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

POK 2026-06-04

Sonio Suspect

Applicant Sonio

K-Number K261519

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BZD 2026-06-04

Orion

Applicant Resmed Corp

K-Number K253553

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LOM 2026-06-04

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX

Applicant DiaSorin, Inc.

K-Number K260770

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SAH 2026-06-04

GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)

Applicant Gt Metabolic Solutions, Inc.

K-Number K253102

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QIH 2026-06-04

DEEPVESSEL Plaque

Applicant Keya Medical Technology Co., Ltd.

K-Number K260497

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NFJ 2026-06-04

Harmony Referral System with Harmony OCT Viewer (Octave)

Applicant Topcon Healthcare Solutions EMEA Oy

K-Number K253893

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IYE 2026-06-04

LUNA 3D

Applicant Lap GmbH Laser Applikationen

K-Number K253004

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JAK 2026-06-04

Respiratory Gating for Scanners (2.1)

Applicant Varian Medical Systems, Inc.

K-Number K253026

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GWG 2026-06-04

Precision S 4K Sinuscope

Applicant Stryker Endoscopy

K-Number K253602

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MHX 2026-06-04

Radius VSM and Accessories

Applicant Masimo Corporation

K-Number K254209

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OAS 2026-06-04

Dental Cone Beam Computed Tomography System

Applicant Yofo Medical Technology Co., Ltd.

K-Number K260662

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HGX 2026-06-04

Spectra Platinum Mini

Applicant Uzinmedicare Co., Ltd.

K-Number K260956

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