16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
AURAFLEX TPO-AB
FDA 510(k)
FDA Class 2
·Immunology
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
Express SD Biliary Monorail Premounted Stent System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026
APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDO·November 13, 2014
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025
2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·May 15, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·December 29, 2010
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
FDA Adverse Event
Malfunction
·MPRI·Product code NVN·February 9, 2013
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·November 13, 2014
EXPRESS SD RENAL/BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015