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    TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr. Catheters The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040044704·Rongeur 5

    RMO

    FDA UDI
    Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST

    Natus

    FDA UDI
    XLTEK·00382830020831·P32-STIM POD 1 (E-H)-10' (CR)

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746103513·BRACKET NARROW TWIN LEFT LATERAL 018 TQ=+14 A=+...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450136850·

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523148806·Straight Implant Trial 25mm x 9mm x 7mm

    MICROPERFORATION INSTRUMENT

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    CAVERMAP SURGICAL AID

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code DQX·July 9, 2009

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code DQX·July 9, 2009

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code DQX·September 4, 2009

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.·Product code DQX·September 4, 2009

    SYNCHRO 14 NEURO GUIDEWIRE

    FDA Adverse Event
    Injury ·NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION·Product code DQX·July 24, 2007

    SYNCHRO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION·Product code DQX·August 18, 2009

    SYNCHRO -10 NEURO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV·Product code DQX·December 15, 2006

    SYNCHRO-14 NEURO GUIDEWIRE

    FDA Adverse Event
    Malfunction ·NEUROVASCULAR , A DIV. OF BOSTON SCIENTIFIC CORP·Product code DQX·December 19, 2006

    SYNCHRO 14 GUIDEWIRE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORP.·Product code DQX·September 20, 2007