BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    Leva® Anterior Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EQUIVITAL, MODEL EQ-01

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIPER SYSTEM, EXPEDIUM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VARIABLE ANGLE SCREW

    FDA Adverse Event
    Injury ·SOFAMOR DANEK MFG·Product code MCV·April 9, 1998

    TSRH SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·SOFAMOR DANEK MFG·Product code KWQ·April 9, 1998

    TSRH SPINAL FIXATION SYSTEM

    FDA Adverse Event
    Injury ·SOFAMOR DANEK MANUFACTURING·Product code KWQ·December 8, 1999

    CANCELLOUS SCREW

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code HWC·January 14, 1994

    INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MCGAW-HORIZON·Product code FRN·March 15, 1993

    INFUSION PUMP

    FDA Adverse Event
    MCGAW-HARIZON·Product code FRN·March 15, 1993

    KINETRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·July 11, 2011

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 11, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 10, 2014

    FLEXI FLO III

    FDA Adverse Event
    ROSS LABORATORIES·Product code FPD·March 28, 1994

    INVACARE INNOVATION IN HEALTH CARE

    FDA Adverse Event
    Death ·INVACARE INNOVATION IN HEALTH CARE·August 31, 1993

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Malfunction ·ZIMMER SURGICAL·Product code GFD·May 2, 2013

    PERMANENT PACING LEAD

    FDA Adverse Event
    Injury ·OSCOR INC.·Product code DTB·July 21, 2022

    AIR DERMATOME HANDPIECE

    FDA Adverse Event
    Injury ·ZIMMER SURGICAL·Product code GFD·January 21, 2015

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024