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

HTN 2026-03-27

SportLinc Syndesmosis Device

Applicant Lincotek Medical

K-Number K252081

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GAW 2026-03-27

STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

Applicant ETHICON, Inc.

K-Number K253572

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PMN 2026-03-27

MDx-Chex for BCP

Applicant Streck, LLC

K-Number K260041

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IYN 2026-03-27

EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System

Applicant Samsung Medison Co., Ltd.

K-Number K254099

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QBP 2026-03-27

OTTO™ Disinfecting Cap

Applicant Icu Medical, Inc.

K-Number K252006

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POK 2026-03-27

Automated Aortic Stenosis Software (AutoAS)

Applicant GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

K-Number K254161

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LOX 2026-03-27

Ryurei

Applicant Terumo Corporation

K-Number K252295

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ITI 2026-03-27

Electrically Powered Wheelchair (Model YC-01)

Applicant Yurob Rehabilitation Medical Co., Ltd.

K-Number K253980

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SDO 2026-03-27

ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)

Applicant Aneuvo

K-Number K252893

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JAK 2026-03-27

Spectral CT Verida Family

Applicant Philips Medical Systems Technologies , Ltd.

K-Number K253649

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ITI 2026-03-27

Electric wheelchair

Applicant Foshan Dahao Medical Technology Co., Ltd.

K-Number K253307

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LON 2026-03-26

VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)

Applicant BIOMERIEUX

K-Number K260281

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