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

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    AGILIS NXT STEERABLE INTRODUCER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PERFORMAX

    FDA UDI
    Respironics, Inc.·00606959008038·PERFORMAX PEDIATRIC MASK WITH ENTRAINMENT ELBOW...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0380830·T-Handle, Ratcheting, Quarter Square Collar

    CARTO XP EP NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·September 3, 2018

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·April 29, 2013

    DUROM US ACETABULAR COMPONENT 48/42 H

    FDA Adverse Event
    Other ·ZIMMER GMBH·Product code KWA·April 28, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·July 23, 2008

    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

    1000317571-2021-00127

    FDA Adverse Event
    Injury ·CONVATEC LTD·Product code FRO·March 17, 2021

    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