BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    Xultan 5.5 Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776179311·VAN BUREN URETHRAL SOUND FRENCH

    ELIBRA DYNAMIC KNEE BALANCER

    FDA 510(k)
    FDA Class 2 ·Neurology

    AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REAMER SHAFT, MOD, TRINKLE 8.0X284 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HWE·February 13, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 14, 2014

    DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code HTW·June 14, 2013

    SYNVISC (HYLAN G-F 20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·June 21, 2011

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 18, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·June 17, 2019

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·January 23, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 16, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·October 8, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 17, 2019

    OSTEO-SITE BONE BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KNW·July 11, 2019

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. 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, Cardiac Rhythm Management Division·January 22, 2020