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

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    Flex Body Speeder

    FDA 510(k)
    FDA Class 2 ·Radiology

    MDI DS-DNA TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    BioMin Restore Plus

    FDA 510(k)
    FDA Class 2 ·Dental

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 24, 2014

    COLLEAGUE PRE-P1.7

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

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code IOR·July 1, 2013

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    FDA Adverse Event
    Injury ·LIVANOVA CANADA CORP.·Product code LWR·December 8, 2017

    SOLO SMART STENTLESS HEART VALVE

    FDA Adverse Event
    Injury ·LIVANOVA CANADA CORP.·Product code LWR·December 8, 2017

    PERCEVAL S HEART VALVE

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA S.R.L.·Product code LWR·December 8, 2017

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA S.R.L.·Product code LWR·December 8, 2017

    PERCEVAL SUTURELESS AORTIC HEART VALVE

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA S.R.L.·Product code LWR·December 8, 2017

    MITROFLOW DLA

    FDA Adverse Event
    Malfunction ·LIVANOVA CANADA CORP.·Product code LWR·December 8, 2017

    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