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

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    MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Dental

    AUSAM TOTAL ALBUMIN ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NUMED Z-MED PTV CATHERERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ROUND FILTER POLYPROVPYLENE

    FDA Adverse Event
    Malfunction ·SPS MEDICAL SUPPLY CORP·Product code FRG·June 25, 2013

    INFINITY DENTAL IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·ACE SURGICAL SUPPLY CO.·Product code DZE·May 1, 2013

    8010042-2008-00050

    FDA Adverse Event
    Malfunction ·Product code CBK·April 16, 2008

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·May 12, 2011

    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