BEUDAMED
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    HEMATOXYLIN II

    FDA 510(k)
    FDA Class 1 ·Hematology

    STRADIS

    FDA UDI
    STRADIS MEDICAL, LLC·M75268215401·CUSTOM SURGICAL KIT ENDOVENOUS PACK

    Synexis Sphere Rx

    FDA 510(k)
    FDA Class 2 ·General Hospital

    RUSCH EDGAR TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ALARIS PUMP MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORP.·Product code FPA·January 15, 2014

    UNKNOWN RIGHT REJUVENATE/AGBII HIP

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·October 24, 2012

    PORTEX TRACHEOSTOMY TUBE

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL INTERNATIONAL LTD·Product code BTO·June 1, 2015

    ARCOM XL 44-36 RTNV+3 HMRL BRG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·October 10, 2017

    COMP RVRS SHLDR GLNSP STD 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·October 12, 2017

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    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