BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    HipXpert 3D Display and Anchoring Application

    FDA 510(k)
    FDA Class 2 ·Neurology

    CUSHING FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896084766·CUSHING FORCEPS TUNGSTEN CARBIDE SERRATED TIP

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457200840·External Hex Universal

    PHOENIX SFS

    FDA UDI
    Orthofix US LLC·18257200080205·60MM OFFET COMPRESSOR/DISTRACTOR TIP

    ON-Q C-BLOC: 600ML, 2-14ML/HR SELECT-A-FLOW

    FDA Adverse Event
    Malfunction ·I-FLOW, LLC·Product code MEB·November 29, 2012

    BD SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·April 10, 2020

    T2 ARTHRODESIS NAIL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BD 5ML SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 15, 2020

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    FDA Adverse Event
    Other ·BECKMAN COULTER, INC.·Product code JJE·October 15, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    INTRAVASCULAR SHUNT

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DWF·July 1, 2013

    O-ARM 1000 IMAGING SYSTEM 3RD EDITION

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OXO·November 20, 2020

    BD 5ML SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 3, 2020

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021