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

OAP 2025-10-30

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K252414

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ESW 2025-10-30

Niti-S Esophageal Stent; Esophageal TTS Stent

Applicant Taewoong Medical Co., Ltd.

K-Number K243619

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GEX 2025-10-30

Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)

Applicant Boston Scientific Corporation

K-Number K252529

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JMT 2025-10-30

AllTest Urinary Tract Infection Test

Applicant Hangzhou AllTest Biotech Co., Ltd.

K-Number K252607

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EBI 2025-10-30

Freeprint® denture flex

Applicant Detax GmbH

K-Number K252430

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QAI 2025-10-29

SER Pen Carain MicroSystem (MP1209SP)

Applicant Su-Ko Technologies, LLC

K-Number K253153

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HTN 2025-10-29

Synchfix EVT

Applicant Wright Medical Technology, Inc. (Stryker Corporation)

K-Number K251643

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KWS 2025-10-29

AETOS Shoulder System Meta Humeral Prosthesis Size 0

Applicant Smith & Nephew, Inc.

K-Number K252416

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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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