BEUDAMED
    16 results · 20ms · 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 ×

    OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964151279·Endo Carry-on Procedure Kit contains Intercept ...

    MedStream

    FDA UDI
    MEDICAL SPECIALTIES DISTRIBUTORS, LLC·00842472103007·TRACH CARE KIT FOR PEDS W STERILE WATER

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450051573·

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0105070·Draw Rod, Primal T- Handle

    QUICK SET

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·August 22, 2025

    ULTRASOUND SCANNER TYPE 2102

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANTAGE THC TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ENDOPATH ETS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code KOG·March 11, 1998

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·March 19, 2013

    INJECTION GOLD PROBE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MIAMI·Product code KNS·March 8, 2011

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·March 10, 2008

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.

    FDA Enforcement
    Class II ·Completed·Accuray Incorporated·September 6, 2023

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016