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

PEN 2025-04-18

LIAISON PLEX Gram-Negative Blood Culture Assay

Applicant Luminex Corporation

K-Number K243013

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OBP 2025-04-17

Ultimate rTMS

Applicant Brain Ultimate, Inc.

K-Number K243460

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HGX 2025-04-17

Lacevo Wearable Breast Pump (Model S70)

Applicant Shenzhen TPH Technology Co., Ltd.

K-Number K250829

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DQY 2025-04-17

FlowGuide (FG60F); GuidionShort (GS60F)

Applicant Imds Operations B.V.

K-Number K242337

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QDG 2025-04-17

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)

Applicant Fluoptics Sas (A Getinge Group Company}

K-Number K250455

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JWH 2025-04-17

EXULT Knee Replacement System

Applicant Corentec Co., Ltd.

K-Number K250889

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QCI 2025-04-17

Ultimate rTMS for OCD (M-series)

Applicant Brain Ultimate, Inc.

K-Number K243459

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OAS 2025-04-17

Dental Cone Beam Computed Tomography System

Applicant Yofo Medical Technology Co., Ltd.

K-Number K243337

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PLQ 2025-04-17

RELiZORB (100300/100301)

Applicant Alcresta Therapeutics, Inc.

K-Number K250499

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MUJ 2025-04-17

RayCare (2024A SP1)

Applicant RaySearch Laboratories AB (PUBL)

K-Number K242992

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LPL 2025-04-17

miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus

Applicant Benq Materials Corporation

K-Number K242056

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DQK 2025-04-17

VitalRhythm

Applicant Vitalconnect, Inc.

K-Number K242129

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