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

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    COPRA TEMP PMMA-DISK

    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131256775·NERA PRO, MINIRITE 312 WL STG

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131664·TiBase HIO 3.5 1.0G NE

    ELEMENTS OBTURATION UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    POWDERED VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    RELOAD FOR 60MM ECHELON

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 22, 2021

    BD SAFETYGLIDE¿ NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·September 22, 2022

    PFNA-II Ø9 SM 130° L200 TAN

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HSB·May 29, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·October 1, 2014

    ATTAIN LV

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·LEE LABORATORIES, INC.·Product code MDB·December 12, 2023

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. 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.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015