BEUDAMED
    8 results · 37ms · Sources: EU EUDAMED, US FDA

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    iLet® ACE Pump

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Q2 Blood Administration Sets

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MR COMPATIBLE RITA MODEL 90 ELECTOSURGICAL ACCESSORY

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    PASSIVE PLUS

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

    CXDI-55G

    FDA Adverse Event
    Malfunction ·CANON, INC.·Product code MQB·June 28, 2013

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·August 18, 2011

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026