BEUDAMED
    22 results · 23ms · Sources: EU EUDAMED, US FDA

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    MV INTRADERMIC NEEDLES; MAGIC NEEDLE; MAGIC NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481118142·LOCATOR R-Tx Abutment For Outlink 4.1mm Externa...

    ZAVATION F3D-Z CIF

    FDA UDI
    Zavation LLC·00197157020200·F3D-Z CIF 13mmx15mmx6mm -6 deg

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450158708·

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1106000·Tray, Base, 6", Arcamed

    VATEA ENDONTIC IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    SAFARI

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·September 9, 2022

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 9, 2023

    BAXANO IO-FLEX SYSTEM

    FDA Adverse Event
    Other ·BAXANO, INC.·Product code HAE·July 2, 2012

    MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 40 MM

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code MNH·May 14, 2013

    CARPENTIER-EDWARDS® PERIMOUNT® RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code DYE·June 1, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 5, 2023

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·January 10, 2023

    VASERLIPO SYSTEM

    FDA Adverse Event
    Injury ·SOLTA MEDICAL, INC·Product code QPB·October 21, 2022

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089; Model AED20, part 972200

    FDA Recall
    Terminated ·MRL, Inc., A Welch Allyn Company·Product code MKJ·June 15, 2006