BEUDAMED
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    GORE-TEX REGENERATIVE MATERIAL

    FDA 510(k)
    FDA Class 2 ·Dental

    GIO DIGITAL PRESSURE GUAGES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DSG RELAXER SPLINT

    FDA 510(k)
    FDA Unclassified ·Unknown

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·January 18, 2013

    COMBISET WITH BVM

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FJK·November 12, 2010

    ENDEAVOR SPRINT RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 9, 2014

    Brand Name: Canturio Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona Personalized Knee System.

    FDA Recall
    Open, Classified ·Canary Medical, Inc.·Product code QPP·May 2, 2025

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017