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

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    FUKUDA DENSHI DYNASCOPE MODEL DS-5700

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Affiniti™ EH²

    FDA UDI
    TORNIER, INC.·00846832002245·

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040039042·Channels K-Files 21mm, #60

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65820200841·Channels K-Files 21mm

    NA

    FDA UDI
    STRYKER CORPORATION·04546540755841·LARGE PLUNGER WITH 2.4MM CANNULATION

    MICROVASIVE LITHOTRIPTOR FLEXPROBE II

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ENRAF-NONIUS SONOPULS 190 SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·March 25, 2013

    3 MOTOR ADVANCE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 10, 2011

    ALARIS® PUMP MODULE

    FDA Adverse Event
    Injury ·CAREFUSION·Product code FRN·May 26, 2016

    1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015