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

HEB 2025-10-09

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

Applicant Cotton High Tech S.L.

K-Number K252939

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OHS 2025-10-09

ORA Method LED Gua Sha (GS-04)

Applicant Shenzhen Kaiyan Medical Equipment Co., Ltd.

K-Number K252272

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MRC 2025-10-09

cleadew GP hydra one

Applicant Ophtecs Corporation

K-Number K251876

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ODC 2025-10-09

Orca Air/Water and Suction Valves

Applicant Boston Scientific

K-Number K252910

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DXN 2025-10-09

Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)

Applicant Honsun (Nantong) Co., Ltd.

K-Number K251795

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LFL 2025-10-08

CUSA® Clarity Ultrasonic Surgical Aspirator System

Applicant Integra LifeSciences Corporation

K-Number K251162

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DYB 2025-10-08

14Fr Low Profile Introducer Kit

Applicant Abiomed, Inc.

K-Number K252766

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LLZ 2025-10-08

ProKnow DS

Applicant Elekta Solutions AB

K-Number K251363

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OAS 2025-10-08

GT300; GT300-C

Applicant Genoray Co., Ltd.

K-Number K250060

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HWC 2025-10-08

MetaFore Small Screw System

Applicant Extremity Medical, LLC

K-Number K250536

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SET 2025-10-08

Elecsys Phospho-Tau (181P) Plasma

Applicant Roche Diagnostics

K-Number K252163

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KTI 2025-10-08

Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01

Applicant Serpex Medical, Inc.

K-Number K252874

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