| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K193492 |
08/17/2020 |
23andMe Personal Genome Service (PGS) Pharmacogenetic Reports |
23andMe, Inc. |
Lisa Charter |
| K201115 |
08/27/2020 |
Next Generation Balloon Dilation System |
Acclarent Inc. |
David Locke |
| K201174 |
08/12/2020 |
TruDi Curette |
Acclarent, Inc. |
Leena Sorathia |
| K193318 |
08/20/2020 |
Distinct« Early Detection Pregnancy Test |
Acon Laboratories Inc. |
Qiyi Xie |
| K200009 |
08/05/2020 |
Adaptive Biotechnologies clonoSEQ Assay |
Adaptive Biotechnologies Corporation |
Megan Duncan |
| K202099 |
08/28/2020 |
AOS GalileoÖ Trochanteric Nail System |
Advanced Orthopaedic Solutions, Inc. |
Jolie Krance |
| K192723 |
08/18/2020 |
Coloring Liquid |
Aidite (Qinhuangdao) Technology Co., Ltd. |
Zhang Wei |
| K201020 |
08/26/2020 |
BriefCase |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K202036 |
08/21/2020 |
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal |
Alcon Laboratories, Inc. |
Sherri Lakota |
| K193589 |
08/31/2020 |
TrueTear Intranasal Tear Neurostimulator |
Allergan |
Barbara Simon |
| K201521 |
08/06/2020 |
Medina Anterior Cervical Plate System |
Alliance Partners, LLC |
Desiree Crawford |
| K201199 |
08/28/2020 |
Jada System |
Alydia Health |
Colby Holtshouse |
| K202276 |
08/14/2020 |
BracePaste Band and Build LC |
American Orthodontics |
Andre Leak |
| K192944 |
08/13/2020 |
AncestryDNA Factor V Leiden Genetic Health Risk Test |
Ancestry Genomics, Inc. |
Raajdeep Venkatesan |
| K192947 |
08/13/2020 |
AncestryDNA Saliva Collection Kit |
Ancestry Genomics, Inc. |
Raajdeep Venkatesan |
| K200093 |
08/20/2020 |
Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug |
Anhui lntco Medical Products Co., Ltd. |
Jacken Cai |
| K191644 |
08/06/2020 |
TK Safety Needle |
Anhui Tiankang Medical Technology Co., Ltd. |
Bai Baodong |
| K191640 |
08/26/2020 |
TK Intravascular Administration Set |
Anhui Tiankang Medical Technology Co.,Ltd. |
Bai Baodong |
| K192953 |
08/27/2020 |
APTOS Threads û Polypropylene Surgical Sutures |
APTOS, LLC. |
Nikolai Pirtskhalaichvili |
| K201076 |
08/06/2020 |
Anchor Dual Lumen Guidewire Catheter |
Aqure Medical, Inc. |
Jie Xia |
| K201749 |
08/21/2020 |
Arthrex SwiveLock Anchor |
Arthrex Inc. |
Jessica Singelais |
| K200895 |
08/13/2020 |
Univers Revers Modular Glenoid System, Half Augment Baseplate |
Arthrex Inc. |
Ivette Galmez |
| K193066 |
08/06/2020 |
Steripack cases and Tray Systems |
Avalign Technologies, Inc. |
Hiren Patel |
| K201830 |
08/27/2020 |
ANSER Clavicle Pin |
Baat Medical Products BV |
Teake Bulstra |
| DEN190042 |
08/28/2020 |
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer |
Baxter Healthcare Corporation |
Kristen Bozzelli |
| K201405 |
08/30/2020 |
LabPro Data Management System |
Beckman Coulter Inc. |
Christina Thomas |
| K201099 |
08/12/2020 |
BD PhaSeal Optima Closed System Drug Transfer Device |
Becton, Dickinson and Company |
Amy Honey |
| K201641 |
08/06/2020 |
Disposable Laparoscope Trocar |
Beijing Biosis Healing Biological Technology Co., Ltd. |
Jiali Zhou |
| K200359 |
08/11/2020 |
NuEra Tight, NuEra Tight EMS |
Bios s.r.l. |
Maurizio Bianchi |
| K201750 |
08/06/2020 |
Pentaray Nav eco High-Density Mapping Catheter |
Biosense Webster, Inc |
Richard Lauhead |
| K192611 |
08/13/2020 |
Cuffix |
