BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    INTRALASE FS LASER

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

    WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)

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

    COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TORNIER AEQUALIS REVERSE SHOLDER PROSTHESIS

    FDA Adverse Event
    Malfunction ·TORNIER INC.·Product code HSD·June 18, 2009

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·February 12, 2013

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code GAW·September 23, 2009

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Injury ·SURGICAL SPECIALITIES CORP·Product code GAW·February 25, 2014

    CONTOUR THREAD OR CONTOUR THREADS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP (DBA ANGIOTECH)·Product code GAW·October 22, 2009

    2520274-2013-11062

    FDA Adverse Event
    Malfunction ·SYNTHES USA·Product code OVE·April 8, 2013

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - BROOKFIELD·Product code JFP·April 6, 2011

    LD CV EZTRK 2 BP IS1 4542 80CM US

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008

    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

    Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

    FDA Enforcement
    Class II ·Ongoing·Draegar Medical Systems, Inc.·May 4, 2022