BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    Tempus LS - Manual

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SOFTFORM FACIAL IMPLANT

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

    APEX 800 LASER SYSTEM, MODEL APEX 800

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

    Widex

    FDA UDI
    Widex A/S·05706069735789·Widex BEYOND B-F2 (Tan silk S-440 ) Telecoil, R...

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 11, 2011

    DRILL, TRI-FLAT T2 FEMUR Ø4,2X340 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSZ·July 2, 2013

    PROLENE HERNIA SYSTEM UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·March 26, 2019

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·April 3, 2017

    TALENT TAA

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 10, 2013

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018