BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION

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

    DAVID SIMMONDS ANESTHESIA EXTENSION TUBES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER

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

    SYNCRA CRT-P

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code NVZ·February 11, 2013

    ACCU-CHEK MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·January 10, 2011

    EXPEDIUM. 6.5MM POLYAXIAL SCREW

    FDA Adverse Event
    Injury ·DEPUY SYNTHES SPINE·Product code NKB·July 24, 2014

    LARGE EX-FIX 11MM CRBN FBR ROD 250MM / MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    LARGE EX-FIX 11MM CRBN FBR ROD 300MM / MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021