BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    Boston One Step Liquid Enzymatic Cleaner

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GORNEY SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896098398·GORNEY SCISSORS STRAIGHT BLADE POWER CUT GOLD

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694036382·CalFix, Drill Guide, 3.5mm Screws

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540695208·CANNULA,F. 62-00400,TRAUMA TIP

    uCT 530, uCT 550

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001

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

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·March 26, 2015

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OZO·January 20, 2021

    DA VINCI SI SURGICAL SYSTEM

    FDA Adverse Event
    INTUITIVE SURGICAL,INC.·Product code NAY·August 11, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 24, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 1, 2013

    SCREWDRIVER BLADE FOR FRACTURE SCREWS 2.0 / 2.3 / 2.7MM UNIVERSAL FRACTURE MODUL

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code LXH·April 25, 2014

    GORE-TEX CARDIOVASCULAR PATCH

    FDA Adverse Event
    Death ·W. L. GORE & ASSOCIATES, INC.·Product code DXZ·April 19, 2021

    V60 VENTILATOR

    FDA Adverse Event
    Death ·RESPIRONICS CALIFORNIA, INC·Product code MNT·August 20, 2020

    SWAB ALCOHOL

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code LKB·April 8, 2020

    SERVO I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·October 23, 2004

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014