10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SPIROSCOPE
FDA 510(k)
FDA Class 2
·Anesthesiology
CHS
FDA UDI
Smith & Nephew, Inc.·03596010413307·CANNULATED OSTEOTOMY BLADE PLATE CHILD 3HOLE 45MM
M1350A FETAL MONITOR (INTRAPARTUM)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
F-20 TOTAL HIP PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·January 9, 2013
UNK DEPUY DURALOC 28 X 54 LIPPED LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LPH·November 19, 2010
ADVANIX? BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·July 1, 2014
Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025