BEUDAMED
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    PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450297544·

    SPL-50 SPIROLYSER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS

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

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·January 23, 2013

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·January 23, 2013

    X-ALT HIP

    FDA Adverse Event
    ENCORE MEDICAL, L.P.·Product code LPH·March 20, 2013

    UNKNOWN DEPUY ASR HIP

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 24, 2011

    HEARTSTREAM XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 12, 2008

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 21, 2018

    OPTIFLUX 180NRE DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·August 13, 2018

    OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY

    FDA Adverse Event
    Malfunction ·OGDEN MANUFACTURING PLANT·Product code KDI·July 27, 2018

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR - CARDIAC THERAPIES·Product code DQX·January 24, 2011

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·July 10, 2010

    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 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

    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