Biovo Technologies Ltd. |
Barbara Sokoletsky |
| K200981 |
08/11/2020 |
Mega Plus MIS Spine System |
BK Meditech, Co., Ltd |
Byoungjun Park |
| K202224 |
08/28/2020 |
SpaceOAR System |
Boston Scientific Corporation |
Jeanne OToole |
| K201159 |
08/17/2020 |
WallFlex Colonic Stent System with Anchor Lock Delivery System |
Boston Scientific Corporation |
Catherine Sanford |
| K200822 |
08/13/2020 |
Braid |
Braid.Health |
Vivian Liu |
| K202050 |
08/19/2020 |
Cranial 4Pi Immobilization |
Brainlab AG |
Chiara Cunico |
| K200957 |
08/21/2020 |
Brainsway Deep TMS System |
Brainsway Ltd. |
Ahava Stein |
| K193201 |
08/21/2020 |
BTL-785F |
BTL |
David Chmel |
| K200923 |
08/26/2020 |
Single-use Surgical Mask |
BYD Precision Manufacturer Co.Ltd. |
Yubo Guan |
| K201871 |
08/12/2020 |
Surgical Mask |
C & S Paper Yunfu Co., Ltd. |
Xu Zhiming |
| K201251 |
08/05/2020 |
CarboClear Navigated Instruments |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K201926 |
08/07/2020 |
CarboClear« Pedicle Screw System, CarboClear« II Pedicle Screw System |
CarboFix Orthopedics Ltd. |
Hila Wachsler-Avrahami |
| K193177 |
08/26/2020 |
CER-S |
CardioCalm |
Fabio Badilini |
| K201933 |
08/11/2020 |
ImagenSPECT 3.0 |
Cardiovascular Imaging Technologies |
James A. Case |
| K201932 |
08/07/2020 |
X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) |
CareRay Digital Medical System Co., Ltd. |
Leilei Li |
| K200780 |
08/05/2020 |
XBit Series Digital Color Doppler Ultrasound System |
CHISON Medical Technologies Co., Ltd. |
Qifei Liu |
| K200714 |
08/26/2020 |
AVIEW |
Coreline Soft Co., Ltd |
Hyeyi Park |
| K193545 |
08/04/2020 |
Corin Optimized Positioning System (OPS) Femoral |
Corin USA |
Lucinda Gerber |
| K201805 |
08/26/2020 |
VersaOne Reusable Positioning Trocar System |
Covidien |
Stephanie Wilde |
| K200796 |
08/26/2020 |
Emprint Ablation System with Thermosphere Technology |
Covidien LLC |
Liron Bar yaakov |
| K201952 |
08/05/2020 |
CrossGlide ETS Plus |
CrossBay Medical |
Piush Vidyarthi |
| K192863 |
08/26/2020 |
MONDRIAN Lumbar Interbody Fusion Cage System |
CTL Medical Corporation |
Sean Suh |
| K201067 |
08/07/2020 |
CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) |
CUPID Limited |
Durgesh Garg |
| K200373 |
08/26/2020 |
Deltaven Fast Flash Closed I.V. Catheter Systems |
Delta Med Spa |
Raschi Olga |
| K192682 |
08/14/2020 |
Orthocem, Ortho Bite |
Dentscare Ltda |
Roberta Uyara |
| K193408 |
08/16/2020 |
Sirona Dental CAD/CAM System with CEREC Chairside Software |
Dentsply Sirona |
Karl Nittinger |
| K200191 |
08/19/2020 |
Sirona Dental CAD/CAM System with InLab Software |
Dentsply Sirona |
Karl J. Nittinger |
| K201831 |
08/31/2020 |
CONFIDENCE Spinal Cement System |
DePuy Spine, Inc. |
Sergio M. Cordeiro |
| K202012 |
08/18/2020 |
Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System |
Devicor Medical Products, Inc. |
Gwendolyn P. Payne |
| K200809 |
08/07/2020 |
D-LUX+ |
Diadent Group International |
Kab Sun Lee |
| K193005 |
08/28/2020 |
DIMI RRT System |
Dialco Medical Inc. |
Danijela Domljanovic |
| K201505 |
08/22/2020 |
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K200859 |
08/28/2020 |
Infinity M300 |
Draeger Medical Systems, Inc. |
Thomas Ostrowski |
| K201476 |
08/28/2020 |
DreaMed Advisor Pro |
DreaMed Diabetes Ltd |
