80 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOGRAPH TRUE PET/CT FAMILY SOFTWARE
FDA 510(k)
FDA Class 2
·Radiology
WIMRT MODULE FOR ARTP PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SYNTEC OS SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WAVEWRITER ALPHA 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 15, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 14, 2023
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 4, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·December 17, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·June 16, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 11, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·July 8, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·March 19, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 8, 2024
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 28, 2021
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·January 28, 2022
DRETLER UNIVERSAL URETEROSCOPY STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·February 22, 2022
BANDER URETERAL DIVERSION STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·February 9, 2022
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