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

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    Scan Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ER150/M2

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CONSENSUS KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS, INC.·Product code LZG·February 4, 2010

    UNKNOWN DEPUY FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·October 16, 2008

    GENESIS DUAL XP RECHARGEABLE IPG

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 4, 2011

    ACUVUE 2 BRAND CONTACT LENSES

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·June 28, 2013

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF, INC·Product code NJE·March 12, 2015

    INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 11, 2014

    INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 11, 2014

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code OUT·February 6, 2015

    UNKNOWN CERECYTE MICROCOIL

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF, INC·Product code HCG·January 28, 2015

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF, INC·Product code NJE·October 2, 2017

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·CODMAN AND SHURTLEFF, INC·Product code NJE·October 2, 2017

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021