BEUDAMED
    9 results · 23ms · 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 ×

    IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MEGA PLUS MIS SPINE SYSTEM

    FDA UDI
    BK MEDITECH CO.,LTD.·08809665583291·MIS Cannulated Screw, Ø5.0 x 35mm, Ø6.0mm Rod

    Monkey Rings™ External Fixation System

    FDA UDI
    Paragon 28, Inc.·00889795115188·Schanze Screw, Blunt, Ø5.0mm X 35mm, 160mm SHAN...

    RECORD KEEPING/DATA MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AXOSTIM NERVE STIMULATOR, MODIFICATION

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

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·February 15, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEATHCARE CORPORATION·Product code FKX·July 29, 2014

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021