11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mazor X System (Mazor X Stealth Edition)
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
BT3/6, BT12
FDA 510(k)
FDA Class 2
·Cardiovascular
GMK-REVISION FEMUR CEMENTED PS SIZE 4NARROW / RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 20, 2019
ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·October 17, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 21, 2013
EYE SURGERY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·June 22, 2011
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 27, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 11, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 19, 2022
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: 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. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013