| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K193085 |
05/11/2020 |
PuraDERM Gel |
3-D Matrix, Inc. |
Lisa Spirio |
| K193055 |
05/13/2020 |
Purzir Dental Zirconia |
3DBioCAD |
Gyu D. Cho |
| K191362 |
05/20/2020 |
LifeFlow Blood System |
410 Medical, Inc. |
Galen Robertson |
| K193293 |
05/14/2020 |
XV Lung Ventilation Analysis Software |
4Dx Limited |
Terrence Thiel |
| K200002 |
05/29/2020 |
Anterior Spine Truss System û Stand Alone (ASTS-SA) Interbody Fusion Device |
4Web, Inc. |
Jessee Hunt |
| K192887 |
05/04/2020 |
Revitive Medic Plus, Revitive Advanced 2 |
Actegy, Ltd. |
Lawrence Brookfield |
| K200944 |
05/26/2020 |
UNIEXPERT 2 PLUS |
Adani |
Vladimir Linev |
| K191847 |
05/22/2020 |
Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps |
Adeor Medical AG |
Florian Gehrmann |
| DEN190031 |
05/11/2020 |
NP Screen |
Advance Sentry Corporation |
Leo Chui |
| K200950 |
05/08/2020 |
Ventricular Catheter |
Aesculap, Inc. |
Kathy A. Racosky |
| K200659 |
05/09/2020 |
Dermalux Tri-Wave MD |
Aesthetic Technology Ltd. |
Dale Needham |
| K192016 |
05/19/2020 |
SMOOV O10 |
Alber GmbH |
Michael Vent |
| K200035 |
05/04/2020 |
Ultravision Visual Field Clearing System |
Alesi Surgical Ltd. |
David Broderick |
| K200995 |
05/21/2020 |
InsigniaÖ Anterior Cervical Plate System |
Alphatec Spine, Inc. |
Sandy Gill |
| K200936 |
05/22/2020 |
InvictusÖ CT Spinal Fixation System |
Alphatec Spine, Inc. |
Ruby Zheng |
| K200056 |
05/18/2020 |
Catalys Precision Laser System |
AMO Manufacturng USA, LLC |
Laarni Ricafort |
| K190559 |
05/22/2020 |
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports |
AngioDynamics, Inc. |
Vidyalakshmi Jayaraman |
| K192048 |
05/14/2020 |
Single Use Endoscope Valves Set |
Anrei Medical (Hangzhou) Co., Ltd. |
Yang HuiBing |
| K201106 |
05/21/2020 |
IntraMarX 3D Radiopaque Marker |
AnX Robotica Corp. |
Steven Gu |
| DEN190037 |
05/22/2020 |
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule |
AnX Robotica, Inc. |
David Duan |
| K192244 |
05/11/2020 |
Arcad SmileStudio and Aligner System |
ArcadLab |
Emerson Cano |
| K201112 |
05/27/2020 |
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP |
Arrow International Inc. |
Shajunath Nirupama |
| K200352 |
05/20/2020 |
Axis Spine Technologies ALIF |
Axis Spine Technologies Ltd |
Edwin Lindsay |
| K192577 |
05/07/2020 |
Actreen Hi-Lite Intermittent Urinary Catheters |
B. Braun Medical Inc. |
Anita J. Nemeth |
| K192930 |
05/12/2020 |
Dymaxeon Spine System |
Back 2 Basics Direct, LLC |
Lou Keppler |
| K200870 |
05/01/2020 |
Carnation Ambulatory Monitor |
Bardy Diagnostics, Inc |
Jocelyn Kersten |
| K200640 |
05/08/2020 |
ALTAPORE SHAPE |
Baxter Healthcare Corporation |
Phillip Romei |
| K193553 |
05/18/2020 |
VarseoSmile Temp |
BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG |
Tanja Gotz |
| K192295 |
05/01/2020 |
PDT-FACE |
Beijing ADSS Development Co., Ltd. |
Su CuiYing |
| K191826 |
05/14/2020 |
KeYi Total Hip System |
Beijing KeYi Medical Device Technology Co., Ltd. |
Jenny Jiang |
| K192446 |
05/21/2020 |
CO2 Mainstream Module |
Beijing Kingst Commercial & Trade Co.,Ltd. |
Judong Gao |
| K192488 |
05/22/2020 |
CO2 Sidestream Module |
Beijing Kingst Commercial & Trade Co.,Ltd. |
