BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)

    FDA 510(k)
    FDA Class 2 ·Neurology

    15L8 Transducer

    FDA UDI
    SIEMENS MEDICAL SOLUTIONS USA, INC.·04056869005140·

    16PW - Cal OSHA

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588025971·16PW - Cal OSHA

    BREATHEX OMEGA CPAP DEVICE, MODEL 322

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ProteXsure Safety Capsule System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 15, 2014

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 18, 2011

    ESTEEM

    FDA Adverse Event
    Other ·ENVOY MEDICAL·Product code OAF·July 19, 2013

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    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