BEUDAMED
    15 results · 35ms · Sources: EU EUDAMED, US FDA

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    IMALUX NIRIS IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EPICOR MEDICAL ABLATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDIPRIME

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRIAGE D-DIMER PANEL

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

    ACCURUS 400VS

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·March 5, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 30, 2011

    FINELINE II

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

    Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·January 24, 2018

    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