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

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    OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CALLOS BONE VOID FILLER, SKAFFOLD NEXT GENERATION BONE VOID FILLER, OSTEO VATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LUNAPADS

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 8, 2025

    GREENLIGHT XPS MOXY FIBER OPTIC

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS·Product code GEX·May 9, 2013

    9617604-2008-00097

    FDA Adverse Event
    Injury ·Product code BSY·August 4, 2008

    SERVO-S

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·April 29, 2011

    BD INTIMA-II 22GAX1.00IN PRN SLM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·December 8, 2023

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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