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

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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FLE 2026-02-26

Enbio PRO

Applicant Enbio Group AG

K-Number K260254

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HIH 2026-02-26

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

Applicant Shanghai AnQing Medical Instrument Co., Ltd.

K-Number K254251

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FYA 2026-02-26

Copioumed AAMI 3 Surgical Gown

Applicant Copioumed International, Inc.

K-Number K251860

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GEX 2026-02-26

CAPRI

Applicant ORO Co., Ltd.

K-Number K254271

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OWN 2026-02-26

KARL STORZ ICG Imaging System with RUBINA® Lens

Applicant Karl Storz SE & CO. KG

K-Number K254242

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HGM 2026-02-26

ANNE Maternal

Applicant Sibel Health, Inc.

K-Number K253021

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MAX 2026-02-26

SWINGO-3D Lumbar Cage System

Applicant Implanet

K-Number K254017

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