BEUDAMED
    11 results · 19ms · Sources: EU EUDAMED, US FDA

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    PATIENT MONITOR #404

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OSTEO-G BONE VOID FILLER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T1/T2/T3 TURBINE FAMILY

    FDA 510(k)
    FDA Class 1 ·Dental

    QUICKVUE AT-HOME OTC COVID-19 TEST

    FDA Adverse Event
    Malfunction ·QUIDEL CORPORATION·Product code QKP·February 17, 2023

    FLANGE FIXTURE AND ABUTMENT

    FDA Adverse Event
    Injury ·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 24, 2014

    XEROFRM GZE 4X3YD RL FOIL PK STRL

    FDA Adverse Event
    Other ·COVIDIEN·Product code FRO·November 2, 2012

    PD1200 DEFIBRILLATOR/PACEMAKER

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code LDD·July 25, 2007

    Custom Made Implant System with Minimum Invasive Grower (MIG) component

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 8, 2018

    OSSEOTITE® IMPLANT 3.75 X 13MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·August 26, 2021

    OSSEOTITE® IMPLANT 3.75 X 13MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·August 26, 2021

    Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018