BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    CustomizedBone Service

    FDA 510(k)
    FDA Class 2 ·Neurology

    GC INITIAL MC, AL AND LF

    FDA 510(k)
    FDA Class 2 ·Dental

    ASI Plethysmogrpah Analyzer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    TERA HARZ CLEAR

    FDA Adverse Event
    Injury ·GRAPHY INC.·Product code NXC·June 16, 2025

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 10, 2014

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·September 9, 2011

    3MM COARSE DIAMOND BALL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 27, 2024

    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239

    FDA Enforcement
    Class I ·Ongoing·Bard Peripheral Vascular Inc·March 12, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021