BEUDAMED
    18 results · 27ms · Sources: EU EUDAMED, US FDA

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    ARCHITECT TOTAL BILIRUBIN

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BD PYXIS¿ MEDSTATION¿ ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·May 7, 2026

    BD PYXIS¿ MEDSTATION¿ ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·April 29, 2026

    ArgenZ HT+ 98x10 D2

    FDA UDI
    ARGEN CORPORATION, THE·D818121985·Dental porcelain/ceramic restoration kit

    JAY FUSHION CRYO

    FDA Adverse Event
    Injury ·SUNRISE MEDICAL (US) LLC·Product code KNN·August 28, 2021

    ASAHI GUIDE WIRE EXTENSION 165CM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDX LCS LASER SERIES

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BD PYXIS¿ MEDSTATION¿ ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·September 11, 2025

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·January 8, 2026

    BD PYXIS¿ MEDSTATION¿ ES

    FDA Adverse Event
    Malfunction ·CAREFUSION 303, INC.·Product code BRY·September 18, 2025

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·May 21, 2013

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 13, 2011

    30348 30805 DELUXE JACKSON KIT

    FDA Adverse Event
    Malfunction ·ANATOMIC CONCEPTS·Product code CCX·August 13, 2008

    SCEPTER XC

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code DQY·December 6, 2023

    MODELB 110V ELECTRO DERMATOME COMPLETE KIT

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code GFD·August 21, 2015

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015

    Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·November 24, 2021