BEUDAMED
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    TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PARIETEX COMPOSITE (PCO) MESH

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

    MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE

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

    PARAPAC 'MEDIC' (K020899)

    FDA Adverse Event
    Death ·SMITHS MEDICAL INTERNATIONAL·Product code BTL·August 6, 2004

    ARGON MEDICAL DEVICES

    FDA Adverse Event
    Injury ·ARGON MEDICAL DEVICES·Product code LJS·March 18, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·March 7, 2011

    DELTEC COZMO INSULIN PUMP

    FDA Adverse Event
    Injury ·SMITHS MEDICAL MD, (FORMERLY DELTEC, INC)·Product code LZG·March 21, 2008

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    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