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

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    PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    K012364

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·February 3, 2015

    AML HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROTEMP H

    FDA 510(k)
    FDA Class 2 ·Dental

    SEE H10 NARRATIVE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·September 11, 2017

    UNKNOWN LINER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·April 19, 2013

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWP·July 10, 2008

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·April 29, 2011

    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