Judong Gao |
| K193185 |
05/04/2020 |
Anscare SIMO Negative Pressure Wound Therapy (NPWT) System |
BenQ Materials Corporation |
Miranda Chang |
| K193122 |
05/15/2020 |
Biocore9 Humeral Resurfacing System |
Biocore9, LLC. |
Stan Matlak |
| K200512 |
05/07/2020 |
ETEST Plazomicin (PLZ) (0.016-256 ╡g/mL) |
bioMΘrieux S.A. |
Alexia Bosquet |
| K201178 |
05/29/2020 |
iLab Polaris Multi-Modality Guidance System |
Boston Scientific |
Kevin Lam |
| K200483 |
05/21/2020 |
SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller |
Boston Scientific Corporation |
Inderdeep Tiwana |
| K192692 |
05/28/2020 |
Brainomix 360 e-CTA |
Brainomix Limited |
Gwilym Owen |
| K200435 |
05/07/2020 |
Catalyst+, Catalyst+ HD |
C-Rad Positioning AB |
Thomas Matzen |
| K201111 |
05/26/2020 |
GentleMax Pro Plus |
Candela Corporation |
Yverre Bobay |
| K200274 |
05/21/2020 |
CariCloud |
Caristo Diagnostics |
James Davis |
| K200457 |
05/22/2020 |
Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming |
CC Wellness LLC |
Marlent Perez |
| K193441 |
05/26/2020 |
Aqua Naina Sterile Saline Solution |
Chemtex USA, Inc. |
Haribabu Talasila |
| K192642 |
05/13/2020 |
308nm Excimer System |
Chongqing Peninsula Medical Technology Co., Ltd. |
Zhang Sudi |
| K200920 |
05/29/2020 |
Idys ALIF ZP 3DTi |
Clariance, SAS |
Fadwa Bahr |
| K200871 |
05/04/2020 |
Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator |
Control Medical Technology |
Shawn Fojtik |
| K200629 |
05/29/2020 |
Aspire Mechanical Aspirator G |
Control Medical Technology |
Shawn Fojtik |
| K201086 |
05/21/2020 |
Advincula Delineator Uterine Manipulator |
CooperSurgical, Inc. |
Kyle Hooper |
| K193220 |
05/05/2020 |
AVIEW LCS |
Coreline Soft Co., Ltd |
Hyeyi Park |
| K200395 |
05/07/2020 |
LOSPA II Knee System (EXULT Knee Replacement System) |
Corentec Co., Ltd |
Sungwon Yang |
| K192656 |
05/01/2020 |
Optimized Positioning System (OPS) Insight |
Corin USA |
Lucinda Gerber |
| K200146 |
05/07/2020 |
HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor |
Covidien, llc |
Shani Frenkel |
| K200700 |
05/14/2020 |
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter |
Creagh Medical Ltd. |
Amy Yanta |
| K193043 |
05/11/2020 |
Critical Alert CommonPath Enterprise |
Critical Alert |
John Elms |
| K200991 |
05/13/2020 |
EVOL Spinal Interbody System |
Cutting Edge Spine, LLC |
Kyle Kuntz |
| K192262 |
05/29/2020 |
Dental Zirconia Blocks |
De Corematrix Co.Ltd. |
Kaixuan Liu |
| K193496 |
05/06/2020 |
CharmFil |
Dentkist, Inc. |
Shin Haeng Lee |
| K192392 |
05/26/2020 |
DiaPlus |
Diadent Group International |
Kab Sun Lee |
| K192586 |
05/06/2020 |
LIAISON« Folate |
Diasorin Inc. |
John C. Walter |
| K193404 |
05/18/2020 |
UF(II) Bar holder abutment |
DIO Corporation |
JiAe Park |
| K201124 |
05/19/2020 |
TOPAZ Mobile DR System |
DRGEM Corporation |
Ki-Nam Yang |
| K192069 |
05/06/2020 |
Aerodentis System |
Dror Orthodesign |
Michael Nadav |
| K192879 |
05/21/2020 |
Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System |
Edan Instruments, Inc |
Melody Huang |
| K191590 |
05/05/2020 |
AA temp temporary restoration 3D printing photoreactive resin |
Enlighten Materials Co., Ltd |
Jiun Ming Su |
| K200253 |
05/27/2020 |
Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector |
Ethicon Endo-Surgery |
Emily Nesbitt |
| K200841 |
05/11/2020 |
Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 |
Ethicon Endo-Surgery, Llc |
Nathan Anderson |
| K200169 |
05/14/2020 |
VFS1 Bipolar Electrosurgical Generator |
FHC, Inc. |
Kelly Moeykens |
| K201131 |
05/28/2020 |
firefly T-2 |
Firstkind Limited |
Neil Buckley |
| K181691 |
05/26/2020 |
High-speed air turbine handpiece / Low-speed air turbine handpiece |
Foshan Wenjian Medical Instrument Co., Ltd. |
Wen Huang |
| K192209 |
05/08/2020 |
Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate |
Fresenius Medical Care Renal Therapies Group, LLC |
Denise Oppermann |
| K192286 |
05/01/2020 |
FUJIFILM EP-6000 Video Processor |
FUJIFILM Corporation |
Randy Vader |
| K200964 |
05/08/2020 |
Sonosite PX Ultrasound System |
FUJIFILM SonoSite, Inc. |
Sudipta Chakrabarti |
| K200997 |
05/14/2020 |
Lumipulse G CA19-9-N |
Fujirebio Diagnostics, Inc. |
Kristin Maddaloni |
| K200479 |
05/15/2020 |
AquaPulse Auxiliary Water Connector |
GA Health Company Limited |
Cindy Ye |
| K193334 |
05/15/2020 |
Pristina Serena Bright |
GE Healthcare |
Barthelemy Arman |
| K192633 |
05/01/2020 |
GUS831 Compressor Nebulizer |
Globalcare Medical Technology Co., Ltd. |
Janice Deng |
| K190118 |
05/13/2020 |
Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K200305 |
05/26/2020 |
NPseal |
Guard Medical Inc. |
Machiel Van der Leest |
| K193516 |
05/04/2020 |
Sonata« Sonography-Guided Transcervical Fibroid Ablation System 2.1 |
Gynesonics, Inc |
Diane King |
| K191512 |
05/21/2020 |
LotusCatheter (Lotus No Balloon Catheter) |
Hakki Medical Technologies, Inc. |
Shereen Said Hakky |
| K193228 |
05/04/2020 |
Hamilton-G5 |
Hamilton Medical AG |
Simone Haller |
| K192342 |
05/21/2020 |
Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) |
Hangzhou AGS MedTech Co., Ltd. |
Chunqi Han |
| K200173 |
05/01/2020 |
Stone Retrieval Balloon |
Hangzhou AGS MedTech Co., Ltd. |
Chunqi Han |
| K193189 |
05/06/2020 |
RFID Localization System |
Health Beacons, Inc. |
Nancy Confrey |
| K200988 |
05/26/2020 |
Maximus System |
Hill-Rom Services Pte Ltd |
Alvin Tan |
| K200866 |
05/17/2020 |
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) |
Hologic, Inc. |
Anila Tarte |
| K200782 |
05/13/2020 |
Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite |
Howmedica Osteonics Corp. |
Nora O'Connor |
| K193233 |
05/27/2020 |
Restoration« Modular Hip System |
Howmedica Osteonics Corp. (aka Stryker Orthopaedics) |
Nora O'Connor |
| K200846 |
05/05/2020 |
BalteumÖ Lumbar Plate System |
Huvexel Co., Ltd |
Sung Kyu Hur |
| K200966 |
05/07/2020 |
Icare HOME Tonometer |
Icare Finland Oy |
Hannes Hyvonen |
| K200235 |
05/29/2020 |
KONG-TL VBR System, KONG-C VBR System |
icotec ag |
Marina Hess |
| K193423 |
05/22/2020 |
VADER«one Pedicle System MIS and LightMore« Pedicle System 6.0 |
Icotec AG |
Marina Hess |
| K192218 |
05/08/2020 |
Custom Legacy and Custom InterActive Titanium Abutments |
Implant Direct Sybron Manufacturing , LLC |
Reina Choi |
| K192399 |
05/20/2020 |
Infinity Angioplasty Balloon Catheter |
Infinity Angioplasty Balloon Company, LLC |
Tiffini Wittwer |
| K200293 |
05/05/2020 |
InMode System with vTone Applicator |
