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

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    MODIFICATION TO: CERCON BASE

    FDA 510(k)
    FDA Class 2 ·Dental

    CARESIDE HEMOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    OIL FOR TISSUE CULTURE

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NANOTITE TM CERTAIN PREVAIL IMPLANT 4/5/4 X 15MM

    FDA Adverse Event
    Injury ·BIOMET 3I·Product code DZE·December 4, 2023

    ADAPTA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·April 10, 2013

    6.0MM TI CURVED SOFT ROD 80MM

    FDA Adverse Event
    SYNTHES MONUMENT·Product code NKB·March 31, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code LKK·May 21, 2008

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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