BEUDAMED
    8 results · 18ms · 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 ×

    AXSYM TOXO IGG ANTIBODY ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MODEL 5866-37M LEAD ADAPTOR KIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFIED AM-SERIES DIALYZERS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·February 11, 2013

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·July 18, 2014

    SYNCHRON CX5 DELTA

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·January 10, 2011

    VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

    VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H, 145DX16H, 145DX18H, 145DX20H, 150DX16H, 150DX18H, 150DX20H

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017