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

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    MariGen Wound Extra

    FDA 510(k)
    FDA Unclassified ·Unknown

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613017880·K-Wire, Double Ended, Trocar Point, Diameter Si...

    BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT

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

    ARTICULEZE M HEAD 36MM +5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·July 11, 2013

    AML SM STATURE 12.0MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·July 11, 2013

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 11, 2013

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·November 25, 2013

    S-ROM M HEAD 36MM +0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·November 25, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 2, 2008

    PT²?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·June 26, 2013

    NIM-SPINE MAINFRAME

    FDA Adverse Event
    Injury ·XOMED MFG JACKSONVILLE·Product code GWF·August 4, 2011

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·September 24, 2019

    AEQUALIS STEM FOR FRACTURE D.6.5 HA-COATED

    FDA Adverse Event
    Injury ·TORNIER S.A.S.·Product code KWS·January 5, 2026

    TrueBeam Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Recall
    Terminated ·Vision RT Ltd Dove House, Arcadia Avenue London United Kingdom·Product code IYE·June 30, 2016

    TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

    FDA Enforcement
    Class II ·Terminated·Vision RT Ltd·August 31, 2016

    Merge PACS versions 7.3, 7.3.1, 8.0 and 8.0.1

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 31, 2019

    Merge OrthoPACS versions 7.3, 7.3.1, 8.0 and 8.0.1

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 31, 2019

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020