BEUDAMED
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    Sonata Transcervical Fibroid Ablation System 2.2

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

    Ceramco® iC

    FDA UDI
    Dentsply International Inc.·D00142507050·

    Universal Abutment

    FDA UDI
    BICON, LLC·00813110021991·Universal Abutment UA5 LP 15° - 2.5mm Post

    TIUNITE IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator

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

    TELEGRAPH®

    FDA UDI
    FOURNITURES HOSPITALIERES INDUSTRIE·03661489507052·

    UNKNOWN DEEP BRAIN STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·September 12, 2011

    UNKNOWN DEPUY STEM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWY·December 2, 2008

    FEMTO LDV SYSTEM

    FDA Adverse Event
    Injury ·SIE AG; SURGICAL INSTRUMENT ENGINEER·Product code GEX·July 19, 2013

    The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·November 20, 2024

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013