BEUDAMED
    13 results · 31ms · Sources: EU EUDAMED, US FDA

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    EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809869903·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND OPEN T...

    K042172

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code FPA·September 2, 2022

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Injury ·ETHICON ENDO SURGERY, INC.·Product code LFL·December 12, 2005

    CTS-485 ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ASCENT XXL CLOSED BOX FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYRINGE 0.5ML 31GA 6MM 10 BAG 500 NLA

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·March 27, 2020

    PROLIFT PELVIC FLOOR REPAIR

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTP·April 9, 2013

    TEMPBOND CLEAR WITH TRICLOSAN

    FDA Adverse Event
    Injury ·KERR COPORATION·Product code EMA·April 6, 2011

    FINELINE II

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 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

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

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

    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