BEUDAMED
    25 results · 20ms · Sources: EU EUDAMED, US FDA

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    COAT-A-COUNT DIRECT ANDROSTENEDIONE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACOUSTIQ LISTENING DEVICE

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

    RENAMEL ESTHETIC RESTORATIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    CAROTID WALLSTENT MONORAIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIM·November 28, 2007

    NEXSTENT MONORAIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NIM·October 30, 2007

    EYE SURGERY STRETCHER OBS 3/07

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FPO·February 11, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 24, 2014

    UNIFY CRT-D, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 10, 2011

    MAVERICK2 MONORAIL PTCA CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LOX·February 16, 2007

    QUANTUM MAVERICK BALLOON CATHETER

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORP.·Product code LOX·August 23, 2007

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·August 3, 2007

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code NIQ·January 8, 2008

    STERLING MONORAIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code DQY·April 4, 2007

    NEXSTENT MONORAIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code NIM·April 4, 2007

    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code NFA·November 9, 2007

    NEXSTENT MONORAIL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIM·October 5, 2007

    NEXSTENT MONORAIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code NIM·December 6, 2007

    VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    NEXSTENT MONORAIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code NIM·March 22, 2007