BEUDAMED
    21 results · 27ms · Sources: EU EUDAMED, US FDA

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    ONX Large External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 20, 2020

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·December 29, 2020

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 12, 2020

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 12, 2020

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QKP·September 22, 2020

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QKP·September 16, 2020

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 13, 2020

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 8, 2020

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 12, 2020

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011

    CATGUT CHROMIC 2/0 (3.5) 100M

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code GAL·October 6, 2014

    SJM MASTERS SERIES VALVE EXPANDED CUFF W/ SILZONE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO INC·Product code LWQ·July 3, 2013

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    FDA Adverse Event
    Malfunction ·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 12, 2020

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019