BEUDAMED
    17 results · 38ms · Sources: EU EUDAMED, US FDA

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    ALLOCRAFT DBM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARFIL DC CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    ASCENT XXL OPEN BOX FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 6, 2021

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·July 17, 2024

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·May 7, 2020

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 11, 2013

    GUIDANT 4.5MM HEARTSTRING PROXIMAL SEAL

    FDA Adverse Event
    Malfunction ·GUIDANT CARDIAC SURGERY·Product code DXC·May 23, 2008

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTL. LTD.·Product code KWA·April 7, 2011

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FMI·September 20, 2023

    VERTEX RECONSTRUCTION SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·February 17, 2021

    BD NTIMA-II Y 24GAX0.75IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·October 9, 2023

    HEARTMATE 3 SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·March 14, 2022

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·March 14, 2022

    Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    FilmArray BCID Panel, IVD, Rx Only, BioFire Diagnostics, REF: RFIT-ASY-0126, and RFIT-ASY-0127, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/410851; BACT/ALERT FN Plus/410852; BACT/ALERT PF Plus/410853

    FDA Enforcement
    Class II ·Terminated·BioFire Diagnostics, LLC·April 24, 2019

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012