FDA 510(k) Decisions During July, 2020  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K200496 07/24/2020 Aer X 3B Medical Inc. Yasser Estafanous
K200766 07/02/2020 3M Attest Steam Chemical Integrator Test Pack 3M Company Mary Fretland
K201834 07/30/2020 HI-TORQUE PROCEED Guide Wire Family Abbott Vascular Charlotte Pullman
K200387 07/21/2020 Ace Medical Surgical Instruments Ace Medical Alex Ebner
K192231 07/08/2020 Dental Glass Ceramics Blocks Aidite (Qinhuangdao) Technology Co., Ltd. Zhang Wei
K200218 07/13/2020 Digiscan FDX Allengers Medical Systems Limited Sanjeev K. Marjara
K200248 07/01/2020 Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators Allwin Medical Devices, Inc. Digish Mehta
K200450 07/10/2020 X-Cube 70 Alpinion Medical Systems Co., Ltd. Boyeon CHO
K200449 07/10/2020 X-Cube 90 Alpinion Medical Systems Co., Ltd. Boyeon Cho
K201098 07/17/2020 Ambu Duodeno System Ambu Innovation GmbH Oliver V Ruepprecht
K200531 07/15/2020 iHealth Infrared No-Touch Forehead Thermometer Andon Health Co., Ltd. Liu Yi
K200413 07/29/2020 Symphony Aroa Biosurgery Ltd. Tina O'Brien
K201132 07/27/2020 Arthrex Compression Screws Arthrex Inc. Samantha Passman
K193345 07/08/2020 Arthrex DynaNite Compression Plate Arthrex Inc. Rebecca R. Homan
K201235 07/06/2020 Arthrex MaxForce MTP Compression Plates and Screws Arthrex Inc. Rebecca R. Homan
K201786 07/30/2020 Arthrex Mini Hip PushLock Arthrex Inc. Kelsey Roberts
K193575 07/24/2020 Arthrex SutureTape Arthrex Inc. Ivette Galmez
K201542 07/08/2020 Arthrex Eclipse Shoulder Prosthesis System Arthrex, Inc. David L Rogers
K200674 07/02/2020 AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector Atrility Medical, LLC Matthew Knoespel
K200568 07/10/2020 B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System B & J Manufacturing Ltd Billy Yu
K200154 07/08/2020 B&J DVT Compression Devices MHH800/MHH800SQ B & J Manufacturing Ltd. Billy Yu
K192366 07/20/2020 Intravascular Extension Sets and Accessories Baxter Healthcare Corporation Gary Chumbimune
K200280 07/30/2020 MEDRAD Imaging Bulk Package Transfer Spike Bayer Medical Care Inc. Leslie S O'Nan
K201234 07/15/2020 BD SoloShot Mini Syringe/ BD Auto Disable Syringe Becton, Dickinson, and Company Avital Merl
K201243 07/10/2020 Disposable Specimen Retrieval Bag Beijing Biosis Healing Biological Technology Co., Ltd. Jiali Zhou
K192880 07/02/2020 InferRead Lung CT.AI Beijing Infervision Technology Co.,Ltd. Xiaoyan Fan
K193172 07/02/2020 Luna XD Ti Interbody Fusion System Benvenue Medical, Inc. Laurent Schaller
K200959 07/29/2020 Biolox« delta Ceramic Heads, Biolox« delta Option Ceramic Heads MR Labeling Biomet UK Ltd. Caleb Barylski
K193237 07/31/2020 Carto Octaray Mapping Catheter with Trueref Technology Biosense Webster, Inc. Richard Lauhead
K201040 07/29/2020 Bioflux Software II Biotricity Spencer LaDow
K201833 07/31/2020 BiPad Hand Activated, Disposable Bipolar Electrocautery Cords BiPad Surgical, Inc. Louis Cornacchia
K201751 07/22/2020 Pedicle Screw System Black Box Medical LLC Todd Stanaford
K201713 07/23/2020 AVVIGO Guidance System Boston Scientific Corporation Kevin Catalano
K201792 07/28/2020 TRUSELECT Microcatheter Boston Scientific Corporation Aoife Tobin
K201276 07/13/2020 ExacTrac Dynamic Brainlab AG Chiara Cunico
