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

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    Overjet Caries Assist

    FDA 510(k)
    FDA Class 2 ·Radiology

    Surgical mask

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

    STAT PROFILE CRITICAL CARE XPRESS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RF3000 RADIOFREQUENCY GENERATOR

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEI·August 25, 2011

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·November 4, 2014

    PRIMEADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 12, 2013

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·September 6, 2024

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·September 6, 2024

    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