BEUDAMED
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    MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CoverLoc

    FDA UDI
    TORNIER, INC.·00846832070190·DEPTH GAUGE

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040043622·Plastic Filling Instrument DE

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964001046·The ENDO CARRY-ON Procedure Kit contains all of...

    PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COOPERSURGICAL

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code ITX·May 29, 2026

    TUFF TT IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·November 11, 2024

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM F/IM NAILS-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·September 20, 2013

    4.0MM TI LOCKING SCREW W/T25 STARDRIVE 44MM F/IM NAILS-STER

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·September 20, 2013

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·May 18, 2015

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·February 6, 2013

    STAIR PRO - MODEL 6252

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPP·February 18, 2011

    UNKNOWN DEPUY INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HSH·February 18, 2008

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 27, 2015

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILS

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·April 11, 2018

    ORTHO VISION ANALYZER ID-MTS

    FDA Adverse Event
    Injury ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code KSZ·November 18, 2022

    Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

    Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 14, 2018

    EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a touch panel user interface for quick routing of 2K/4K procedural video to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·July 10, 2024