Inbal Beinglass Peled |
| K200648 |
08/17/2020 |
EKOS PE Endovascular Device with Control System 4.0 (CS4.0) |
EKOS Corporation |
Joshua Kim |
| K201979 |
08/25/2020 |
Cervical Plate System |
Eminent Spine, LLC |
Stephen Courtney |
| K191591 |
08/18/2020 |
BB Base 3D printing resin for denture base |
Enlighten Materials Co., Ltd |
Jiun Ming Su |
| K192075 |
08/07/2020 |
ProSealÖ Closed System drug Transfer Device (CSTD) |
Epic Medical Pte. Ltd. |
Freddie Lee |
| K201143 |
08/06/2020 |
VICRYL Mesh |
Ethicon, Inc. |
Valerie Smith Beyer |
| K202116 |
08/21/2020 |
EzDent-i/ E2/ Prora View/ Smart M Viewer |
Ewoo soft Co., Ltd. |
Young Seok Kim |
| K200667 |
08/03/2020 |
EyeArt |
Eyenuk, Inc |
Kaushal Solanki |
| K201472 |
08/26/2020 |
VenSure Balloon Device, VenSure Nav Balloon Device |
Fiagon GmbH |
Dirk Mucha |
| K202130 |
08/20/2020 |
FUJIFILM Video Laparoscope |
Fujifilm Corporation |
Randy Vader |
| K200973 |
08/27/2020 |
Synapse 3D Cardiac Tools |
FUJIFILM Corporaton |
Randy Vader |
| K192380 |
08/24/2020 |
ST AIA-PACK BNP |
Fujirebio Diagnostics, Inc. |
Stacey Dolan |
| K201960 |
08/13/2020 |
SpaceFlex Knee - 80mm Size |
G21 S.r.l |
Filippo Foroni |
| K192464 |
08/25/2020 |
Injection Pen Needle |
Gangan Medical Technology Jiangsu Co., Ltd. |
Wu Shuhui |
| K200775 |
08/14/2020 |
LOOP LED Curing Light System |
Garrison Dental Solutions, LLC |
Alex Hull |
| K192597 |
08/17/2020 |
Cytrans Granules |
GC America, Inc. |
Mark Heiss |
| K193578 |
08/20/2020 |
Non-spermicidal Lubricated Male Latex Condom |
Global Protection Corp. |
Christina Cataldo |
| K191041 |
08/28/2020 |
Orthodontic Fixation Screw [Smart Anchor Miniscrew] |
GNI Co., LTD |
Duk Soo Kim |
| K200592 |
08/10/2020 |
GS Medical AnyPlus PEEK Cage System |
GS Medical Co., Ltd. |
Andrea Watt |
| K201530 |
08/05/2020 |
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) |
Hartalega Ngc Sdn. Bhd. |
Kuan Mun Leong |
| K201772 |
08/25/2020 |
Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) |
Hartalega NGC Sdn. Bhd. |
Kuan Mun Leong |
| K201531 |
08/05/2020 |
Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) |
Hartalega SDN. BHD. |
Kuan Kam Hon |
| K191938 |
08/28/2020 |
FitRelief TENS&EMS Wireless Device |
Heat In A Click LLC. |
Guy Levi |
| K201217 |
08/04/2020 |
HemoCue Hb 301 System |
HemoCue AB |
Maria Fagerberg |
| K201513 |
08/21/2020 |
Quantra QPlus System |
HemoSonics, LLC |
Anne Zavertnik |
| K193429 |
08/13/2020 |
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup |
Howmedica Osteonics Corp |
Alexandra Kirby |
| K201722 |
08/11/2020 |
Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System |
Hyperfine Research, Inc. |
Robert Fasciano |
| K190580 |
08/05/2020 |
NADIA SI Fusion System |
Ilion Medical Inc |
Tania Fuentes-Davitt |
| K201961 |
08/13/2020 |
IlluminOss Photodynamic Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K200324 |
08/06/2020 |
NHancer Rx |
IMDS Operations B.V. |
E Schulting |
| K200858 |
08/06/2020 |
Mini Sterilizable Tray |
Implant Direct Sybron Manufacturing, LLC |
Reina Choi |
| K201636 |
08/20/2020 |
Hercules Suture Anchor System |
In2Bones USA, LLC |
Christine Scifert |
| K201981 |
08/27/2020 |
Magicore System |
InnoBioSurg Co., Ltd. |
Bo-Yeon Lim |
| K200586 |
08/20/2020 |
Straumann TLX Implant System |
Institut Straumann AG |
Renate Reiss |
