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

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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OLO 2026-07-30

Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))

Applicant Suite 201, National Innovation Centre

K-Number K261410

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LDF 2026-07-30

Sync AV II Temporary Pacing Catheter

Applicant Swift Sync, Inc.

K-Number K252042

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KWI 2026-07-30

Arthrex Radial Head Replacement System

Applicant Arthrex, Inc.

K-Number K260624

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LFL 2026-07-30

neXus Ultrasonic Surgical Aspirator System

Applicant Misonix, LLC

K-Number K261448

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OLO 2026-07-29

SPINEART Navigation Instrument System

Applicant Spineart SA

K-Number K261205

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QNA 2026-07-29

Stone Clear (BWSC-LP9-02)

Applicant Sonomotion, Inc.

K-Number K262200

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