BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    PALAPRESS(R) VARIO RESIN

    FDA 510(k)
    FDA Class 2 ·Dental

    OMEGA

    FDA UDI
    Stryker GmbH·07613154482481·Basic Locking Screw Rack

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471121942·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 125mm

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981142223·Mariner Implant Tray, 10.5 Iliac Screw Caddy

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515227408·Goodhill Ear Fcps, very del, 6mm jaws

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707051723·.022 U6R DBT/NC -10T 5 OFF

    A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ODFS PACE

    FDA 510(k)
    FDA Class 2 ·Neurology

    STEALTHSTATION¿ S8 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·January 28, 2025

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP.·Product code DSQ·May 6, 2014

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 10, 2010

    2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 26MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWC·January 8, 2013

    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