BEUDAMED
    12 results · 27ms · Sources: EU EUDAMED, US FDA

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    SCOTT NEEDLE & SCOTT MICK IMPLANTER

    FDA 510(k)
    FDA Class 1 ·Radiology

    MODEL 80-1983, ELECTROSURGICAL GENERATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    GALILEO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·September 21, 2007

    M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CRITICAL CARE ASSESSMENT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PIIC CLASSIC UPGRADE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MHX·January 24, 2024

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 12, 2014

    NC QUANTUM APEX¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·October 23, 2012

    CXD II

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code KDJ·August 16, 2010

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    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

    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