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

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    HALO

    FDA 510(k)
    FDA Class 2 ·Radiology

    ABDOMINAL SPATULA

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896075238·ABDOMINAL SPATULA MALLEABLE BLADES

    AugMENTA Penile Implant

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Stone Retrieval Balloon

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BALL HEADS: MECTACER 01.29.209 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·March 16, 2023

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

    ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·August 8, 2011

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

    Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·April 3, 2013

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

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