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

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    NovaLine SP-C35 Transducer Protector (956007)

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

    ANATOMIC PEEK CERVICAL FUSION SYSTEM

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994366412·IMPLANT 4240164 ANATOMIC C 16X14X 11MM

    ARKEO, Wedge Fixation System

    FDA UDI
    Auxano Medical LLC·00810199190112·ARKEO Smooth K-Wire, 1.6x4

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776371845·Bruns Curette hex handle straight oval #2

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183938·Integra® Jarit® Bruns Oval Cup Curette, 9-1/4",...

    Vantage Elan 1.5T, MRT-2020, V6.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    K-Y BRAND WARMING JELLY PERSONAL LUBRICANT

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

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 24, 2008

    COLLEAGUE

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

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·July 18, 2013

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013