| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K202598 |
09/08/2020 |
3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Le |
3A Medical Products Co., Ltd |
Slinda Ma |
| K202727 |
09/17/2020 |
Peregrine Endoscopy System |
3NT Medical Ltd. |
Ehud Bendory |
| K202782 |
09/22/2020 |
num Vapocoolant |
623 Medical, LLC |
Ty Schlander |
| K202888 |
09/28/2020 |
Confirm Rx Insertable Cardiac Monitor |
Abbott (St. Jude Medical) |
Laura Sparks |
| K202876 |
09/28/2020 |
Confirm Rx Insertable Cardiac Monitor |
Abbott (St. Jude Medical) |
Juni Sarkar |
| K202525 |
09/01/2020 |
Alinity i STAT High Sensitivity Troponin-I |
Abbott Laboratories Diagnostics Division |
Judi Wallach |
| K202977 |
09/30/2020 |
Alinity m STI Assay |
Abbott Molecular, Inc. |
Stacy Ferguson |
| K202797 |
09/23/2020 |
Drakon and Sequre Microcatheters |
Accurate Medical Therapeutics Ltd. |
Osnat Harbater |
| K202728 |
09/18/2020 |
Action Trackchair Hawk |
Action Manufacturing Inc. |
Alan Macht |
| K202830 |
09/25/2020 |
Axiostat Patch |
Advamedica Inc. |
Leo Mavely |
| K202808 |
09/23/2020 |
Brainance MD |
Advantis Medical Imaging Single Member P.C. |
Paris Ziogkas |
| K202938 |
09/30/2020 |
Aesculap Caiman 5 Seal and Cut Technology System |
Aesculap Inc. |
Omunique (Nikki) Luke |
| K202688 |
09/15/2020 |
AFS Medical Sterile Single-Use Access Port System |
AFS Medical Co. Ltd. |
Min Ah Kim |
| K202992 |
09/30/2020 |
BriefCase, RIB Fractures Triage (RibFx) |
Aidoc Medical, Ltd. |
Nimrod Epstein |
| K202587 |
09/08/2020 |
ATEC Lateral Interbody System |
Alphatec Spine, Inc. |
Sandy Gill |
| K202812 |
09/24/2020 |
IdentiTi Cervical Standalone Interbody System |
Alphatec Spine, Inc. |
Ruby Zheng |
| K202879 |
09/28/2020 |
EOGas 4 Endo-SteriTest RRBI |
Andersen Sterilizers, Inc. |
William K. Andersen |
| K202791 |
09/22/2020 |
iHealth Clinical Digital Thermometer |
Andon Health Co., Ltd. |
Liu Yi |
| K202753 |
09/21/2020 |
iHealth Wireless No-Touch Forehead Thermometer |
Andon Health Co., Ltd. |
Liu Yi |
| DEN200062 |
09/28/2020 |
Parsortix PC1 Device |
ANGLE Europe Ltd. |
Andrew Newland |
| K202532 |
09/01/2020 |
Disposable Surgical Gowns |
Anhui Medpurest Medical Technology Co.,Ltd |
Long Shushan |
| K202987 |
09/30/2020 |
Rescue Pulmonary Grasping Forceps |
Anrei Medical (Hangzhou) Co., Ltd |
Huibing Yang |
| K202885 |
09/28/2020 |
GlucoSure HT Plus Blood Glucose Monitoring System |
Apex BioTechnology Corp. |
Lisa Liu |
| K202534 |
09/01/2020 |
MTM301 Blood Glucose and Ketone Monitoring System |
Apex Biotechnology Corp. |
Lisa Liu |
| K202818 |
09/24/2020 |
Voyant Fine Fusion Device (EB230) |
Applied Medical |
Blake Stacy |
| K202539 |
09/02/2020 |
Nutriglide(TM) Nasal Feeding Tube |
Applied Medical Technology, Inc. |
Joy Tubero |
| K202880 |
09/28/2020 |
J-Plasma Precise FLEX Handpiece |
Apyx Medical Corporation (formerly Bovie Medical Corporation |
Lauren Tiller |
| K202777 |
09/22/2020 |
VeriFixxÖ Small Bone Implant |
Armis Biopharma, Inc. |
Franklin Okumu |
| K202535 |
09/01/2020 |
Arthrex FastThread Interference Screw |
Arthrex Inc. |
Jessica L. Singelais |
| K202582 |
09/08/2020 |
Arthrex SynergyID Endoscopic Imaging System |
Arthrex Inc. |
Heli F. Chambi Infantas |
| K202581 |
09/08/2020 |
Arthrex TightRope II |
Arthrex Inc. |
Kelsey N. Roberts |
| K202884 |
09/28/2020 |
SR-1 Skin Treatment System |
AVAVA, Inc. |
Lewis Levine |
| K202531 |
09/01/2020 |
Azer Scientific Universal Transport Medium |
Azer Scientific, Inc. |
Autumn N. Tellup |
| K202768 |
09/21/2020 |
KOSMO Femoral Stem |
b-One Ortho Corp. |
Allison Gecik |
| K202618 |
09/10/2020 |
IV Administration Sets |
B. Braun Medical Inc. |
Kimberly Smith |
| K202843 |
09/25/2020 |
Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) |
B.J.ZH.F.Panther Medical Equipment Co., Ltd |
Jiahui Li |
| K202706 |
09/16/2020 |
Surgical Gown (Sterile), Surgical Gown (Non-sterile) |
B.J.ZH.F.Panther Medical Equipment CO., LTD. |
Wenyue Han |
| K202825 |
09/24/2020 |
BTI Extra-Short Dental Implant System UnicCa |
B.T.I. Biotechnology Institute, S.L. |
Jose Roman Rivero |
| K202932 |
09/29/2020 |
ABT12 multi-purpose solution |
Bausch & Lomb Incorporated |
Melissa Thomas |
| K202844 |
09/25/2020 |
Medical Surgical Gowns |
Beijing Biosis Healing Biological Technology Co., Ltd |
Ting Jiang |
| K202566 |
09/04/2020 |
Wiygul Catheter |
Big Blue Biotech, Inc. |
Russ Olsen |
| K202739 |
09/18/2020 |
Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System |
Bioland Technology Ltd. |
Yiqing Feng |
| K202934 |
09/29/2020 |
Blood Pressure Monitor |
Bioland Technology Ltd. |
Yiqing Feng |
| K202969 |
09/30/2020 |
Biomet Microfixation OmniMax MMF System |
Biomet Microfixation |
Lauren Jasper |
| K202639 |
09/11/2020 |
si-Mochi |
Biostone Ltd |
Wei-Jen Lo |
| K202852 |
09/28/2020 |
