BEUDAMED
    14 results · 25ms · Sources: EU EUDAMED, US FDA

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    LESIONPOINT RF CANNULA

    FDA 510(k)
    FDA Class 2 ·Neurology

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm

    ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNTHES ANKLE ARTHRODESIS PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMARTSET GHV GENTAMICIN 40G

    FDA Adverse Event
    Injury ·DEPUY CMW - 9610921·Product code LOD·March 3, 2020

    SMARTSET GHV GENTAMICIN 40G

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code MBB·January 11, 2021

    SMARTSET GHV GENTAMICIN 40G

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code MBB·May 20, 2021

    SMARTSET GHV GENTAMICIN 40G

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code MBB·January 11, 2021

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 11, 2013

    TRILLIUM AFFINITY NT HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Injury ·MEDTRONIC PERFUSION SYSTEMS·Product code DTZ·May 23, 2008

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    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. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014