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

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    Single-Use Flexible Ureteroscope

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

    Calasept®

    FDA UDI
    Directa AB·17310230000078·

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120656·Guidewire 2.0x230mm Drill Tip

    HiRes™ Auria™ Processor

    FDA UDI
    Advanced Bionics, LLC·07630016805585·Dark Sienna Metallic

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702777505·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE/DOTTED SILIC...

    IDODENTINE

    FDA UDI
    UNION DENTAL SA·08435288443591·IDODENTINE DISC DARK PINK V3 98,5/30mm

    PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    2.5 3-FLTD DRILL BIT QC/230/200 CALIB

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·August 25, 2025

    CUSTOM PAK

    FDA Adverse Event
    Injury ·ALCON - HOUSTON·Product code KYG·November 13, 2008

    UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM.

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code MMI·September 1, 2011

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code LPB·July 16, 2013

    2.5 3-FLTD DRILL BIT QC/230/200 CALIB

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTW·August 4, 2022

    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

    ANN PH NAIL RT 9X160MM

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code HSB·September 29, 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

    2.5 3-FLTD DRILL BIT QC/230/200 CALIB

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·March 1, 2023

    M2A-MAGNUM MOD HD SZ 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·December 14, 2017

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·December 14, 2017

    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