BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    Pump In Style Advanced, Advanced Personal Double Breastpump

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SignaLoc Screw

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215116989·

    PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HYBRID TROCAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SEALING UNIT FROM 5MM TROCARS

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015

    REDUCING CONVERTER 10/12MM TO 5MM

    FDA Adverse Event
    Malfunction ·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·June 17, 2013

    MCLEAN-RING ENTERAL FEEDING TUBE SET

    FDA Adverse Event
    Injury ·COOK INCORPORATED·Product code DQY·November 30, 2007

    TRANSTAR 72 IN DOUBLE MONITORING KIT

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL, ASD·Product code DRS·September 26, 2008

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·May 16, 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