BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Unistik® ShieldLock, Unistik VacuFlip

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STILLE Raspatories

    FDA UDI
    Stille AB·07332339211295·RASPATORY JOSEPH STILLE 4 mm 17 cm 6.75 in

    DURALOC

    FDA UDI
    DEPUY ORTHOPAEDICS, INC.·10603295107118·DURALOC SCREW-IN TRIAL LINER 10 L 32mm ID 54mm OD

    Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SAMARITAN AED, MODEL SAM-01

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 4, 2014

    SYNERGY

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 18, 2011

    CENTRA BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 2, 2013

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026