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

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    EBV/EA-CHECK TM TEST KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Brigade

    FDA UDI
    Nuvasive, Inc.·00887517964236·Brigade Lateral Trial, 11x38x32mm 30°

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083016005·STR, 4 electrode, MPD-CS-S, 2mm electrode spacing

    MICROSPEED EC MOTORSYSTEM GD650/GD653

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNGO.PLAZA

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADULT BREATHING CIRCUIT DUAL HEATED

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·June 15, 2007

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 30, 2014

    CAREASSIST BED

    FDA Adverse Event
    Malfunction ·HILL-ROM PLUVIGNER·Product code FNL·November 16, 2010

    BIVONA TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code JOH·January 2, 2013

    Colonoscope, Model Number PCF-H180AL.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·November 25, 2015

    Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.

    FDA Recall
    Terminated ·Stryker Howmedica Osteonics Corp.·Product code JDI·October 15, 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