BEUDAMED
    10 results · 20ms · 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 ×

    GRANDIO FLOW

    FDA 510(k)
    FDA Class 2 ·Dental

    ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PROPHYPEARLS

    FDA 510(k)
    FDA Class 1 ·Dental

    DRILL GUIDE WITH GRADUATION FOR 2.4MM DRILL BIT

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code FZX·April 10, 2013

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 2, 2014

    NEONATAL PICC

    FDA Adverse Event
    Malfunction ·ARGON MEDICAL DEVICES·Product code LJS·April 4, 2011

    PHENOM CATHETER

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code QJP·October 15, 2025

    cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018