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

ITX 2026-07-30

SmartGuide Disposable Guides and Grids

Applicant UC-CARE , Ltd.

K-Number K260161

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IYN 2026-07-30

LOGIQ Focus

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K261835

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MBI 2026-07-30

AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down

Applicant Stryker Endoscopy

K-Number K262369

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CCL 2026-07-30

PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)

Applicant Salter Labs

K-Number K261389

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QIH 2026-07-30

cmAngio® V2.0

Applicant Curemetrix, Inc.

K-Number K260980

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NHB 2026-07-30

SeptAlign (SPLN001)

Applicant Spirair, Inc.

K-Number K260620

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GXP 2026-07-30

TnR Cranial Implant

Applicant T&R BIOFAB CO., Ltd.

K-Number K251959

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IYN 2026-07-30

Handheld Ultrasound Scanner

Applicant IMGFAX CO., LTD.

K-Number K261288

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SAP 2026-07-30

Motivista (CT-155)

Applicant Click Therapeutics, Inc.

K-Number K254038

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GWN 2026-07-30

SMARTVERTIGO™ Vestibular Assessment System

Applicant VertigoDx, Inc.

K-Number K260566

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EIH 2026-07-30

Obsidian® Press Over Zirconia

Applicant Prismatik Dentalcraft, Inc.

K-Number K262239

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MOS 2026-07-30

dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T

Applicant Philips Medical Systems Nederland B.V.

K-Number K262330

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