BEUDAMED
    11 results · 30ms · Sources: EU EUDAMED, US FDA

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    Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COMPUTED TOMOGRAPHY X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    STATIC VESSEL ANALYZER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PULSE GEN MODEL 102

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code LYJ·October 17, 2014

    DELTAPAQ - PLATINUM MICROCOIL

    FDA Adverse Event
    Malfunction ·MICRUS ENDOVASCULAR, LLC·Product code HCG·June 21, 2013

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·July 7, 2011

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Injury ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021

    VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·December 25, 2019