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

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    REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Premier K-FILES

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6919053299·FILES PKG 6 31MM 45

    ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPD-SCAN, MODELS ARK-10000 AND ARK-9000

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    RAD-8

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·February 4, 2016

    INSIGNIA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 11, 2013

    SYNVISC (HYLAN G-F20) INJECTION

    FDA Adverse Event
    Other ·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·May 28, 2008

    CRYSTALLINE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 27, 2011

    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    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