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

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    INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·March 22, 2013

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·March 17, 2011

    ACCLAIM ELBOW PIN ASSEMBLY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDC·March 31, 2008

    G7 10 DEG E1 LINER 28MM A

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·October 2, 2019

    G7 10 DEG ARCOMXL LINER 28MM A

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·October 2, 2019

    G7 PPS LTD ACET SHELL 44A

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·October 2, 2019

    G7 HI-WALL E1 LINER 28MM A

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code PBI·October 2, 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

    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