BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    IGAR System (1001.A)

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SmoothCool HR System

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

    TENDRIL SDX

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

    AMIS BROACH HANDLE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL, SA·Product code LZO·July 6, 2011

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 12, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

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

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