BEUDAMED
    4 results · 24ms · 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.
    Filters Regulation: Us FDA ×

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·ANTI-HBC IGM

    IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions Diagnostics·April 9, 2014

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·SPHINCTER 800 URINARY CONTROL SYSTEM

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE