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

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    MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON

    FDA 510(k)
    FDA Class 2 ·Hematology

    PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 14, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 22, 2013

    MRI LOW-PROFILE IMPLANTED PORT

    FDA Adverse Event
    Malfunction ·BARD ACCESS SYSTEMS INC·Product code LJT·April 19, 2011

    VCARE

    FDA Adverse Event
    Malfunction ·CONMED CORPORATION·Product code LKF·July 2, 2008

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    FDA Adverse Event
    Death ·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023

    FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR

    FDA Adverse Event
    Death ·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022