InMode Ltd. |
Amit Goren |
| K192652 |
05/27/2020 |
TRV |
Interacoustics A/S |
Erik Nielsen |
| K201043 |
05/12/2020 |
Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) |
iRay Technology Taicang Ltd. |
Junjie Qian |
| K201004 |
05/01/2020 |
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W |
iRay Technology Taicang Ltd. |
Meng Li |
| K192405 |
05/01/2020 |
Image Guidance System for Radiotherapy |
Jiangsu Rayer Medical Technology Co., Ltd. |
Peng Li |
| K192449 |
05/27/2020 |
Joline Kyphoplasty System Allevo |
Joline GmbH & Co. KG |
Peter Kohlbecher |
| K200419 |
05/22/2020 |
Kalera Vacuum Aspiration Catheter (K-VAC) |
Kalera Medical, Inc. |
Jee Shin |
| K192727 |
05/20/2020 |
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) |
Kamiya Biomedical Company |
Shawn Kaplan |
| K200390 |
05/18/2020 |
V.A.C. DERMATAC Drape |
KCI USA, Inc |
Margaret Marsh |
| K192540 |
05/01/2020 |
Kitazato ET Catheters |
Kitazato Corporation |
Futoshi Inoue |
| K192420 |
05/29/2020 |
Crownjun Nylon Suture |
Kono Seisakusho Co., Ltd. |
Hiroyuki Arai |
| K201184 |
05/05/2020 |
Lascod Impression Materials |
Lascod Spa |
Gualtiero Cozzi |
| K200287 |
05/15/2020 |
BP-BT Kiosk |
LD Technology LLC |
Albert Maarek |
| K183110 |
05/04/2020 |
LIVIA |
LifeCare Ltd. |
Amnon Nahum Sharon |
| K193539 |
05/28/2020 |
REVOLVE ENVI 600 Advanced Adipose System |
LifeCell Corporation |
Bozhana Hegarty |
| K200653 |
05/07/2020 |
AMF Revision TT Cones |
LimaCorporate S.p.A |
Roberto Gabetta |
| K193535 |
05/07/2020 |
EZER, Portable X-ray System |
Livermoretech Inc. |
Jae Hong Kim |
| K200501 |
05/11/2020 |
ArtiSential Laparoscopic Instrument-Electrodes |
LivsMed Inc. |
Dong Wook Lee |
| K193602 |
05/29/2020 |
LV Liberty Vision Model 1 90Yttrium Brachytherapy Source |
LV Liberty Vision Corporation |
Paul T. Finger |
| K200860 |
05/20/2020 |
HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) |
M.I. Tech Co., Ltd |
Inae Kim |
| K200910 |
05/02/2020 |
BOSS Balloon Guide Catheter |
Marblehead Medical |
Kristin Mortenson |
| K191334 |
05/29/2020 |
Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 |
MATIA Robotics (US) Inc |
Necati Hacikadiroglu |
| K200935 |
05/08/2020 |
Mazor X |
Mazor Robotics Ltd. |
Shiran Conforti |
| K200749 |
05/19/2020 |
CUBEScan BioCon-900S |
Mcube Technology Co., Ltd. |
Hye-Ri Choi |
| K201136 |
05/12/2020 |
CureÖ Lumbar Plate System |
Meditech Spine, LLC |
Bruce Dunaway |
| K192283 |
05/06/2020 |
MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator |
Medron, LLC |
David Kujawa |
| K200511 |
05/29/2020 |
ROSA ONE Brain application |
Medtech S.A. |
Serge Tabet |
| K191745 |
05/15/2020 |
Medtronic Commander Flex |
Medtronic Care Management Services |
Gordon Nelson |
| K201189 |
05/29/2020 |
Stealthstation S8 Spine Software v1.3.0 |
Medtronic Navigation, Inc. |
Jason Woehrle |
| K201068 |
05/21/2020 |
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface |
Medtronic, Inc. |
Sammie C. Joseph-Fredericks |
| K201118 |
05/26/2020 |
Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level |
Medtronic, Inc. |
Jen Correa |
| K201011 |
05/13/2020 |
Medtronic Model 5392 External Pulse Generator (EPG) |
Medtronic, Inc. |
Alexandra Theisen |
| K193457 |
