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

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    ROCHE-CREACTIVE PROTEIN (LATEX)

    FDA 510(k)
    FDA Class 2 ·Immunology

    ASTRALIS 7, MODEL 557545

    FDA 510(k)
    FDA Class 2 ·Dental

    SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OLYMPUS ESG-100, 100...120 V~,

    FDA Adverse Event
    Injury ·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 27, 2022

    UNKNOWN IMPLANTABLE STIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LGW·April 23, 2013

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·May 1, 2011

    VERITY DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·July 11, 2008

    NUVASIVE HELIX ACP SYSTEM

    FDA Adverse Event
    Malfunction ·NUVASIVE, INC.·Product code KWQ·June 1, 2022

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024