BEUDAMED
    16 results · 28ms · Sources: EU EUDAMED, US FDA

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    HOMECHECK MULTIPLE DRUG CUP TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Key Surgical K-Wires and Steinmann Pins

    FDA UDI
    KEY SURGICAL, INC.·00849771013082·Steinmann Pins, Single trocar, 3 shank end, 1/8...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293517·

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049682·Steinmann Pins, Single trocar, 3 shank end, 1/8...

    HARDYDISK CEFOPERAZONE, 75 MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SUMMIT DUOFIX HIP PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 12, 2023

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTEC)·Product code NEW·November 14, 2008

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009

    ENDOLOOP* LIGATURE

    FDA Adverse Event
    Malfunction ·ETHICON, INC·Product code GAN·April 22, 2013

    ASR UNI FEMORAL IMPL SIZE 53

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011

    CONTOUR TEST STRIPS (50)

    FDA Adverse Event
    Malfunction ·BAYER HEALTHCARE LLC·Product code NBW·July 2, 2008

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·March 12, 2009

    SUMMIT DUOFIX TAP SZ5 HI OFF

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 12, 2015

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·October 31, 2008

    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