BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    DEPUY GCK TIBIAL COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·August 22, 2017

    STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·August 22, 2017

    PALFIQUE ESTELITE LV CLEAR

    FDA 510(k)
    FDA Class 2 ·Dental

    OPTILUX CURING LIGHTS

    FDA 510(k)
    FDA Class 2 ·Dental

    SERVICE, CCU, HIGH DEF, 560P, 2NDGEN

    FDA Adverse Event
    Malfunction ·SMITH & NEPHEW, INC.·Product code GCJ·May 9, 2016

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 16, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·April 19, 2011

    GE OEC 6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008

    STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HXX·May 9, 2016

    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