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

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    TubeClear System

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

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00142006460·CC-526

    10PW - MARC - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588096469·10PW - MARC - Poly White

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540685032·MESH PRE-FORMED F. 1.7/1.9MM SCREWS

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68120064600000·Locking Collar Starter

    REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162

    FDA 510(k)
    FDA Class 2 ·Dental

    DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE

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

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    TAPER SLEEVE ADAPTER 12/14 +8

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·July 1, 2013

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·December 22, 2016

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·May 20, 2013

    LEAD MODEL UNKNOWN

    FDA Adverse Event
    Injury ·CYBERONICS·Product code LYJ·May 20, 2013

    PULSE GEN MODEL UNK

    FDA Adverse Event
    Malfunction ·CYBERONICS·Product code LYJ·May 20, 2013

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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