BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    Corelink Foundation 3D Anterior Lumbar System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Comprehensive® Reverse Shoulder

    FDA UDI
    Biomet Orthopedics, LLC·00880304677197·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197083638·Masson Needle Holder TC 41.0cm...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197083621·MASSON TC Needle Holder, straight 27.0cm...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197385602·Masson Needle Holder TC 35.5cm...

    GM HELIX IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 2, 2019

    ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES

    FDA 510(k)
    FDA Class 2 ·Dental

    SLENDERTONE FLEX MAX, MODEL 517 US

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GM HELIX IMPLANT 6.0X8 MM

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 21, 2019

    GM HELIX IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 20, 2019

    GM HELIX ACQUA IMPLANT 6.0X10

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·March 18, 2019

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 20, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE·Product code ITI·July 27, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 17, 2014

    GM HELIX IMPLANT 6.0X8

    FDA Adverse Event
    Injury ·NEODENT - JJGC S.A.·Product code DZE·June 17, 2019

    COMP PRIMARY STEM 9MM MICRO

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·January 15, 2018

    SINGLE USE 6MM PIERCER PROBE - SLIM - 180MM - STERILE

    FDA Adverse Event
    Injury ·ORTHOFIX SRL·Product code JDX·July 4, 2019

    ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 11327600

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·August 16, 2023

    Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·December 23, 2020

    Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

    FDA Recall
    Terminated ·Biomet, Inc.·Product code KWS·November 25, 2020