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

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    KMEDIC EXTERNAL FIXATION DEVICES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CTXA Hip Extended Reference Data

    FDA UDI
    MINDWAYS SOFTWARE, INC.·B052DICTXAHIPEXTDB0·The CTXA Hip Extended Reference Data is an acce...

    BD

    FDA UDI
    PRYOR PRODUCTS·00761887000308·5 leg plastic IV Stand

    Humelock Reversed Shoulder

    FDA UDI
    FX SOLUTIONS·03701037306352·HUMELOCK REVERSED EPIPHYSEAL RASP Ø36mm

    RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM

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

    VERTE-STACK K030736, K041197

    FDA Adverse Event
    Death ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MQP·January 4, 2019

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 2, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 7, 2011

    COSYCOT INFANT WARMER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code FMT·April 15, 2008

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    6.5MM TI RECON SCREW WITH T25 STARDRIVE 105MM

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·April 23, 2018

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    Instructions For Use document of the GPS Trackers.

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·November 4, 2020

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    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