12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Propeller Sensor Model 2014-R
FDA 510(k)
FDA Class 2
·Anesthesiology
FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTELON SURGICAL SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WALLSTENT RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code JCT·March 21, 2025
PEDICLE SCREW MONOAXIAL SCREW 5X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·September 10, 2019
WALLSTENT ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 22, 2025
WALLSTENT ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MAF·December 1, 2025
MAYFAIR HEAD HOLDER
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION OH/USA·Product code HBL·October 6, 2014
HEARTMATE LVAD
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·June 5, 2013
OXIMAX N-595 PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY TYCOHEALTH·Product code DQA·June 21, 2011
WALLSTENT? RP ENDOPROSTHESIS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·July 21, 2025
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023