BEUDAMED
    602 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 ×

    BIF MK W/DT4 W/SS 84

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code KRA·August 3, 2009

    BIF MK W/DT4 W/SS 84

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code DRS·August 3, 2009

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 20, 2019

    GUT CHROMIC SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAL·April 25, 2019

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·April 25, 2019

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAN·November 15, 2019

    TRIFURCATED MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·January 11, 2012

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·January 19, 2012

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·April 8, 2014

    ALINITY I CYCLOSPORINE REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code MKW·May 27, 2021

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·April 24, 2012

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·June 6, 2012

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·April 30, 2012

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·May 25, 2012

    DIMENSION VISTA® SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code MKW·May 1, 2012

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·April 24, 2012

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·April 30, 2012

    ARCHITECT CYCLOSPORINE

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MKW·April 24, 2012