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

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    NEOSALUS CREAM

    FDA 510(k)
    FDA Unclassified ·Unknown

    BD INTERLINK BLUNT PLASTIC CANNULA

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·August 9, 2021

    BD INTERLINK BLUNT PLASTIC CANNULA

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 29, 2021

    SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 11, 2021

    SCULPTING RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BD MICRO-FINE + INSULIN SYRINGE WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·May 10, 2021

    UNKNOWN_NEUROVASCULAR_PRODUCT

    FDA Adverse Event
    Injury ·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·LIVANOVA USA, INC.·Product code MUZ·May 2, 2013

    VALIANT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·September 15, 2014

    9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2011

    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