23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYMETREX LONG TERM HEMODIALYSIS CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
STRYKER KNIFELIGHT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CPELVISOFT ACELLULAR COLLAGEN BIOMESH
FDA Adverse Event
Injury
·TISSUE SCIENCE LABORATORIES·Product code FTM·May 24, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 27, 2011
9600EMI
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008
SILVERHAWK ATK
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MCW·April 8, 2024
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 18, 2019
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 2, 2020
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 18, 2021
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 21, 2021
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·June 21, 2019
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·January 25, 2024
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·January 29, 2019
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 12, 2020
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·March 12, 2020
CXI SUPPORT CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code KRA·December 8, 2022
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·March 31, 2022
CXI SUPPORT CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·October 10, 2019
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