BEUDAMED
    18 results · 31ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    APTUS HELI-FX GUIDE - 22CM DEFLECTABLE LENGTH; APTUS HELI-FX GUIDE - 28CM DEFLECTABLE LENGTH; APTUS HELI-FX APPLIER WITH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131268655·ALTA PRO, DESIGNRITE 10 WL CNB

    HEMOSTAT ROCHESTER-PEAN 5-1/2" CURVED

    FDA UDI
    W.H. Holden, Inc.·D9281400360·

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319704417·Kelly Hemostatic Forceps 5-1/2" (13.8cm), straight

    GlucoLeader Enhance Blood Glucose Monitoring System

    FDA UDI
    HMD BIOMEDICAL INC.·04711200720617·GlucoLeader Enhance GEBH Blood Glucose Monitori...

    FX 222-02 POWERED WHEELCHAIR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INVIRO SNAP SAFETY INSULIN SYRINGE, 1 CC, MODEL 102905

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·August 26, 2019

    EQUINOXE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWT·February 6, 2019

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 20, 2012

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·October 3, 2014

    LIGAMAX-5MM ENDO CLIP APPLIER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·May 31, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·June 25, 2011

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code MIH·August 25, 2020

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS

    FDA Adverse Event
    Death ·WILLIAM COOK EUROPE·Product code MIH·October 5, 2022

    EQUINOXE SHOULDER COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·January 9, 2024

    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

    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