BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    ATLAS-BASED AUTOSEGMENTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014607566·SKYTRON 6700, 6701 3.25" SOFTCARE PLUS

    BELMONT UNIT, MODEL 2000 SERIES

    FDA 510(k)
    FDA Class 1 ·Dental

    COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·December 23, 2011

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTL.·Product code MNI·September 16, 2011

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTL.·Product code MNI·October 14, 2011

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 12, 2013

    TWISTER PLUS ROTATABLE RETRIEVAL DEVICE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC·Product code GCJ·September 5, 2014

    AU681-02E CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013

    PASS LP

    FDA Adverse Event
    Injury ·MEDICREA·Product code MNI·April 17, 2013

    ENDOPATH ETS FLEX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·December 23, 1997

    GORE® TRI-LOBE BALLOON CATHETER

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code DQY·February 24, 2021

    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