K200818 07/17/2020 3DMax MID Anatomical Mesh C.R. Bard, Inc. Shannon Green
K193603 07/20/2020 Benesta Medical Sterilization Tray Caldera Medical, Inc Vicki Gail
K201122 07/23/2020 Canon non-mydriatic retinal camera CR series Canon Inc. Akira Hirai
K193097 07/14/2020 Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation Paul Biggins
K200856 07/10/2020 SmartLinx Vitals Plus Patient Monitoring System Capsule Technologie SAS Peter Kelley
K200621 07/22/2020 Caption Interpretation Automated Ejection Fraction Software Caption Health Sam Surette
K191101 07/31/2020 Kendall NPWT Incision Management Dressing Kit Cardinal Health Christine Kuntz-Nassif
K200824 07/29/2020 Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown Cardinal Health 200, LLC Caroline Miceli
K200584 07/31/2020 xPORT 304 (miCOR) System Lens Fragmentation System Carl Zeiss Meditec Cataract Technology Inc Gary Mocnik
K200894 07/02/2020 Agape Cooling Personal Lubricant CC Wellness LLC Marlent Perez
K193450 07/23/2020 Pre-SeedÖ Fertility Lubricant Church & Dwight Co., Inc. Joelle Reinson
K201898 07/31/2020 Clear Guide SCENERGY Clear Guide Medical Jack Kent
K193380 07/20/2020 CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set Codman & Shurtleff, Inc. Kirsten Franco
K200142 07/30/2020 SpeediCath Soft Coloplast Delaney McDougal
K201593 07/08/2020 Looking Glass 4K Integrated Visualization System ConMed Corporation Kavita Amin
K201000 07/13/2020 Biodesign Staple Line Reinforcement Cook Biotech Incorporated Nick Wang
K201851 07/30/2020 EXULT Femoral component trial - Left, EXULT Femoral component trial - Right Corentec Co., Ltd Sungwon Yang
K201672 07/17/2020 Signia Stapler (with new software) Covidien Katherine Y Choi
K201179 07/20/2020 GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable Covidien llc Ligia Mastronardi
K200427 07/10/2020 Sonicision Cordless Ultrasonic Dissector Covidien, llc Celso Duran
K200039 07/31/2020 P pro Crown & Bridge DeltaMed GmbH Michael Zimmerman
K201479 07/24/2020 DemeMASK DemeTECH Corporation Tracy Chadwrick
K191152 07/06/2020 MIS Ti-base Abutment Dentsply Sirona Karl Nittinger
K201321 07/24/2020 DePuy Synthes 2.7mm VA LCP Clavicle Plate System DePuy Synthes Stacey Bonnell
K201442 07/31/2020 Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers Diatron Group Frank Matuszak
K192847 07/21/2020 AUTOLIGN Diorco Co., Ltd. Yongkyu Jin
K190790 07/31/2020 Flex Fit DK Mungyo Corporation Kang Nae In
K193628 07/12/2020 AGE Automatic Wrist Blood Pressure Monitor Dongguan E-Test Technology Co., Ltd Victor Wan
K193624 07/10/2020 Automatic Upper Arm Blood Pressure Monitor Dongguan E-Test Technology Co., Ltd Victor Wan
K193627 07/12/2020 Automatic Upper Arm Blood Pressure Monitor Dongguan E-Test Technology Co., LTD Victor Wan
K201069 07/31/2020 VibrantVue Scleral Saline Dry Eye Innovations, LLC Donald R. Sanders
K200654 07/22/2020 Rubicon SA System Dymedix Diagnostics, Inc. Jim Moore
K201365 07/17/2020 True 3D Viewer EchoPixel, Inc. Michael Gabler
K200655 07/16/2020 FibroScan« 630 Echosens Karine Bonenfant
K201605 07/15/2020 EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage EIT Emerging Implant Technologies GmbH Barbara Wirth
K200355 07/22/2020 Duranext Abutments Elegant Dental Corp. Gary Fingerman
