22 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WELL LEAD TRACHEOSTOMY TUBE
FDA 510(k)
FDA Class 2
·Anesthesiology
COMPOSIX E/X MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
REPROCESSED ELECTROSURGICAL ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013
FLEXTEND IS-1 BI POSITIVE FIX
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code DTB·May 8, 2008
CONCERTO II CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·April 6, 2011
PKG, BABCOCK FORCEPS, PADDLE, P/N 0250080250. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
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 Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019
Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-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
Endotrig ETF Hook Blade, Catalog Number 1052-1 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 ECTR Hook Blade, Catalog Number 2055-1 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 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
Endintrak 2 Hook Blade, Angled, Catalog Number 4058A-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 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 Recall
Terminated
·Stryker GmbH Bohnackerweg 1 Selzach Switzerland·Product code HRX·July 25, 2019
Endintrak 2 Hook Blade, Catalog Number 4058-1 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 ECTR Push Blade, Catalog Number 2053-1 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