BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    TIBURON SURGICAL DRAPE

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

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768482·GENUMEDI PSS GREEN IV

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517574688·CoRoent Ant TLIF Ti, 13x10x40mm 4°

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925016576·GOLDMAN CVD PICK DULL.7.8 RAD

    ArgenZ HT+ 98x25 ML OM1B

    FDA UDI
    ARGEN CORPORATION, THE·D818130404·Dental porcelain/ceramic restoration kit

    VANISHPOINT SYRINGE 25GX1

    FDA Adverse Event
    Malfunction ·RTRACTABLE TECHNLLOGIES·Product code MEG·November 8, 2013

    ASCENDX VCF REDUCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    C. DIFFICILE TOX A/B II

    FDA 510(k)
    FDA Class 1 ·Microbiology

    *

    FDA Adverse Event
    Malfunction ·*·Product code CBK·May 14, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·June 16, 2011

    ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE-2.5

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 20, 2008

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·October 30, 2017

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 9, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·February 28, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code GEX·February 8, 2018

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    FDA Adverse Event
    Injury ·COOK INC·Product code GEX·April 25, 2018

    Achillon minimally invasive Achilles tendon suture system

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code MCZ·July 2, 2004

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024