BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    Zeolite Hemostatic Cotton

    FDA 510(k)
    FDA Unclassified ·Unknown

    GLOBAL

    FDA UDI
    DEPUY (IRELAND)·10603295105336·GLOBAL GLENOID TRIAL SIZER 56mm X-LARGE

    Arthrex SwiveLock Anchor

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 4, 2014

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·July 22, 2011

    1.6MM KIRSCHNER WIRE W/TROCAR POINT 150MM

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code LRN·July 12, 2013

    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

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

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