BEUDAMED
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    Guardian

    FDA UDI
    COLLEGE PARK INDUSTRIES, INC.·00195411420513·Knee Lock Kit Extension Spring

    TCM

    FDA Adverse Event
    Injury ·RADIOMETER MEDICAL APS·Product code KLK·February 26, 2010

    PHILIPS TC02 MODULE

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code KLK·June 22, 2010

    PHILIPS TC02 MODULE

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code KLK·June 22, 2010

    DIGITAL MONITORING SYSTEM

    FDA Adverse Event
    Injury ·SENTEC AG·Product code KLK·April 19, 2022

    TCM

    FDA Adverse Event
    Injury ·RADIOMETER MEDICAL APS·Product code KLK·April 13, 2007

    NONIN MODEL 8604-D-L PULSE OXIMETER

    FDA Adverse Event
    Death ·NONIN MEDICAL·Product code KLK·December 9, 1994

    FAST TROC

    FDA Adverse Event
    SENSORMEDICS CORP.·Product code KLK·June 2, 1997

    TCM

    FDA Adverse Event
    Injury ·RADIOMETER MEDICAL APS·Product code KLK·November 28, 2007

    RADIOMETER - COPENHAGEN

    FDA Adverse Event
    Injury ·RADIOMETER·Product code KLK·February 12, 1997

    TC MONITOR

    FDA Adverse Event
    Malfunction ·RADIOMETER MEDICAL APS·Product code KLK·February 9, 2005

    DISPOSABLE SENSOR

    FDA Adverse Event
    Injury ·CRITICARE SYSTEM, INC.·Product code KLK·September 23, 1993

    TC MONITOR

    FDA Adverse Event
    Malfunction ·RADIOMETER MEDICAL APS·Product code KLK·September 15, 2005

    TCM3 TINA MONITOR

    FDA Adverse Event
    Injury ·RADIOMETER AMERICA INC.·Product code KLK·January 9, 1998

    TCM3 TINA MONITOR

    FDA Adverse Event
    Injury ·RADIOMETER AMERICA INC.·Product code KLK·January 9, 1998

    HP

    FDA Adverse Event
    Injury ·HEWLETT-PACKARD CO. MEDICAL PRODUCTS GROUP·Product code KLK·March 10, 1999

    DATASCOPE

    FDA Adverse Event
    Injury ·DATASCOPE CORPORATION·Product code KLK·January 8, 1993

    TC Monitor - Transcutaneous Monitor for p02 and pC02, Model #TCM4, (Cutaneous Oxygen Monitor)

    FDA Recall
    Terminated ·Radiometer America Inc·Product code KLK·February 2, 2005

    TCM4 Series Monitoring System (Base Unit) 391-876 (affected device) CompactFlash cards: 914-698 (Defective Device Component)

    FDA Recall
    Terminated ·Radiometer America Inc·Product code KLK·April 7, 2006

    D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor)

    FDA Recall
    Terminated ·Radiometer America Inc·Product code KLK·November 1, 2005