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

FRC 2024-12-12

Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)

Applicant Terragene S.A.

K-Number K242453

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FZE 2024-12-12

Medicon Epiplating System

Applicant Cmf Medicon Surgical, Inc.

K-Number K241253

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OPT 2024-12-12

Infrascanner Model 2500 (Model 2500)

Applicant Infrascan, Inc.

K-Number K241389

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GWF 2024-12-12

Natus Ultrapro S100 (982A0594)

Applicant Natus Neurology Incorporated

K-Number K243495

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GWL 2024-12-12

NExT Station; NExT Station Advanced

Applicant Eb Neuro S.P.A.

K-Number K242832

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DQK 2024-12-12

Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)

Applicant Ge Medical Systems Information Technologies, Inc.

K-Number K243540

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KPS 2024-12-12

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Applicant Shanghai United Imaging Healthcare Co., Ltd.

K-Number K243538

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JXM 2024-12-11

Alinity c Benzodiazepines Reagent Kit

Applicant Microgenics Corporation

K-Number K243498

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MUJ 2024-12-11

Eclipse Treatment Planning System (18.1)

Applicant Varian Medical Systems

K-Number K242378

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QJP 2024-12-11

Access25 Delivery Microcatheter

Applicant Penumbra, Inc.

K-Number K242033

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NDC 2024-12-11

EndoTool IV (3.1)

Applicant Monarch Medical Technologies

K-Number K241088

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OAP 2024-12-11

FAQ (302)

Applicant Foreo, Inc.

K-Number K242747

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