BEUDAMED
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    KARL STORZ REMORGIDA FORCEPS

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

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471122833·K-WIRE - DOUBLE TROCAR 0.8mm DIA x 75mm

    RII Multi-function Infrared Thermometer, Model TH52Z

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNFIX -LR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·December 5, 2018

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·February 14, 2013

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 17, 2011

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·July 28, 2014

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017