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

JAK 2025-01-07

uCT 780

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K241079

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DQY 2025-01-07

COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)

Applicant OrbusNeich Medical (Shenzhen) Co., Ltd.

K-Number K242588

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LNH 2025-01-07

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

Applicant Canon Medical Systems Corporation

K-Number K243335

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LLZ 2025-01-07

ApolloHipX (THR.SS.0001)

Applicant Corin U.S.A. Limited

K-Number K241808

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NKB 2025-01-07

MASADA Modular Spinal Fixation System

Applicant Astura Medical

K-Number K243259

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KPR 2025-01-07

GXR-Series Diagnostic X-Ray System

Applicant DRGEM Corporation

K-Number K242019

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PTA 2025-01-07

GlutenID Celiac Genetic Health Risk Test

Applicant Targeted Genomics, LLC

K-Number K241456

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INI 2025-01-06

Mobility Scooter (YL-09B, YL-07)

Applicant Yongkang Yile Vehicle Co., Ltd.

K-Number K242139

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JAA 2025-01-06

Soteria E-View

Applicant Omega Medical Imaging, LLC

K-Number K242488

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DZE 2025-01-06

SD TL Implant System

Applicant Arum Dentistry Co., Ltd.

K-Number K242753

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LLZ 2025-01-06

Brainomix 360 e-CTA

Applicant Brainomix Limited

K-Number K242123

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OLO 2025-01-06

TMINI Miniature Robotic System

Applicant THINK Surgical, Inc.

K-Number K243481

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