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

JEY 2026-07-25

METICULY Patient-specific CMF solution

Applicant Meticuly Co., Ltd.

K-Number K253206

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EOQ 2026-07-25

MONARCH™ Platform (MON-000008)

Applicant Auris Health, Inc.

K-Number K260382

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OBJ 2026-07-24

VERAFEYE Imaging Catheter (VF-VIC-002)

Applicant Luma Vision Limited

K-Number K261849

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MHX 2026-07-24

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K253277

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NKB 2026-07-24

QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)

Applicant MANTIZ Co., Ltd.

K-Number K260362

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IRP 2026-07-24

Air Compression Massager (EP30B001 I)

Applicant Wavepulse (Xiamen) Healthcare Technology Co., Ltd.

K-Number K260948

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OLO 2026-07-24

TMINI Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K261024

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IYO 2026-07-24

Accuro 3S

Applicant Rivanna Medical, Inc.

K-Number K253452

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OWN 2026-07-24

PerfusiX-Imaging

Applicant LIMIS Development B.V.

K-Number K254180

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QIH 2026-07-24

SwiftMR

Applicant Airs Medical, Inc.

K-Number K261349

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IOR 2026-07-24

GEN 4 JOY Wheelchair

Applicant Free Wheelchair Mission

K-Number K252370

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MLP 2026-07-24

Temporary Keratoprosthesis (QuickSet TKP™)

Applicant Eyekon Medical, Inc.

K-Number K261312

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