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

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    BLAKE MEDICAL BREATHING TUBE SUPPORT

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MOTIVA IMPLANTS

    FDA Adverse Event
    Injury ·ESTABLISHMENT LABS S.A.·Product code FTR·April 17, 2025

    CS100

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·May 9, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·January 8, 2013

    ECHELON*FLEX60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GDW·November 18, 2010

    2) Signa Advantage SP (K942604 Signa Advantage SP MR System) A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 9, 2010

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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