BEUDAMED
    10 results · 27ms · Sources: EU EUDAMED, US FDA

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    DISPOSABLE PATIENT CABLE MODEL 5807

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KORONA

    FDA UDI
    HNM TOTAL RECON LLC·00841742100654·KORONA Quad Staple - (L)15mm, 14mmx12mm

    GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BEHRING COAGULATION TIMER ANALYZER (BCT)

    FDA 510(k)
    FDA Class 2 ·Hematology

    TILOCK PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Injury ·GENESYS SPINE·Product code NKB·December 12, 2013

    PENUMBRA SYSTEM SEPARATOR 054

    FDA Adverse Event
    Death ·PENUMBRA, INC.·Product code NRY·May 8, 2014

    TRILOGY O2

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·October 17, 2012

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC., USA·Product code LFR·September 21, 2007

    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

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015