BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO

    FDA 510(k)
    FDA Class 1 ·Microbiology

    JELCO PROTECTIV

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL·Product code FOZ·October 26, 2011

    GYNECARE X-TRACT MORCELLATOR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code HET·June 8, 2006

    BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    M.F.S. LOW AIR LOSS PULSATING BED

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 1.2 M

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·February 15, 2024

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, 1.2 M

    FDA Adverse Event
    Malfunction ·ICU MEDICAL COSTA RICA LTD.·Product code FPA·February 15, 2024

    ISOFLEX S

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·February 28, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-522LNAS

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·January 20, 2011

    SUPER SUCKER SHORT (BX/20)

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code KDC·December 18, 2013

    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