BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    SWABCAP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065845·EXTRAORAL ELASTICS 3/8" 8 oz

    HRH-127-ALLEGRA HEAD ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    NC-STAT

    FDA 510(k)
    FDA Class 2 ·Neurology

    QUADRA BROACH SIZE 0

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL, SA·Product code JDI·September 7, 2012

    BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2019

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·April 29, 2013

    AXIALIF

    FDA Adverse Event
    Injury ·TRANS1·Product code KWQ·May 10, 2011

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    FDA Adverse Event
    Injury ·ADVANCED STERILIZATION PRODUCTS·Product code FEB·July 29, 2008

    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

    PASS LP - LIAPASS

    FDA Adverse Event
    Injury ·MEDICREA TECHNOLOGIES·Product code MNI·March 29, 2013

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·July 11, 2019

    LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 25, 2019

    LINER: MPACT FLAT PE HC LINER 36/ER

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·December 17, 2020

    MPACT LINER FLAT PE HC LINER Ø 32/D

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·January 5, 2016

    CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 17, 2022

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015