BEUDAMED
    21 results · 23ms · Sources: EU EUDAMED, US FDA

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    Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Intraoral Scan Body NP

    FDA UDI
    RP - CONEXOES RESTAURADORAS LTDA·07901059074963·

    TMC SpeedTMT

    FDA UDI
    Treace Medical Concepts, Inc.·00810111225373·Inserter Rod

    GORNEY SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896055049·GORNEY SCISSORS STRAIGHT DOUBLE BEVELED BLADE P...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540695185·UNIV. CHEEK RETRACTOR,WITH LIGHT SOURCE

    SCREWDRIVER BLADE FOR FRACTURE SCREWS 2.0 / 2.3 / 2.7MM UNIVERSAL FRACTURE MODUL

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code LXH·April 25, 2014

    RADIOLUCENT INSRT H&LE FOR EXPERT NL/100

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·October 1, 2021

    QUANTA LITE CCP ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    MEDISUL DISPOSABLE VAGINAL SPECULUM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BONE SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE)

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code JEY·January 30, 2017

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·August 11, 2011

    ANCURE ENDOGRAFT

    FDA Adverse Event
    GUIDANT ENDOVASCULAR SOLUTIONS·Product code MIH·September 26, 2008

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code LXH·January 31, 2017

    VERSACROSS CONNECT LAAC ACCESS SOLUTION

    FDA Adverse Event
    Injury ·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023

    Kit BD Max CT/GC/TV; Catalog # 442970

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) Sterile Rx Only Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247 <eilkendorf Germany Distributed by Integra NeuroSciences 311 Enterprise Drive Plainsboro, NJ 08536, USA

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·December 24, 2014

    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022