K201018 07/15/2020 Encision AEM enTouch 2X Scissor Encision Inc. Pete Geary
K201280 07/27/2020 Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed Ethicon Endo-Surgery LLC Nathan Anderson
K201556 07/08/2020 Intraosseous Fixation System Extremity Medical, LLC. Mary Hoffman
K192969 07/10/2020 Ezra Plexo Software Ezra AI Inc. David Girard
K200803 07/31/2020 BEAR and BEAR mini FOREO, Inc. Laura HoShue
K192928 07/09/2020 Optiflux Enexa F500 Dialyzer Fresenius Medical Care Reanal Therapies Group LLC Denise Oppermann
K200850 07/06/2020 Fujifilm Ultrasonic Processor FUJIFILM Corporation Randy Vader
K191146 07/15/2020 Humelock TiN Coated Glenosphere FX Shoulder USA, Inc. Kathy Trier
K191698 07/16/2020 TiN Coated Humeral Head FX Shoulder USA, Inc. Kathy Trier
K200061 07/09/2020 HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) Galil Medical Inc. Amy Mckinney
K193484 07/02/2020 GC Fuji Triage EP GC America Inc. Mark Heiss
K193113 07/09/2020 GC Temp Print GC America Inc. Mark Heiss
K200138 07/01/2020 Versana Premier GE Medical Systems Ultrasound and Tracey Ortiz
K200743 07/23/2020 Vivid E80/ Vivid E90/ Vivid E95 GE Medical Systems Ultrasound and Tracey Ortiz
K200497 07/16/2020 Vivid S60N, Vivid S70N GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz
K201279 07/10/2020 ASSISTO Universal Applicator Clamping Device Geomed Medizin-Technik GmbH & Co. KG Hanno Haug
K200047 07/10/2020 ExcelsiusGPS Cranial 1.0 Module Globus Medical Inc. Jennifer Antonacci
K201087 07/31/2020 CORBEL Spacers Globus Medical, Inc. Jennifer Antonacci
K183471 07/02/2020 IC-WHCD100 (Inspire) Good Doctors Co.,Ltd. Sungro Joo
K191875 07/20/2020 Owgels Oxygen Concentrator Guangzhou Life Light Electronic Technology Co., Ltd. Erika Meng
K193272 07/09/2020 GTK Trocars Guangzhou TK Medical Instrument Co., Ltd. Tracy Weng
K193528 07/22/2020 Empty EVA Bag Haemotronic, Spa Paola Franciosi
K201299 07/10/2020 HD Steth HD Medical, Inc. Stephanie Anderson
K200498 07/17/2020 SCENARIA View Hitachi Healthcare Americas Aaron Pierce
K201042 07/13/2020 PROBEAT-CR Hitachi Ltd. Tomoyuki Seino
K201343 07/10/2020 Triathlon Total KneeSystem Howmedica Osteonics Corp. dba Stryker Orthopaedics Shikha Khandelwal
K192294 07/31/2020 I Do I Do Biotech Co., Ltd Jae-Hyung Song
K201798 07/17/2020 myQA iON IBA Dosimetry GmbH Andreas Suchi
K193417 07/30/2020 FractureDetect (FX) Imagen Technologies, Inc. Robert Lindsey
K200801 07/28/2020 Quantisal Oral Fluid Collection Device Immunalysis Corporation Wenying (Jessica) Zhu
K201149 07/15/2020 CoLink Plating System In2Bones USA, LLC Christine Scifert
K200203 07/10/2020 Infrascanner InfraScan, Inc. Baruch Ben Dor
K201150 07/22/2020 InMode RF Multi-System InMode Ltd. Amit Goren
K200947 07/02/2020 InMode System with the Morhpeus8 Applicators InMode Ltd. Amit Goren
K201621 07/15/2020 Magicore II System InnoBioSurg Co., Ltd. Bo-Yeon Lim
K201614 07/15/2020 TxTiHA IBF System, AxTiHA Stand-Alone ALIF System Innovasis, Inc. Marshall McCarty
K192998 07/22/2020 Reprocessed BRK Transseptal Needle Innovative Health, LLC. Amanda Babcock
K200060 07/30/2020 Reprocessed NRG Transseptal Needle Innovative Health, LLC. Rick Ferreira
K201780 07/22/2020 True Tulip System, True M.I.S. System Innovative Surgical Designs, Inc. Jon Rinehart
