BEUDAMED
    22 results · 25ms · Sources: EU EUDAMED, US FDA

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    CADD MEDICATION CASSETTE RESERVOIR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CADD MEDICATION CASSETTE

    FDA Adverse Event
    Malfunction ·NULL·Product code FPA·February 4, 2022

    Mouse anti-Ki-67 (MIB-1) 2ndGen Predilute

    FDA UDI
    LIFE TECHNOLOGIES CORPORATION·10190302007740·

    PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET

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

    BCI 3403 SLEEP SCREENING PULSE OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    9616240-2006-00341

    FDA Adverse Event
    Malfunction ·Product code FII·June 14, 2006

    9616240-2006-00332

    FDA Adverse Event
    Other ·Product code FII·June 1, 2006

    PHOENIX

    FDA Adverse Event
    Malfunction ·GAMBRO DASCO·Product code FII·May 10, 2006

    9616240-2006-00339

    FDA Adverse Event
    Malfunction ·Product code FII·June 9, 2006

    9616240-2006-00340

    FDA Adverse Event
    Malfunction ·Product code FII·June 9, 2006

    9616240-2006-00350

    FDA Adverse Event
    Malfunction ·Product code FII·June 23, 2006

    9616240-2006-00345

    FDA Adverse Event
    Malfunction ·Product code FII·June 14, 2006

    PHOENIX

    FDA Adverse Event
    Malfunction ·GAMBRO DASCO·Product code FII·May 10, 2006

    PHOENIX

    FDA Adverse Event
    Malfunction ·GAMBRO DASCO·Product code FII·May 10, 2006

    DEPUY ASR XL FEM IMP SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 26, 2013

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·April 14, 2011

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR DEVICES·Product code DQX·July 10, 2008

    4.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HTW·March 8, 2019

    Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·May 29, 2013

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014