BEUDAMED
    11 results · 36ms · Sources: EU EUDAMED, US FDA

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    VITEK 2 YEAST VORICONAZOLE

    FDA 510(k)
    FDA Class 2 ·Microbiology

    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003672·KoKo Standard Pulmonary Function Filter, White ...

    BREAS HA50 HUMIDIFIER, MODEL HA50

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLYFORM SYNTHETIC MESH

    FDA Adverse Event
    Injury ·PROXY BIOMEDICAL LTD.·Product code FTL·April 23, 2013

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 5, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011

    PEDICLE PROBE 2.4MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code HXB·May 14, 2015

    PEDICLE PROBE 2.4MM

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code HXB·May 14, 2015

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015