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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is kitted within an instrumentation tray. The Integra EGR System includes a range of instruments for endoscopic approach to the Gastrocnemius Aponeurosis Recession. The cutting instrument features a retracting blade for cutting the gastrocnemius aponeurosis. Associated instruments include an elevator, a cannula, and a cannula obturator, which are all consumable instruments provided sterile. The EGR System is indicated for the treatment of posterior heel cord contracture (Equinus) in those patients who fail to respond to conservative management.

    FDA Recall
    Terminated ·Integra LifeSciences Corp.·Product code NBH·January 6, 2012

    Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·September 4, 2019

    Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·September 4, 2019

    Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·September 4, 2019

    Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·September 4, 2019

    Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·September 4, 2019

    Invacare 2G Tarsys Seating System, Model 2GR.

    FDA Recall
    Terminated ·Invacare Corporation·Product code ITI·December 15, 2003

    Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1

    FDA Recall
    Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·April 30, 2019

    Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Recall
    Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019

    Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Recall
    Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019

    Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Recall
    Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019

    Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Recall
    Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019

    Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Recall
    Terminated ·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019

    Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 26, 2019

    DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·June 16, 2021

    Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc·July 3, 2019

    Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc·July 3, 2019

    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc·July 3, 2019

    Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·September 4, 2019

    Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system is designed for the treatment of plantar fasciosis. The EPF system is a minimally invasive surgical technique for chronic plantar fasciitis (fasciosis). The EGR system is designed for the treatment of gastrocnemius equinus.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·September 4, 2019