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

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    TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Contax

    FDA UDI
    DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2202830·Contax Activator. Self etching, self conditioni...

    NEXT Fine Spearmint Prophy Paste Box 200

    FDA UDI
    Preventech·D024220283·NEXT Fine Spearmint Prophy Paste Box of 200 2.0...

    BACK-UP MEIER STEERABLE GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    4.0MM THREE-FLUTED DRILL BIT QC/260MM/65MM CALIBRATION

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HTW·March 16, 2021

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

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

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·August 16, 2011

    RIATA ST ACTIVE FIXATION

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

    ALINITY I B12

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION LONGFORD·Product code CDD·July 15, 2020

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

    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