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

EMA 2025-07-11

Choice 2 DC

Applicant Bisco, Inc.

K-Number K250156

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CAW 2025-07-11

FreeStyle Comfort (AS200 / FreeStyle Comfort)

Applicant Caire, Inc.

K-Number K250671

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GAG 2025-07-11

AEON™ Endoscopic Powered Stapler

Applicant Lexington Medical, Inc.

K-Number K251482

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QYX 2025-07-11

Rhythm Express Remote Cardiac Monitoring System (RX-1 mini)

Applicant VivaQuant, Inc.

K-Number K241179

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HTN 2025-07-11

RipCord

Applicant TriMed, Inc.

K-Number K251134

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FOZ 2025-07-11

BD Cathena™ Safety IV Catheter

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K-Number K251155

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EMA 2025-07-11

ResiCem EX

Applicant Shofu Dental Corporation

K-Number K251470

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IYN 2025-07-10

Sonosite LX Ultrasound System

Applicant FUJIFILM Sonosite, Inc.

K-Number K251830

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EIH 2025-07-10

ARENA Star, Galaxy Star

Applicant Arum Dentistry Co., Ltd.

K-Number K250063

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OVD 2025-07-10

CONDUIT™ SYNFIX™ Evolution Secured Spacer System

Applicant Avalign Technologies, Inc.

K-Number K250072

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DWF 2025-07-10

RAP Femoral Venous Cannulae

Applicant LivaNova USA, Inc.

K-Number K250283

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KNW 2025-07-10

Marquee™ Disposable Core Biopsy Instrument and Instrument Kit

Applicant Bard Peripheral Vascular, Inc.

K-Number K250032

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