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

GEX 2021-06-04

Surgical Green Laser System

Applicant Realton (Suzhou) Medical Technology Co., Ltd.

K-Number K202828

View Details →

OMP 2021-06-04

Kendall NPWT Incision Management Device

Applicant Cardinalhealth

K-Number K202217

View Details →

FLL 2021-06-04

Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85)

Applicant Guandong Genial Technology Co., Limited

K-Number K210014

View Details →

MBI 2021-06-04

Fix2Lock (PEEK Self Punching)

Applicant Osteonic Co., Ltd.

K-Number K202763

View Details →

IZL 2021-06-04

Micro C Medical Imaging System, M01

Applicant Oxos Medical, Inc.

K-Number K211473

View Details →

NUH 2021-06-04

Perfect EMS

Applicant Tenscare, Ltd.

K-Number K200694

View Details →

IPF 2021-06-03

Intellihab System

Applicant Cymedica Orthopedics, Inc.

K-Number K210604

View Details →

NKB 2021-06-03

ASTRA Spine System

Applicant Spinecraft, LLC

K-Number K211323

View Details →

DYB 2021-06-03

Breezeway II

Applicant Oscor, Inc.

K-Number K210627

View Details →

DSA 2021-06-03

PCA-C1 series Patient Cable

Applicant QT Medical, Inc.

K-Number K200722

View Details →

FXX 2021-06-03

Allmed Surgical Face Masks (Ear loops)

Applicant Allmed Medical Products Co., Ltd.

K-Number K202128

View Details →

GEX 2021-06-03

SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)

Applicant Gyrus Acmi, Inc.

K-Number K211401

View Details →

Page 1331 of 2685

↑