BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

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    SOLO-CARE PLUS MULTIPURPOSE SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Capstone Control PTC Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169677791·SPACER 5031522 CONTROL PTC 24 DEG 15X22

    Capstone Control Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169677890·SPACER 4031522 CONTROL 24 DEG 15X22

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189713·LEVAMED ACTIVE ANKLE SUP BLACK L II

    TRANSQ3

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RESORBABLE BONE PINS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASR UNI FEMORAL IMPL SIZE 46

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·April 2, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·August 22, 2014

    ACTIVA PC

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·March 25, 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

    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