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

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    S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SECRMARK BIOPSY SITE MARKING SYSTEM

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

    MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)

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

    MYSPINE STANDARD DRILL GUIDE T07

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code MNI·May 10, 2019

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·October 1, 2014

    PELVILACE TO BIOURETHRAL SUPPORT SYS

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code PAG·May 16, 2013

    TOTAL PROTEIN GEN.2

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CEK·June 17, 2011

    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·January 1, 2014

    ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.

    FDA Enforcement
    Class II ·Terminated·OrthoPediatrics Corp·September 10, 2014