BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

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    RENAFLO II

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

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377018403·RELINE-C Screw, 3.5x46mm FA PT

    MAXIM ACCEL KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    3M ATTEST(TM) AUTO-READER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PERFORMANCE TOTAL KNEE PROSTHESIS

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code HRY·October 25, 2019

    PERFORMANCE DISTAL FAB LM/RL MED

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016

    PERFORMANCE DISTAL FAB LL/RM MED

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code JWH·October 18, 2016

    VANGRD CR POR/HA FEM - RT 72.5

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 31, 2016

    TINBN VNGRD INT CR ANAT FEMORAL R 62.5 MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 31, 2016

    VANGUARD CR POROUS/HA FEM - RT 72.5

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 23, 2016

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 1, 2014

    DEVICE TWO:5.5MM REVERE PEDICLE SCREW

    FDA Adverse Event
    Injury ·GLOBUS MEDICAL, INC.·Product code MNH·June 18, 2009

    DEPUY

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·August 27, 2010

    VANGUARD CEMENTLESS POROUS CR FEMORAL LT 65

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·April 20, 2017

    VANGUARD CRUCIATE RETAINING POROUS HA FEMUR - RIGHT 65 MM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·May 12, 2017

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012