BEUDAMED
    13 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.
    Filters Regulation: Us FDA ×

    MONA LISA ASPIRATION NEEDLE

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

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091032208·Baltic Denture System BDLoad Sw6 PLSEbm6DFs B2pink

    SOAR Retractor System

    FDA UDI
    SPINEOLOGY INC.·M7403032208·22MM X 80MM Tube

    Battalion

    FDA UDI
    ALPHATEC SPINE, INC.·00840967187563·Battalion, LLIF Trial, 6°, 22 mm Wide, 08 mm X ...

    K032008

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code LJT·May 31, 2007

    CEDIA CYCLOSPORINE PLUS ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895

    FDA 510(k)
    FDA Class 2 ·Immunology

    DRILL/BURR ATTACHMENT FOR 2.35MM SHAFTS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·April 3, 2013

    RAPID PORT EZ

    FDA Adverse Event
    Malfunction ·ALLERGAN, INC.·Product code LTI·March 4, 2011

    DEEP BRAIN STIMULATION LEAD KIT

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·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 TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    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