BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    Excipio LV Thrombectomy Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    K SERIES CPAP SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Pro M Class

    FDA 510(k)
    FDA Class 1 ·Dental

    TENDRIL SDX

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

    SINGLE-PIECE PMMA LENS

    FDA Adverse Event
    Injury ·BAUSCH + LOMB·Product code HQL·August 18, 2011

    DOUBLE FENESTRATED GRASPER INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·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