BEUDAMED
    14 results · 31ms · Sources: EU EUDAMED, US FDA

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    T.E.N.S. ELECTRODE NON-STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CLARUS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 18, 2014

    POWERFLEX P3 PTA DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS EUROPA, N.V.·Product code LIT·October 25, 2010

    UNK

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 17, 2012

    HANAROSTENT?? ESOPHAGUS TTS (CCC)

    FDA Adverse Event
    Malfunction ·M.I.TECH CO., LTD.·Product code JCQ·December 12, 2025

    SINGLE USE GUIDEWIRE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION·Product code OCY·August 23, 2024

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    FDA Adverse Event
    Injury ·SHIRAKAWA OLYMPUS CO., LTD.·Product code ODG·August 23, 2024

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    FDA Adverse Event
    Injury ·SHIRAKAWA OLYMPUS CO., LTD.·Product code ODG·August 23, 2024

    HANAROSTENT ESO TTS FC 18 DM 6CM 180

    FDA Adverse Event
    Injury ·M.I.TECH CO LTD·Product code ESW·August 23, 2024

    Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·September 7, 2022

    Optima Coil System Model OPTI0520CSF10. For endovascular embolization.

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·July 26, 2022

    The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. it is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single-patient-use device which should not to be reused, re-sterilized, opened or tampered with. The Optima Coil System and XCEL Detachment Controller(s) are sold separately. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller.

    FDA Recall
    Open, Classified ·BALT USA, LLC·Product code HCG·January 4, 2022