BEUDAMED
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    Arthrex PushLock

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cancellous Screw, Cannulated

    FDA UDI
    I.T.S. GmbH·09120034308093·Cancellous Screw, Cannulated, D=7,3mm, L=40mm,

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023506·B-P HIP SELF-ALIGNING ACETABULAR CUP & BEARING ...

    3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W

    FDA 510(k)
    FDA Class 2 ·Radiology

    PSS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·May 27, 2021

    TRULIANT TIB IMP CRC INSERT SZ 4, 15MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 30, 2022

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·October 15, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·June 7, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 23, 2011

    TRULIANT TIB IMP PS INSERT SZ 3.5 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 23, 2024

    TRULIANT PS CEM FEM PS CEM LEFT SZ 4

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 19, 2022

    ADVANCED PATELLA 29M 3 PEG IMPLANT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·August 15, 2024

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 4

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 19, 2022

    GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use of the system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·March 25, 2015

    GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·November 19, 2014