05/12/2020 |
AUDERE Lumbar Spacer System |
Met One Technologies |
Kyle Atwood |
| K192694 |
05/14/2020 |
PAL Single-Use Cannulas |
MicroAire Surgical Instruments |
Glenn Gerstenfeld |
| K191906 |
05/18/2020 |
MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF |
MiRus, LLC |
Jordan Bauman |
| K201172 |
05/29/2020 |
CFP-3131, CFP-2222 |
MX Imaging, Inc. |
John Ross |
| K200878 |
05/18/2020 |
Natus NeuroWorks |
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) |
Sanjay Mehta |
| K200348 |
05/08/2020 |
Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) |
Neocis Inc. |
Thomas E. Claiborne |
| K200124 |
05/13/2020 |
InCore MPJ System |
Nextremity Solutions, Inc. |
Elise Fox |
| K200969 |
05/21/2020 |
NEXXT MATRIXX System |
Nexxt Spine LLC |
Andy Elsbury |
| K192693 |
05/07/2020 |
Nuvo Nano Portable Oxygen Concentrator |
Nidek Medical Products, Inc. |
Olivia Mullen |
| K200737 |
05/21/2020 |
SPY Portable Handheld Imaging (SPY-PHI) System |
Novadaq Technologies ULC. (now a part of Stryker) |
Agatha Szeliga |
| K193016 |
05/08/2020 |
PRECICE Bone Transport System |
NuVasive Specialized Orthopedics, Inc. |
Madison Heffron |
| K193617 |
05/08/2020 |
Precice« Screws |
NuVasive Specialized Orthopedics, Inc. |
Madison Heffron |
| K200956 |
05/21/2020 |
NuVasive Thoracolumbar Plates |
NuVasive, Incorporated |
Daniela Mahan |
| K201078 |
05/20/2020 |
NuVasive« ACP System |
NuVasive, Incorporated |
Ivanna Lopez |
| K200914 |
05/05/2020 |
Healix Compression Screw System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K200546 |
05/05/2020 |
ZeeroMED View |
O3 Enterprise SRL |
Andrea Poli |
| DEN190026 |
05/01/2020 |
iTEAR Neurostimulator |
Olympic Ophthalmics, Inc. |
Michael Gertner |
| K192103 |
05/11/2020 |
Thunderbeat Open Fine Jaw Type X Hand Instrument |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K200246 |
05/22/2020 |
JPS JuniOrtho Plating System |
Orthofix Srl |
Gianluca Ricadona |
| K200606 |
05/01/2020 |
O-Genesis Graft Delivery System |
Orthofix, Inc. |
Troy Brooks |
| K200259 |
05/04/2020 |
Headless Compression Screw System |
OsteoCentric Extremities, LLC |
Todd Evans |
| K192981 |
05/28/2020 |
Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 |
Penumbra, Inc |
Teri Nguyen |
| K200279 |
05/01/2020 |
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine |
Phadia AB |
Carina Magnusson |
| K200410 |
05/22/2020 |
Reconnaissance PV .018 OTW Digital IVUS Catheter |
Philips Image Guided Therapy Corporation |
Mary Stanners |
| K192914 |
05/27/2020 |
Stimuplex Onvision System |
Philips Medical Systems Nederland B.V. |
Gert de Vries |
| K200917 |
05/01/2020 |
Azurion R2.1 |
Philips Medical Systems Nederland BV |
Michelle Campbell |
| K201053 |
05/14/2020 |
PercuNav Image Fusion and Interventional Navigation |
Philips Ultrasound, Inc |
Travis Catania |
| K201012 |
05/01/2020 |
EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System |
Philips Ultrasound, Inc. |
Deep Pal |
| K192222 |
05/12/2020 |
EZ-Inject Single use Needle |
POONGLIM Pharmatech Inc. |
Cho Hee Min |
| K200303 |
05/19/2020 |
Reform Pedicle Screw System |
Precision Spine |
Micheal C. Dawson |
| K200317 |
05/14/2020 |
Support Catheter |
QXMedical, LLC |
Fernando Di Caprio |
| K201058 |
