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

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    HARDYDISK ERYTHROMYCIN, 15MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    FOUNDATION HYBRID COMPOSITE

    FDA 510(k)
    FDA Class 2 ·Dental

    AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EXCELSIOR SL-10 MICROCATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC, NEUROVASCULAR DIV.·Product code DQY·July 10, 2009

    EXCELSIOR SL-10 PRE-SHAPED 45 CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION·Product code DQO·December 12, 2007

    EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIV·Product code DQO·April 25, 2007

    EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION·Product code DQO·November 14, 2007

    EXCELSIOR SL-10 MICROCATHETER

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORPORATION·Product code DQO·May 1, 2007

    EXCELSIOR SL-10 PRE-SHAPED CATHETER

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP·Product code DQO·September 14, 2006

    EXCELSIOR SL-10 MICROCATHETER

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP·Product code DQO·January 3, 2007

    EXCELSIOR SL-10 MICROCATHETER

    FDA Adverse Event
    Death ·BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV·Product code DQO·September 15, 2006

    EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHER

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR, DIVISION OF BOSTON SCIENTIFIC CORPORATION·Product code DQO·January 3, 2007

    EXCELSIOR SL-10 PRE-SHAPED J MICROCATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION·Product code DQO·August 17, 2007

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 13, 2013

    SP*2 FEMORAL IMPACTOR

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LXH·August 8, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 16, 2011

    B1005, ACUCISE ENDOPYELOTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code EYB·April 17, 2017

    EXCELSIOR SL-10 MICROCATHETER

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP·Product code DQO·September 14, 2006

    EXCELSIOR 1018 MICROCATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP, NEUROVASCULAR·Product code FOZ·August 2, 2006

    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