BEUDAMED
    16 results · 32ms · Sources: EU EUDAMED, US FDA

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    Gammex PI Hybrid Surgical Gloves

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ProLift Lateral

    FDA UDI
    Life Spine, Inc.·00190837142247·

    HANDHELD PULSE OXIMETER MODEL M800

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·January 8, 2017

    BD ANGIOCATH¿ IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 19, 2017

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

    CONTAK RENEWAL

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 6, 2011

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LWP·June 7, 2013

    BD ANGIOCATH IV CATHETER 20GA 1.88IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·June 24, 2020

    BD INSYTE¿ PERIPHERAL VENOUS CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·March 20, 2018

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    Precise Treatment Table. To be used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 17, 2013

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014