BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032584·Baltic Denture System BDLoad Lm6 PLSEbil2DFl D2...

    MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ECAT ACCEL PET SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    ABREVA CONCEAL

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KGX·April 1, 2013

    NI

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·March 23, 2011

    COBAS INTEGRA 400

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 21, 2008

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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