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

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    FilmArray Pneumonia Panel plus

    FDA 510(k)
    FDA Class 2 ·Pathology

    n.a.

    FDA UDI
    Karl Storz GmbH & Co. KG·04048551076767·FISCH-BELLUCCI Scissors, blades 7 mm

    BD Difco™ Salmonella O Antiserum Group F Factor 11

    FDA UDI
    BECTON, DICKINSON AND COMPANY·00382902226017·BD Difco™ Salmonella O Antiserum Group F Factor...

    24M - Par Electric West Class A FA/Burn

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588226019·24M - Par Electric West Class A FA/Burn

    Cal OSHA - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588026015·Cal OSHA - 18 Metal

    Portex

    FDA UDI
    ICU MEDICAL, INC.·15019517086188·

    POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Single-use Sterile medical laser fiber

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    1823260-2017-01925

    FDA Adverse Event
    Malfunction ·September 7, 2017

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·November 4, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 25, 2011

    VITROS 250 CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·July 12, 2013

    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (CRP) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.

    FDA Enforcement
    Class III ·Terminated·Michigan Instruments, Inc.·May 16, 2018

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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