BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INVADER MTHFR 677

    FDA 510(k)
    FDA Class 2 ·Hematology

    OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31

    FDA 510(k)
    FDA Unclassified ·Unknown

    KYPHON HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 25, 2017

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·April 7, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 19, 2020

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 4, 2019

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Injury ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 17, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·December 17, 2018

    KYPHX® HV-R¿ BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·February 7, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·October 12, 2017

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MDT KYPHON NEUCHATEL MFG·Product code NDN·July 9, 2020

    INSYNC III

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWP·October 10, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    UNICEL DXC 600I SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·June 17, 2011

    ACHIEVE MAPPING CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRF·July 12, 2017

    FLEXCATH ADVANCE STEERABLE SHEATH

    FDA Adverse Event
    Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·July 12, 2017

    Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 6, 2017