BEUDAMED
    24 results · 27ms · Sources: EU EUDAMED, US FDA

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    INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INFUSOMAT SPACE

    FDA Adverse Event
    Malfunction ·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0620000·Universal Removal Set

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702395563·Elvarex Forte 3/Knee High/Slant-Open Toe-Elepha...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702417920·Elvarex 3/Knee High/Slant-Closed Toe-Elephantia...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702450217·E2/AD/OT/NOP5-T-ZI/BLU

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702479652·Elvarex 1/Thigh High/Open Toe/Dotted 5 cm silic...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702246162·Elvarex 2/Thigh High/Closed Toe-Elephantiasis-V...

    VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KSEA UNIMAT 12

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

    ARCHITECT TOTAL B-HCG REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code DHA·November 6, 2023

    WALLFLEX DUODENAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 17, 2013

    4.0MM TI QUICK LOCK CANCELLOUS SCREW

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWQ·April 12, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·June 18, 2008

    Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24

    FDA Enforcement
    Class II ·Ongoing·ICU Medical Inc.·September 10, 2025

    B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 100-48, 100 ml x 2 ml/hr Used to provide an optional filling device for the Easypump.

    FDA Recall
    Terminated ·I-Flow Corporation·Product code FMF·August 1, 2008

    B. Braun Blistered Omnifix L.L. Syringe packaged in the Easypump LT 60-24, 60 ml x 2 ml/hr

    FDA Recall
    Terminated ·I-Flow Corporation·Product code FMF·August 1, 2008

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    FDA Recall
    Terminated ·I-Flow LLC·Product code BSO·June 1, 2012

    I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.

    FDA Recall
    Terminated ·I-Flow LLC·Product code BSO·June 1, 2012