BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MODIFICATION TO MINISPIR, SPIROLAB III

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PORTABLE INTENSIVE CARE UNIT

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    NICOLET VASOGUARD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PB560 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 22, 2011

    PB560 VENTILATOR X1

    FDA Adverse Event
    Malfunction ·NELLCOR PURITAN BENNETT·Product code CBK·April 20, 2011

    RADIFOCUS OPTITORQUE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

    HI-TORQUE PROGRESS GUIDE WIRE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code DQX·April 29, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·April 28, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP.·Product code MKJ·July 23, 2008

    FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·August 11, 2020

    FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·April 2, 2020

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·September 17, 2018

    FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·January 22, 2020

    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