BEUDAMED
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    HELENA HEMOGLOBIN DETECT COLUMN SYS

    FDA 510(k)
    FDA Class 2 ·Hematology

    Deltaven Fast Flash

    FDA UDI
    DELTA MED SPA·08032248005365·Safety IV catheter in PUR with closed system, d...

    MODIFICATION TO MAGNETOM RHAPSODY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MEDART 620

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

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORP·Product code DSQ·April 11, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 2, 2012

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code LFL·August 17, 2007

    MECTALIF OBLIQUE (TI PEEK)OBLIQUE INTERBODY FUSION DEVICE PEEK/TI 12X28X13 L10°

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MAX·February 5, 2024

    OPTETRAK LOGIC KNEE COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·February 12, 2025

    THREE PEG PATELLA 32MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 3, 2024

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012