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

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    UNIDRIVE SIII System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ZESPIN SI Joint Fusion System

    FDA UDI
    Aegis Spine, Inc.·00840273321590·Locking Screw Ø8x55mm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694021333·FPS 3.5mm x 20mm Locking Screw

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·34546540355936·Locking Screws, Cross-Pin

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694075701·FPS 3.5 x 20mm Locking Screw Sterile Qty 2

    MAMMOMAT INSPIRATION PRIME

    FDA 510(k)
    FDA Class 2 ·Radiology

    Blustone Synergy Interbody Fusion System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·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