BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    6248VAL ADJUSTABLE VALVE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATRICURE BIPOLAR SYSTEM

    FDA Adverse Event
    Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·April 11, 2013

    ST104 TRANSPORT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·March 16, 2011

    CC IRON/MAGNESIUM CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC·Product code JIX·May 22, 2008

    MRHK TIB INS 13MM XS/S S1/S2

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·June 7, 2017

    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·April 24, 2019

    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