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

EBG 2026-04-17

Dura-Arch

Applicant Hangzhou SHINING3D Dental Technology Co., Ltd.

K-Number K261261

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KPI 2026-04-17

PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)

Applicant Pontemedag

K-Number K252334

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JWY 2026-04-17

MTS Gepotidacin 0.016-256 µg/mL

Applicant Liofilchem s.r.l.

K-Number K260696

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KTT 2026-04-17

DYNEX® External Fixation Systems

Applicant Vilex, LLC

K-Number K260900

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IYO 2026-04-17

EdgeFlow UW20

Applicant Edgecare, Inc.

K-Number K252237

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GZL 2026-04-17

Wovyn Depth Electrode

Applicant Sensomedical Labs, Ltd.

K-Number K253970

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OBJ 2026-04-17

Novasight Hybrid System

Applicant Conavi Medical, Inc.

K-Number K252945

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LJS 2026-04-17

Neonav ECG Tip Location System

Applicant Navi Medical Technologies

K-Number K260929

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FMF 2026-04-17

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)

Applicant Chirana T.Injecta,A.S.

K-Number K252279

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BZD 2026-04-17

MySleepDash

Applicant Somnetics International, Inc. (Dba Transcend Inc)

K-Number K252338

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DYB 2026-04-17

Edwards eSheath+ introducer set

Applicant Edwards Lifesciences

K-Number K254279

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HWC 2026-04-17

TITAN Nail; APTUS K-Wire System

Applicant Medartis AG

K-Number K260934

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