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

GJS 2025-02-27

microINR System

Applicant Iline Microsystems, S.L.

K-Number K243543

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QRK 2025-02-26

Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K244031

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ONF 2025-02-26

DEKA LOTUS

Applicant El.En S.P.A.

K-Number K250281

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LJS 2025-02-26

pilot TLS

Applicant Vygon Corporation

K-Number K241587

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OGZ 2025-02-26

Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i); Dualpro™ IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 )

Applicant Infraredx, Inc.

K-Number K241576

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QIH 2025-02-26

Ventripoint Medical System Plus (VMS+) 4.0

Applicant Ventripoint Diagnostics , Ltd.

K-Number K241222

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GEI 2025-02-26

Vasoview Hemopro 3 Power Supply

Applicant Maquet Cardiovascular, LLC

K-Number K243918

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NRY 2025-02-26

Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set

Applicant Perfuze, Ltd.

K-Number K250012

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FMK 2025-02-26

Heel Incision Safety Lancet (SteriHeel 2)

Applicant SteriLance Medical (Suzhou), Inc.

K-Number K244036

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MQV 2025-02-26

BonVie+

Applicant Elute, Inc.

K-Number K250346

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LLZ 2025-02-26

aiCockpit AI Viewer

Applicant Fovia, Inc.

K-Number K241546

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FYA 2025-02-26

Medline Level 4 Surgical Gown with Breathable Sleeves

Applicant Medline Industries, LP

K-Number K242844

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