BEUDAMED
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    HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VISION 9000 PHASED ARRAY TORSO COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    QUATTRODE LEAD WIDE SPACED, 30 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 8, 2015

    FAST1 INTRAOSSEOUS INFUSION SYSTEM

    FDA Adverse Event
    Other ·PYNG MEDICAL CORP.·Product code FMI·June 10, 2009

    J-VAC BULB RESERVOIR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code KOG·April 23, 2013

    ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY

    FDA Adverse Event
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code LFX·April 29, 2011

    CAPSURE SP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

    BD¿ SYRINGE WITH NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·May 22, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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