05/06/2020 |
Accuvue+ |
Radmedix LLC |
Gabriel Issa |
| K192418 |
05/27/2020 |
Phacoemulsification Needle (Tip) and Irrigation Sleeve |
Raico LLC |
Ravi Nallakrishnan |
| K200032 |
05/26/2020 |
ReWalk P6.0 |
ReWalk Robotics Ltd. |
Ofir Koren |
| K200984 |
05/27/2020 |
Guardian Needle Electrode |
Rhythmlink International, LLC |
Gabriel Orsinger |
| K200417 |
05/02/2020 |
RIST Radial Access Catheter |
RIST Neurovascular, Inc. |
Marianne Grumwaldt |
| K193096 |
05/14/2020 |
S.I.N. Dental Implant System |
S.I.N. -Sistema de Implante Nacional S.A. |
Denise Domiciano |
| K201120 |
05/27/2020 |
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card |
Safecare Biotech(Hangzhou)Co.,Ltd. |
Alex Qiu |
| K200699 |
05/07/2020 |
HS70A Diagnostic Ultrasound System |
Samsung Medison Co., Ltd. |
Ji Yea Lee |
| K200885 |
05/28/2020 |
Meridian Anterior Plate System, Regatta Lateral Plate System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K200290 |
05/11/2020 |
Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) |
SeaSpine Orthopedics Corporation |
Caryn Sailor |
| K192560 |
05/22/2020 |
Surgical Gown |
Shandong Kangli Medical Equipment Technology Co., Ltd. |
Zhuang Liu |
| K200751 |
05/21/2020 |
Photodynamic Therapy (PDT) Equipment |
Shangdong Huamei Technology Co., Ltd. |
Xu QingHua |
| K200746 |
05/15/2020 |
IPL Treatment Systems |
Shanghai Apolo Medical Technology Co., Ltd. |
Felix Li |
| K200116 |
05/28/2020 |
PicoSecond Nd: YAG Laser System |
Shanghai Apolo Medical Technology Co., Ltd. |
Felix Li |
| K192179 |
05/01/2020 |
Oral/Enteral Syringe |
Shanghai Kindly Enterprise Development Group Co., Ltd |
Weixin Zhang |
| K193176 |
05/05/2020 |
uMR 780 |
Shanghai United Imaging Healthcare Co., Ltd |
Xin Gao |
| K200864 |
05/19/2020 |
5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ |
Shenzhen Beacon Display Technology Co., Ltd. |
Fu Ailing |
| K200026 |
05/12/2020 |
Disposable ECG Cable |
Shenzhen Changke Connect Electronics Co., Ltd. |
Yahui Zhou |
| K193391 |
05/21/2020 |
BeneVision Central Monitoring System |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K200979 |
05/28/2020 |
DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System |
Shenzhen Mindray Bio-Medical Electronics Co., LTD. |
Shi Jufang |
| K192972 |
05/07/2020 |
Patient Monitor |
Shenzhen Mindray Bio-medical Electronics Co., LTD. |
Yanhong Bai |
| K200509 |
05/29/2020 |
ADVIA Centaur Vitamin D Total (VitD) |
Siemens Healthcare Diagnostics Inc. |
Paul DaSilva |
| K201130 |
05/26/2020 |
ACUSON Juniper Diagnostic Ultrasound System |
Siemens Medical Solutions USA, Inc. |
Hyunjung Lee |
| K201034 |
05/14/2020 |
Syngo.CT CaScoring |
Siemens Medical Solutions USA, Inc. |
Tabitha Estes |
| K200213 |
05/11/2020 |
Biograph mMR with syngo MR E11P-AP01 system software |
Siemens Medical Solutions, USA, Inc. |
Cordell L. Fields |
| K201062 |
05/18/2020 |
syngo Ultrasound Apps Suite (sUSAS) |
Siemens Medical Solutions, USA, Inc. |
Christine Dunbar |
| K192866 |
05/07/2020 |
Chemfort CSTD |
Simplivia Healthcare Ltd. |
Itsik Shmueli |
| K200367 |
05/14/2020 |
Distal Humerus Plating System |
Skeletal Dynamics, Inc. |
Ana M. Escagedo |
| K200701 |
05/14/2020 |
Skeletal Dynamics Midshaft Humerus Plating System |
