BEUDAMED
    12 results · 23ms · Sources: EU EUDAMED, US FDA

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    A1CNOW FOR HOME USE

    FDA 510(k)
    FDA Class 2 ·Hematology

    UNITY IS PATIENT VIEWER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARDYDISK CEFOTETAN, 30MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ETERNITY NAVI XJ-70

    FDA Adverse Event
    Injury ·B+L FOR ADVANCED VISION SYSTEM (AVS)·Product code HQL·May 26, 2011

    UNKNOWN ZIMMER M/L TAPER STEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWY·March 22, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·March 17, 2011

    CONMED AUTOMATIC APPLIER 5MM

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDO·April 1, 2008

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 1, 2022

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·September 1, 2022

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

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