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

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    Panoura X-ERA PF/NF/MF

    FDA 510(k)
    FDA Class 2 ·Dental

    JOYSTICK-RH

    FDA UDI
    Aktormed GmbH·04260463841985·

    DURASHIELD PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    COMPACT TOUCH STS

    FDA 510(k)
    FDA Class 2 ·Radiology

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 17, 2014

    SOLETRA

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

    RELIA SR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 21, 2013

    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