Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DQA 2020-11-27

Spo2 Sensor

Applicant Jkh USA, LLC

K-Number K202851

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DQA 2020-11-27

Pulse Oximeter

Applicant Guangdong Long Yao Electronic Technology Co., Ltd.

K-Number K201294

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MBI 2020-11-27

Arthrex FiberTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K203268

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MBH 2020-11-25

ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology

Applicant Depuy Ireland UC

K-Number K202194

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NUH 2020-11-25

Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300

Applicant Everyway Medical Instruments Co.,Ltd

K-Number K202470

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DQK 2020-11-25

CARTO® 3 EP Navigation System with Signal Processing Unit

Applicant Biosense Webster, Inc.

K-Number K200484

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NEY 2020-11-25

AveCure BT Microwave Ablation System

Applicant Medwaves, Inc.

K-Number K192406

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MAX 2020-11-25

SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu aPOD-L NanoMetalene; SeaSpine Vu ePOD System; and SeaSpine Reef TH System, SeaSpine Vu aPOD Prime NanoMetalene IBD; and SeaSpine Shoreline ACS, SeaSpine Cambria System; SeaSpine Regatta Lateral System; and SeaSpine Meridian System, Shoreline Cervical Interbody RT System; and SeaSpine Beachside System

Applicant SeaSpine Orthopedics Corporation

K-Number K201193

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BZD 2020-11-25

SysMed S/T

Applicant Sysmed (China) Co., Ltd.

K-Number K192177

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MBI 2020-11-25

TopLock Anchor System

Applicant Fusion Orthopedics, LLC

K-Number K193377

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DQK 2020-11-25

EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled

Applicant ABBOTT MEDICAL

K-Number K202066

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GEX 2020-11-25

Dermatological Carbon Dioxide Laser Systems

Applicant Zhuolu Jontelaser Manufacturing Technology Co., Ltd.

K-Number K202250

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