K201676 07/16/2020 Barricaid Instrument Tray Intrinsic Therapeutics, Inc. Regina Shih
K201296 07/09/2020 i-Rapha Solution IRM Inc Kim Yun Ik
K200941 07/09/2020 Rapid LVO iSchemaView Inc. Jim Rosa
K192385 07/02/2020 ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable ivWatch, LLC Holly Novak
K193526 07/17/2020 Syringe with safety needle, Safety needle Jiangsu Caina Medical Co., Ltd Jianwei Pan
K193022 07/20/2020 Retractable Safety Insulin Syringe Jiangsu Caina Medical Co.,Ltd. Xinyan Ruan
K192681 07/28/2020 Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) Jiangsu Kangbao Medical Experiment Co., Ltd. Rujun Tang
K200561 07/01/2020 StimPlus Patch, StimPlus Patch, StimPlus Patch JKH Health Co., LTD Pu Jiang
K192663 07/30/2020 Joimax Intracs System joimax GmbH Gary Mocnik
K200599 07/08/2020 Digital Thermometer Joytech Healthcare Co., Ltd Ren Yunhua
K201355 07/22/2020 Endomat Select, IBS Shaver Software, License Karl Storz SE & Co. KG Alexey Davidov
K201571 07/08/2020 ACTIV.A.C. Negative Pressure Wound Therapy System KCI USA, Inc Jesus Valencia
K192386 07/16/2020 KeraStat Cream KeraNetics Luke Burnett
K201660 07/16/2020 KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System Kyocera Medical Technologies, Inc. Anthony DeBenedictis
K192481 07/28/2020 AccelFix Lumbar Plate System L&K Biomed Co., Ltd. KiHyang Kim
K200464 07/23/2020 LG Pra. L Derma LD Scalp Care LG Electronics, Inc. Eunmi Ji
K201338 07/13/2020 Allograft MIS Delivery System LifeNet Health Brittany Beasley
K200690 07/15/2020 LifeSignals ECG Remote Monitoring Patch Platform LifeSignals, Inc. Saravanan Balasubramanian
K200656 07/08/2020 Delta Multihole TT Pro Acetabular System Limacorporate S.P.A. Michela Zanotto
K193259 07/02/2020 Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer Little Doctor Electronic (Nantong)Co.,Ltd Iris Du
K201663 07/16/2020 AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories Lumenis Ltd. Shlomit Segman
K193515 07/14/2020 Mako Total Knee Application Mako Surgical Corp. Shikha Khandelwal
K200504 07/29/2020 BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote MED-EL Elektromedizinische Geraete GmbH Carolin Ralser
K193559 07/10/2020 NextAR TKA Platform Medacta Inernational SA Stefano Baj
K200960 07/13/2020 Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) Medline Industires, Inc. Adam Ostrower
K200791 07/31/2020 Navigation Enabled Intruments Medos International, SARL Daria Bochenek
K200795 07/03/2020 LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit Medtronic, Inc. Eric Kalmes
K201449 07/01/2020 SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring Medtronic, Inc. Lisa Corbin
K193392 07/20/2020 BioSiCar Silicone Implant Metalware Technology Corp. Megan Chang
K201690 07/21/2020 Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Prerana Gurubasavaraj
K201689 07/21/2020 Riptide Aspiration System Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Kristy Ann Darling
K201487 07/02/2020 Traxcess 7 Mini Guidewire Micro Vention Inc. Ganesh Balachandar
K193601 07/24/2020 Single Use Electrosurgical Knife Micro-Tech (Nanjing) Co., Ltd. Sally He
K201488 07/17/2020 Rover Micro-X Ltd. Mark Norman
K200738 07/23/2020 Microlife Upper Arm Automatic Digital Blood Pressure Monitor Microlife Intellectual Property GmbH Gerhard Frick
