BEUDAMED
    21 results · 24ms · Sources: EU EUDAMED, US FDA

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    BIOBOLT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASCENT F-COAT MODEL: 006-00097

    FDA 510(k)
    FDA Class 2 ·Dental

    REGENECARE WOUND GEL

    FDA 510(k)
    FDA Unclassified ·Unknown

    FASTTAKE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·December 26, 2001

    OT ULTRAMINI METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·July 29, 2019

    MBT CEM KEEL TIB TRAY SZ3

    FDA Adverse Event
    Injury ·9616671 DEPUY (IRELAND)·Product code NJL·May 20, 2013

    VARIAX DR AIMING BLOCK FIXATION PIN

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG (MDR)·Product code HRS·September 26, 2014

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code MJN·June 10, 2011

    COMP RVS CNTRL SCR 6.5X30MM ST

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 26, 2021

    COMP NON-LCKNG SCREW 4.75X25MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 26, 2021

    VERSA-DIAL/COMP TI STD TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 26, 2021

    COMP PRIMARY STEM 11MM STD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·August 26, 2021

    COMP RVRS SHDR GLEN BSPLT +HA

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 26, 2021

    ARCOM XL 44-36 STD HMRL BRNG

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 26, 2021

    COMP RVRS SHLDR GLNSP STD 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 26, 2021

    COMP LOCKING SCREW 4.75X30MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 26, 2021

    COMP RVS TRAY CO 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 26, 2021

    COMP NON-LCKNG SCREW 4.75X20MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·August 26, 2021

    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

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021