80 results · 33ms · Sources: EU EUDAMED, 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