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

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    REPROCESSED BALOON INFLATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRESS-FIT HEAD RESURFACING DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SEE H10

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011

    BACT/ALERT® FA PLUS BLOOD CULTURE BOTTLE

    FDA Adverse Event
    Malfunction ·BIOMERIEUX INC.·Product code MDB·August 19, 2019

    GRAFTON DBM

    FDA Adverse Event
    Injury ·MEDTRONIC EATONTOWN·Product code NUN·July 6, 2019

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011

    ACCU-CHEK MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 27, 2008

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012