DiviTum TKa |
Biovica International AB |
Joakim Arwidson |
| K202824 |
09/24/2020 |
BRS Procedure Face Mask |
Blackbriar Regulatory Services, LLC |
Vincent Angelico |
| K202584 |
09/08/2020 |
iSleeve Introducer Set |
Boston Scientific Corporation |
Kripa Pandya |
| K202847 |
09/25/2020 |
AccuBrain |
BrainNow Medical Technology Limited |
Junbing Huang |
| K202792 |
09/22/2020 |
BRIUS Clear Aligners |
Brius Technologies, Inc |
Kate Garrett |
| K202737 |
09/18/2020 |
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System |
Canon Medical Systems Corporation |
Paul Biggins |
| K202767 |
09/21/2020 |
Vantage Orian 1.5T, MRT-1550, V6.0 |
Canon Medical Systems Corporation |
Paul Biggins |
| K202788 |
09/22/2020 |
Sonomed IV, Sonomed V |
Carci Industria E Comercio De Aparelhos Cirurgicos E Orto |
Orlando Orlandi |
| K202751 |
09/21/2020 |
TandemHeart Pump and Escort Controller |
CardiacAssist, Inc. |
Megan Walsh |
| K202765 |
09/21/2020 |
ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs |
Careplus (M) SDN BHD |
Lim Kwee Shyan |
| K202611 |
09/09/2020 |
Catalyst OrthoScience R1 Reverse Shoulder System |
Catalyst OrthoScience, Inc. |
Dale Davison |
| K202937 |
09/30/2020 |
Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 |
Ceragem Co, Ltd. |
Hyeonggeun Hwang |
| K202793 |
09/22/2020 |
Cercare Medical Neurosuite |
Cercare Medical ApS |
Mikkel Bo Hansen |
| K202615 |
09/09/2020 |
Nordiwell Medical Face Mask |
Changzhou Combat Protective Equipment Co., Ltd. |
Yanmei Song |
| K202714 |
09/16/2020 |
Medical Face Mask |
Chongqing Chaoke Industry Development Co., Ltd. |
Liu Xincheng |
| K202759 |
09/21/2020 |
Disposable medical surgical mask |
Chongqing COE Display Technology Co., Ltd. |
Liu Qingjun |
| K202956 |
09/30/2020 |
Erisma LP Navigated Instruments |
Clariance, SAS |
Fadwa Bahr |
| K202857 |
09/28/2020 |
ClearPath Aligner |
ClearPath Orthodontics Ltd |
Waqas Wahab |
| K202575 |
09/04/2020 |
ClearPoint Array System |
ClearPoint Neuro, Inc. |
Pete Piferi |
| K202713 |
09/16/2020 |
TrueView 100 Pro |
CompAI Healthcare (Shenzhen) Co.,ltd |
Wang Yan |
| K202757 |
09/21/2020 |
CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor |
Contec Medical Systems Co., Ltd. |
Xueyong Li |
| K202955 |
09/30/2020 |
Contour Light CL-100 |
Contour Research, LLC |
Doug Dreier |
| K202858 |
09/28/2020 |
Flex-ThreadTM Distal Fibula Intramedullary Nail System |
Conventus Orthopaedics, LLC |
Amanda Pentecost |
| K202756 |
09/21/2020 |
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) |
CooperVision, Inc. |
Marie Dutton |
| K202637 |
09/11/2020 |
F3D Corpectomy System |
CoreLink, LLC |
Steven Mounts |
| K202805 |
09/23/2020 |
Optimized Positioning System (OPS) Insight |
Corin USA |
Lucinda Gerber |
| DEN200055 |
09/08/2020 |
GI Genius |
Cosmo Artificial Intelligence - AI, LTD |
Steven A. Kradjian |
| K202701 |
09/16/2020 |
GIA Stapler with Tri-Staple Technology |
Covidien |
Leo Chen |
| K202864 |
09/28/2020 |
Tri-Staple 2.0 Reloads |
Covidien |
Carolina Cabezas |
| K202917 |
09/29/2020 |
LigaSure Exact Dissector, Nano-coated |
Covidien llc |
Nancy Sauer |
| K202874 |
09/28/2020 |
Puritan Bennett Cuff Pressure Manager |
Covidien llc |
Jenny Liu |
| K202691 |
09/15/2020 |
Ortholock Anchorage Devices |
Craniofacial Technologies, Inc. |
Kevin Kaveh |
| K202909 |
09/29/2020 |
CreoDent Solidex Customized Abutment |
CreoDent Prosthetics, Ltd. |
Calvin Shim |
| K202517 |
09/01/2020 |
Cytrellis Dermal Micro-Coring System |
Cytrellis Biosystems, Inc. |
Karen H. Cronholm |
| K202928 |
09/29/2020 |
DV. Target |
Deepvoxel INC |
Jerry Liu |
| K202690 |
09/15/2020 |
Remunity Pump for Remodulin (treprostinil) Injection |
DEKA Research and Development |
Paul Smolenski |
| K202773 |
09/21/2020 |
s-Clean SQ-SL Implant System Mini |
Dentis Co., Ltd. |
Gyu Ri Kim |
| K202629 |
09/11/2020 |
Dentsply Sirona Universal Spray Glazes |
Dentsply Sirona |
Karl Nittinger |
| K202769 |
09/21/2020 |
VELYSÖ Robotic-Assisted Solution |
DePuy Ireland UC |
Erin Combs |
| K202546 |
09/02/2020 |
LVivo Seamless |
DiA Imaging Analysis Ltd |
Michal Yaacobi |
| K202574 |
09/04/2020 |
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus |
DiaSorin Inc. |
John C Walter |
| K202573 |
09/04/2020 |
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus |
DiaSorin Inc. |
John C Walter |
| K202755 |
09/21/2020 |
Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack |
DiaSorin Molecular LLC |
Sharon Young |
| K202633 |
09/11/2020 |
ScanX Edge |
Dⁿrr Dental SE |
Oliver Lange |
| K202549 |
09/03/2020 |
Solax Electric Scooter (Model: S202261B) |
Dongguan Prestige Sporting Goods Co., Ltd |
Zhang Zhao |
| K202632 |
09/11/2020 |
Electric wheelchair (S7204/S7205) |
Dongguan Prestige Sporting Goods Co., Ltd. |
Zhang Zhao |
| K202655 |
09/14/2020 |
