BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    EMERGENCY DEPARTMENT LACERATION KIT-

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)

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

    NOVAKONE SPHERICAL AND TORIC LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TERUMO TCM II COOLING AND HEATING SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DWC·October 19, 2012

    HOMECHOICE PRO

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2014

    TEGADERM CHG DRESSING

    FDA Adverse Event
    Injury ·3M HEALTHCARE·Product code FRO·August 10, 2010

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024