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

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    C-BOOT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 1, 2020

    GPW-SF

    FDA 510(k)
    FDA Class 2 ·Dental

    PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RAINBOW R1 25L SENSOR

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·June 19, 2015

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 8, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·March 10, 2011

    CONTAK RENEWAL 3

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

    HARMONY DELIVERY CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPV·February 13, 2026

    Vancomycin Screen Agar

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·December 30, 2015

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

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