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

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    REVOLUTION 45MHZ IVUS IMAGING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014608129·STERIS SURGI-GRAPHIC 6000 4" SOFTCARE

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 5, 2024

    MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01

    FDA 510(k)
    FDA Class 1 ·Microbiology

    STERILE LATEX POWDERED PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 5, 2024

    LUXOR

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code GES·April 24, 2013

    TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·May 6, 2011

    CORAIL2 NON COL HO SIZE 12

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code LZO·July 22, 2008

    FAST-FIX 360 CURVED NDL DELIVERY SYS

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code GAT·August 29, 2022

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015