BEUDAMED
    21 results · 25ms · Sources: EU EUDAMED, US FDA

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    Taperloc® Complete Hip Stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LCP

    FDA UDI
    Synthes GmbH·10886982141224·1.8MM LCP BUTTRESS PIN 24MM

    K-Wire Sleeve

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222754·K-Wire Sleeve

    MICRO FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896060449·MICRO FORCEPS WITH PLATFORM CURVED TUNGSTEN CAR...

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776165468·DEAVER RETRACTOR

    Initia Total Hip System

    FDA UDI
    KYOCERA CORPORATION·04547898307942·MXHO LINER 40-72/74

    MeDiCa

    FDA UDI
    SCIMEDX CORPORATION·00813545026936·A-nDNA-A Crithidia luciliae 96 Test Kit

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780024811·Integra® Jarit® Deaver Retractor, 6-3/4", Doubl...

    FREESTYLE

    FDA Adverse Event
    Injury ·THERASENSE, INC.·Product code LFR·July 31, 2003

    MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316

    FDA 510(k)
    FDA Class 2 ·Immunology

    FREESTYLE LIBRE 2 PLUS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC·Product code QBJ·May 20, 2026

    CPR-D PADZ

    FDA Adverse Event
    Death ·BIO-DETEK INCORPORATED·Product code MKJ·January 17, 2025

    LIFECARE PCA PLUS INFUSER

    FDA Adverse Event
    Other ·HOSPIRA, INC.·Product code MEA·October 6, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 1, 2013

    SMR SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code MBF·December 7, 2023

    SMR SHOULDER

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·March 3, 2025

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    dS Breast 7ch 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 4, 2024