BEUDAMED
    13 results · 19ms · Sources: EU EUDAMED, US FDA

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    SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED

    FDA 510(k)
    FDA Class 2 ·Hematology

    LoFric®

    FDA UDI
    Wellspect AB·07392532135309·Single Use Urinary Catheter LoFric Nelaton 6" 12FR

    LoFric®

    FDA UDI
    Wellspect AB·07333387038902·Single Use Urinary Catheter LoFric Nelaton 6" 12FR

    SERAGARD INJECTION PATCH

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 8, 2013

    TRAJECTORY GUIDE KIT, BIOPSY, EXTERNAL

    FDA Adverse Event
    Injury ·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 30, 2011

    INDURA CATHETER

    FDA Adverse Event
    Malfunction ·RICE CREEK MANUFACTURING·Product code LKK·May 9, 2008

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·April 10, 2025

    XP-CR Tibial Tray - Interlok 71mm Item # 195273

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 18, 2019

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018