10 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·04260516877077·SICvantage Gingiva Shaper blue, anterior, conca...
SIC invent Dental Implant Systems
FDA UDI
SIC invent AG·ESIC9503371·SICvantage Gingiva Shaper blue, anterior, conca...
SIS FISTULA PLUG
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
AiORTA - Plan
FDA 510(k)
FDA Class 2
·Radiology
VERSYS FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER INC·Product code LPH·February 25, 2016
HOMEPUMP ECLIPSE: 100 ML, 100 ML/HR
FDA Adverse Event
Injury
·I-FLOW, LLC·Product code MEB·February 6, 2013
DEEP BRAIN STIMULATION LEAD
FDA Adverse Event
Malfunction
·MPROC, VILLALBA·Product code MHY·December 14, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 22, 2014
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020