BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    6PW - CPRotector® ONE Deluxe - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030012·6PW - CPRotector® ONE Deluxe - Poly White

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193113517·HA PEEK EVOS Straight, ,8mmx9mmx 22mm , FLAT 0...

    6PW - CPRotector® TWO Economy - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030005·6PW - CPRotector® TWO Economy - Poly White

    UNIVERSAL SYSTEM, MODEL QV-800

    FDA 510(k)
    FDA Class 2 ·Radiology

    INZONE DETACHMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ARCHITECT C16000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 22, 2022

    ARCHITECT C16000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·October 2, 2019

    CENTRAX DURATION 22.2MM X 52MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·October 17, 2008

    SCREW-IN

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·July 2, 2013

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    FDA Adverse Event
    Death ·AVANOS MEDICAL INC.·Product code KNT·September 27, 2019

    ARCHITECT C16000

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code JJE·April 11, 2023

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    CORTRAK 2 ENTERAL ACCESS SYSTEM

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KNT·September 19, 2019

    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code HSX·March 21, 2023

    LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08

    FDA Enforcement
    Class II ·Ongoing·Linkbio Corp.·May 10, 2023

    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

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024