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

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    IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

    FDA 510(k)
    FDA Class 2 ·Neurology

    5530 3L SYRINGE

    FDA UDI
    HANS RUDOLPH, INC.·00817136021768·5530 3L SYR PER NSPIRE

    LAGUNA PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)

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

    R3 XLPE INSERT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDI·May 25, 2025

    NITE GUARD

    FDA Adverse Event
    Malfunction ·RANIR LLC·Product code OBR·May 1, 2014

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code OUT·May 15, 2013

    RESTORE PRIME ADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC EUROPE SARL·Product code LGW·June 2, 2011

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Enforcement
    Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025