10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Neo ADVISE software
FDA 510(k)
FDA Class 2
·Neurology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776377168·Ruskin Rongeur, 6", straight, 2x15mm, double ac...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780142720·Integra® Jarit® RUSKIN RONGEUR, Stright Bite
SCANNING LASERLINK
FDA 510(k)
FDA Class 2
·Ophthalmic
BBP BONE SUBSTITUTES
FDA 510(k)
FDA Class 2
·Dental
7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE® CLEA
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·January 31, 2024
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·November 13, 2008
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·September 1, 2011
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 16, 2013
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