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

LOL 2026-01-27

Access anti-HAV IgM

Applicant Beckman Coulter, Inc.

K-Number K251995

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LNH 2026-01-26

Ascent3T Neonatal Magnetic Resonance Imaging System

Applicant Eyas Medical Imaging, Inc.

K-Number K253499

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DPS 2026-01-26

MAC 7 Resting ECG Analysis System

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K251670

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KDI 2026-01-26

Tablo Hemodialysis System (PN-0008000, PN-0006000U)

Applicant Outset Medical, Inc.

K-Number K253412

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GEX 2026-01-24

Vydence Family of Lasers

Applicant Vydence Medical Industria E Commercio Ltda

K-Number K252753

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GEX 2026-01-24

Holmium Laser Therapeutic Apparatus (HZ-40)

Applicant Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

K-Number K253633

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OLO 2026-01-23

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System

Applicant Point Robotics MedTech, Inc.

K-Number K252755

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LZA 2026-01-23

Syntex Exam Gloves

Applicant Basic Medical Technology, Inc.

K-Number K253160

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GCJ 2026-01-23

Pneumo Dissector Hook

Applicant Ab Medica Sas

K-Number K252957

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MOS 2026-01-23

3.0T AIR 32CH HNA

Applicant Ge Healthcare Coils (Usa Instruments, Inc.)

K-Number K253738

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OAP 2026-01-23

TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K253669

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DSI 2026-01-23

BodyGuardian Remote Monitoring System (BGRMS v3.0)

Applicant Boston Scientific Cardiac Diagnostic Technologies, Inc.

K-Number K243349

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