BEUDAMED
    11 results · 25ms · Sources: EU EUDAMED, US FDA

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    NCTC-135 MEDIUM N3262

    FDA 510(k)
    FDA Class 1 ·Hematology

    AMLUCK, YA HORNG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Precision Spine Interspinous Plate System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021

    BI-METRIC POROUS FEMORAL 9X125MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LZO·June 5, 2014

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·October 4, 2010

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    JUNCHENG·Product code ITJ·November 29, 2012

    HF-RESECTION ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

    HF-RESECTION ELECTRODE

    FDA Adverse Event
    Malfunction ·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023

    UNKNOWN

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code KNS·October 21, 2022

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017