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

QFM 2025-03-21

Rayvolve PTX-PE

Applicant AZmed

K-Number K243808

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SAF 2025-03-21

Signos Glucose Monitoring System

Applicant Signos, Inc.

K-Number K250106

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OUR 2025-03-21

Catamaran SI Joint Fusion System

Applicant Tenon Medical

K-Number K250403

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QJP 2025-03-21

Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter

Applicant Stryker Neurovascular

K-Number K242289

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OMC 2025-03-21

REMI Remote EEG Monitoring System

Applicant Epitel

K-Number K243185

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FFK 2025-03-21

EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)

Applicant Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

K-Number K243032

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QUT 2025-03-21

IntelliSep Test (CV-ICG-048)

Applicant Cytovale, Inc.

K-Number K250513

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MQL 2025-03-21

CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF)

Applicant Casebioscience, Inc.

K-Number K242107

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GEI 2025-03-21

FiAPC plus probes

Applicant Erbe Elektromedizin GmbH

K-Number K243451

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JKA 2025-03-21

BD Vacutainer® Multiple Sample Luer Adapter

Applicant Becton, Dickinson and Company

K-Number K243649

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SBF 2025-03-21

ARVIS Surgical Navigation System

Applicant Kico Knee Innovation Company Pty Limited

K-Number K243980

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MQL 2025-03-21

V-GRAD

Applicant Vitromed GmbH

K-Number K241833

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