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

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    POWERHOHN AND POWERLINE CATHETERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PULSE

    FDA UDI
    Nuvasive, Inc.·00195377049186·PULSE Confirmation Block

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117551·Distal Reamer (Hudson)

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690127857·Distal Reamer (Hudson)

    6.0 X 5.7MM DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)

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

    CONSULT DIAGNOSTICS HCG CASSETTE

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code JHI·April 4, 2013

    ARCHITECT ANTI-HBS

    FDA Adverse Event
    Other ·ABBOTT LABORATORIES·Product code LOM·May 22, 2008

    VITALITY

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 23, 2013

    Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.

    FDA Enforcement
    Class II ·Terminated·Veridex, LLC·March 19, 2014

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024