BEUDAMED
    27 results · 22ms · Sources: EU EUDAMED, US FDA

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    LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526780736·LEVAMED ACTIVE ANKLE SUP SLVR L I

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810057370403·STRETCHER PAD 24" W X 3.5" H X 74" L STANDARD

    n/a

    FDA UDI
    Ortho Development Corporation·00822409075485·12/14 Press-Fit Broach 12x21

    PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET

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

    MALE LATEX COMDOM WITH DOTTED SURFACE

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

    GYNECARE GYNEMESH* PS

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTO·April 26, 2013

    IV STAR

    FDA Adverse Event
    Malfunction ·CODAN·Product code FPA·April 29, 2011

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Injury ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·July 23, 2008

    BD PHASEAL OPTIMA INJECTOR (N35-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·August 2, 2019

    BD PHASEAL¿ OPTIMA SYSTEM, INJECTOR, N35-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·August 5, 2019

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016

    DREAMSTATION CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·December 15, 2021

    CONNECTOR C35-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·April 30, 2021

    BD PHASEAL¿ OPTIMA CONNECTOR (C35-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·October 14, 2021

    BD INJECTOR N35-O¿

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·May 28, 2019

    INFUSION ADAPTER C100-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·March 2, 2020

    BD PHASEAL¿ OPTIMA SYSTEM, CONNECTOR, C35-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·August 15, 2019

    BD PHASEAL¿ OPTIMA INJECTOR (N35-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 20, 2019