Disposable Medical Mask |
Dongguan Runlin Medical Supplies Technology Co., LTD |
Weiming Chen |
| K202673 |
09/15/2020 |
X-cera Pre-shaded Zirconia Blanks |
Dongguan Xiangtong Co., Ltd. |
Charles Shen |
| K202591 |
09/08/2020 |
Body Infrared Thermometer HT-820D |
Dongguan Xintai Instrument Co., Ltd. |
Wei Wang |
| K202572 |
09/04/2020 |
GXR-Series Diagnostic X-Ray System |
DRGEM Corporation |
Ki-Nam Yang |
| K202940 |
09/30/2020 |
First Relief v1 |
DyAnsys, Inc |
Srini Nageshwar |
| K202856 |
09/28/2020 |
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, A |
Edan Instruments, Inc. |
Ying Dai |
| K202892 |
09/28/2020 |
Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s |
Edan Instruments, Inc. |
Alice Yang |
| K202789 |
09/22/2020 |
Monaco Rtp System |
Elekta Solutions AB |
Irina Proutski |
| K202558 |
09/04/2020 |
Ellusa Bipolar Wands |
Ellusa, LLC |
Suzanne Lucas |
| K202562 |
09/04/2020 |
Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set |
Ellusa, LLC |
Suzanne Lucas |
| K202588 |
09/08/2020 |
BNA Platform |
elminda, Ltd |
Keren Elghouzzi-Kazachinsky |
| K202685 |
09/15/2020 |
Eon Aligner |
Eon Dental Jordan LLC |
Fadi Samawi |
| K202754 |
09/21/2020 |
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU |
eResearchTechnology GmbH |
Margit Kohlen |
| K202665 |
09/14/2020 |
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm |
Ethicon Endo-Surgery, LLC |
Nathan Anderson |
| K202693 |
09/15/2020 |
NeoWave Pain Relief and Recovery System, Model# T16-2020 |
Eva Medtec, Inc |
Irene Waldridge |
| K202849 |
09/28/2020 |
Everyway Analog OTC TENS, model N103A/N302 |
Everyway Medical Instruments Co., Ltd |
Paul Hung |
| K202948 |
09/30/2020 |
EzOrtho |
Ewoo Soft Co., Ltd. |
Young Seok Kim |
| K202835 |
09/25/2020 |
Auryon Atherectomy System |
Eximo Medical Ltd. |
Yoel Zabar |
| K202845 |
09/25/2020 |
Bodygard SFS Surgical Gown Level 3 |
Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi |
Ali Serdar Serteser |
| K202616 |
09/09/2020 |
ClearCap Distal Attachment |
Finemedix Co., Ltd. |
Seok-Jun Ma |
| K202991 |
09/30/2020 |
Fotona XPulse Pro Laser Platform |
Fotona d.o.o. |
Marko Berdajs |
| K202985 |
09/30/2020 |
LightWalker Laser System Family |
Fotona d.o.o. |
Pucer Anja |
| K202914 |
09/29/2020 |
SternaFuse Fixation System |
Fusion Innovations, LLC |
Mark Schumacher |
| K202959 |
09/30/2020 |
PolyLock Plating System |
Fusion Orthopedics, LLC |
Eli Jacobson |
| K202838 |
09/25/2020 |
Andorate Universal Endoscope Tip Guard |
GA Health Company Limited |
Cindy Ye |
| K202560 |
09/04/2020 |
AquaPulse Irrigation Tubing |
GA Health Company Limited |
Cindy Ye |
| K202872 |
09/28/2020 |
Prase PEEK Anterior Cervical Interbody Spacer |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K202878 |
09/28/2020 |
Prase-AP Anterior Cervical Plate System |
GBS Commonwealth Co., Ltd. |
Jimmy Kim |
| K202966 |
09/30/2020 |
SIGNA Architect |
GE Healthcare (GE Medical Systems, LLC) |
Andrew Menden |
| K202658 |
09/14/2020 |
Vivid E80/ Vivid E90/ Vivid E95 |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
Tracey Ortiz |
| K202817 |
09/24/2020 |
GEO Bone Screw System |
Gramercy Extremity Orthopedics, LLC |
Michael Simpson |
| K202846 |
09/25/2020 |
TERA HARZ |
Graphy Inc. |
Tae-woo Kim |
| K202761 |
09/21/2020 |
Medical Surgical Mask (Non-sterile) |
Guangdong GoodFeeling Hygiene Material Tec Co., Ltd. |
Zheng Zhijin |
| K202891 |
09/28/2020 |
Blood Pressure Monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Endless Chan |
| K202599 |
09/08/2020 |
Transtek Wrist Blood Pressure Monitor |
Guangdong Transtek Medical Electronics Co., Ltd. |
Nicole Hu |
| K202650 |
09/14/2020 |
Medical disposable face mask non sterile |
Guangdong Zhong Ling Industrial Group Co., Ltd. |
Ann Ho |
| K202766 |
09/21/2020 |
EOS Air Cleaner |
Guangzhou Ajax Medical Equipment Co., Ltd. |
Atwood Lee |
| K202567 |
09/04/2020 |
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx |
Guangzhou Wondfo Biotech Co., Ltd. |
Yi Mei |
| K202671 |
09/14/2020 |
DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K202636 |
09/11/2020 |
Metallic Fabric Electrodes |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K202638 |
09/11/2020 |
Pain Therapy Device |
Guangzhou Xinbo Electronic Co., Ltd. |
Sammy Li |
| K202627 |
09/11/2020 |
Medical Face Masks |
Guilin HBM Sanitary Protections, Inc |
Liu Xin |
| K202698 |
09/16/2020 |
Prefilled Syringe |
Hangzhou Primecare Medical Co., Ltd. |
Xueqing Yan |
| K202952 |
09/30/2020 |
Amber Mill Q Series & Amber Mill Direct Series |
HASS Corp. |
Yongsu Kim |
| K202842 |
09/25/2020 |
Medical surgical mask |
Henan Huibo Medical Co.,Ltd. |
Hui Lu |
| K202882 |
09/28/2020 |
Affinity |
Hermes Medical Solutions AB |
Joakim Arwidson |
| K202716 |
09/17/2020 |
Ignite Anatomic Shoulder System |
