BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    ERISMA-LP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450193518·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450193501·

    CAL-CHEX CD PLUS

    FDA 510(k)
    FDA Class 2 ·Hematology

    ARCOS INTERLOCKING DISTAL STEMS

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 21, 2024

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·March 25, 2022

    ACCU-CHEK ® NANO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·May 20, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014

    POLYSORB 3/0 30 U/D V-20 115Q

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GAM·June 3, 2011

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019