BEUDAMED
    8 results · 24ms · Sources: EU EUDAMED, US FDA

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    B.Light Clear Evo and B.Light Restore Evo

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

    Dexcom G7 Continuous Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MULTIX Impact E

    FDA 510(k)
    FDA Class 2 ·Radiology

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·August 4, 2011

    SETROX S 45

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·November 4, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·July 5, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

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

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