BEUDAMED
    2,842 results · 27ms · Sources: EU EUDAMED, US FDA

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    FDA UDI
    COLLEGE PARK INDUSTRIES, INC.·00195411212019·Knee Stop Bumper Replacement Kit

    ROSCOE

    FDA UDI
    COMPASS HEALTH BRANDS CORP.·00092237601136·Roscoe Black Knee Scooter

    USA Elite

    FDA UDI
    Gyrus ACMI, LLC·00821925002661·USA Elite System and USA Series Cold Knife, Str...

    ROSCOE MEDICAL

    FDA Adverse Event
    Injury ·TAICANG JINGQUAN METAL PRODUCTS CO., LTD.·Product code ITJ·May 29, 2018

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·November 18, 2008

    CIRCON ACMI K-SB

    FDA Adverse Event
    Injury ·*·Product code EMF·August 23, 2004

    ROSCOE KNEE SCOOTER

    FDA Adverse Event
    Injury ·Product code ITJ·August 2, 2016

    ELITE AND USA COLD KNIFE, STRAIGHT BLADE, 3/PKG

    FDA Adverse Event
    Other ·GYRUS ACMI INC.·Product code EZO·December 28, 2010

    KNEE SCOOTER

    FDA Adverse Event
    Malfunction ·ROSCOE MEDICAL / COMPASS HEALTH·Product code ITI·September 7, 2017

    Magnetic Resonance Imaging Diagnostic Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·June 10, 2020

    Cardiovascular Monitoring Device accessory - Product Usage: The chest pneumograph (also referred to as the pneumatic bellows, respiration bellows, or respiration sensor) monitors bellows-derived respiration by detecting abdominal or chest wall motion. The chest pneumograph is an accessory to a MRI patient monitoring system or MRI gating solution. The Chest Pneumograph is indicated for use by healthcare professionals with the Wireless Sp02 (wSp02) Module or Toshiba KSB gating unit when bellows-derived respiration sensing is needed during MRI scans for gating.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·June 10, 2020

    INTERLINK Y-TYPE BLOOD/SOLUTION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code KSB·January 4, 2002

    3ME-SC203A TSCDII 110V

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code KSB·December 29, 2017

    Y-TYPE BLOOD SOLUTION SET

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code KSB·September 26, 2000

    Y-TYPE BLOOD SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code KSB·July 19, 2000

    3ME-SC203A TSCDII 110V

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code KSB·December 21, 2018

    PLASMAPHERESIS SET

    FDA Adverse Event
    Other ·HAEMONETICS CORP.·Product code KSB·October 6, 2009

    FENWAL BLOOD RECIPIENT SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORP.·Product code KSB·June 2, 2005

    FENWAL BLOOD RECEPIENT SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code KSB·June 8, 2005

    3ME-SC203A TSCDII 110V

    FDA Adverse Event
    Injury ·TERUMO BCT·Product code KSB·December 21, 2018