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

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    Filters Regulation: Us FDA ×

    LEECH, MEDICINAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925014695·SHEA TORP PROSTHESIS 1 MM SHAFT DIAMETER 4 MM L...

    TALOS®-C HA

    FDA UDI
    MEDITECH SPINE, LLC·B167521409070·

    Vusion CS Plus

    FDA UDI
    Ortho Development Corporation·00822409025404·14 mm x 9 mm x 7 Degree Lordotic

    ARTHREX SMALL FRAGMENT PLATES AND SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·October 2, 2018

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·October 2, 2018

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·October 2, 2018

    ALIGN S URETHRAL SUPPORT SYSTEM

    FDA Adverse Event
    Injury ·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTN·May 24, 2013

    NC QUANTUM APEX BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·June 27, 2011

    RESTORE ADVANCED RECHARGEABLE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 28, 2008

    TOTAL KNEE REPLACEMENT

    FDA Adverse Event
    Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·November 10, 2016

    PATIENT SPECIFIC TOTAL FEMUR

    FDA Adverse Event
    Injury ·STANMORE IMPLANTS WORLDWIDE·Product code KRO·August 15, 2018

    MICROFRANCE® INSTRUMENT

    FDA Adverse Event
    Malfunction ·XOMED MICROFRANCE MFG·Product code GEI·April 15, 2015

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013

    Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc. Oncology Systems·May 22, 2013