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

SDO 2026-04-20

xStep (xStep)

Applicant Spinex, Inc.

K-Number K253638

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FYA 2026-04-20

Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)

Applicant Hubei Xinxin Non-Woven Co., Ltd.

K-Number K253003

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DQK 2026-04-20

EnSite X EP System

Applicant ABBOTT MEDICAL

K-Number K260212

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EBG 2026-04-17

Dura-Arch

Applicant Hangzhou SHINING3D Dental Technology Co., Ltd.

K-Number K261261

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SHR 2026-04-17

XplantR Explant Tool

Applicant Hjarta Care, LLC

K-Number DEN250033

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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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