BEUDAMED
    9 results · 29ms · Sources: EU EUDAMED, US FDA

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    SIMPLASTIN EXCEL S

    FDA 510(k)
    FDA Class 2 ·Hematology

    COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DizzyDoctor System 1.0.0

    FDA 510(k)
    FDA Class 2 ·Neurology

    ST FRANCIS HSP TULSA OK 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·December 18, 2012

    PULSE GEN MODEL 102R

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·June 18, 2014

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 26, 2010

    11/13 S-ROM 40MM M SPEC+3

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code KWA·December 20, 2012

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020