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

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    MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI

    FDA 510(k)
    FDA Class 2 ·Neurology

    SPINAL CORD AND IMMOBILIZATION TRACTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INFINION ENHANCEMENT PACKAGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    CADD MEDICATION CASSETTE

    FDA Adverse Event
    Malfunction ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code FPA·June 16, 2025

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 8, 2013

    DUROM US ACETABULAR COMPONENT 56/50 P

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 25, 2011

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code GEI·May 9, 2008

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

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

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

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018