BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Dental

    GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H)

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·June 12, 2023

    IMPLANT, ENDOSSEOUS, ROOT-FORM

    FDA Adverse Event
    Injury ·J DENTAL CARE SRL·Product code DZE·August 28, 2025

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 25, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    6000CMS

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 16, 2013

    VERSYS FEMORAL HEAD

    FDA Adverse Event
    Injury ·ZIMMER, TURPEAUX INDUSTRIAL PARK·Product code JDI·March 31, 2016

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025