BEUDAMED
    12 results · 26ms · Sources: EU EUDAMED, US FDA

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    HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.

    FDA 510(k)
    FDA Class 2 ·Hematology

    Rampart-O

    FDA UDI
    SPINEOLOGY INC.·M7402803016·Rampart-O

    Rampart-O

    FDA UDI
    SPINEOLOGY INC.·M7403803016·Asm, Rampart-O

    PRO-FEMUR R

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTHYDERM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    XENFORM

    FDA Adverse Event
    Other ·TEI BIOSCIENCES INC.·Product code FTM·June 28, 2013

    DUAL-LUMEN HICKMAN CATHETER

    FDA Adverse Event
    Injury ·BARD ACCESS SYSTEMS, INC·Product code LJS·May 5, 2014

    SYSTEM 5 SAGITTAL SAW

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·October 17, 2012

    ETHICON ENDO SURGERY

    FDA Adverse Event
    Malfunction ·ETHICON ENDOSURGERY, INC.·Product code LFL·August 11, 2010

    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Enforcement
    Class II ·Ongoing·Osteomed, LLC·December 15, 2021

    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

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018