| 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 Equipment 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 |
| K200676 |
07/08/2020 |
ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA |
Zirkonzahn srl |
Julian Steger |
