BEUDAMED
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    MODIFICATION TO RESTORATION MODULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    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

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·May 9, 2008

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 6, 2011

    JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·June 16, 2021

    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

    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