BEUDAMED
    20 results · 26ms · Sources: EU EUDAMED, US FDA

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    AEON Endoscopic Stapler

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

    DJO SURGICAL

    FDA UDI
    Encore Medical, L.P.·00190446909033·SPECIAL, RSP 2.4mm CANNULATED GLENOID REAMER, S...

    NA

    FDA UDI
    Synthes GmbH·10886982143174·2.0MM LOCKING SCREW SLF-TPNG WITH STARDRIVE REC...

    36M - Black & Veach - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588011820·36M - Black & Veach - Metal

    BABY DOPPLEX 4002-TWINS, MODEL BD4002

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

    CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510

    FDA 510(k)
    FDA Class 2 ·Immunology

    ENDURANT STENT GRAFT

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MIH·March 19, 2018

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code LWR·February 6, 2018

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·August 11, 2011

    LAMITRODE TRIPOLE 16

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 26, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    HARMONIC ACE 5MM SHEAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 10, 2025

    HEARTWARE VENTRICULAR ASSIST SYSTEM- PUMP

    FDA Adverse Event
    Injury ·HEARTWARE, INC.·Product code DSQ·August 20, 2018

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code ONU·August 2, 2018

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code ONU·August 2, 2018

    STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWQ·November 14, 2019

    DUROMEDICS BILEAFLET HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWQ·November 14, 2019

    UNK - CONSTRUCTS: ZERO-P

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code OVE·April 14, 2021

    EXCOR BLOOD PUMP PU VALVES,15 ML IN/OUT Ø9 MM

    FDA Adverse Event
    Malfunction ·BERLIN HEART GMBH·Product code DSQ·December 17, 2018

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012