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

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    DENTAL IMPRESSION MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    CODMAN® ACCU-FLO®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780536765·CODMAN® ACCU-FLO® Dotted Ventricular Catheter 15cm

    CODMAN® ACCU-FLO®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780517443·CODMAN® ACCU-FLO® Dotted Ventricular Catheter 15cm

    CODMAN ACCU-FLO

    FDA UDI
    Cerenovus, Inc.·10886704040255·CODMAN ACCU-FLO Dotted Ventricular Catheter 15cm

    PROFEMUR Z REVISION HIP STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    O&P CRANICAL MOLDING HELMET

    FDA 510(k)
    FDA Class 2 ·Neurology

    E SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·April 28, 2014

    TI LOW PROFILE SCREW 6.5X40MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·November 6, 2012

    CV DRAPING PACK A & B

    FDA Adverse Event
    Other ·MEDLINE INDUSTRIES, INC.·Product code KKX·August 26, 2010

    EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.

    FDA Enforcement
    Class II ·Terminated·Dako North America Inc.·November 11, 2015

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026