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

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    Suture, Nonabsorbable, Silk

    FDA Pre-Market Approval
    FDA Class 2 ·SILK SUTURES

    Suture, Nonabsorbable, Silk

    FDA Pre-Market Approval
    FDA Class 2 ·SILK SUTURES

    Suture, Nonabsorbable, Silk

    FDA Pre-Market Approval
    FDA Class 2 ·SILK SUTURES

    Suture, Nonabsorbable, Silk

    FDA Pre-Market Approval
    FDA Class 2 ·SILK SUTURES

    None

    FDA UDI
    INTUITIVE SURGICAL, INC.·00886874110867·BLUE SYSTEM CABLE, FIBERCONENT

    VITAL SIGNS CLEAR PRESSURE INFUSOR

    FDA Adverse Event
    Malfunction ·VYAIRE MEDICAL·Product code KZD·October 23, 2020

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 10, 2015

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 20, 2014

    MONARCH IOL DELIVERY SYSTEM-CARTRIDGE

    FDA Adverse Event
    Other ·ALCON LABORATORIES, INC./HUNTINGTON·Product code KYB·March 7, 2002

    QUICKIE

    FDA Adverse Event
    Malfunction ·SUNRISE MEDICAL, MPD·Product code IOR·June 6, 2000

    REDIGUARD IAB CATHETER

    FDA Adverse Event
    Injury ·BARD VASCULAR SYSTEM·Product code DSP·August 5, 1998

    DAVINCI SI

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·March 6, 2023

    OEC 9800 Systems with 9-inch Image Intensifier

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·August 9, 2023

    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