BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    ARTHREX BIO-COMPRESSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040119631·COIL SPRING SPOOL OPEN 15 (38cm) .014 x .036

    THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Injury ·ANGIOMED GMBH & CO.·Product code FGE·November 21, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO.·Product code FGE·November 5, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code FGE·February 20, 2009

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO.·Product code FGE·November 4, 2008

    LIFESTENT FLEXSTAR XL BILIARY STENT

    FDA Adverse Event
    Malfunction ·ANGIOMED GMBH & CO, MEDIZINTECHNIK·Product code FGE·February 13, 2009

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 16, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 4, 2014

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·June 13, 2008

    HARMONY DELIVERY CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPV·October 3, 2025

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 15, 2022

    DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·September 14, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022