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

KPR 2025-08-28

Definium Tempo Select

Applicant Ge Hualun Medical Systems Co. , Ltd.

K-Number K250788

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QEW 2025-08-28

Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System

Applicant Imperative Care, Inc.

K-Number K252057

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NGX 2025-08-28

truFlex

Applicant Syrma Johari Medtech Limited

K-Number K251594

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QOG 2025-08-28

SmartPilot YpsoMate NS-A2.25

Applicant Ypsomed AG

K-Number K243901

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MNR 2025-08-28

Somfit D

Applicant Compumedics Limited

K-Number K252383

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LYZ 2025-08-28

Powder-Free Vinyl Exam Gloves, clear

Applicant Basic Medical Technology, Inc.

K-Number K252505

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NKB 2025-08-28

JAZZ Spinal System

Applicant Implanet

K-Number K252437

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JWY 2025-08-28

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL

Applicant Thermo Fisher Scientific

K-Number K252014

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CBK 2025-08-28

SV600, SV800 Ventilator

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K-Number K243767

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CCK 2025-08-28

Medical Gas Analyzer (AG200)

Applicant Prior Care Science Technology, Ltd.

K-Number K250148

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NAY 2025-08-28

da Vinci SP Firefly Imaging System

Applicant Intuitive Surgical, Inc.

K-Number K252350

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PGY 2025-08-28

RadiForce GX570; RadiForce GX570-AR

Applicant Eizo Corporation

K-Number K252030

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