75 results
·
32ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OptoMonitor II
FDA 510(k)
FDA Class 2
·Cardiovascular
CXI TRIFORCE
FDA 510(k)
FDA Class 2
·Cardiovascular
LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 13, 2011
FEMORAL NAIL, A/R S2 Ø10X360 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·June 11, 2013
PALMAZ SCHATZ STENT UNKNOWN
FDA Adverse Event
Injury
·CORDIS EUROPA, N.V.·Product code MAF·September 12, 2008
TRIFORCE¿ PERIPHERAL CROSSING SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 1, 2015
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 25, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 25, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 26, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 31, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 31, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 14, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 26, 2019
SOEHENDRA STENT RETRIEVER
FDA Adverse Event
Injury
·COOK ENDOSCOPY·Product code FGE·September 26, 2017
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 23, 2019
UNIVERSA FIRM URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·August 27, 2019
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025