8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LumiRex Ureteroscope
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BI-MENTUM ALTRX® Dual Mobility Liner
FDA 510(k)
FDA Class 2
·Orthopedic
Durex Silicone
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR
FDA Adverse Event
Injury
·DEXCOM, INC.·Product code MDS·September 2, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 11, 2014
4.5MM CORTEX SCREW SELF-TAPPING 38MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 23, 2013
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·February 7, 2023
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016