BEUDAMED
    18 results · 29ms · Sources: EU EUDAMED, US FDA

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    CT BRAIN PERFUSION FOR ZIOSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERFORMAX

    FDA UDI
    Respironics, Inc.·00606959008045·PERFORMAX PEDIATRIC MASK WITH ENTRAINMENT ELBOW...

    Caplugs/Evergreen

    FDA UDI
    CAPlugs·00810044206920·SERA SEPARA 4.25", 9ML

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0380840·T-Handle, Primal, Large, Impact, Quarter Square...

    AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LINOX TD 65/16

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·April 29, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·May 10, 2011

    OXIMAX N-595 PULSE OXIMETER

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY TYCO HEALTHCARE·Product code DQA·July 23, 2008

    LUER-LOK

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 20, 2025

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

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·November 11, 2025

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

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·November 11, 2025

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

    FDA Adverse Event
    Malfunction ·BD SUZHOU (MDS)·Product code FOZ·November 25, 2024

    EMBRYO RPLCMNT CATHETER

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code MQF·September 24, 2019

    ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·July 9, 2014

    Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is also used to insert the OsteoSponge¿ SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.

    FDA Enforcement
    Class II ·Terminated·Bacterin International, Inc.·April 15, 2015

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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