/2018 IGTFusion IGI Technologies Will Plishker
K181228 08/31/2018 IlluminOss Bone Stabilization System IlluminOss Medical, Inc. Robert Rabiner
K173541 08/24/2018 EPINAUT Imedicom Co., Ltd. Priscilla Chung
K173663 08/17/2018 Electronic Stethoscope DS3011A IMEDIPLUS INC. Shirley Lai
K180169 08/08/2018 EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, Imperative Care Inc. Jake Wolenberg
K181359 08/15/2018 InterActive SMARTBase Abutments Implant Direct Sybron Manufacturing LLC Reina Choi
K181473 08/27/2018 DENV Detect NS1 ELISA InBios International, Inc. Estela Raychaudhuri
K180619 08/16/2018 Bongo InnoMed Healthscience, Inc. Javier Collazo
K181584 08/10/2018 Redi-Spine Innovative Surgical Designs, Inc. Jon Rinehart
K173516 08/17/2018 NuBorne Infant Warmer International Biomedical Amy Pieper
K181982 08/21/2018 MIDAScope and Introducer Kit, and MIDASystem IntraVu, Inc. Plamena Entcheva-Dimitrov
K180351 08/07/2018 EndoWrist Mercury Bipolar Grasper Intuitive Surgical, Inc. Vishal Kanani
K181502 08/29/2018 Zio AT ECG Monitoring System, ZEUS System iRhythm Technologies, Inc. Rich Laguna
K180775 08/17/2018 Watch-PAT300 Itamar Medical, Ltd. Koby Sheffy
K180574 08/17/2018 Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor J & J Solutions, Inc. d/b/a/ Corvida Medical Dana Schramm
K180536 08/30/2018 Neodent Implant System û GM Line JJGC Industria e Comercio de Materiais Dentarios S.A. Julianne de Oliveira Capucho Lechechem
K173024 08/22/2018 Non-invasive blood pressure measurement systems Joytech Healthcare Co.,Ltd Ren Yunhua
K180777 08/03/2018 K2M Expandable Interbody System K2M, Inc. Nancy Giezen
K180131 08/14/2018 Vicks RapidRead Digital Thermometer Kaz USA, Inc., A Helen of Troy Company Matt J. Baun
K181749 08/01/2018 SuperCable« Iso-ElasticÖ Cerclage System Kinamed, Incorporated Heather Neely
K180962 08/13/2018 KLS Martin Individual Patient Solutions KLS-Martin L.P. Jennifer Damato
K181146 08/03/2018 ASK System L and K Biomed Corporation Limited Semi Jang
K181430 08/09/2018 LENSAR Laser System - fs 3D (LLS-fs 3D) LENSAR, Inc. Keith Peck
K180907 08/03/2018 HORIZON TMS Therapy System Magstim Company Ltd. Tom Campbell
K173890 08/23/2018 GMK Sphere - Kinematic Alignment Medacta International SA Stefano Baj
K181635 08/23/2018 GMK Sphere CR Tibial Inserts Medacta International SA Stefano Baj
K181009 08/24/2018 APTUS CMC-I Fusion Plate System Medartis AG Andrea Schweizer
K181425 08/05/2018 APTUS« Proximal Humerus System Medartis AG Andrea Schweizer
K171890 08/20/2018 BEXCORE Breast Biopsy System, Biopsy Needle Medical Park CO., LTD Hye-Yeon Park
K181543 08/31/2018 CureÖ OPEL-C Plate System Meditech Spine, LLC Bruce Dunaway
K181182 08/02/2018 DYNACORD Suture Medos International SARL Tatyana Korsunsky
K181809 08/03/2018 GRYPHON« Anchors with DYNACORDÖ Suture Medos International SARL Tatyana Korsunsky
K181257 08/02/2018 PlasmaBlade X 3.0S, PlasmaBlade X 4.0 Medtronic Advanced Energy Heather Valley
K181060 08/24/2018 Solitaire 2 and Solitaire Platinum Revascularization Device Medtronic Neurovascular Amnon Talmor
K181954 08/22/2018 autoLog IQ Autotransfusion System MEDTRONIC PERFUSION SYSTEMS Sue Fidler
K182119 08/29/2018 CD HORIZONÖ Spinal System Medtronic Sofamor Danek USA, Inc. Ankit K. Shah
K181973 08/21/2018 Medtronic Model 5392 External Pulse Generator (EPG) Medtronic, Inc. Brenna Loufek
K181978 08/13/2018 ZeniusÖ, IliadÖ and KoraÖ Spinal Fixation Systems Medyssey USA, Inc. Shawn Kim
K180802 08/29/2018 Meta P&Bond META BIOMED, CO., LTD. Suk Song Oh
K170050 08/23/2018 Z-CAD smile Metoxit AG Dipl.-Ing Stefan Leyen
K163578 08/03/2018 EasyTouch Safety Pen Needle MHC Medical Products, LLC. John Edmiston
K181683 08/28/2018 BD MAX CT/GC/TV 20-Day QC Panel Microbiologics, Inc. Tina Sobania
K181711 08/15/2018 BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel Microbiologics, Inc. Tina Sobania
K181666 08/01/2018 Smart One MIR Medical International Research Gerda Van Houts
DEN170052 08/10/2018 Natural Cycles Natural Cycles Nordic AB Raoul Scherwitzl
