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

OCW 2026-02-13

Endomina EZFuse system

Applicant Endo Tools Therapeutics S.A.

K-Number K252400

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DXN 2026-02-13

Wearable Ambulatory Blood Pressure Monitor (WBP-02A)

Applicant Shenzhen Hingmed Medical Instrument Co., Ltd.

K-Number K251581

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MOF 2026-02-13

Willow 18 Guidewire

Applicant Arbor Endovascular, LLC

K-Number K260130

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QOF 2026-02-13

VELO Respiratory Test

Applicant Lex Diagnostics Limited

K-Number K251742

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OLI 2026-02-13

Contour Light (CL-100)

Applicant Contour Research, LLC

K-Number K243854

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ODP 2026-02-13

Hive™ Standalone Cervical System and Hive™ C Interbody System

Applicant NanoHive Medical, LLC

K-Number K254105

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HGX 2026-02-13

Motion InBra (YM-8801) wearable breast pump

Applicant Medela, LLC

K-Number K253149

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DXH 2026-02-13

PreemptiveAI Clinical SDK

Applicant Measure Labs, Inc. (Dba Preemptiveai, Inc.)

K-Number K250233

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LPL 2026-02-13

DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal

Applicant Alcon Laboratories, Inc.

K-Number K254052

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KPS 2026-02-13

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K253564

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GEH 2026-02-13

CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)

Applicant Medinice S.A.

K-Number K251928

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DXT 2026-02-13

MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)

Applicant Bayer Medical Care, Inc.

K-Number K252891

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