BEUDAMED
    22 results · 20ms · Sources: EU EUDAMED, US FDA

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    MASTERSCREEN IOS

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TeleSense 3 Lead Patient Cable 40"

    FDA UDI
    SCOTTCARE CORPORATION, THE·00856298006145·

    HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Widex

    FDA UDI
    Widex A/S·05706069727197·Widex EVOKE E-PA (Deep Blue S-440 ) RC coil

    LIBERTY CYCLER SET, DUAL PT CONNECT

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FKX·May 3, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 25, 2014

    ANTI-HUMAN GLOBULIN (RABBIT/MURINE MONOCLONAL)

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code DEW·April 19, 2011

    4.5 BROAD SCP PLT 26-H STER

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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

    Model Number L101, ESSENTIO DR SL Pacemaker

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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021

    ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)

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