41 results
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15ms
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Sources: EU EUDAMED, US FDA
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·May 4, 2016
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
FDA Enforcement
Class I
·Terminated·Heartware, Inc.·October 26, 2016
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Enforcement
Class I
·Terminated·HeartWare Inc·March 4, 2015
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Enforcement
Class II
·Terminated·HeartWare Inc·May 21, 2014
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Enforcement
Class I
·Terminated·HeartWare Inc·April 30, 2014
K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90179, UDI # 10888857108929, Size 28x6mm, 18 Product Usage: Used to simulate the height of the cage and expand the spine disc space to determine the optimal implant size base on patient anatomy.
FDA Enforcement
Class II
·Terminated·K2M, Inc·May 27, 2020
Ventilator Tubing
FDA Enforcement
Class II
·Terminated·Instrumentation Industries Inc·November 18, 2015
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Enforcement
Class II
·Terminated·Orthovita, Inc., dBA Stryker Orthobiologics.·June 5, 2013