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

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    ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RUSCH BRONCHUS BLOCKER KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ETEST GATIFLOXACIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    UNKNOWN GEL IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·December 18, 2019

    UNKNOWN GEL IMPLANTS

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·December 18, 2019

    MAVERICK²¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·May 2, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 15, 2014

    9900

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

    NV GXL LNR, LIPPED, 36MM ID, GROUP 3 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·May 14, 2024

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 6MM

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·February 10, 2023

    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