BEUDAMED
    24 results · 23ms · Sources: EU EUDAMED, US FDA

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    Tiche PTA Balloon Dilatation Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NA

    FDA UDI
    Synthes GmbH·10886982152220·5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE...

    QUIK-CHECK HOME PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HEMCON HEMOSTATIC GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    VALLEYLAB

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·April 10, 2025

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·April 21, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 22, 2024

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·August 8, 2014

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code BTS·March 19, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·August 15, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

    BD NANO¿ 2ND GEN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022

    INRATIO2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 11, 2013

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023

    BD NANO¿ 2ND GEN PEN NEEDLE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·August 8, 2014

    UNK - SCREWS: 4.0 MM CANNULATED

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·June 3, 2022

    URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019

    Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/15 OR Table 722059; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024