BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO NC-STAT

    FDA 510(k)
    FDA Class 2 ·Neurology

    CD HORIZON® Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00885074030142·CONNECTOR 7041320 5.5 6.35 CLS LAT 20 TI

    SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HARMONIC HD 1000I SHEARS 20CM SHAFT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 23, 2022

    UNK

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code HCG·June 22, 2017

    UNK

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code HCG·June 22, 2017

    UNNK

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code HCG·June 22, 2017

    UNK

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code HCG·June 22, 2017

    UNK

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code HCG·June 22, 2017

    UNK

    FDA Adverse Event
    Injury ·MEDOS INTERNATIONAL SARL·Product code HCG·June 22, 2017

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·April 8, 2013

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 9.75CM

    FDA Adverse Event
    Malfunction ·COSTA RICA·Product code LTI·May 9, 2008

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - CORK·Product code MCX·April 6, 2011

    Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·December 18, 2019

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504 178575 178576 178577 178578 178579 178580 178730 178731 178732 178733 178734 178735 178354S 178754 178755 178756 178757 178758 178759 Product Usage: 1) Correction of revision of unsuccessful osteotomy, arthrodesis or previous joint replacement 2) Tumor resections 3) Revision of previously failed total joint arthroplasty 4) Trauma The ComPreSs Distal Femoral Replacement System is intended for uncemented use.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019

    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