22 results
·
21ms
·
Sources: EU EUDAMED, US FDA
PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SCANLAN® Legacy Micro Forceps
FDA UDI
SCANLAN INTERNATIONAL INC·00846159033571·Legacy FRCP FH 1X2MT 0.5MM DD 10"
ILT 0.014 CATHETER, MODEL C114NL2
FDA 510(k)
FDA Class 2
·Cardiovascular
MACROPOREDX DISTRACTOR SYSTEM
FDA 510(k)
FDA Class 2
·Dental
AUTOSOFTÂ XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·August 2, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·September 13, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 24, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·September 13, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 14, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·September 13, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·September 13, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·September 13, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 14, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·September 13, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·September 13, 2024
GEL-FILL MAMMARY IMPLANT, 500 CC
FDA Adverse Event
Injury
·MCGHAN MEDICAL, INC.·Product code FTR·November 11, 1994
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 14, 2013
DILATATION CATHETER, BALLOON
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LJE·March 1, 2011
IAB: 8 FR- 40 CC
FDA Adverse Event
Injury
·ARROW INTL., INC.·Product code DSP·February 25, 2008
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013