BEUDAMED
    13 results · 29ms · Sources: EU EUDAMED, US FDA

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    SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET

    FDA 510(k)
    FDA Class 2 ·Neurology

    SEDLINE KIT

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code MWI·December 7, 2017

    PERIPHERALLY INSERTED CENTRAL CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FADASIS MEDICAL FM-1 NO BLENDER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PICC NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007

    PICC NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007

    CONICAL EXTRACTION SCREW FOR 5.5MM LOCKING SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES (USA) MONUMENT·Product code HWB·April 11, 2013

    L9000 LIGHTSOURCE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·March 15, 2011

    LEXOS VR-T

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code LWS·May 21, 2008

    PICC-NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS·Product code DQO·April 28, 2004

    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

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018