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

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    Fingertip Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZenFlex

    FDA UDI
    Kerr Corporation·00195062029769·Rotary Files

    Origin Lateral Offset Collared Hip Stem

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215017811·

    Origin Hip Stem

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215051808·

    PYRENEES Cervical Plate System

    FDA UDI
    VB Spine LLC·10888857298880·Stop Drill, Size Dia. 2.5x14 mm

    Paxeon Origin

    FDA UDI
    PAXEON RECONSTRUCTION LLC·08177570205035·

    AED MONOPOLAR LAP ACCESSORIES

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

    DUSIMETRY CHECK

    FDA 510(k)
    FDA Class 2 ·Radiology

    STRATUS Stem - High Offset - Collared - Size 15

    FDA UDI
    AMPLITUDE SAS·03701089504959·

    ECHELON*FLEX60 LONG

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 21, 2013

    DUROM ACETABULAR COMPONENT

    FDA Adverse Event
    Other ·ZIMMER GMBH·Product code KWA·July 8, 2011

    DURA STAR RX PTCA BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code LOX·September 25, 2008

    INNOVA IGS 530

    FDA Adverse Event
    Injury ·GE MEDICAL SYSTEMS SCS·Product code OWB·August 2, 2019

    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