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

QJI 2026-06-29

Omnipod 6 algorithm

Applicant Insulet Corporation

K-Number K261461

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GEI 2026-06-29

Irrigation Tubing Bipolar Cord Set

Applicant New Deantronics Taiwan , Ltd.

K-Number K251492

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NHA 2026-06-27

MIST IC

Applicant Imagine Milling Technologies, LLC

K-Number K261122

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GWF 2026-06-27

BraiN20® (BraiN20)

Applicant Time IS Brain, S.L.

K-Number K253301

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OLZ 2026-06-27

SOMNUM (SOMNUM)

Applicant Honeynaps Co., Ltd.

K-Number K253390

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NHA 2026-06-26

BioHorizons CEREC Compatible Ti-Bases

Applicant BioHorizons Implant Systems, Inc.

K-Number K260061

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OLO 2026-06-26

VERTICALE® Navigation Instruments

Applicant Silony Medical GmbH

K-Number K253921

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SAN 2026-06-26

PhAST instrument and PhAST Blood Culture Gram-negative Panel

Applicant Phast Corp.

K-Number K253316

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CGL 2026-06-26

i-STAT Crea cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K261039

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DXF 2026-06-26

LightningWire Transseptal Puncture System (TPS)

Applicant ElectroWire Medical

K-Number K261745

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DQO 2026-06-26

Arterial Pressure Monitoring Set/Tray

Applicant Spectrum Vascular

K-Number K261455

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MBI 2026-06-26

Arthrex FiberButton

Applicant Arthrex, Inc.

K-Number K260018

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