BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    Brain Perfusion (BP) application

    FDA 510(k)
    FDA Class 2 ·Radiology

    A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43

    FDA 510(k)
    FDA Class 1 ·Dental

    MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS

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

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·June 11, 2013

    ADULT REUSABLE HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 28, 2011

    GE OEC 8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC·Product code JAA·September 25, 2008

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Injury ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

    COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023

    COMPR NANO HMRL PPS 34MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024

    PRUITT F3 CAROTID SHUNT

    FDA Adverse Event
    Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021

    COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024

    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