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

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    EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    eMotion Faros ECG Mobile

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEALIGHT IPL

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IMP,TSV,MCOL MG,3.7MM,11.5MML

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·February 17, 2023

    IMP,TSV,MCOL MG,3.7MM,11.5MML

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·October 8, 2024

    IMP,TSV,MCOL MG,3.7MM,11.5MML

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·July 9, 2024

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011

    UNKNOWN DEPUY SROM TROCHANTER WASHER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code HTN·November 21, 2008

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·July 18, 2013

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·December 26, 2024

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 6, 2025

    BELLATEK¿ HYBRID BAR 5 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·February 18, 2025

    BELLATEK HYBRID BAR 5 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·March 18, 2025

    BELLATEK HYBRID BAR 4 IMPLANTS

    FDA Adverse Event
    Malfunction ·BIOMET 3I·Product code NHA·January 6, 2025

    TECNIS SIMPLICITY

    FDA Adverse Event
    Injury ·AMO PUERTO RICO MFG. INC.·Product code HQL·February 7, 2023

    Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15

    FDA Enforcement
    Class II ·Terminated·Hospira Inc.·August 24, 2016