K181483 08/27/2018 Tranquil Interbody System Nexus Spine, LLC Jared Crocker
K180186 08/23/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K180428 08/15/2018 Stat Profile Prime Plus Analyzer System Nova Biomedical Corporation Adam Heroux
K181386 08/24/2018 NuVasive Brigade Lateral System NuVasive, Incorporated Jessica Silverman
K173205 08/29/2018 Equinox Advantage O-Two Medical Technologies Inc. David Zhang
K171435 08/03/2018 VirtuOst Vertebral Fracture Assessment O.N. Diagnostics, LLC. David Kopperdahl
K173197 08/21/2018 Reusable NIBP Cuff Orantech Inc. Yunxi Xiong
K180179 08/24/2018 Firebird« Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird« NXG Spinal Fixation System; Phoenix« Minimally Invasive Spinal Fixation System; Phoenix« CDXÖ Minimally Invasive Spinal Fixation System; JANUS« Midline Fixation Screw Orthofix Inc. Jacki Koch
K181347 08/15/2018 Aries« Lumbar Interbodies Osseus Fusion Systems, LLC Robert Pace
K173575 08/17/2018 OsteoReady Dental Implant System OsteoReady LLC Robert Gottlander
K172906 08/29/2018 REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement OsteoRemedies, LLC Eric Stookey
K181977 08/14/2018 WiScope Digital Endoscope System OTU Medical Inc. Doris Dong
K180173 08/23/2018 Freespira Palo Alto Health Sciences, Inc. Simon Thomas
K180957 08/21/2018 exGraft, exGraft Carbon ePTFE Vascular Grafts PECA Labs Doug Bernstein
K182004 08/21/2018 PENTAX Medical Endoscopic Ultrasound System PENTAX of America, Inc. William Goeller
K173761 08/17/2018 Penumbra System Reperfusion Catheter JET 7 Penumbra, Inc. Michaela Mahl
K181479 08/03/2018 Ingenia Ambition S and Ingenia Ambition X Philips Medical Systems Nederland B.V. Jan Van de Kerkhof
K181830 08/02/2018 Azurion R2.0 Philips Medical Systems Nederland BV Owen Callaghan
K181966 08/17/2018 SmartPerfusion Philips Medical Systems Nederlands B.V. Chandrika Srinivasan
K181797 08/03/2018 Philips CT Big Bore Sliding Gantry Configuration Phillips Medical Systems (Cleveland) Inc. Michael Chilbert
K180234 08/10/2018 physiQ Heart Rhythm Module physiQ Inc. George Allen Hides
K181253 08/10/2018 Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup PJM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC Ira Nusbaum
K181983 08/17/2018 PreXion 3D Excelsior PreXion Corporation Katsumi Hayashi
K171549 08/31/2018 Intelligent Mesh Nebulizer Qingdao Future Medical Technology Co., Ltd. Wang WeiLai
K181313 08/27/2018 BenQ Diagnostic Ultrasound System Qisda Corporation Johnson Sheu
K171547 08/02/2018 Qualisys Clinical System Qualisys AB Henrik Wiberg
K173496 08/30/2018 Sofia 2 Lyme FIA, Sofia Lyme Control Set Quidel Corporation Jennifer S. Rial
K180770 08/01/2018 Propeller Sensor for Neohaler Reciprocal Labs Corporation David Hubanks
K181968 08/20/2018 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card Safecare Biotech(Hangzhou)Co.,Ltd. Alex Qiu
K181828 08/07/2018 Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile Scientia Vascular LLC David Sabodski
K181414 08/14/2018 uCT 530, uCT 550 Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K181104 08/29/2018 Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style Shenzhen Combei Technology CO., LTD Kevin Fong
K173454 08/16/2018 Multi-parameter Patient Monitor, models C30 Shenzhen Comen Medical Instruments Co.,Ltd. Hongbo Yan
K173368 08/31/2018 Reusable & Disposable SpO2 Sensors Shenzhen Coreray Technology, Ltd. Simon Fan
K173123 08/13/2018 Pulse Oximeter Shenzhen IMDK Medical Technology Co., Ltd. Xia Yuan
K173869 08/02/2018 Med-link Reusable Blood Pressure Cuff Shenzhen Med-link Electronics Tech Co., Ltd Baihan Feng
K180073 08/29/2018 Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set Shenzhen Vitavitro Bio-tech Co., Ltd Jenny Lin
K181407 08/15/2018 Artis zee/zeego & Artis Q/Q.zen Siemens Medical Solution USA, Inc. Patricia D. Jones
K181767 08/17/2018 Cios Select Siemens Medical Solutions USA, Inc. Patricia D. Jones
K181074 08/17/2018 Simple Science Antimicrobial Facial and Eyelid Cleanser Simple Science LLC Eoin Croke
