BEUDAMED
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    IRISTAIN FORMULA 2, PARTS 1 AND 2

    FDA 510(k)
    FDA Class 1 ·Hematology

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978075280·BONE 893-530 16MM DOWEL TREPHINE

    Arthrex®

    FDA UDI
    ARTHREX, INC.·00888867050563·LO-PRO SCRW,TI,3.5MMX 30MM

    Deklene MAXX

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

    HEMOTOLOGY CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Hematology

    DXTEND SCREW LOCK D4.5X30MM

    FDA Adverse Event
    Malfunction ·DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG. # 30038955·Product code KWS·June 25, 2014

    UNIDENTIFIED ASR HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KXA·July 6, 2015

    UNKNOWN DEPUY ASR ACETABULAR CUP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·January 2, 2013

    KREULOCK SCREW, TI, 3.5X30

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code HRS·August 4, 2025

    LOCKING SCREW, TITANIUM 3.5MM X 22MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

    LO-PRO SCRW,TI,3.5MMX 26MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

    LO-PRO SCRW,TI,3.5MMX 38MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

    LO-PRO SCRW,TI,3.5MMX 30MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

    CALCANEAL FRAC PERIMETER PLT,XS,RT

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HRS·April 18, 2019

    LO-PRO SCRW,TI,3.5MMX 24MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

    LO-PRO SCRW,TI,3.5MMX 34MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

    LO-PRO SCRW,TI,3.5MMX 36MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

    LOCKING SCREW, TITANIUM 3.5MM X 28MM

    FDA Adverse Event
    Injury ·ARTHREX, INC.·Product code HWC·April 18, 2019

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Enforcement
    Class II ·Terminated·GE OEC Medical Systems, Inc·August 29, 2012

    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