BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 13, 2013

    HUDSON HEATED-WIRE VENTILATOR CIRCUIT

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BZO·February 23, 2011

    CONTAK RENEWAL 4

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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