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

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    ApolloVue S100 Image System

    FDA 510(k)
    FDA Class 2 ·Radiology

    EarQ

    FDA UDI
    Oticon A/S·05707131351326·G30 S, BTE PP 13 2.4G 105 C093 EARQ

    Lockheed - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111384349·REILL MICRO NH STR W/RAT 6"

    APPLE ECG (ELECTROCARDIOGRAPH) APP

    FDA Adverse Event
    Injury ·APPLE INC.·Product code QDA·July 5, 2023

    SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML

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

    FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TREPCHEK TREPONEMAL ANTIBODY EIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    EXCELLENCE PS+

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    SETROX 5 53

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

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·June 26, 2013

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·March 26, 2019

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·March 29, 2019

    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 L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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