Ignite Orthopedics LLC |
Matt Purdy |
| K202887 |
09/28/2020 |
IlluminOss Bone Stabilization System |
IlluminOss Medical, Inc. |
Robert Rabiner |
| K202832 |
09/25/2020 |
Implacil Implant System |
Implacil de Bortoli Material Odontologico Ltda |
Thiago Toni |
| K202524 |
09/01/2020 |
Standard Sterilizable Tray |
Implant Direct Sybron Manufacturing, LLC |
Reina Choi |
| K202970 |
09/30/2020 |
Ventway Sparrow |
Inovytech Medical Solutions Ltd. |
Dana Hofeller |
| K202544 |
09/02/2020 |
Instylla Delivery Kit |
Instylla, Inc. |
Jennifer Greer |
| K202708 |
09/16/2020 |
Surgical Face Masks |
Intco Medical(HK) Co., Ltd. |
Max Li |
| K202968 |
09/30/2020 |
Da Vinci SP Surgical System |
Intuitive Surgical, Inc. |
Connor McCarty |
| K202571 |
09/04/2020 |
da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories |
Intuitive Surgical, Inc. |
Elaine Lee |
| K202834 |
09/25/2020 |
da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) |
Intuitive Surgical, Inc. |
Brandon Hansen |
| K202527 |
09/01/2020 |
Zio ECG Utilization Software (ZEUS) System |
iRhythm Technologies, Inc. |
Gabrielle Logan |
| K202760 |
09/21/2020 |
Iridex 810 Laser |
Iridex Corporation |
Bill Hyatt |
| K202855 |
09/28/2020 |
Orthodontic Facemask |
ITA.O Italian Orthodontic System S.r.l. |
Alessandra Ferroni |
| K202603 |
09/08/2020 |
Temp Pal |
iWEECARE Co., Ltd. |
Glen Tseng |
| K202912 |
09/29/2020 |
ARIX Ankle Distal Tibia System |
Jeil Medical Corporation |
Ahhyeon Woo |
| K202794 |
09/23/2020 |
Surgical face mask: F-Y1-A |
Jiande Chaomei Daily Chemicals Co., Ltd |
Zhu Lipin |
| K202577 |
09/08/2020 |
Medical Surgical Mask-Model MP002-5, MP002-6 |
Jiangmen Sure&Me Medical Product CO., LTD |
Liang Meixia |
| K202905 |
09/29/2020 |
Disposable Face Mask |
Jiangsu Excellence Medical Supplies Co., Ltd |
Jing Zhu |
| K202605 |
09/08/2020 |
Standard Procedure Mask, Standard Surgical Mask |
Jiangsu Medplus Non-woven Manufacturer Co., Ltd. |
Shuying An |
| K202640 |
09/11/2020 |
Surgical Mask |
Jiangsu Medpure Biological Technology Co., Ltd. |
Jianwen Fei |
| K202570 |
09/04/2020 |
Insulin Syringe, Insulin Syringe with Safety Retractable |
Jiangsu Micsafe Medical Technology Co., Ltd |
Tony Yang |
| K202904 |
09/29/2020 |
Surgical Face Mask |
Jiangxi Feilikang Medical Technology Co., Ltd. |
Shijun Zhang |
| K202719 |
09/17/2020 |
Disposable Medical Face Masks |
Jiangxi Sanxin Medtec Co., Ltd. |
Shuiqing Sun |
| K202796 |
09/23/2020 |
SANSIN Tubing Sets for Hemodialysis |
Jiangxi Sanxin Medtec Co., Ltd. |
Shuiqing Sun |
| K202515 |
09/01/2020 |
NUVO Implant System û NUVO Instrument Kit Cases |
JJGC Industria e Comercio de Materiais Dentarios S.A. |
Mariana Soares Hartmann |
| K202839 |
09/25/2020 |
Overlapped Compression Therapy |
JKH HEALTH CO., LTD. |
Pu Jiang |
| K202851 |
09/28/2020 |
Spo2 Sensor |
JKH USA, LLC |
Bill Quanqin Dai |
| K202889 |
09/28/2020 |
Able Medical Devices Valkyrie Thoracic Fixation System |
JM Longyear Manufacturing, LLC D.B.A. Able Medical Devices |
Wade DePas |
| K202528 |
09/01/2020 |
Cannulated Power Driver Attachment |
K2M Inc. |
Megan Callanan |
| K202925 |
09/29/2020 |
KARL STORZ ICG Imaging System |
KARL STORZ Endoscopy_America, Inc. |
Alita McElroy |
| K202957 |
09/30/2020 |
Flexible Video Cysto-Urethroscope (C-view) |
KARL STORZ Endoscopy-America, Inc |
Winkie Wong |
| K202899 |
09/29/2020 |
Procedure Mask, Surgical Mask |
Kenpax International Limited |
Solomon Chen |
| K202747 |
09/21/2020 |
Klarity Bolus |
Klarity Medical & Equipment (GZ) Co., Ltd. |
Lucy Li |
| K202521 |
09/01/2020 |
PtoleMedic System |
Lento Medical Innovation, Inc. |
David W. Schlerf |
| K202836 |
09/25/2020 |
GX Navigation Instrument System |
Life Spine Inc. |
Angela Batker |
| K202868 |
09/28/2020 |
LifeSignals Multi-Parameter Remote Monitoring Platform |
LifeSignals, Inc. |
Saravanan Balasubramanian |
| K202915 |
09/29/2020 |
IRIS Thermocoagulator and Digital Colposcope |
Liger Medical, LLC |
Wm. Dean Wallace |
| K202848 |
09/25/2020 |
S2 Pigment Removal System |
Lightsense Technologies Ltd |
Deganit Barak |
| K202898 |
09/29/2020 |
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System |
Lightstone Medical Products (Ningbo) Co Ltd |
Julian Zhu |
| K202979 |
09/30/2020 |
MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra |
Lode B.V. |
J.R. Fransens |
| K202901 |
09/29/2020 |
Longeviti ClearFit Cranial Implant |
Longeviti Neuro Solutions, LLC |
Heather Hourihan |
| K202551 |
09/03/2020 |
Cor-Knot Micro |
LSI Solutions, Inc. |
Christopher B. Miller |
| K202973 |
09/30/2020 |
HANAROSTENT Benefit Biliary (NNN) |
M.I.Tech Co., Ltd. |
Inae Kim |
| K202919 |
09/29/2020 |
ATS 5000 Automatic Tourniquet Instrument |
McEwen and Associates Consulting Ltd. |
Julie Kerr |
| K202679 |
09/15/2020 |
Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 |
McGovern Medical School |
K. Lance Gould |
| K202684 |
09/15/2020 |
GMK Total Knee System - TiNbN Coating |
Medacta International SA |
Stefano Baj |
| K202568 |
09/04/2020 |
Mpact« 3D Metal Implants - DMLS Technology |
Medacta International SA |
Stefano Baj |
| K202730 |
09/18/2020 |
Quadra-P |
Medacta International SA |
Stefano Baj |
| K202589 |
09/08/2020 |
APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System |
Medartis AG |
Andrea Kiefer-Schweizer |
| K202748 |
09/21/2020 |
Enteral Feeding Catheter |
Medcaptain Life Science Co., Ltd. |
David Xia |
| K202578 |
09/08/2020 |
KardiFlex NC Coronary Dilatation Catheter |
Medcaptain Life Science Co., Ltd. |
David Xia |
| K202619 |
09/10/2020 |
KardiFlex PTCA Balloon Dilatation Catheter |
Medcaptain Life Science Co., Ltd. |
David Xia |
| K202668 |
09/14/2020 |
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50╡g/dm2 per Glove of Extractable Protein |
Medline Industries, Inc. |
Jennifer Mason |
| K202974 |
09/30/2020 |
DenTek Fresh Protect Dental Guard |
Medtech Products, Inc. |
Vincent Argiro |
| K202771 |
09/21/2020 |
CD Horizon Spinal System |
Medtronic |
Raphael McInnis |
| K202620 |
09/10/2020 |
FlexCath Advance Steerable Sheath and Dilator |
Medtronic CryoCath LP |
Matthew Lobeck |
| K202552 |
09/03/2020 |
Midas Rex Attachments and Dissecting Tools |
Medtronic Powered Surgical Solutions (MPSS) |
Jainam Shah |
| K202800 |
09/23/2020 |
Pacific Plus PTA Catheter |
Medtronic Vascular,Inc(formerly d.b.a ev3 Inc.,Covidien llc) |
Rupali Gupta |
| K202623 |
09/10/2020 |
Novapak Nasal Sinus Packing and Stent |
Medtronic Xomed |
Matthew Harmon |
| K202913 |
09/29/2020 |
NeuroCap (Model DEC22) |
Memory MD Inc |
Boris Goldstein |
| K202610 |
09/09/2020 |
Ventrax Delivery System |
Merit Medical Systems, Inc. |
Elizabeth Lazaro |
| K202617 |
09/09/2020 |
Metapex Plus |
Meta Biomed Co., Ltd. |
Suk Song Oh |
| K202822 |
09/24/2020 |
Helianthus |
Metaltronica Spa |
Gloria Pesce Delfino |
| K202965 |
09/30/2020 |
CURA-Temp |
Mgnewton LTD. |
Byoung Wook Ahn |
| K202963 |
09/30/2020 |
ELEC Master, ELEC Master Dual |
Mgnewton Ltd. |
Byoung-Wook Ahn |
| K202850 |
09/28/2020 |
Concerto Versa, Detachable Coil |
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular |
Rita De Rama |
| K202729 |
09/18/2020 |
Microlife Upper Arm Automatic Digital Blood Pressure Monitor |
Microlife Intellectual Property GmbH |
Gerhard Frick |
| K202786 |
09/22/2020 |
Dental Low-speed Handpieces and Accessories |
MicroP Technology (Taiwan), Inc. |
Ina Lin |
| K202705 |
09/16/2020 |
Prime and DYNASTY« Additive Manufacturing Shells |
MicroPort Orthopedics Inc. |
Gillen Gonzales |
| K202718 |
09/17/2020 |
Qmenta Care Platform Family |
Mint Labs, Inc., d/b/a. QMENTA |
Paulo Rodrigues |
| K202993 |
09/30/2020 |
Buzzy« (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool« (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) |
MMJ Labs, LLC |
Amy Baxter |
| K202837 |
09/25/2020 |
GoSpiro |
Monitored Therapeutics, Inc. |
Michael Taylor |
| K202523 |
09/01/2020 |
TMJ Relax |
Moonwalker Innovations Inc |
Charles Sutera |
| K202635 |
09/11/2020 |
MY01 Continuous Compartmental Pressure Monitor |
MY01, Inc. |
Charles Allan |
| K202960 |
09/30/2020 |
General Cutting Contra Handpiece |
Nakanishi Inc. |
Masaaki Kikuchi |
| K202953 |
09/30/2020 |
Aurolase Therapy, Laser Delivery Device (LDD) |
Nanospectra Biosciences, Inc. |
David Jorden |
| K202667 |
09/14/2020 |
Personal Lubricant Jelly |
Nantong Health & Beyond Hygienic Products Inc. |
Michael Zhu |
| K202897 |
09/29/2020 |
Natural Cycles |
Natural Cycles Nordic AB |
Raoul Scherwitzl |
| K202780 |
09/22/2020 |
Sectum |
Neauvia North America |
Misty Williams |
| K202526 |
09/01/2020 |
OmniTom Elite |
NeuroLogica Corporation, a subsidiary of Samsung Electronics |
Ninad Gujar |
| K202621 |
09/10/2020 |
NeuroSENSE Monitoring System, Model NS-901 |
NeuroWave Systems Inc. |
Tatjana Zikov |
| K202781 |
09/22/2020 |
Neuspera Neurostimulation System (NNS) |
Neuspera Medical Inc. |
Alexander Yeh |
| K202962 |
09/30/2020 |
Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Ev |
New Deantronics Taiwan Ltd |
Jane Liu |
| K202803 |
09/23/2020 |
Activmotion S DTO |
Newclip Technics |
Gaelle LUSSORI |
| K202929 |
09/29/2020 |
Nexpowder |
Nextbiomedical Co., Ltd. |
Jin Young Lee |
| K202990 |
09/30/2020 |
NinesMeasure |
Nines, Inc. |
Russell Stewart |
| K202647 |
09/11/2020 |
Surgical Mask |
Ningbo Green Textile Co., Ltd. |
Carol No Last Name Provided |
| K202745 |
09/18/2020 |
Disposable medical face mask |
Ningbo Jingeao Electronics Inc. |
Yiyun Yu |
| K202746 |
09/18/2020 |
Surgical mask |
Ningbo Jingeao Electronics Inc. |
Yiyun Yu |
| K202709 |
09/16/2020 |
Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges |
