BEUDAMED
    18 results · 30ms · Sources: EU EUDAMED, US FDA

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    SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033981·Baltic Denture System BDLoad BDLoad ↓ Sm7 PLSEu...

    ECLIPSE

    FDA 510(k)
    FDA Class 2 ·Radiology

    AHL GENERIC GLASS IONOMER LUTING CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code IOR·April 3, 2013

    WEB-BASED DATA MANAGEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·March 18, 2011

    4.0MM OPEN CONNECTOR CLOSURE TOP

    FDA Adverse Event
    Injury ·ABBOTT SPINE·Product code HXX·April 24, 2008

    SMARTNAIL

    FDA Adverse Event
    Injury ·CONMED CORPORATION·Product code MAI·July 29, 2019

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·November 1, 2022

    GLIDESHEATH

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DYB·December 16, 2022

    GLIDESHEATH

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DYB·July 30, 2021

    Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·November 30, 2022

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Panda iRes Infant Radiant Warmer. Device sold under the following product names: Panda iRes Warmer and Panda iRes Bedded Warmer.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 28, 2018

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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

    Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 17, 2019

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024