| K193046 |
08/13/2020 |
Straumann« Retentive System û Novaloc TiN Abutments |
Institut Straumann AG |
Ana C.M. Vianna |
| K200033 |
08/19/2020 |
HemosIL von Willebrand Factor Antigen |
Instrumentation Laboratory Co. |
Nikita Malladi |
| K200529 |
08/12/2020 |
Orion |
Interacoustics A/S |
Erik Nielsen |
| K200534 |
08/12/2020 |
VisualEyes |
Interacoustics A/S |
Erik Nielson |
| K200890 |
08/06/2020 |
Invacare Perfecto2V Oxygen Concentrator |
Invacare Corporation |
Elijah Wreh |
| K192275 |
08/19/2020 |
invisa-RED ELITE |
IR Technology LLC |
Thomas A. Namynanik |
| K200763 |
08/12/2020 |
Osteo-site Vertebral Balloon |
IZI Medical |
Qiang Cao |
| K192551 |
08/10/2020 |
1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle |
Jiangsu Caina Medical Co., Ltd. |
Xinyan Ruan |
| K200939 |
08/20/2020 |
Electronic Blood Pressure Monitor |
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd |
Rui Li |
| K200649 |
08/03/2020 |
Arm-Type Fully Automatic Digital Blood Pressure Monitor |
Joytech Healthcare Co., Ltd |
Ren Yunhua |
| K201006 |
08/07/2020 |
K2M Navigation Instruments |
K2M, Inc. |
Oonagh Lahiff |
| K200740 |
08/11/2020 |
HD Video Rhino Laryngoscope |
KARL STORZ Endoscopy - America, Inc. |
Irina Fedorov |
| K201399 |
08/17/2020 |
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0░, 30░, 45░, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0░, 30░, 45░, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0░, 30░, 45░, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Opt |
Karl Storz-Endoscopy-America, Inc. |
Alita McElroy |
| K201334 |
08/18/2020 |
Keystone Dental XL Dental Implant System |
Keystone Dental Inc. |
Linda Jalbert |
| K193522 |
08/25/2020 |
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA |
Kitazato Corporation |
Futoshi Inoue |
| K192845 |
08/17/2020 |
Sperm Freeze, Sperm Fridge |
Kitazato Corporation |
Futoshi Inoue |
| K201052 |
08/31/2020 |
KLS Martin Individual Patient Solutions (IPS) Planning System |
KLS-Martin L.P. |
Jennifer Damato |
| K201500 |
08/04/2020 |
Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer |
Life Spine Inc. |
Angela Batker |
| K201232 |
08/13/2020 |
Limbus Contour |
Limbus AI Inc. |
Jon Giambattista |
| K201938 |
08/07/2020 |
LZI Fentanyl II Enzyme Immunoassay |
Lin-Zhi International, Inc. |
Bernice Lin |
| K191670 |
08/04/2020 |
CureOs TCP |
Linacol Muh Dan Kim Cev Tek Med Ith Ihr San Ve Tic |
Mehmet Ali Cengiz |
| K200353 |
08/06/2020 |
ManaFlow |
ManaMed, Inc |
Trevor Theriot |
| K200351 |
08/05/2020 |
PlasmaFlight |
ManaMed, Inc. |
Trevor Theriot |
| K201432 |
08/29/2020 |
Masimo O3 Regional Oximeter System |
Masimo Corporation |
Sindura Penubarthi |
| K193626 |
08/10/2020 |
Masimo Rad-97 Pulse CO-Oximeter and Accessories |
Masimo Corporation |
Linus Park |
| K201310 |
08/07/2020 |
Accipiolx |
MaxQ Al Ltd. |
Joshua Schulman |
| K201995 |
08/19/2020 |
CUBEScan BioCon-1100 |
Mcube Technology Co., Ltd. |
Hye-Ri Choi |
| K193175 |
08/11/2020 |
Lateralized Glenosphere |
Medacta Inernational SA |
Stefano Baj |
| K193666 |
08/04/2020 |
Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) û Regular Cuff; Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) - Extended Cuff |
Medline Industries, Inc. |
Leontyne Banks |
| K201883 |
08/07/2020 |
6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor |
