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

LFD 2026-02-27

Allday Moisturizing Rinse

Applicant Elevate Oral Care

K-Number K253778

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GCJ 2026-02-27

C-Lant Port

Applicant Vigor Medical Technologies , Ltd.

K-Number K252714

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CIG 2026-02-27

Atellica CH Diazo Total Bilirubin (D_TBil)

Applicant Siemens Healthcare Diagnostics, Inc.

K-Number K251998

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GEX 2026-02-27

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

Applicant Beijing HuaCheng Taike Technology Co., Ltd.

K-Number K253829

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HRS 2026-02-27

HKT Anatomical Locking Trauma System

Applicant Hankil Tech Medical Co., Ltd.

K-Number K254249

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MVL 2026-02-27

One-Stop

Applicant Mediclus Co., Ltd.

K-Number K253797

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ETN 2026-02-27

Evala Nerve Stimulator (EPNR002)

Applicant Epineuron Technologies, Inc.

K-Number K253536

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KWQ 2026-02-26

Aster

Applicant Osteonic Co., Ltd.

K-Number K254182

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KCT 2026-02-26

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

Applicant DePuy Mitek, Inc.

K-Number K253791

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OBR 2026-02-26

Owl Night Guard

Applicant Owl Dental Lab, Inc.

K-Number K253641

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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

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OSN 2026-02-26

ENOS Software Guided External Fixation System

Applicant Disior, Ltd.

K-Number K253764

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