Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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

HQF 2025-10-29

Navilas Laser System 577sl (156691)

Applicant Od-Os GmbH

K-Number K251772

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NFO 2025-10-29

Medi Lift Essential Eye Mask

Applicant Ya-Man, Ltd.

K-Number K250618

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MMI 2025-10-29

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

Applicant Ortho-Clinical Diagnostics, Inc.

K-Number K252393

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IYN 2025-10-29

LOGIQ E10

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K251985

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DQY 2025-10-29

Telescope Guide Extension Catheter

Applicant Medtronic, Ireland

K-Number K252390

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HGX 2025-10-29

Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-)

Applicant Shenzhen Root Innovation Technology Co., Ltd.

K-Number K253283

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MBI 2025-10-29

Arthrex SutureTak Suture Anchor

Applicant Arthrex, Inc.

K-Number K252314

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PGY 2025-10-29

LCD Monitor (C1216W, C822W, C821W)

Applicant Shenzhen Beacon Display Technology Co., Ltd.

K-Number K253242

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PHX 2025-10-29

JARVIS Diaphyseal Stem Standard

Applicant FH Industrie

K-Number K253345

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IYN 2025-10-29

LOGIQ E10s

Applicant GE Medical Systems Ultrasound and Primary Care Diagnostics

K-Number K251963

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JWH 2025-10-29

Freedom Infinia Total Knee System

Applicant Maxx Orthopedics, Inc.

K-Number K253314

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GCJ 2025-10-29

3D Laparoscope

Applicant Guangdong Optomedic Technologies, Inc.

K-Number K252697

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