BEUDAMED
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    CleaniCal

    FDA 510(k)
    FDA Class 2 ·Dental

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446888369·Special, EMPOWR Partial Knee Tib Temp Trial, Sz...

    HHM

    FDA UDI
    Oticon A/S·05707131355065·G500 SC, MINIRITE T 312 2.4G C063 HHM

    SEE H10

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KXA·November 1, 2011

    CEMENTED FEMORAL HEAD RESURFING DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DC-TELL

    FDA 510(k)
    FDA Class 2 ·Dental

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·April 5, 2013

    TENDRIL STS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·January 13, 2014

    ENDEAVOR RESOLUTE RX CORNARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·August 5, 2011

    SMALL HEXAGONAL SCREWDRIVER SHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·July 2, 2013

    INJECTOR LOCKING N40-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 15, 2021

    BD PHASEAL OPTIMA INJECTOR (N40-O)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 14, 2021

    INJECTOR LOCKING N40-O

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 21, 2021

    Pentax Video Colonoscope Model: EC34-i10L

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDF·January 3, 2020

    Pentax Video Colonoscope Model: EC38-i10L

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FDF·January 3, 2020

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDS·June 12, 2014

    Video Cystoscope models ECY-1570 and ECY-1570K

    FDA Recall
    Terminated ·Pentax of America Inc·Product code FAJ·July 13, 2017

    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

    FDA Recall
    Terminated ·Pentax Medical Company·Product code KOG·July 17, 2014

    Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    FDA Recall
    Terminated ·Pentax Medical Company·Product code FDF·April 6, 2016

    Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally when indications consistent with the need for observation are observed.

    FDA Recall
    Terminated ·Pentax of America Inc·Product code EQL·December 12, 2016