BEUDAMED
    11 results · 34ms · Sources: EU EUDAMED, US FDA

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    ORTHOKROME* FACTOR VIII

    FDA 510(k)
    FDA Class 2 ·Hematology

    HTH®-Right 18mm

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199003950·

    FORA IR20B EAR THERMOMETER, MODEL TD-1261F, FORA IR21B EAR THERMOMETER, MODEL TD-1261E

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EINSTEIN PROCESSING AND REVIEW WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    PHYSICA KR TIBIAL LINER LEFT #8

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HRY·May 11, 2021

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2023

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND·Product code CBK·May 6, 2014

    DEPUY ASR XL FEM IMP SIZE 51

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 7, 2013

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 26, 2010

    SMR CONNECTOR SMALL R

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·November 6, 2020

    Zeiss brand IOLMaster, Version 1-5, 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