BEUDAMED
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    SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Transducer Cover

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436122648·Sterile (15.2 x 25.4cm) flat-folded polyethylen...

    JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THEKEN LARGE CEMENT RESTRICTOR

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015

    QUADROX-I NEO. MIT RESERVOIR

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015

    OXYGENATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

    OXYGENRATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

    BIPAP A30

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 31, 2022

    BIPAP ST

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 20, 2022

    BIPAP ST

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 20, 2022

    BIPAP AVAPS

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 20, 2022

    BIPAP ST

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 3, 2022

    BIPAP A30

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 20, 2022

    BIPAP AVAPS

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 20, 2022

    BIPAP ST

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 20, 2022

    BIPAP A30

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 30, 2022

    BIPAP AVAPS

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 16, 2022

    BIPAP AVAPS

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·March 20, 2022