BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    LIFECARE REMOTE ALARM #34-001

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981144555·Modular Trial 16x14x12mm, 10 Deg Lordosis, w/ D...

    DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S

    FDA 510(k)
    FDA Unclassified ·Unknown

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    ENSEAL 5MM ROUND TIP 35CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·October 8, 2010

    ACCU-CHEK ® COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 7, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012