BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Transcend 365 miniCPAP System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TRANSCEND 365 MINICPAP SYSTEM

    FDA Adverse Event
    Injury ·SOMNETICS INTERNATIONAL, INC.·Product code BZD·October 6, 2021

    FUKUSHIMA SUCTION TUBE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B0991803880·FUKUSHIMA SUCTION TUBE

    COLLACARE DENTAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS

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

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 19, 2022

    L CATH PICC KIT

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL DEVICES, INC.·Product code LJS·October 6, 2014

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 20, 2013

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Injury ·BECKMAN COULTER INC.·Product code MMI·July 27, 2011

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014