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

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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INI 2026-03-12

Power Mobility Scooter (MJMA01, MJMA02)

Applicant Nanjing Mijo Technology Co., Ltd.

K-Number K253936

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HRX 2026-03-12

VantageTM Lumbar Decompression Kit

Applicant Allevion Medical, LLC

K-Number K252546

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MBI 2026-03-12

Trax EX Anchor

Applicant Trax Surgical, Inc.

K-Number K251750

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QFG 2026-03-12

MiniMed Flex pump

Applicant Medtronic Minimed, Inc.

K-Number K253743

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SFP 2026-03-12

Medical Mesh Nebulizer (AirICU Max+)

Applicant AIRICU, Inc.

K-Number K251584

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GXY 2026-03-12

Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

Applicant Bionit Labs Srl

K-Number K260453

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