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

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    Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T

    FDA 510(k)
    FDA Class 2 ·Radiology

    BBL™ CultureSwab™ EZ

    FDA UDI
    COPAN ITALIA SPA·38053326002145·BBL™ CultureSwab™ EZ CultureSwab EZ Swab Single

    VITAL SIGNS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SIEMENS INFINITY SC 6002XL MODIFICATIONS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 3, 2014

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 15, 2011

    QUADRA ASSURA CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 11, 2013

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023

    BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

    FDA Recall
    Open, Classified ·Copan Italia Via Francesco Perotti 10·Product code JTW·May 2, 2025

    BD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic, SterileR, Rx Only

    FDA Enforcement
    Class II ·Ongoing·Copan Italia·June 18, 2025

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025