BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM

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

    MODIFICATION TO EBI ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRIAGE D-DIMER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·May 11, 2018

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·NATIONAL MEDICAL DEVICES INC.·Product code MIB·March 1, 2018

    TRIAGE PROFILER SOB PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019

    TRIAGE PROFILER SOB PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DAP·May 7, 2019

    TRIAGE D-DIMER TEST

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·October 2, 2019

    TRIAGE D-DIMER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·September 17, 2019

    TRIAGE D-DIMER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code GHH·May 7, 2019

    TRIAGE D-DIMER PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR, INC.·Product code GHH·August 17, 2018

    SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·March 7, 2013

    APIX TABLE

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code KXJ·March 25, 2011

    VITALITY DS

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    VUELOCK PLATE, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code KWQ·April 16, 2020

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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