Isoray Medical Inc

FDA Filings

This page includes the latest FDA filings for Isoray Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005520039
FEI Number3005520039
NameISORAY MEDICAL, INC
Owner & OperatorISORAY MEDICAL, INC
Contact Address350 HILLS Street SUITE 106
Richland WA 99354 US
Official Correspondent
  • Leslie White
  • x-509-3751202-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address350 Hills St Ste 106
RICHLAND, WA 99354 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Isoray Medical, Inc.
Sirius MRI Markers, Cs-131 Preloaded Strands With Sirius MRI Markers In 18 Gauge Needles2020-12-31
ISORAY MEDICAL, INC.
Blu Blade 2019-04-05
ISORAY MEDICAL, INC
Blu Build Spacer Cartridge Model BBC-12018-10-17
ISORAY MEDICAL, INC
Blu Build Sleeve Carrier Model BBS-12018-10-17
ISORAY MEDICAL, INC
Blu Build Real Time Loader Device Model BBL-12018-10-17
ISORAY MEDICAL, INC
Blu Blade Model BB-12018-10-17
Isoray Medical Inc.
GammaTile2018-07-06
ISORAY MEDICAL, INC
GliaSite RTS Cesitrex2014-11-06
ISORAY MEDICAL, INC
Proxcelan Model PL-32012-11-06
ISORAY MEDICAL, INC
Proxcelan Model PL-22012-11-06
ISORAY MEDICAL, INC
Proxcelan Model PL-12012-11-06
ISORAY MEDICAL, INC
Proxcelan Model PL-52012-11-06
ISORAY MEDICAL, INC
GliaSite RTS2011-12-02
ISORAY MEDICAL, INC.
GLIASITE RTS2011-08-05
ISORAY MEDICAL, INC.
PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-22009-08-28
ISORAY MEDICAL, INC.
PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-52009-08-07
ISORAY MEDICAL, INC
Proxcelan Model PL-42007-10-29
ISORAY MEDICAL, INC
Proxcelan Model PL-32007-10-29
ISORAY MEDICAL, INC
Proxcelan Model PL-22007-10-29
ISORAY MEDICAL, INC
Proxcelan Model PL-12007-10-29
ISORAY MEDICAL, INC
Proxcelan Model Cs-12006-07-31

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