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

QIH 2025-04-10

cmAngio® (V1.6)

Applicant Curemetrix, Inc.

K-Number K250754

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EBZ 2025-04-10

LED Curing Light (C01-X, C02-X)

Applicant Premium Plus (Dongguan) Limited

K-Number K250009

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JAK 2025-04-10

Vitrea CT VScore

Applicant Canon Medical Informatics, Inc.

K-Number K243240

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QBJ 2025-04-09

Dexcom G7 15 Day Continuous Glucose Monitoring System

Applicant Dexcom, Inc.

K-Number K243214

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FTL 2025-04-09

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped

Applicant Davol, Inc.

K-Number K250098

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BZQ 2025-04-09

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

Applicant Faceheart Corp.

K-Number K243966

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NUH 2025-04-09

Patch-TEA (Model TRI-21)

Applicant Transtimulation Research, Inc.

K-Number K243613

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SEF 2025-04-09

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

Applicant Becton Dickinson Inc. (Bd)

K-Number K242429

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GWG 2025-04-09

AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)

Applicant Integra LifeSciences Corporation

K-Number K250752

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QQU 2025-04-09

Luminopia

Applicant Luminopia, Inc.

K-Number K243819

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SEC 2025-04-09

Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))

Applicant Active Protective Technologies, Inc.

K-Number DEN240021

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OMB 2025-04-09

autoSCORE (V 2.0.0)

Applicant Holberg Eeg AS

K-Number K243743

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