Medos International SARL |
Elizabeth Messana |
| K193278 |
08/07/2020 |
MedSource CathMED IV Catheter |
MedSource Labs |
Emilie Andrews |
| K191296 |
08/11/2020 |
Pointe Scientific Creatinine Kinase (CK) Reagent Set |
MedTest Dx |
William Cripps |
| K201362 |
08/19/2020 |
CD HorizonÖ Fenestrated Screw Set, CD HorizonÖ Spinal System, KyphonÖ HV-RÖ Bone Cement |
Medtronic |
Shweta Sharma |
| K192712 |
08/03/2020 |
Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter |
Medtronic Inc |
Sharon Fahy |
| K201267 |
08/26/2020 |
Adaptix Interbody System with Titan nanoLOCK Surface Technology |
Medtronic Sofamor Danek |
Diamond Wallace |
| K193082 |
08/07/2020 |
Fountain ValveTip Infusion Catheter |
Merit Medical Systems, Inc |
Spriha Pandey |
| K201166 |
08/28/2020 |
Temno Elite Biopsy System |
Merit Medical Systems, Inc |
Niloufar Samimi |
| K201907 |
08/06/2020 |
ClariVein IC |
Merit Medical Systems, Inc. |
Michaela Rivkowich |
| K192809 |
08/25/2020 |
Dental Handpiece |
Micro-NX Co., Ltd. |
Sojeong Park |
| K200848 |
08/14/2020 |
Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit |
Micron Medical Corporation |
Elizabeth Greene |
| K201667 |
08/06/2020 |
Midmark Extraoral Imaging System (EOIS) |
Midmark Corporation |
Mark Kenar |
| K201807 |
08/27/2020 |
ANCORIS |
MiEGmbH |
Thomas Kuehl |
| K202072 |
08/26/2020 |
MindsEye Expandable Port |
Minnetronix Neuro, INC. |
Matt Adams |
| K201549 |
08/26/2020 |
Motex Anti-Fog Surgical Face Mask |
Modern Healthcare Corp. |
Ke-Min Jen |
| K201619 |
08/07/2020 |
EndoTool IV System |
Monarch Medical Technologies, LLC |
Ann Marie Gaitan |
| K201056 |
08/21/2020 |
NeuroBlate System |
Monteris Medical, Inc. |
David H. Mueller |
| K193130 |
08/07/2020 |
MVP Aligner System |
MVP Aligners, LLC |
Daniel Michaeli |
| K193264 |
08/11/2020 |
Disposable High Speed Air Turbine Handpiece |
Ningbo HPDOVE Dental Instruments Co., Ltd. |
Liyue Huang |
| K201010 |
08/14/2020 |
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite |
Nobio Ltd. |
Galit Gershon |
| K192291 |
08/20/2020 |
TidalPort-AP Implantable Apheresis Vascular Access Port |
Norfolk Medical Products, Inc. |
Natan Pheil |
| K201623 |
08/11/2020 |
LION Photocoagulator |
Norlase ApS |
Jan Forstberg |
| K201141 |
08/26/2020 |
FIRMM |
Nous Imaging, Inc. |
Todd Deckard |
| K201286 |
08/11/2020 |
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch |
Nurse Assist, LLC |
Romeo Crisologo |
| K201567 |
08/10/2020 |
Precice« Bone Transport System |
NuVasive Specialized Orthopedics, Inc. |
Madison Heffron |
| K201850 |
08/04/2020 |
Vector Hammertoe Correction System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K200369 |
08/28/2020 |
OES Elite Ureteroscopes and Accessories |
Olympus Winter & Ibe GmbH |
Stefanie Weber |
| K191955 |
08/05/2020 |
Enhanced External Counter Pulsation Device Plus Omay-A |
Omay(Guangzhou)Med Technologies Co., Ltd. |
Peixian Su |
| K200977 |
08/05/2020 |
Modular Toga |
Operating Room Innovations, Inc. |
Mark McBride |
| K202068 |
08/14/2020 |
The AIO Solution 3.0 |
Orfit Industries NV |
Eddy Marivoet |
| K190600 |
08/18/2020 |
ORION Spinal System |
Orion Biotech Inc. |
Yuki Chen |
| K200587 |
08/25/2020 |
VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder |
OrthoSensor, Inc. |
Deborah Escobar Johnson |
| K193207 |