Ningbo Verykind Medical Device Co., Ltd. |
Hong Pengfei |
| K202944 |
09/30/2020 |
NEBULAE SRS Laparoscopic Surgical Smoke Removal System |
Northgate Technologies Inc. |
Todd Gatto |
| K202813 |
09/24/2020 |
URO-TOUCH 9 French Probe |
Northgate Technologies Inc. |
Todd Gatto |
| K202988 |
09/30/2020 |
Tixel System |
Novoxel Ltd. |
Ronen Shavit |
| K202972 |
09/30/2020 |
Anterior Cervical Plate System |
Nutech Spine and Biologics |
Grant Horton |
| K202657 |
09/14/2020 |
Javelin Tailor's Bunion Fixation System |
Nvision Biomedical Technologies, Inc |
Diana Langham |
| K202622 |
09/10/2020 |
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate |
O & M Halyard, Inc. |
Steven Dowdley |
| K202670 |
09/14/2020 |
Nam illumination probe with chopper |
Oculight Ltd. |
Jinman Kim |
| K202989 |
09/30/2020 |
Myopia Master |
OCULUS OptikgerΣte GmbH |
Eckhard Loh |
| K202661 |
09/14/2020 |
Evis Exera III Duodenovideoscope Olympus TJF-Q190V |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K202646 |
09/11/2020 |
Visera Elite II Video System Center |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K202943 |
09/30/2020 |
OptoMonitor 3 |
Opsens Inc. |
Marc Chaunet |
| K202950 |
09/30/2020 |
StitchKit COMBO |
Origami Surgical |
John Gillespie |
| K202764 |
09/21/2020 |
Ortho Solutions Plating System |
Ortho Solutions UK Ltd |
Andy Leither |
| K202651 |
09/14/2020 |
NOA Sleep Apnea and Snoring Device |
Orthoapnea S.L. |
Jose Repolles Llecha |
| K202949 |
09/30/2020 |
CONSTRUX Mini PEEK Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K202666 |
09/14/2020 |
CONSTRUX Mini PTC Spacer System |
Orthofix Inc. |
Natalia Volosen |
| K202519 |
09/01/2020 |
OrthoNext Platform System |
Orthofix Srl |
Gianluca Ricadona |
| K202971 |
09/30/2020 |
DRPx Locking Distal Radius Plate System |
Orthopaedic Implant Company |
Douglas Fulton |
| K202810 |
09/23/2020 |
AutoStrut G2 |
OrthoSpin Ltd |
Oren Cohen |
| K202675 |
09/15/2020 |
InRoad« Dental Synthetic Bone Graft |
Osteogene Tech Corp |
Daniel S. Oh |
| K202680 |
09/15/2020 |
OsteoMed ExtremiFix Mini & Small Cannulated Screw System |
OsteoMed LLC |
Andrew "Drew" Johnson |
| K202806 |
09/23/2020 |
Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) |
OSTEONIC Co., Ltd. |
Da Kyung Ham |
| K202763 |
09/21/2020 |
Fix2Lock (PEEK Self Punching) |
Osteonic Co., Ltd. |
Da Kyung Ham |
| K202883 |
09/28/2020 |
Sterile bone screw (PEEK ACL screw) |
Osteonic Co., Ltd. |
Sungmoo Hwang |
| K202663 |
09/14/2020 |
Suture Wing |
Osteonic Co., Ltd. |
Dakyung Ham |
| K202689 |
09/15/2020 |
Dentilube Spray |
Oxy2plus, LLC |
Chun nan Lin |
| K202674 |
09/15/2020 |
Medidenta High Speed Handpieces |
Pac-Dent, Inc. |
Jiahe Li |
| K202920 |
09/29/2020 |
OptiComp |
Pac-Dent, Inc. |
Jiahe Li |
| K202831 |
09/25/2020 |
The iMask Child's Face Mask |
Pac-Dent, Inc. |
Jiahe Li |
| K202699 |
09/16/2020 |
E-Cath STIM acc. Tsui |
PAJUNK GmbH Medizintechnologie |
Christian G.H. Quass |
| K202922 |
09/29/2020 |
END 200 Endoscopic Tubeset |
Palliare Ltd. |
John OÆDea |
| K202799 |
09/23/2020 |
EVA15 |
Palliare Ltd. |
John O'Dea |
| K202662 |
09/14/2020 |
Parcus Titanium Interference Screws |
Parcus Medical, LLC |
Alejandra Anderson |
| K202821 |
09/24/2020 |
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 |
Penumbra, Inc. |
Michaela Mahl |
| K202540 |
09/02/2020 |
EliA Rib-P |
Phadia AB |
Carina Magnusson |
| K202541 |
09/02/2020 |
EliA RNA Pol III |
Phadia AB |
Sheryl Skinner |
| K202564 |
09/04/2020 |
DigitalDiagnost C90 |
Philips Medical Systems DMC GmbH |
Ming Xiao |
| K202750 |
09/21/2020 |
Knee+ |
Pixee Medical |
Lucie Pecheur |
| K202542 |
09/02/2020 |
Allura Vaginal Stent |
PMT Corporation |
Matt Cree |
| K202595 |
09/08/2020 |
Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask |
Premier Guard USA LLC |
Howard Sherman |
| DEN200059 |
09/18/2020 |
POMC/PCSK1/LEPR CDx Panel |
PreventionGenetics, LLC |
Jerry Machado |
| K202820 |
09/24/2020 |
Australis Anterior Lumbar Cage System |
Prism Surgical Designs Pty Ltd |
Emma May Young |
| K202961 |
09/30/2020 |
AquaBeam Robotic System |
PROCEPT BioRobotics Corporation |
Sara Muddell |
| K202518 |
09/01/2020 |
Promaxo MRI System |
Promaxo, Inc. |
Eva Hellman |
| K202681 |
09/15/2020 |
Promisemed Covered Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K202682 |
09/15/2020 |
Promisemed Triple Safety Pen Needle |
Promisemed Hangzhou Meditech Co., Ltd. |
Zearou Yang |
| K202529 |
09/01/2020 |
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring |
ProSomnus Sleep Technologies, Inc. |
Divya Mavalli |
| K202580 |
09/08/2020 |
Disposable Surgical Mask |
Qingdao Likangyuan Medical Device Co., Ltd. |
Ying Xu |
| K202628 |
09/11/2020 |
Disposable Medical Face Mask |
Qinghai Zhong Dao Win-win Medical Protective Equipment Co., |
