Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 2026-02-27

Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)

Applicant Beijing HuaCheng Taike Technology Co., Ltd.

K-Number K253829

View Details →

HRS 2026-02-27

HKT Anatomical Locking Trauma System

Applicant Hankil Tech Medical Co., Ltd.

K-Number K254249

View Details →

MVL 2026-02-27

One-Stop

Applicant Mediclus Co., Ltd.

K-Number K253797

View Details →

ETN 2026-02-27

Evala Nerve Stimulator (EPNR002)

Applicant Epineuron Technologies, Inc.

K-Number K253536

View Details →

KWQ 2026-02-26

Aster

Applicant Osteonic Co., Ltd.

K-Number K254182

View Details →

KCT 2026-02-26

PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid

Applicant DePuy Mitek, Inc.

K-Number K253791

View Details →

OBR 2026-02-26

Owl Night Guard

Applicant Owl Dental Lab, Inc.

K-Number K253641

View Details →

QAS 2026-02-26

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

Applicant Aidoc Medical , Ltd.

K-Number K253578

View Details →

OSN 2026-02-26

ENOS Software Guided External Fixation System

Applicant Disior, Ltd.

K-Number K253764

View Details →

FLE 2026-02-26

Enbio PRO

Applicant Enbio Group AG

K-Number K260254

View Details →

HIH 2026-02-26

InnovexView (GC146-17, GC150-20, GC155-23)

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K254251

View Details →

FYA 2026-02-26

Copioumed AAMI 3 Surgical Gown

Applicant Copioumed International, Inc.

K-Number K251860

View Details →

Page 136 of 2728

↑