5 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
×
THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·November 8, 2017
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter (D-132704-S, D-132705-S)
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·November 8, 2017
THERMOCOOL SMARTTOUCH SF Uni-Directional Product Codes D-1347-01-S, D-1347-02-S, D-1347-03-S
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·November 8, 2017
Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. 1) The Varian Low Energy Linear Accelerator is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment i is indicated. (2) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·September 26, 2012
THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·November 8, 2017