BEUDAMED
    15 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    eMVFit (MVF-10M)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Oticon

    FDA UDI
    Sbo Hearing A/S·05714464057672·OTICON PLAY PX 2 MINIRITE T C094

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319745472·St. Mark's Perineal Retractor, frame and rake b...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319745502·St. Mark's Perineal Retractor Blades, 4" deep, ...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319745519·St. Mark's Perineal Retractor, frame only

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319745489·St. Mark's Perineal Retractor Blades, 2" deep, ...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319745496·St. Mark's Perineal Retractor Blades, 3" deep, ...

    ARTHROCARE NASASTENT CMC NASAL DRESSING

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    15F X 55CM EXCELL SPLIT -TIP CATHETER, MODELS 10300606, 10300706

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

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·August 17, 2011

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 10, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·July 17, 2013

    CLEO® 90 INFUSION SET

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code FPA·May 16, 2017

    CLEO® 90 INFUSION SET

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code FPA·May 16, 2017

    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