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

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    SCIZER (SC1-M410)

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

    PCRopsis

    FDA UDI
    ENTOPSIS, LLC·B55012301000·PCRopsis™ Reagent 123 (100 mL) mediates extract...

    Calasept®

    FDA UDI
    Directa AB·17310230000054·

    INSERTION GUIDE, EXTENDED HUMERAL NAIL

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665027754·

    RHEAD

    FDA UDI
    Stryker GmbH·00886385023366·Awl

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702826944·ELVAREX 2/CHAP STYLE/SLANT, CLOSED TOE, E-VERSI...

    HiRes™ Auria™ Processor

    FDA UDI
    Advanced Bionics, LLC·07630016805608·Silver Metallic

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702777567·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE/DOTTED 5 CM ...

    MEDFUSION 3500 PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FRN·October 29, 2024

    Abutment Design

    FDA 510(k)
    FDA Class 2 ·Dental

    COMINED STANDARD SOLUTION

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

    ALARIS PUMP MODULE

    FDA Adverse Event
    Injury ·CAREFUSION CORP·Product code FRN·June 4, 2014

    ZENIX

    FDA UDI
    Zoll Medical Corporation·00198843000339·ZENIX, HOSPITAL FULLY LOADED CONFIGURATION

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011

    TYDINGS TONSIL SNARE, 7 3/8", 12 SNARE WIRES, 25 G

    FDA Adverse Event
    Malfunction ·*·Product code KBZ·July 25, 2008

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 16, 2013

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    FDA Enforcement
    Class II ·Ongoing·GE OEC Medical Systems, Inc·December 25, 2024

    GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·March 19, 2025