08/07/2020 |
TaiChiA |
Our United Corporation |
Qi Liu |
| K201704 |
08/04/2020 |
CoFix System |
Paradigm Spine GmbH |
Branko Sostarko |
| K193595 |
08/19/2020 |
Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 |
Penumbra, Inc. |
Teri Nguyen |
| K202251 |
08/31/2020 |
Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX) |
Penumbra, Inc. |
Anush Puvvada |
| K201137 |
08/19/2020 |
Asept Surgical Face Mask |
PFM Medical, Inc |
Jessica Jho |
| K201352 |
08/17/2020 |
3D Auto LAA |
Philips Healthcare |
Travis Catania |
| K181645 |
08/13/2020 |
StimaWELL 120MTRS |
Pierenkemper GmbH |
Thorsten Reichel |
| K193364 |
08/24/2020 |
Intimate Rose Kegel Exercise System |
Plus EV Holdings dba Intimate Rose |
Aaron Wilt |
| K201079 |
08/05/2020 |
Aurora« Anterior Lumbar Plate Sytstem |
Prism Surgical Design Pty Ltd. |
Emma May Young |
| K201502 |
08/06/2020 |
Vitra 810 |
Quantel Medical |
Bruno Pages |
| K201177 |
08/17/2020 |
RadGil2 |
R3 X-Ray L.L.C |
Robert Hase |
| K201637 |
08/12/2020 |
Aurora Evacuator +Coag |
Rebound Therapeutics |
Naomi Gong |
| K193355 |
08/03/2020 |
Electrodes Handpieces for Mygen V-1000 RF System |
RF Medical Co., Ltd |
Kwang S Choi |
| K201518 |
08/14/2020 |
Route 92 Medical 088 Access System |
Route 92 Medical |
Kathy Tansey |
| K200133 |
08/13/2020 |
hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream |
Safecare Biotech (Hangzhou) Co., Ltd. |
Selina Zhang |
| K201168 |
08/04/2020 |
ECG Monitor App |
Samsung Electronics Co., Ltd |
Taejong Jay Yang |
| K192062 |
08/27/2020 |
Nucleoss T6 Dental Implant System |
Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. St |
Ezgi Ozbudak |
| K200216 |
08/21/2020 |
4K UHD Camera System |
Scivita Medical Technology Co., Ltd. |
Ruqin Wu |
| K202064 |
08/26/2020 |
Admiral ACP System |
SeaSpine Orthopedics Corporation |
Aly Alvarez |
| K201240 |
08/05/2020 |
Mariner Cap System |
SeaSpine Orthopedics Corporation |
Alicia McArthur |
| K193210 |
08/04/2020 |
HYPER DLR |
Shanghai United Imaging Healthcare Co., Ltd. |
Shumei Wang |
| K201162 |
08/27/2020 |
Essence 55SP Large Monitor System |
Shenyang Torch-Bigtide Digital Technology Co., Ltd. |
Fu Ailing |
| K192657 |
08/07/2020 |
Sterile High-pressure Angiographic Syringes for Single-use |
Shenzhen Boon Medical Supply Co., Ltd |
Mingan Mu |
| K193338 |
08/25/2020 |
Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes |
Shenzhen Med-link Electronics Tech Co., Ltd. |
Fei Liu |
| K201693 |
08/21/2020 |
DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
Zhang Wei |
| K201444 |
08/13/2020 |
Syngo.via RT Image Suite |
Siemens Medical Solutions USA, Inc. |
Cynthia Busch |
| K192620 |
08/12/2020 |
SNA-001 Silver Photoparticle Topical Gel |
Sienna Biopharmaceuticals, Inc. |
Paul Lizzul |
| K201953 |
08/11/2020 |
OMNI PLUS Surgical System |
Sight Sciences, Inc. |
Edward J. Sinclair |
| K191708 |
08/14/2020 |
Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K192883 |
08/05/2020 |
Spartan Hip Stem |
Signature Orthopaedics Pty Ltd. |
Declan Brazil |
| K193476 |
08/19/2020 |
VariLymph 12 pro |
SLK Medical GmbH |
Matthew Reid |
| K192671 |
08/28/2020 |
Hemostatic Xerogel Sponge |
Solaplus Biotech Co., Ltd. |
Xiangui Shen |
| K201054 |
08/12/2020 |
SOMNOscreen plus |
Somnomedics GmbH |
Stephanie Wolski |
| K201916 |
08/13/2020 |
Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator |
Sorin Group Italia S.r.l |
Luigi Vecchi |
| K200958 |
08/28/2020 |
MODULIF-A Anterior Lumbar Interbody Fusion System |
Spinal Stability, LLC |
David Krueger |
| K200597 |
08/19/2020 |
Straumann BLX Gold Abutments |
Straumann USA, LLC (On behalf of Institut Straumann AG) |
Chanrasmey White |
| DEN200001 |
08/07/2020 |
Cell-Free DNA BCT |
Streck, Inc. |
Deborah Kipp |
| K201585 |
08/10/2020 |
Monterey AL Interbody System |
Stryker Corporation |
Alexia Haralambous |
| K201715 |
08/05/2020 |
Smart Toe II, X Fuse |
Stryker GmbH |
Jemin Dedania |
| K200064 |
08/14/2020 |
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft |
SurGenTec, LLC |
Travis Greenhalgh |
| K193563 |
08/19/2020 |
Medline ReNewal Reprocessed Harmonic ACE+7 Shears |
Surgical Instrument Service and Savings Inc (dba Medline ReN |
Gail Gassner |
| K193653 |
08/26/2020 |
Hydrophilic Coating Guide Wire |
Suzhou Hengrui Disheng Medical Co.,Ltd. |
Ling Li |
| K200881 |
08/27/2020 |
Oral-B iO Test Drive Power Brush Trial Program Kit |
The Procter & Gamble Company |
Michael A. Kaminski |
| K201958 |
08/04/2020 |
ETD Family of Electrotherapy Devices |
TheraSigma, LLC |
Jim Klett |
| K200926 |
08/28/2020 |
OrthoGold 100 |
Tissue Regeneration Technologies, LLC |
John Warlick |
| K193537 |
08/19/2020 |
Omnichroma Flow |
Tokuyama Dental Corporation |
Keith A. Barritt |
| K201632 |
08/14/2020 |
TOMTEC-ARENA |
TOMTEC Imaging Systems GmbH |
Marc Bergenthal |
| K193006 |
08/09/2020 |
MagVenture TMS Therapy û for treatment of OCD, MagVenture TMS Therapy system |
Tonica Elektronik A/S |
Sanne Barsballe Jessen |
| K200954 |
08/03/2020 |
Glaucoma Module |
Topcon Healthcare Solutions, Inc. |
Ramya Sundaram |
| K193247 |
08/05/2020 |
LATITUDE EVÖ Total Elbow Arthroplasty |
Tornier Inc. |
Renee Stoffel |
| K201244 |
08/07/2020 |
Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices |
TransMed7, LLC |
James Vetter |
| K190864 |
08/27/2020 |
Konix Anti-Fog Solution |
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler |
Nurham Irmak |
| K200838 |
08/12/2020 |
Tyece OTC TENS Model |
Tyece Limited |
Parshid Falahati |
| K193312 |
08/12/2020 |
UNIKO PointCloudÖ Knee Instruments |
Unik Orthopedics, Inc. |
Charlie Chi |
| K202108 |
08/28/2020 |
External Counterpulsation System, Soulaire |
Vamed Medical Instrument Co., Ltd. |
Ji Ma |
| K201248 |
08/12/2020 |
Syringe Holder accessory |
Vapocoolshot, Inc. |
Jacob Leibovici |
| K201588 |
08/11/2020 |
CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K193240 |
08/17/2020 |
Universal Cylinder Applicator Family |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K193260 |
08/21/2020 |
U-Cem Premium & MAZIC Cem |
Vericom Co., Ltd. |
Yun Ki Kim |
| K192991 |
08/03/2020 |
Vesco Medical Extension Feeding Set |
Vesco Medical LLC |
Chris O'Keefe |
| K200990 |
08/07/2020 |
VIDAvision |
VIDA Diagnostics Inc. |
Sandra Stapleton |
| K202054 |
08/24/2020 |
Dynex Ring Fixation System, Diametrix Ring Fixation System |
Vilex, LLC |
Joyce Thacker |
| K201856 |
08/26/2020 |
Provicol QM Aesthetic |
VOCO GmbH |
M. Th. Plaumann |
| K201360 |
08/19/2020 |
Reusable and Disposable SpO2 Sensors |
Xinkang Medical Instrument Co. Ltd. |
Xu Changsheng |
| K200695 |
08/24/2020 |
MATRx plus |
Zephyr Sleep Technologies |
Sabina Bruehlmann |
