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 2026-01-24

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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QKB 2026-01-23

AccuContour 4.0

Applicant Manteia Technologies Co., Ltd.

K-Number K251351

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QAJ 2026-01-23

Elitone for Men

Applicant Elidah, Inc.

K-Number K253285

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NEU 2026-01-23

HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)

Applicant Devicor Medical Products, Inc.

K-Number K253761

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FRO 2026-01-23

New Day Skin Spray

Applicant Silk Holdings, Inc.

K-Number K252568

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