K193607 07/21/2020 BOBBY Balloon Guide Catheter MicroVention, Inc. Stephanie Onstot
K193252 07/02/2020 Contour ProtegeAI MIM Software Inc. Lynn Hanigan
K201575 07/08/2020 CMDR 2C (Multiple Models) MinXray, Inc Keith Kretchmer
K182759 07/29/2020 BoniPlus Dental G-Mesh System MontJade Engineering Co., Ltd. Yu Sheng Lin
K200082 07/30/2020 BD Univia RightFit Enteral Extension Sets and Transitional Adapters MPS Medical, Inc. Barry Kazemi
K193321 07/30/2020 MY01 Continuous Compartmental Pressure Monitor MY01, Inc. Charles Allan
K201618 07/15/2020 Nalu Neurostimulation SCS system Nalu Medical, Inc Michele Chin-Purcell
K200742 07/24/2020 JUSHA-CP610 LCD Monitor Nanjing Jusha Display Technology Co., Ltd. Zilong Liang
K200805 07/28/2020 Neocis Guidance System (NGS) with Patient Splints Neocis Inc. Thomas E. Claiborne
K201837 07/31/2020 UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge NeoTract, Inc. Brian Gall
K193063 07/14/2020 EMBOTRAP III Revascularization Device Neuravi, Ltd. Niall Fox
K200927 07/24/2020 Transept Cervical Plate System Neurostructures, Inc. Moti Altarac
K200785 07/27/2020 StratumÖ Reduced Size Foot Plating System Nextremity Solutions, Inc. Adam Finley
K193456 07/16/2020 Arm Blood Pressure Monitor Ningbo Ranor Medical Science & Technology Co., Ltd. Emma Hu
K200578 07/16/2020 Infrared Thermometer Model Number RN-50A,RN-50B Ningbo Ranor Medical Science & Technology Co., Ltd. Emma Hu
K201272 07/16/2020 Geneva Nucletron BV Rigo Meens
K201543 07/30/2020 MAGEC« System NuVasive Specialized Orthopedics, Inc. Ivanna Lopez
K192669 07/24/2020 Extremely Thin 003, ZERO ZERO THREE Okamoto U.S.A., Inc. Yu Tadano
K192793 07/17/2020 Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I Olympus Medical Systems Corp. Toshiyuki Nakajima
K201200 07/22/2020 Visera Elite II Video System Center Olympus Medical Systems Corp. Toshiyuki Nakajima
K200542 07/17/2020 Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head Olympus Medical Systems Corp. Toshiyuki Nakajima
K200325 07/14/2020 Orbit Subretinal Delivery System Orbit Biomedical Stacey Backlund
K201794 07/28/2020 Jade OrbusNeich Medical (Shenzhen) Co., Ltd. Daniel Zhang
K200680 07/17/2020 Synvitro Hyadase Origio a/s, a CooperSurgical Company Monika Bak
K193660 07/30/2020 OSSIOfiberÖ Compression Screws Ossio Ltd. Taly Lindner
K200330 07/06/2020 RC-Prime Root Canal Preparation Cream Pac-Dent, Inc Daniel Wang
K201005 07/15/2020 FullFocus Paige.AI, Inc Jillian Sue
K193520 07/23/2020 EVA 15 Insufflator Palliare Ltd. John O'Dea
K192994 07/10/2020 Paragon 28 APEX 3D Total Ankle Replacement System Paragon 28, Inc. Eric Lintula
K201227 07/17/2020 Phantom« Hindfoot TTC/TC Nail System Paragon 28, Inc. Haylie Hertz
K201048 07/02/2020 SherpaPak Pediatric Liver Transport System Paragonix Technologies Lisa Anderson
K201083 07/23/2020 Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors Parcus Medical, LLC Paul Vagts
K200409 07/10/2020 Pelvital System Pelvital USA, Inc. Dale Wahlstrom
K200090 07/23/2020 PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) PENTAX of America, Inc. William Goeller
K200678 07/30/2020 PENTAX Medical Video Bronchoscope EB-J10 Series PENTAX of America, Inc. William Goeller
K201725 07/10/2020 DigitalDiagnost C50 Philips Healthcare (Suzhou) Co., Lit. Claire Zhang
