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

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    Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

    FDA 510(k)
    FDA Class 1 ·General Hospital

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00887709042520·Safeset™ 84" Arterial Pressure Tubing, Reservoi...

    Reliance Cervical IBF System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SHASER HRS2 RX HAIR REMOVAL SYSTEM

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    LCS 3PEG MOD ROT PAT CEM STD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code NJL·November 13, 2008

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·August 18, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·July 9, 2013

    SAFESET 84" ARTERIAL PRESSURE TUBING, RESERVOIR, AND 2 NEEDLELESS VALVES

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code KRA·July 29, 2021

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025