BEUDAMED
    13 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    BLOOD HAND PUMP ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756002240·Wrist Splint

    PULSE

    FDA UDI
    Nuvasive, Inc.·00887517973894·Pulse Driver, Pin

    100° Adolescent Osteotomy Plate 50mm/10mm

    FDA UDI
    mahe medical gmbh·EMAH00501152356010·

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867317130·LOW PROFILE CORTICAL SCW, TI, 5.0x115MM

    REFLEX ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RETIC CHEX LINEARITY

    FDA 510(k)
    FDA Class 2 ·Hematology

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 10, 2013

    MCGHAN

    FDA Adverse Event
    Injury ·Product code FWM·May 20, 2008

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 1, 2011

    2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·February 28, 2023

    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

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020