BEUDAMED
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    BURN DRESSING

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

    IntelliSpace Cardiovascular

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838095250·Cardiovascular Image and Information Management...

    IntelliSpace Cardiovascular

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838125773·Philips IntelliSpace Cardiovascular is a compre...

    IntelliSpace Cardiovascular

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838122000·IntelliSpace Cardiovascular is a comprehensive ...

    IntelliSpace Cardiovascular

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838106970·Cardiovascular Image and Information Management...

    IntelliSpace Cardiovascular

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838100107·Cardiovascular Image and Information Management...

    IntelliSpace Cardiovascular

    FDA UDI
    Philips Medical Systems Nederland B.V.·00884838115378·Cardiovascular Image and Information Management...

    TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CROSSTREES PVA POD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KARL STORZ

    FDA Adverse Event
    Malfunction ·KARL STORZ GMBH & CO.·Product code GEI·May 7, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 13, 2012

    PUMP MMT-712WWBC PRDGM INSULIN ZH EN US

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·September 7, 2010

    IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Nederland B.V.·May 14, 2025

    Philips IntelliSpace Cardiovascular software, Model 830089.

    FDA Recall
    Open, Classified ·Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands·Product code LLZ·April 4, 2024

    Philips IntelliSpace Cardiovascular software, Model 830089.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Nederland B.V.·March 12, 2025

    IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

    FDA Recall
    Open, Classified ·Philips Medical Systems Nederland B.V. High Tech Campus 36 Eindhoven Netherlands·Product code LLZ·April 7, 2025

    IntelliSpace Cardiovascular, Software 8.0.0.4.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Nederland B.V.·September 17, 2025