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

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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MAX 2026-01-23

Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System

Applicant Life Spine, Inc.

K-Number K253748

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DJG 2026-01-23

Evidence MultiSTAT DOA Urine MultiPlex

Applicant Randox Laboratories Limited

K-Number K250741

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OHS 2026-01-23

LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073)

Applicant Shenzhen Rainbow Technology Co., Ltd.

K-Number K253712

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