Skeletal Dynamics, Inc. |
Diana Taylor |
| K193460 |
05/26/2020 |
The iNAP One Sleep Therapy System |
Somnice, Inc. |
Sujith Shetty |
| K193058 |
05/15/2020 |
SonarMed AirWave Airway Monitoring System |
SonarMed, Inc. |
Laura Lyons |
| K192651 |
05/07/2020 |
ZAGA Zygomatic System |
Southern Implants (Pty) Ltd |
Lauranda G Breytenbach |
| K200571 |
05/01/2020 |
PERLA« Posterior Occipito-Cervico-Thoracic Fixation System |
SPINEART |
Franck Pennesi |
| K200989 |
05/14/2020 |
Reliance Endoscope Processing System |
STERIS Corporation |
Jennifer Nalepka |
| K200126 |
05/22/2020 |
VERIFY Assert Self-Contained Biological Indicator |
STERIS Corporation |
Anthony Piotrkowski |
| K200252 |
05/21/2020 |
Getinge Assured MI Steam Migrating Integrator |
SteriTec Products MFG Co Inc |
Jonathan Rutigliano |
| K200205 |
05/13/2020 |
Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled |
Stryker Sustainability Solutions |
Mia McCorkel |
| K200431 |
05/18/2020 |
3D GraftRasp System |
SurGenTec |
Andrew Shoup |
| K193336 |
05/27/2020 |
Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse |
Synedgen, Inc. |
Shenda Baker |
| K200933 |
05/05/2020 |
Syntec Non-Sterile Steinmann Pins System |
Syntec Scientific Corporation |
Nicole Tseng |
| K200400 |
05/21/2020 |
Systane iLux2 |
Tear Film Innovations, Inc. |
Neal Hartman |
| K200747 |
05/15/2020 |
PuriLens Plus Preservative Free Saline |
The LifeStyle Company, Inc. |
Tom Seidner |
| K193420 |
05/06/2020 |
XO Cross Support Catheter |
Transit Scientific |
Jenifer Arnold |
| K193495 |
05/29/2020 |
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter |
Transit Scientific |
Jennifer Arnold |
| K200961 |
05/08/2020 |
Treace Medical Concepts (TMC) Plating System |
Treace Medical Concepts, Inc. |
Rachel Osbeck |
| K192265 |
05/21/2020 |
gi-4000 Electrosurgical Generator |
United States Endoscopy Group, Inc |
Carroll L. Martin |
| K200120 |
05/07/2020 |
LiteSaber Wire Torque Assist Device |
Vesatek, LLC |
David Look |
| K200468 |
05/21/2020 |
V30 system, V20 system, V10 system, V-FC Handpiece |
Viora Ltd. |
Simona Forman Krant |
| K193436 |
05/14/2020 |
VITA Ambria |
VITA Zahnfabrik GmbH H Rauter & Co |
Bernd Walker |
| K200525 |
05/27/2020 |
Medical Diode Laser Hair Removal System |
Weifang Mingliang Electronics CO., LTD |
Li MingLiang |
| K191819 |
05/14/2020 |
Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border |
Winner Medical Co., Ltd. |
Dan Wang |
| K192463 |
05/14/2020 |
PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border |
Winner Medical Co., Ltd. |
Dan Wang |
| DEN180065 |
05/01/2020 |
OGmend Implant System |
Woven Orthopedic Technologies, LLC |
Bob Luzzi |
| K200662 |
05/21/2020 |
X-Guide« Surgical Navigation System |
X-Nav Technologies,LLC. |
Fred Cowdery |
| K190982 |
05/29/2020 |
Automatic Digital Blood Pressure Monitor |
Xiamen Ants Bro Technology Co., Ltd. |
Jane Xu |
| K193665 |
05/28/2020 |
Frozen N |
Yozma BmTech Co., Ltd. |
Jenny Cho |
| K200453 |
05/01/2020 |
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC |
YTY Industry (Manjung) Sdn Bhd |
Punitha Samy |
| K192901 |
05/12/2020 |
HealthVCF |
Zebra Medical Vision Ltd. |
Flair Bar |
| K200315 |
05/05/2020 |
Ziostation2 |
Ziosoft, Inc. |
Tsuyoshi Nagata |
