BEUDAMED
    21 results · 22ms · Sources: EU EUDAMED, US FDA

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    Intraosseous Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EarQ

    FDA UDI
    Oticon A/S·05707131352354·G50 S, MINIRITE 312 2.4G C090 EARQ

    16PW - Krispy Kreme FAK - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015064·16PW - Krispy Kreme FAK - Poly White

    SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML

    FDA Adverse Event
    Injury ·IMPLANT DIRECT SYBRON MANUFACT·Product code DZE·February 6, 2025

    SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·Immunology

    LINOX SD 65/16

    FDA Adverse Event
    Injury ·BIOTRONIK GMBH AND CO.·Product code LWS·October 16, 2008

    TRIPOLE 60-CM LENGTH SCS PADDLE LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 4, 2011

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code LKK·July 2, 2013

    REPLACEMENT HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·September 8, 2015

    BD PHOENIX¿ YEAST ID

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JXB·August 15, 2022

    BD PHOENIX¿ YEAST ID

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JXB·March 8, 2022

    RESTYLANE

    FDA Adverse Event
    Injury ·GALDERMA Q-MED·Product code LMH·March 11, 2015

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·October 24, 2015

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·October 24, 2015

    ACTIVA

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MRU·October 24, 2015

    KINAIRMEDSURG

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH INC.·Product code INX·September 30, 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

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024