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

DYB 2026-04-23

Introducer Sheath Set

Applicant Cardiocycle Medical(Suzhou) Co., Ltd.

K-Number K254248

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CAW 2026-04-23

OxyGo Portable Oxygen Concentrator (1400-7000)

Applicant Mv Life, LLC

K-Number K252407

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QEZ 2026-04-23

Liberant RX Aspiration Catheter

Applicant Medtronic Interventional Vascular, Inc.

K-Number K253589

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QIH 2026-04-23

DS Core CBCT Anatomy

Applicant Dentsply Sirona

K-Number K260785

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ONO 2026-04-23

NeuroBlate System

Applicant Monteris Medical

K-Number K260976

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ETD 2026-04-23

Tula Tympanostomy Tube Delivery Device

Applicant Tusker Medical, Inc.

K-Number K252436

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MOS 2026-04-23

0.55T 12Ch Breast Coil

Applicant Neocoil, LLC

K-Number K260947

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MTD 2026-04-23

OptiMap Catheter - 60mm (OPTI-CATH2-60)

Applicant Cortex, Inc.

K-Number K261012

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QDQ 2026-04-23

Lunit INSIGHT MMG (v1.1.10)

Applicant Lunit, Inc.

K-Number K260320

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LHN 2026-04-23

ProBeam 360 Proton Therapy System v3.0

Applicant Varian Medical Systems, Inc.

K-Number K252815

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EOQ 2026-04-23

EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)

Applicant Olympus Medical Systems Corp.

K-Number K252341

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GXY 2026-04-22

myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)

Applicant Otto Bock Healthcare Products GmbH

K-Number K253256

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