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

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    Procedure mask/Surgical mask/Face mask

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

    Wrist Lacer

    FDA UDI
    MEDICAL SPECIALTIES INCORPORATED·00802357232321·

    SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE

    FDA 510(k)
    FDA Class 1 ·Dental

    SPINEOLOGY SPINOUS PROCESS PLATE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·June 30, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·October 20, 2022

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·October 27, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 16, 2011

    QUICKFLEX XL LV LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 12, 2013

    UNK-CV-SR

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 7, 2024

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 16, 2023

    UNK - SCREWS: LOCKING

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·March 11, 2024

    UNK - SCREWS: LOCKING

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·March 11, 2024

    UNK - PLATES: LCP HOOK PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HRS·March 11, 2024

    UNK - SCREWS: 3.5 MM CORTEX

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·November 21, 2024

    UNK - PLATES: HOOK PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HRS·November 21, 2024

    UNK - CONSTRUCTS: LCP HOOK PLATE/ SCREWS

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·November 21, 2024

    UNK - CONSTRUCTS: LCP HOOK PLATE/ SCREWS

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·March 11, 2024

    UNK - CONSTRUCTS: LCP

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·March 11, 2024

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

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