BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    KardiaMobile Card

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAVIOS CAVITY LINER

    FDA 510(k)
    FDA Class 2 ·Dental

    VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI

    FDA 510(k)
    FDA Class 1 ·Microbiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 29, 2014

    K-WIRE CUTTING PLIERS (MAX 1.6MM)

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·August 6, 2011

    ALTRUA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 8, 2013

    IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·June 6, 2011

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020