BEUDAMED
    15 results · 21ms · Sources: EU EUDAMED, US FDA

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    Powder Free Nitrile Examination Gloves (Blue)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517569646·CoRoent Ant TLIF Ti, 12x10x28mm 4°

    Contax

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2202840·Contax Bond. Self etching, self conditioning ad...

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613153066675·SCREWDRIVER HANDLE, 1.2MM

    BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 12, 2025

    LIBERTE' MONORAIL CORONARY STENT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code MAF·November 3, 2008

    NEXGEN LPS-FLEX GSF FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·August 16, 2011

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    BD CATHENA¿ SAFETY IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·July 7, 2022

    Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

    FDA Enforcement
    Class III ·Ongoing·Randox Laboratories Ltd.·May 15, 2024

    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·June 30, 2025

    Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model Number: 722058. 10. Allura Xper FD20/15 OR Table, Model Number: 722059.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·August 6, 2025