BEUDAMED
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    ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID

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

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319700570·McGlamry Metatarsal Elevator 6-3/8" (16cm), bla...

    JAS AMYLASE LIQUID REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LATERAL OFFSET PROTRACT PRESS FIT HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·April 19, 2013

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC ORTHOPEDIC INC.·Product code KWP·December 4, 2009

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC INC.·Product code KWP·December 4, 2009

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·May 29, 2013

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·April 3, 2013

    DIAGNOST94 - MCP/SCP - DSI

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code JAA·February 15, 2011

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 18, 2014

    TSRH SPINAL SYSTEM

    FDA Adverse Event
    WARSAW ORTHOPEDIC, INC.·Product code KWP·August 26, 2011

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    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