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

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    Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask

    FDA 510(k)
    FDA Class 2 ·Radiology

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515026582·Harrington Pemb Ret, 2 1/2" WD, 7" dp, 12 1/2"

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·June 20, 2019

    APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    REGEN COLLAGEN SCAFFOLD (CS)

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

    VALIANT STENT GRAFT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·January 16, 2019

    AMS ADVANCE MALE SLING SYSTEM

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS (MN)·Product code OTM·October 17, 2014

    PENTA

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·June 14, 2013

    IN TOUCH ZX

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 22, 2011

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·April 27, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·April 11, 2022

    MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·August 19, 2022

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·December 7, 2018

    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