BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    PRIMUS VARIANT SYSTEM PVS99

    FDA 510(k)
    FDA Class 2 ·Hematology

    ORTHOPAEDIC SURGERY GOUGES, REUSABLE

    Device
    EU MDR · Eu Md Class 1 ·ChM spółka z ograniczoną odpowiedzialnością·On the market·32 countries

    YOKE ASSEMBLY MEDICAL GAS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    VALVULOTOME

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code LPH·January 31, 2019

    CONSTRAINED LINER WITH CONSTRAINING RING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWZ·January 31, 2019

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Injury ·MPRI·Product code LWP·February 11, 2013

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 10, 2011

    AED PLUS

    FDA Adverse Event
    Death ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 18, 2014

    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