BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    Portable Nebulizer

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    N/A

    FDA UDI
    Ortho Development Corporation·00822409129683·Uni Knee Keeled Tibial Tray Trial Size 7 Left

    FIT CHECKER ADVANCED

    FDA 510(k)
    FDA Class 2 ·Dental

    TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 25, 2024

    PERIOST-ELEV CURV-SHAFT ROUND EDG W/14 L

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code HTE·June 20, 2013

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·July 1, 2011

    AFF (MARK I) VOLUMTRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·TYLA MEDICAL SYSTEMS·Product code FRN·September 22, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.

    FDA Enforcement
    Class II ·Terminated·Coloplast Manufacturing US, LLC·December 2, 2020

    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