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

NLH 2024-06-07

Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)

Applicant Surgical Instrument Service and Savings, Inc.

K-Number K240972

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QIH 2024-06-07

Cardiac CT Function Software Application

Applicant Circle Cardiovascular Imaging

K-Number K241038

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PKL 2024-06-07

Disposable Hemostatic Clips

Applicant Ningbo Xinwell Medical Technology Co., Ltd.

K-Number K232969

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MHX 2024-06-07

Corvair

Applicant AliveCor, Inc.

K-Number K231010

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QME 2024-06-07

FibriCheck

Applicant Qompium NV

K-Number K232804

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MOS 2024-06-07

iLoop Interventional Coil 0.55T

Applicant Noras Mri Products GmbH

K-Number K241069

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QIH 2024-06-07

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

Applicant Ever Fortune.Ai, Co., Ltd.

K-Number K234042

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SBH 2024-06-07

Libre Rio Continuous Glucose Monitoring System

Applicant Abbott Diabetes Care

K-Number K233861

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NLH 2024-06-07

Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter

Applicant Innovative Health

K-Number K233825

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DPS 2024-06-07

Impala

Applicant AliveCor, Inc.

K-Number K232035

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MSW 2024-06-07

Access Thyroglobulin

Applicant Beckman Coulter, Inc.

K-Number K241423

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FXX 2024-06-07

HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)

Applicant Owens & Minor (O&M) Halyard, Inc.

K-Number K232806

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