K180221 08/08/2018 Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs Smart Glove Corporation Sdn.Bhd Foo Khon Pu
K173461 08/03/2018 ECG recorder and Arrhythmia Detector Smart Solutions Technologies SL Daniel Llorca
K180698 08/21/2018 PICO 7 Single Use Negative Pressure Wound Therapy System Smith & Nephew Medical Limited Lavinia Tompkins
K181533 08/09/2018 EVOS Wrist Fracture Plating System Smith & Nephew, Inc. Bryan Cowell
K173784 08/23/2018 Smylic Invisible Clear Aligners Smylio, Inc Ken Menon
K173844 08/09/2018 Titan Ag 200 Specialty Fibres and Materials Ltd Lindie Marx
K181923 08/17/2018 Quantum Workstation 12.1 Spectrum Medical Ltd Colleen Powell
K181792 08/14/2018 DuoÖ Lumbar Interbody Fusion Device Spineology Inc. Karen Roche
K181480 08/01/2018 MMD Tip Strata Skin Sciences, Inc. Shmuel Gov
K180834 08/10/2018 Altrix Precision Temperature Management System Stryker Medical Brian Orwat
K181308 08/15/2018 SuperGrow 272, Ultimate 272 Super Grow Lasers Jeffrey Stanifer
K181094 08/02/2018 Polydioxanone Surgical Scaffold Surgical Innovation Associates, Inc. Alexei Mlodinow
K180077 08/16/2018 NeuroQ 3.8 Syntermed Kenneth Van Train
K181400 08/21/2018 H. PYLORI CHEKÖ TECHLAB, Inc. Donna T. Link
K181379 08/21/2018 H. PYLORI QUIK CHEK TECHLAB, Inc. Donna T. Link
K173280 08/02/2018 Neonatal ConchaSmart Breathing Circuits Teleflex Medical, Inc Brian Gall
K181367 08/28/2018 Tenex Health TX System Tenex Health, Inc. David Vancelette
K181237 08/03/2018 Glidesheath Slender Tibial Pedal Kit Terumo Medical Corporation Liang Lu
K173732 08/23/2018 Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit The Binding Site Group Ltd Christopher Bradshaw
K181946 08/08/2018 Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL Thermo Fisher Scientific Cynthia Knapp
K180850 08/20/2018 re.t.a Reuseable Tampon Applicator Thinx, Inc. Kerrie Timmons
K173620 08/14/2018 Mag Vita TMS Therapy System w/Theta Burst Stimulation Tonica Elektronik A/S Sanne Barsballe Jessen
K173918 08/17/2018 VersaPAP Positive Airway Pressure (PAP) Device Trudell Medical International Marianne Tanton
K180759 08/09/2018 SECULOKÖ Suture Anchor U & I Corporation Bo-Ram Kang
K180075 08/06/2018 MINUET LCD, MINUET LCD eco Unimom Co. Hong Sang-Hyun
K180598 08/08/2018 UNIQA Dental Implants System UNIQA DENTAL LTD Dima Goberman
K181408 08/27/2018 JO Classic Hybrid Personal Lubricant United Consortium Stephanie Morris
K180888 08/30/2018 LYFT Uplevity, Inc. Thomas Kraft
K181909 08/16/2018 Luminelle DTx Hysteroscopy System UVision360 Inc. Allison London Brown
K173549 08/13/2018 BIAFINE Valeant Pharmaceuticals Melissa Thomas
K173952 08/28/2018 Universal SmartECG VectraCor, Inc. Andrew Schreck
K181262 08/30/2018 SpineJack Expansion Kit Vexim SA Vincent Gardes
K181218 08/07/2018 AlignRT Plus Vision RT Ltd Chris Hannan
K180703 08/01/2018 VITA YZ ST and VITA YZ XT VITA Zahnfabrik H.Rauter GmbH Co. Bernd Walker
K181013 08/21/2018 Fever Scout VivaLnk Inc. Christine Kuo
K181312 08/22/2018 GrandioSO x-tra VOCO GmbH M. Th. Plaumann
K181940 08/17/2018 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement W. L. Gore & Associates, Inc. Michael J. Titus
K173673 08/24/2018 AcuSnare Polypectomy Snare Wilson-Cook Medical, Inc Theresa de Prat
K181557 08/09/2018 INFINITY Total Ankle System Wright Medical Technology, Inc. Tara Conrad
K180373 08/24/2018 CancelleX Porous Titanium Lumbar Interbody Device Xenco Medical, LLC. Gustavo R. Prado
K171377 08/20/2018 Young INFINITY Cordless Handpiece System Young Dental Manufacturing Co 1, LLC Brian Prange
K181740 08/29/2018 ZELTIQ CoolSculpting System ZELTIQ Aesthetics, Inc. Ewald Riechert
K181149 08/03/2018 Therm-X Pro, Therm-X AT, Therm-X Pro Athlete Zenith Technical Innovations Greg Binversie
DEN170090 08/23/2018 MATRx plus Zephyr Sleep Technologies Sabrina Bruehlmann
K181069 08/28/2018 Disposable Insulin Pen Needle Zhejiang Kindley medical devices Co.,Ltd Yong Zhang


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