FDA.reportPublic FDA data

H. Semih Oktay

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30030841713003182398H. Semih Oktay1N2026-01-011783 Forest Drive #254 Annapolis MD US 21401
30381328783038132878H. Semih Oktay1N2026-01-013168 Braverton St Ste 200 Edgewater MD US 21037
30108056273010805627H. Semih Oktay1N2020-04-251783 Forest Drive #254 Annapolis Annapolis MD US 21401
30141119293014111929H. Semih Oktay1N2020-04-251783 Forest Drive #254 Annapolis Annapolis MD US 21401

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3445211393234943P250011ProVee System for BPHMER2025-12-09
1691541242808008P170008EluNIR™ Ridaforolimus Eluting Coronary Stent SystemNIQ2017-11-28
1691541682316884P110004PRESILLION PLUS COCR CORONARY STENT RX SYSTEMMAF2012-04-12
3445211952390332K251734ProVee Video Processing Unit (PV-003)FET2025-09-24
1691541554837835K173581Gallant PTCA Dilatation CatheterLOX2018-01-25
1691541715143544K162434NC Gallant PTCA CatheterLOX2017-01-19
1691542014441856K081956MEDINOL X-SUIT NIR BILIARY METALLIC STENTFGE2009-01-09
2125871154365993
1681961789629520
1681961945169491

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOX22018-01-25
FET12025-09-24
NIQ12017-11-28
MAF12012-04-12
FGE12009-01-09