BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    VitalFlowTM Centrifugal Pump

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GYNE IDEAS MINITAPE RP DEVICE

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

    IDENTITY DR

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

    FRESHLOOK COLORBLENDS UV

    FDA Adverse Event
    Injury ·CIBA VISION CORPORATION DES PLAINES·Product code LPM·August 18, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 12, 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