K201640 07/09/2020 DuraDiagnost Philips Healthcare (Suzhou) Co., Ltd. Mary Zhu
K200513 07/22/2020 DAC Dynamic Active Compression Plate Pioneer Surgical Technology, Inc., DBA RTI Surgical Linda Busklein
K193204 07/17/2020 Cryocheck Chromogenic Factor VIII Precision BioLogic Karen Black
K192411 07/02/2020 Psoria-Shield AURORA Psoria-Shield John Yorke
K200652 07/06/2020 Lollipop BiteBlock RadTec Medical Devices, Inc. Ross Holman
K201796 07/23/2020 1717SCV, 1717SGV Rayence Co., Ltd. Kee Dock Kim
K201186 07/30/2020 KY Grosz Jelly RB Health (US) LLC Elizabeth Viguerie
K200849 07/24/2020 Tempus LS - Manual Remote Diagnostic Technologies, Ltd, a Philips Company Martin Newman
K201389 07/10/2020 Resoundant Acoustic Driver System Resoundant Inc John Hartigan
K200480 07/10/2020 DreamStation 2 System, DreamStation 2 Advanced System Respironics, Inc. Andy Zaltwanger
DEN200015 07/30/2020 cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit Roche Molecular Systems, Inc. Rita Hoady
K200518 07/29/2020 Pitkar External Fixation System - Rail Mechanism S H Pitkar Orthotools Pvt Ltd Vivek Mangalwedhekar
K192561 07/13/2020 TRAUS SUS20 Saeshin Precision Co., Ltd. DongHa Lee
K201648 07/30/2020 SterispineÖ PS Safe Orthopaedics Pierre Dumouchel
K200832 07/30/2020 Safey Peak Flow Meter Safey Medical Devices Pvt Ltd Taher Ali Moiyed
K201002 07/30/2020 Safey Pocket Spirometer Safey Medical Devices Pvt Ltd Taher Ali Moiyed
K201760 07/29/2020 Zoom 14 Guidewire Scientia Vascular LLC Amy McManus
K201293 07/24/2020 Ureterorenoscope System Shanghai AnQing Medical Instrument Co., Ltd. Shuwen Fan
K201109 07/15/2020 CO2 Laser Therapy System Shanghai Apolo Medical Technology Co., Ltd. Felix Li
K193073 07/06/2020 Deep Recon Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang
K201540 07/06/2020 uMR570 Shanghai United Imaging Healthcare Co.,Ltd. Xin GAO
K200637 07/09/2020 SR-8100 Portable X-ray Unit Shantou Institute of Ultrasonic Instruments Co., Ltd. (SIUI) Flower Cai
K201599 07/02/2020 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ Shenzhen Beacon Display Technology Co., Ltd. Fu Ailing
K193625 07/24/2020 Disposable Temperature Probe Shenzhen Changke Connect Electronics Co., Ltd. Yahui Zhou
K200643 07/24/2020 Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous Shenzhen Mindray Bio-Medical Electronics Co., LTD Jiang Xiaoyong
K200836 07/22/2020 8ch Flex Suite Shenzhen RF Tech Co., Ltd. Gary Wang
K192499 07/31/2020 Cyber Blade Sidam s.r.l Andrea Tromba
K201477 07/01/2020 syngo.via View&GO Siemens Healthcare GmbH Elango Alampalayam Rangappan
K193283 07/30/2020 AI-Rad Companion Prostate MR Siemens Medical Solutions USA Inc. Lauren Bentley
K193294 07/10/2020 AI-Rad Companion Engine Siemens Medical Solutions USA, Inc. Lauren Bentley
K193277 07/22/2020 SOMATOM On.site and On.scene Siemens Medical Solutions USA, Inc. Alaine Medio
K201951 07/31/2020 Cemented Origin Hip Stem Signature Orthopaedics Pty Ltd. Declan Brazil
K201662 07/16/2020 REDUCT« Headless Compression Screw System Skeletal Dynamics, Inc. Diana Taylor
K200392 07/07/2020 REXSIN SM ENG CO., LTD Soon-Gu Lee
K201198 07/17/2020 S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable Smith & Nephew Janice Haselton
K201349 07/20/2020 Smith+Nephew Arthroscopes Smith & Nephew Katheen Solomon
