BEUDAMED
    13 results · 23ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO FOSSA URETERAL STONE SWEEPER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0316920·Probe, 1.75" Egg, Steffee, Long, Straight, Impact

    ZIEHM VISION

    FDA 510(k)
    FDA Class 2 ·Radiology

    GROMAN PREPMASTER

    FDA 510(k)
    FDA Class 2 ·Dental

    TITAN

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FHW·June 3, 2022

    ULTRASONIC DISSECTOR QTY OF 6

    FDA Adverse Event
    Malfunction ·COVIDIEN LP·Product code LFL·March 5, 2013

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·March 28, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Death ·RICE CREEK MANUFACTURING·Product code LKK·April 18, 2008

    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 TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013