BEUDAMED
    11 results · 27ms · 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.

    EXTENSION LINE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACUMED

    FDA UDI
    Acumed LLC·10806378043529·2.3mm Locking Drill Guide 6-65mm

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127026843·Shortened Dual Taper Broach, Size 22

    BELIMED STEAM STERILIZER, MODEL MST-V 3-3-6

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SAGITTAL SAW ATTACHMENT

    FDA Adverse Event
    Malfunction ·SYNTHES OBERDORF·Product code HWE·May 8, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 22, 2012

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·September 7, 2007

    2.3MM QUICK RELEASE DRILL

    FDA Adverse Event
    Malfunction ·ACUMED, LLC·Product code HTW·March 8, 2022

    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