K201527 07/22/2020 EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) Smith & Nephew, Inc. Kayla Franklin
K201597 07/31/2020 Liver Incytes, Model 1005 Sonic Incytes George Aliphtiras
K201059 07/30/2020 S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System Sonoscape Medical Corp. Toki Wu
K201434 07/28/2020 Connected OR Hub with Voice Control, Connected OR Hub with Device Control Stryker Meagan Jones
K200880 07/01/2020 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System Stryker GmbH Jackie Perri
K201511 07/31/2020 Reprocessed Endoscopic Trocars and Sleeves Stryker Sustainability Solutions Ramona Kulik
K200869 07/22/2020 Gamma3 System Stryker Trauma GmbH Sanja Jahr
K201699 07/22/2020 Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Surgical Instrument and Savings Inc (dba Medline ReNewal) Stephanie Boyle Mays
K201465 07/17/2020 SuRgical Planner (SRP) BrainStorm Surgical Theater, Inc. Kevin Murrock
K193647 07/29/2020 Superpipe Angiographic Catheter Suzhou Hengrui Disheng Medical Co.,Ltd. Li Ling
K201616 07/28/2020 SyMRI SyntheticMR AB Raymond Kelly
K201633 07/02/2020 Terason uSmart 3200T Plus Ultrasound System Teratech Corporation Benjamin Chiampa
K201035 07/09/2020 ETHICON Linx Esophagus Sizing Tool Torax Medical, Inc. Joseph Ciccone
K200242 07/27/2020 StaClear Syringe TriboFilm Research, Inc. Jackson Thornton
K200063 07/17/2020 AeroEclipse* ONE BAN Trudell Medical International Marianne Tanton
K200537 07/03/2020 Oxxiom True Wearables, Inc. Marcelo Lamego
K192872 07/02/2020 ulrichINJECT CT Motion ulrich GmbH & Co. KG Sven Erdmann
K201607 07/10/2020 Eclipse Treatment Planning System v16.1 Varian Medical Systems, Inc Peter J. Coronado
K201216 07/08/2020 CAPERE Thrombectomy System Vascular Medcure, Inc. Jeffrey P. DuMontelle
K200955 07/08/2020 Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch Vascutek Ltd Heidi Forsyth
K200285 07/02/2020 VenaOne Vena Group, LLC Kasey Vukson
K192511 07/22/2020 Venner PneuXÖ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuXÖ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuXÖ TT (Tracheostomy Tube) Size 9.0 mm Venner Medical (Singapore) PTE Ltd Adrian P Waterton
K201064 07/15/2020 V30 System, V20 System, V10 System, V-FR Handpiece Viora Ltd. Simona F. Krant
K201080 07/15/2020 Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens Visco Vision Inc Evan Huang
K193434 07/21/2020 VITA LUMEX AC VITA Zahnfabrik GmbH H Rauter & Co Bernd Walker
K200550 07/27/2020 Vitalograph Model 2120 In2itive eDiary Vitalograph Ireland Ltd. Tony O'Hanlon
K201307 07/08/2020 VisCalor VOCO GmbH M. Th. Plaumann
K201361 07/29/2020 PNEUMOCLEAR W.O.M. WORLD OF MEDICINE GmbH Soeren Markworth
K201364 07/17/2020 LINK TrabecuLink Femoral Cones Waldemar Link GmbH & Co. KG Stefanie Fuchs
K200383 07/21/2020 Wiggins Medical Surgical Instruments Wiggins Medical Alex Ebner
K201406 07/22/2020 Picowon WON TECH Co., Ltd. Jake Yu
K201586 07/09/2020 XACT Robotic System XACT Robotics Ltd. Chen Levin
K200905 07/16/2020 HealthMammo Zebra Medical Vision Ltd. Flair Bar
K191449 07/16/2020 ZCA All-Poly Acetabular Cups Zimmer, Inc. Caleb Barylski
K200823 07/09/2020 Zimmer, Inc. Hip Joint Prostheses MR Labeling I Zimmer, Inc. Caleb Barylski
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