BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    FAST HEMOGLOBIN CONTROL-LYOPHILIZED

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO MARSPO2, MODEL 2001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LCS COMP RP INSERT STD 15MM

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM 1219655·Product code NJL·May 8, 2014

    M2A MODULAR HEAD COMPONENT 38MM HEAD DIAMETER PLUS 3MM NECK

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·October 23, 2012

    SIGMA PS CEM FEM SZ2.5 L

    FDA Adverse Event
    Injury ·DEPUY RAYNHAM, A DIV OFDEPUY ORTHOPAEDICS, INC.·Product code JWH·August 10, 2010

    Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021

    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·March 22, 2023