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

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    NUVIS ARTHROSCOPE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Gyrus ACMI

    FDA UDI
    Gyrus ACMI, LLC·00821925014657·SHEA TORP PROSTHESIS .85 MM SHAFT DIAMETER 6 MM...

    Humeral Cup Stability

    FDA UDI
    FX SOLUTIONS·03701037311387·TRIAL HUMERAL CUP 135/145° STABILITY Ø40 +3

    Humeral Cup Stability

    FDA UDI
    FX SOLUTIONS·03701037310496·HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +3

    Humeral Cup Stability

    FDA UDI
    FX SOLUTIONS·03701037314173·TRIAL FIXED HUMERAL CUP 135/145° STABILITY Ø40 +3

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 21, 2019

    CADENCE, MODELS 2001 AND 2002

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ANTI-HAV

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 3, 2013

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·August 28, 2008

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 22, 2011

    BD 60ML SYRINGE LUER-LOK TIP

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 13, 2021

    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

    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