BEUDAMED
    22 results · 61ms · Sources: EU EUDAMED, US FDA

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    COOLTOUCH INCORPORATED MODELCT3 ND:YAG SURGICAL LASER SYSTEMS

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

    SURGICAL LASER TECHNOLOGIES

    FDA Adverse Event
    Malfunction ·SURGICAL LASER TECHNOLOIES, INCORPORATED·July 21, 1994

    STAR S4 IR

    FDA Adverse Event
    Injury ·Product code LZS·September 28, 2021

    WAVELIGHT FS200 FEMTOSECOND LASER

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code GEX·July 17, 2017

    PULSE GEN MODEL 103

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·September 9, 2022

    ZILVER PTX 35 DRUG-ELUTING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code NIU·February 28, 2018

    Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb Inc·December 31, 2014

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·April 2, 2019

    STAR S4 IR

    FDA Adverse Event
    Injury ·Product code LZS·September 28, 2021

    ATTAIN SELECT II

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code OJX·January 21, 2016

    Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY

    FDA Recall
    Terminated ·Bausch & Lomb Inc·Product code HQF·November 4, 2014

    ENDO GIA

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·October 31, 2017

    ENDO GIA

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·October 31, 2017

    ENDO GIA

    FDA Adverse Event
    Malfunction ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·October 31, 2017

    RADIESSE(+)

    FDA Adverse Event
    Injury ·MERZ NORTH AMERICA, INC (FRANKSVILLE)·Product code LMH·October 15, 2025

    PULSE GEN MODEL 106

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code LYJ·July 26, 2022

    RADIESSE (+) INJECTABLE IMPLANT

    FDA Adverse Event
    Injury ·MERZ NORTH AMERICA, INC·Product code LMH·December 12, 2023

    CABLE TENSIONER

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code LXH·October 14, 2015

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    MedEnvoy Global BV

    Importer
    🇳🇱 Netherlands·234 Manufacturers