BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450221587·

    OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS-

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VKMO 78000 3 QUADROX-I HMO 70000+VHK7000

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

    VKMO 78000 #QUADROX-I HMO 70000+VHK7000

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·February 25, 2015

    COPPERHEAD CERVICAL INTERBODY CAGE

    FDA Adverse Event
    Injury ·EMINENT SPINE·Product code ODP·January 8, 2016

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, INC·Product code HSX·March 22, 2013

    TGS UKA KNEE SYSTEM

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·May 6, 2013

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·CAYENNE MEDICAL, INC·Product code HSX·February 12, 2014

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·CAYENNE MEDICAL, INC.·Product code HSX·September 25, 2014

    TGS UKA SYSTEM

    FDA Adverse Event
    Injury ·CAYENNE MEDICAL INC.·Product code HSX·May 15, 2014

    TGS UKA KNEE SYSTEM

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·September 10, 2013

    TGS UKA KNEE SYSTEM

    FDA Adverse Event
    Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, LLC·Product code HSX·August 14, 2013

    HLM TUBING SET W/SOFTLINE COATING

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWF·April 6, 2016

    FLO-THRU INTRALUMINAL SHUNT

    FDA Adverse Event
    Malfunction ·SYNOVIS SURGICAL INNOVATIONS·Product code DXC·May 2, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 18, 2014

    IMPLANTIUM

    FDA Adverse Event
    Injury ·DENTIUM USA·Product code DZE·May 4, 2011

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    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