BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    'MYOSTIM EX'

    FDA 510(k)
    FDA Class 2 ·Neurology

    SHOFU RESIN GLAZE

    FDA 510(k)
    FDA Class 2 ·Dental

    HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·June 25, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 15, 2019

    ASPHERE M SPEC 12/14 40 +8.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 10, 2014

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 11, 2010

    CURLIN INFUSION 6000 IV PUMP

    FDA Adverse Event
    Malfunction ·MOOG MEDICAL DEVICES GROUP·Product code FRN·November 1, 2012

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·September 18, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·September 11, 2017

    TFNA HELICAL BLADE L85 TAN

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·May 18, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 30, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 26, 2021

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·June 15, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·January 6, 2020

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·May 18, 2018

    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