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

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    ECLIPSE TREATMENT PLANNING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Preat

    FDA UDI
    Preat Corporation·00842092175620·Preci Post Blue Lab Refill

    Aveta Flex+ Disposable Resecting Device, 2.9 mm

    FDA UDI
    MEDITRINA, INC.·00850006759712·Aveta Flex+ Disposable Resecting Device, 2.9 mm...

    EndoPilot Control Box, Komet

    FDA UDI
    Schlumbohm GmbH & Co. KG·04260482990763·EndoPilot² Control Box, Komet

    Monster Screw System

    FDA UDI
    Paragon 28, Inc.·00889795040565·Over Drill, 2.0 x 110mm, Cannulated, AO

    Paragon 28

    FDA UDI
    Provision·B504OMP9911020110·

    MODIFICATION TO A620 EEG

    FDA 510(k)
    FDA Class 2 ·Neurology

    GLUTARTEST 1 REAGENT STRIP

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

    NEONATAL BUBBLE CPAP DUAL HEATED CIRCUIT KIT

    FDA Adverse Event
    Malfunction ·Product code BZE·March 3, 2021

    BUBBLE CPAP CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·April 19, 2011

    BUBBLE CPAP CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·April 19, 2011

    NORIAN REINFORCED FAST SET PUTTY/3CC

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code GXP·May 19, 2015

    HI TORQUE CONNECT GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BRIVANT, LTD.·Product code DQX·May 3, 2013

    LIFEVEST WCD 3000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 20, 2011

    ARCHITECT I2000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code DHX·August 7, 2008

    rHead Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    BUBBLE CPAP GENERATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·February 16, 2017

    BUBBLE CPAP GENERATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·December 22, 2016

    BUBBLE CPAP GENERATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BZD·February 16, 2017

    ERYTYPE S ABD+REV A1,B

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code QHR·March 3, 2021