8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OVER THE GUIDEWIRE DILATATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BCI-100 FECAL INCONTINENCE SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NEXTEC FIBEROPTIC ILLUMINATOR 300 WATT XENON
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ARTICULEZE M HEAD 36MM +5
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code JDI·January 22, 2013
ENDOPATH** XCEL*
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·December 14, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 10, 2014
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
FDA Enforcement
Class II
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020