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

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    ANATOMIC PEEK CERVICAL FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ArgenZ ST 98x16 ML OM3B

    FDA UDI
    ARGEN CORPORATION, THE·D818130177·Dental porcelain/ceramic restoration kit

    EVONOS

    FDA UDI
    Gyrus ACMI, LLC·00821925013551·ANTOLI-CANDELA BLUNT PROBE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450232262·

    ORLON NONABSORABLE SURGICAL SUTURE USP

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

    HELENA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERPACK

    FDA Adverse Event
    Malfunction ·ICC-NEXERGY·Product code IYN·September 3, 2013

    DORMA 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 16, 2022

    BD PHASEAL PROTECTOR P50J

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

    PROFEMUR(R) MODULAR FEMORAL NECK

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·May 24, 2013

    12/14 ARTICUL 44MM M SPEC+5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWY·September 30, 2014

    REVEAL XT

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DSI·June 16, 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