BEUDAMED
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    Neonav ECG Tip Location System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Blade Handle

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112366·CHUCK HANDLE #3K 10CM LONG

    Burr

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113097·BURR FOR ALGERBRUSH 1.0MM

    ZEOS

    FDA UDI
    SANTA BARBARA IMAGING SYSTEMS, INC.·00812231032077·2.5MM SHEATH, SINGLE STOPCOCK

    EZTrack

    FDA 510(k)
    FDA Class 2 ·Neurology

    Intraosseous Cannula System Bio-MAC¿ and Bio-CORE

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

    CLINICAL INFORMATION CENTER

    FDA Adverse Event
    Malfunction ·GE HEALTHCARE·Product code DSI·November 19, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    MECHANICAL CHAIR/TRANSPORT CHAIR

    FDA Adverse Event
    JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD·Product code INM·July 22, 2013

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) 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; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014