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

LLZ 2026-03-12

Mimics Thoracic Planner

Applicant Materialise NV

K-Number K251964

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QKA 2026-03-12

Urocross Expander System (Model Numbers ES2018 and ES3025)

Applicant Prodeon Medical, Inc.

K-Number K253525

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NGX 2026-03-12

Zionic Pro Max (EMS)

Applicant Termosalud S.L.

K-Number K253636

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DQD 2026-03-12

Tyto Stethoscope (G3)

Applicant Tyto Care , Ltd.

K-Number K252089

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OMP 2026-03-12

Genadyne ASTRA NPWT

Applicant Genadyne Biotechnologies, Inc.

K-Number K253429

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FWP 2026-03-12

MEDPOR Customized Implant Kit

Applicant Stryker Leibinger GmbH & Co KG

K-Number K254233

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DTR 2026-03-12

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W

Applicant Spectrum Medical S.R.L.

K-Number K252541

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KRA 2026-03-12

InVera Infusion Device

Applicant Invera Medical

K-Number K250794

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QZF 2026-03-12

Deep Capsule® (Deep Capsule US)

Applicant Digestaid - Artificial Intelligence Development SA

K-Number K250655

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N/A 2026-03-12

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head

Applicant Signature Orthopaedics Pty, Ltd.

K-Number K252824

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CBK 2026-03-12

VPAP Pediatric Face Mask

Applicant Hsiner Co., Ltd.

K-Number K251888

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KTI 2026-03-12

LungFlow Basket Catheter

Applicant Free Flow Medical, Inc.

K-Number K254040

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