BEUDAMED
    498 results · 33ms · Sources: EU EUDAMED, US FDA

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    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·ASPIRE CRISTALLE DIGITAL BREAST TOMOSYNTHESIS OPTION

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·Aspire Cristalle Digital Breast Tomosynthesis Option

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·ASPIRE Cristalle Breast Tomosynthesis System

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code OTE·June 11, 2025

    ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

    FDA Enforcement
    Class II ·Ongoing·FUJIFILM Healthcare Americas Corporation·August 6, 2025

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707017073·CALIBRA 1ST MOLAR BANDS n.LR 31

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694035736·Cannulated Tap for 7.3mm Screws

    PRECICHEK AutoCode foil packed test strip

    FDA UDI
    HMD BIOMEDICAL INC.·04260236850329·PRECICHEK AutoCode Blood Glucose ACH foil packe...

    Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Qualitative And Quantitative Hepatitis B Virus Antibody Assays

    FDA Pre-Market Approval
    FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBC EIA

    Qualitative And Quantitative Hepatitis B Virus Antibody Assays

    FDA Pre-Market Approval
    FDA Class 2 ·ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·November 3, 2025

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·August 14, 2024

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·August 14, 2024

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2024

    AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·April 27, 2026

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·December 10, 2024

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·April 28, 2025