Zhaochu Chen |
| K202672 |
09/15/2020 |
Precision Delivery Infusion Set |
Quest Medical, Inc. |
Tosan Eweka |
| K202722 |
09/17/2020 |
1212FCA |
Rayence Co., Ltd |
Kee Dock Kim |
| K202902 |
09/29/2020 |
2430MCA with Xmaru W |
Rayence Co., Ltd |
Kee Dock Kim |
| K202601 |
09/08/2020 |
Single-use Sterile medical laser fiber |
Realton (Suzhou) Medical Technology Co., Ltd |
Mingzhu Liu |
| K202702 |
09/16/2020 |
FLARE Single-Use Surgical Laser Fiber |
Realton (Suzhou) Medical Technology Co., Ltd. |
Mingzhu Liu |
| K202828 |
09/24/2020 |
Surgical Green Laser System |
Realton (Suzhou) Medical Technology Co., Ltd. |
Mingzhu Liu |
| K202537 |
09/01/2020 |
ALTMS Magnetic Stimulation Therapy System |
REMED Co., Ltd |
Yonsoo Nam |
| K202569 |
09/04/2020 |
Responsive Arthroscopy Interference Screw System |
Responsive Arthroscopy LLC |
Douglas Kohrs |
| K202903 |
09/29/2020 |
Surgical Face Mask |
Rizhao Sanqi Medical & Health Articles Co., Ltd. |
Julia Yu |
| K202652 |
09/14/2020 |
Servator P SALF Solution with THAM |
S.A.L.F. spa |
Carmelo Gagliano |
| K202556 |
09/03/2020 |
HS30 Diagnostic Ultrasound System |
Samsung Medison Co., LTD |
Ji Yea Lee |
| K202906 |
09/29/2020 |
EndoPilot2 |
Schlumbohm GmbH & Co. KG |
Gerald Schlumbohm |
| K202644 |
09/11/2020 |
Acetaminophen |
Sekisui Diagnostics P.E.I. INC. |
Penny White |
| K202833 |
09/25/2020 |
Sequel External Fixation Device |
Sequel Medical Inc. |
Valentina Kamysheva |
| K202565 |
09/04/2020 |
WAVICIDE-OPA MEC Indicator |
Serim Research Corporation |
Jackie Nelson |
| K202594 |
09/08/2020 |
Medical Surgical Masks-Non Sterile |
Shandong T&F Nonwoven Co., LTD |
Minsheng Zhao |
| K202758 |
09/21/2020 |
Nd: YAG Laser Therapy Systems HM-YL900 |
Shangdong Huamei Technology Co., Ltd. |
Xu QingHua |
| K202916 |
09/29/2020 |
Balloon Guiding Catheter |
Shanghai Heartcare Medical Technology Co., Ltd |
Zongyu Xue |
| K202926 |
09/29/2020 |
Micro Catheter |
Shanghai Heartcare Medical Technology Co., Ltd. |
Zongyu Xue |
| K202741 |
09/18/2020 |
Infrared Forehead Thermometer |
Shenzhen Combei Technology Co., Ltd. |
Kevin Fong |
| K202827 |
09/24/2020 |
308nm Excimer UV-light Skin Therapy System |
Shenzhen GSD Tech Co., Ltd. |
Zoe Yao |
| K202866 |
09/28/2020 |
TENS & EMS Device |
SHenzhen Jianfeng Electronic Technology Co., Ltd. |
Feng Wen |
| K202648 |
09/11/2020 |
Biofeedback Nerve and Muscle Stimulator |
Shenzhen Konmed Technology Co., Ltd. |
Tony No Last Name Provided |
| K202980 |
09/30/2020 |
Laser Therapy Device |
Shenzhen Leaflife Technology Co., Ltd |
Cheng Qiang |
| K202776 |
09/21/2020 |
Fingertip pulse oximeter |
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. |
Aaron Lin |
| K202687 |
09/15/2020 |
Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 |
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd. |
Aaron Lin |
| K202743 |
09/18/2020 |
Med-Link Temp-pulse Oximeter |
Shenzhen Med-link Electronics Tech Co., Ltd |
Jialing Zhang |
| K202785 |
09/22/2020 |
Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Meidcal Electronics Co., LTD |
Ma chao |
| K202826 |
09/24/2020 |
IMMULITE« 2000 Cortisol |
Siemens Healthcare Diagnostics Products Ltd. |
Malgorzata Robak |
| K202683 |
09/15/2020 |
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnos |
Siemens Medical Solutions, USA, Inc. |
Christine Dunbar |
| K202678 |
09/15/2020 |
OMNI Surgical System |
Sight Sciences, Inc. |
Edward J. Sinclair |
| K202918 |
09/29/2020 |
OsteoSyncÖ Ti Dental Mesh |
Sites Medical, LLC |
Greg Stalcup |
| K202631 |
09/11/2020 |
iHelmet Laser Comb |
Slinph Technologies Co., Ltd |
Jian Zou |
| K202783 |
09/22/2020 |
Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing |
Smith & Nephew Medical Limited |
Steeve Lamvohee |
| K202762 |
09/21/2020 |
Circular Fixation with Balanced Cable Transport |
Smith & Nephew, Inc. |
Crystal Higgenbottom-Shaffer |
| K202732 |
09/18/2020 |
SOL-CARE IV Bag Safety Connector |
Sol-Millennium Medical Group |
Jim Barley |
| K202664 |
09/14/2020 |
Clio Prime and Clio Pedo |
Sota Precision Optics, Inc. dba SOTA Imaging |
Bumsuk Kim |
| K202733 |
09/18/2020 |
Quantum Ventilation Module |
Spectrum Medical Ltd |
Colleen Powell |
| K202557 |
09/03/2020 |
Quantum Workstation 12 Elite |
Spectrum Medical Ltd |
Colleen Powell |
| K202660 |
09/14/2020 |
SPRINT PNS System |
SPR Therapeutics, Inc. |
Kathryn Stager |
| K202583 |
09/08/2020 |
BioShield biopsy valve EUS - Linear |
Steris Corporation |
Jacqueline Oliver |
| K202721 |
09/17/2020 |
Celerity 20 Steam Biological Indicator for IUSS |
STERIS Corporation |
Anthony Piotrkowski |
| K202942 |
09/30/2020 |
Straumann 4 mm Short Implants |
Straumann USA, LLC |
Chanrasmey N. White |
| K202607 |
09/09/2020 |
Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs |
