BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    JAZZY FRONTIE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·January 5, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·January 5, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T (EUA)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·January 5, 2023

    MINITUB MULTI-PURPOSE CASSETTES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 3, 2013

    ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL·Product code OLO·September 4, 2014

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 5, 2011

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 22, 2010

    EQUINOXE COMPRESSION SCREW

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·July 29, 2024

    SUP/POST AUG PLATE, R RS GLENOID BASEPLATE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·May 7, 2024

    Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.

    FDA Enforcement
    Class II ·Ongoing·Stryker Howmedica Osteonics Corp.·August 1, 2012

    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