75 results · 32ms · Sources: EU EUDAMED, US FDA

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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