BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    VENUS FREEZE (MP)2 SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NA

    FDA UDI
    MAKO SURGICAL CORP.·00848486002794·BONE PINS (3.2MM X 80MM)

    BONE PIN- 3.2 X 80 MM- STERILE (2 PACK)

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code OLO·June 25, 2015

    BONE PIN, 3.2 X 80 MM, STERILE (2 PACK)

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·November 17, 2015

    BONE PIN- 3.2 X 80 MM- STERILE (2 PACK)

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code OLO·June 25, 2015

    BONE PIN, 3.2 X 80 MM, STERILE (2 PACK)

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 24, 2015

    BONE PIN- 3.2 X 80 MM- STERILE (2 PACK)

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code OLO·June 9, 2015

    UNITED U2 BIPOLAR IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BONE PIN, 3.2MM X 140MM

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL .·Product code JDW·October 14, 2011

    BONE PIN, 3.2MM X 140MM

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code JDW·May 7, 2012

    ACCU-CHEK ® MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·May 14, 2013

    HEART START XL

    FDA Adverse Event
    Death ·PHILIPS HEALTHCARE·Product code MKJ·May 26, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 13, 2008

    ACTIVA

    FDA Adverse Event
    Malfunction ·MPRI·Product code MHY·September 24, 2020

    ACTIVA

    FDA Adverse Event
    Malfunction ·MPRI·Product code MHY·September 24, 2020

    Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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