BEUDAMED
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    QUEST PET IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG

    FDA 510(k)
    FDA Class 2 ·General Hospital

    12.0MM REAMER HEAD-STERILE FOR REAMER/IRRIGATOR/ASPIRATOR

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·May 17, 2016

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 21, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code NBW·January 30, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 1, 2014

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·March 11, 2016

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·March 11, 2016

    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490

    FDA Recall
    Terminated ·Datascope Corporation·Product code DWE·March 11, 2016

    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·December 16, 2014

    HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport. Due to its system combination of integrated oxygenator and centrifugal pump, the HLS Set Advanced is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTQ·March 5, 2015

    Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The oxygenator with diffusion membrane cannot be used for the administration of volatile anesthetic gases because the gas molecules are unable to pass through the diffusion membrane. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

    FDA Recall
    Terminated ·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·March 5, 2015

    TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

    FDA Recall
    Terminated ·Laax, Inc.·Product code GDW·March 25, 2015

    TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).

    FDA Recall
    Terminated ·Laax, Inc.·Product code GDW·March 25, 2015