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

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    REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEURON THERAPEUTICS, INC., 14-GAUGE LUMBAR PUNCTURE SET, MODEL PN1000735

    FDA 510(k)
    FDA Class 2 ·Neurology

    NV EHXL NTRL LNR G3 36MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·July 26, 2024

    STOCKERT 70 RF GENERATOR

    FDA Adverse Event
    Malfunction ·STOCKERT GMBH·Product code DRF·March 27, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·March 18, 2011

    LASSO 2515 VARIABLE CIRCULAR MAPPING CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·March 27, 2008

    BD EMERALD ¿ SYRINGE WITH DETACHED NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·March 29, 2018

    OT INDUO METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 30, 2011

    OT INDUO METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·January 10, 2011

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018