BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    CORRECTED-V.P.S.

    FDA 510(k)
    FDA Class 2 ·Dental

    ACTH IRMA KIT MITSUBISHI YUKA

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACS THERAPEUTIC DRUG MONITORING CONTROL, LEVEL III

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code JOH·March 28, 2017

    PORTEX®BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.,·Product code JOH·June 28, 2016

    STERLING BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·December 3, 2010

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 3, 2014

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·December 7, 2012

    12MM/125 DEG TI CANN TFNA 380MM/RIGHT - STERILE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·January 30, 2019

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015