BEUDAMED
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    CHITOGAUZE

    FDA 510(k)
    FDA Unclassified ·Unknown

    EYEVAN7285

    FDA UDI
    EYEVAN INC.·04582669061210·

    EYEVAN7285

    FDA UDI
    EYEVAN INC.·04582669061203·

    EYEVAN7285

    FDA UDI
    EYEVAN INC.·04582669061234·

    EYEVAN7285

    FDA UDI
    EYEVAN INC.·04582669061227·

    CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE

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

    OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·March 8, 2013

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 12, 2012

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code OAD·May 9, 2013

    V-LOC 180 ABS CLOS DEVICE 3-0 GR 6 V-20

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY US·Product code GAM·September 16, 2014

    AXSYM PLUS ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·May 25, 2011

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·March 14, 2013

    SUPRA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 20, 2012

    SUPERA VERITAS BILIARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·IDEV TECHNOLOGIES, INC.·Product code FGE·December 28, 2012

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code OVE·June 5, 2015

    Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·February 26, 2014

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021