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

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    A3 Total Knee System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Spherical Patella Trial Size Ø31x9mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215139490·

    TANDEMHEART PUMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MINI CANNULATED HEADED AND HEADLESS SCREW SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OLYMPUS EMPOWER H65

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM S.P.A.·Product code GEX·May 19, 2022

    HLM TUBING SET W/BIOLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·October 15, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·July 27, 2011

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·May 26, 2023

    ENNOVATE POLYAX.SCREW 6.5X45MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    ENNOVATE POLYAX.SCREW 7.5X40MM FENESTR.

    FDA Adverse Event
    Injury ·AESCULAP AG·Product code NKB·December 21, 2018

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·April 20, 2018

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 31, 2024

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DTZ·January 31, 2024

    CAPIOX®RX

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·December 9, 2024

    CAPIOX RX OXYGENATOR

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·July 5, 2018

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

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