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

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    GARAVENTA SUPER-TRAC TRE-52

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES

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

    SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY

    FDA 510(k)
    FDA Unclassified ·Unknown

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·July 18, 2017

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·July 18, 2017

    HEMOCUE GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code LFR·May 23, 2011

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    GLUCOSE 201+ ANALYZER

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code CGA·February 26, 2015

    QT SCANNER 2000 MODEL A

    FDA Adverse Event
    Injury ·QT IMAGING HOLDINGS, INC.·Product code IYO·October 30, 2025

    HEMOCUE GLUCOSE 201+ SYSTEM

    FDA Adverse Event
    Malfunction ·HEMOCUE AB·Product code LFR·August 18, 2014

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·March 19, 2013

    CONCERTO CRT-D DR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL, INC.·Product code NIK·March 16, 2011

    PENLET LANCING DEVICE

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code FMK·March 27, 2008

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022