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

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    ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SECURMIX

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION MONTAGE MRI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 20, 2023

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 6, 2024

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·September 11, 2017

    PRECISION NOVI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 15, 2023

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 22, 2013

    PUMP MMT-515PNAP PRDGM INS PL EN US PW

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·June 30, 2008

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·April 18, 2011

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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