String King Lacrosse, LLC |
Thomas Frasca |
| K202592 |
09/08/2020 |
Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) |
Stryker |
Divya Sekar |
| K202659 |
09/14/2020 |
Stryker Arthroscope |
Stryker |
Christie Samsa |
| K202964 |
09/30/2020 |
iBed Wireless with iBed Mobile |
Stryker Corporation |
Cathy Friday |
| K202609 |
09/09/2020 |
Instrument Clamps Electromagnetic |
Stryker Corporation |
Maya Schiel |
| K202749 |
09/21/2020 |
ADAPT for Gamma3 |
Stryker GmbH |
Ugochi Okereke |
| K202752 |
09/21/2020 |
AXS Vecta 46 Intermediate Catheter |
Stryker Neurovascular |
Shivani H. Patel |
| K202522 |
09/01/2020 |
Synchro SELECT Guidewire |
STRYKER NEUROVASCULAR |
Hailey Hinkle |
| K202554 |
09/03/2020 |
Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis |
Stryker Sustainability Solutions |
Aphrodeja Crutch |
| K202547 |
09/02/2020 |
Surgivisio system |
Surgivisio |
Vincent Lere |
| K202927 |
09/29/2020 |
EYE-SYNC |
SyncThink, Inc. |
Dan Beeler |
| K202935 |
09/29/2020 |
Syntec Femoral Nail Extended System |
Syntec Scientific Corporation |
Nicole Tseng |
| K202790 |
09/22/2020 |
Syntec Orthodontic Mini Screw Extended System |
Syntec Scientific Corporation |
Nicole Tseng |
| K202700 |
09/16/2020 |
ART-Plan |
TheraPanacea |
Edwin Lindsay |
| K202725 |
09/17/2020 |
ETD4000 |
TheraSigma, LLC |
Jim Klett |
| K202612 |
09/09/2020 |
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) |
Thermo Fisher Scientific |
Cynthia Knapp |
| K202740 |
09/18/2020 |
Klassic Knee System Tibial Inserts, PS-Max |
Total Joint Orthopedics, Inc. |
Chris Weaber |
| K202579 |
09/08/2020 |
TruAbutment DS, TruBase |
TruAbutment Inc. |
Eunjin Jang |
| K202593 |
09/08/2020 |
Turbett Instrument Pod |
Turbett Surgical Inc. |
Rob Turbett |
| K202697 |
09/16/2020 |
United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask |
United Sewing Automation Inc. |
Benjamin Webb |
| K202921 |
09/29/2020 |
Uro-G Cystoscope |
UroViu Corporation |
Thomas Lawson |
| K202860 |
09/28/2020 |
Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A |
Valley Contax, Inc. |
Josh Adams |
| K202703 |
09/16/2020 |
Vascutek Gelsoft Plus ERS Vascular Graft |
Vascutek Ltd |
Chirag Merchant |
| K202742 |
09/18/2020 |
Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory |
Viasonix Ltd. |
Dan Manor |
| K202862 |
09/28/2020 |
Gx-IVF, Gx-TL, Gx-MOPS PLUS |
Vitrolife Sweden AB |
Sarah Hood Hagberg |
| K202543 |
09/02/2020 |
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip |
Volcano Corporation |
Patrick Juarez |
| K202596 |
09/08/2020 |
Insulia Diabetes Management Companion |
Voluntis, S.A. |
Kevin Howard |
| K202694 |
09/16/2020 |
Vycor Medical Viewsite Brain Access System (ôVBASö) and VBAS with Alignment Clip (ôVBAS ACö) (together the ôVBAS Familyö) |
Vycor Medical INC. |
Theo Novak |
| K202924 |
09/29/2020 |
LinkSymphoKnee System |
Waldemar Link GmbH & Co. KG |
Stefanie Fuchs |
| K202710 |
09/16/2020 |
Disposable Medical Face Mask |
Wanxinda (Guangzhou) Technology Product Co., Ltd |
Zeng Xueping |
| K202548 |
09/02/2020 |
Surgical Face Mask |
Wanxinda (Guangzhou) Technology Product Co., Ltd |
Zeng Xueping |
| K202653 |
09/14/2020 |
Gymform Total ABS |
Well Brain International Ltd. |
Victor K. Wai |
| K202894 |
09/28/2020 |
Wiltrom Spinal Fixation System |
Wiltrom Corporation Limited |
Freda Lin |
| K202982 |
09/30/2020 |
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) |
Winner Medical Co., Ltd. |
Haoyuan He |
| K202815 |
09/24/2020 |
PROPHECY Preoperative Navigation Alignment System |
Wright Medical Technology, Inc. |
Paxia Her |
| K202861 |
09/28/2020 |
Needle Stimulator |
Wuxi Jiajian Medical Instrument Co., Ltd |
Caihong Sun |
| K202893 |
09/28/2020 |
Transcutaneous Electrical Nerve Stimulator |
Wuxi Jiajian Medical Instrument Co., Ltd |
Caihong Sun |
| K202931 |
09/29/2020 |
Disposable Trocar |
Wuxi Shukang Medical Appliance Co., Ltd. |
Xiaoqing Yuan |
| K202802 |
09/23/2020 |
TT Electric Breast Pump, TT Double Electric Breast Pump |
Wuxi Xinzhongrui Baby Supplies Co., Ltd. |
Zhang Chunyan |
| K202954 |
09/30/2020 |
Disposable Surgical Mask |
Xiamen Probtain Medical Techology Co., Ltd |
Jianli Kang |
| K202983 |
09/30/2020 |
easy Hairfull |
Y&J BIO Co., Ltd. |
Kwang Sic Kim |
| K202536 |
09/01/2020 |
Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate |
YTY Industry (Manjung) SDN BHD |
Punitha Samy |
| K202624 |
09/10/2020 |
Z-Span Plate System |
Zavation Medical Products LLC |
Frankie Cummins |
| K202823 |
09/24/2020 |
Innomed NPWT Silicone Foam Dressing |
Zhejiang Longterm Medical Technology Co., LTD |
Chloie Zsang |
| K202676 |
09/15/2020 |
Disposable Medical Face Mask |
Zhejiang Senhong Medical&Instrument Co., Ltd. |
Eric Jian |
| K202641 |
09/11/2020 |
DNA/RNA Shield Collection Tube |
Zymo Research |
Julie Ogi |
