BEUDAMED
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    ULTRAZYME PLUS GOT, #64953,65033&65034

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268214671·CUSTOM SURGICAL KIT VEIN PACK

    Partial Pelvis Replacement

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575048564·4 hole flanges

    EUROTROL HEMATOCRIT CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    AUTOCON II 400 ELECTROSURGICAL GENERATOR

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

    2.0MM CANNULATED DRILL BIT/QC 150MM

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HWE·August 4, 2015

    CATGUT PLAIN 5 (9) 25M

    FDA Adverse Event
    Malfunction ·B. BRAUN SURGICAL S.A.·Product code GAL·January 14, 2014

    ARTICUL/EZE BALL 28 +5 BR

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 6, 2012

    REALIZE ADJ GASTRIC BAND-C

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL_·Product code LTI·August 31, 2010

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 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