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

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    SCANNING LASERLINK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ArgenZ ST 98x20 ML B3B

    FDA UDI
    ARGEN CORPORATION, THE·D818130195·Dental porcelain/ceramic restoration kit

    BBP BONE SUBSTITUTES

    FDA 510(k)
    FDA Class 2 ·Dental

    NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X

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

    BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·December 12, 2022

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 8, 2023

    BD PHASEAL PROTECTOR P50J

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·July 7, 2023

    TOTAL ASR FEM IMP SIZE 55

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·May 24, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 18, 2014

    ACRYSOF TORIC

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·June 10, 2011

    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