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

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    ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743519·LEVAMED ANKLE SUPPORT SILVER III

    RMO

    FDA UDI
    Rmo, Inc.·00885797099754·LING RETNR BOND 4X4 6 CASE KIT

    BUSCH®, BNA®

    FDA UDI
    BUSCH & CO. GmbH & Co. KG·D8120102531·Steel, round, rosehead

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023963·PADDLE SPREADER, 13MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102130·Shaver, Open 13mm

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033119686·

    SILENT NIGHT V

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    SURGITRON IEC II

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

    M-SERIES DC POWER SUPPLY

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·May 25, 2012

    REMSTAR AUTO M SERIES

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·April 14, 2024

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 5, 2024

    PREMIUM SURGICLIP AUTOSUTURE CLIP APPLIER

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FZP·March 18, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 1, 2011

    VECTRA GENISYS

    FDA Adverse Event
    Other ·CHATTANOOGA GROUP·Product code IPF·March 11, 2008

    VERCISE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·April 7, 2021

    Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.

    FDA Enforcement
    Class II ·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014