FDA.reportPublic FDA data

Nasal haemostatic balloon

Definition
A device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. This is a single-use device.
GUDID devices
65
Last updated
2026-06-05 06:05:24

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00821925034532Gyrus ACMIGyrus ACMI, LLC8909112018-09-13
00821925040335Gyrus ACMIGyrus ACMI, LLC8909222018-09-13
00749756142526DeRoyalDEROYAL INDUSTRIES, INC.34-2012021-07-12
00749756142533DeRoyalDEROYAL INDUSTRIES, INC.34-2022021-07-12
00817470000504Rapid RhinoSmith & Nephew, Inc.RR 9002015-08-29
00817470006612Rapid RhinoSmith & Nephew, Inc.RR 4502015-08-29
00817470006629Rapid RhinoSmith & Nephew, Inc.RR 5502015-08-29
00817470006636Rapid RhinoSmith & Nephew, Inc.RR 7502017-08-11
00817470006643Rapid RhinoSmith & Nephew, Inc.RR 5522015-08-29
00817470006650Rapid RhinoSmith & Nephew, Inc.RR 7522015-08-29
00817470006674Rapid RhinoSmith & Nephew, Inc.RR 550022015-08-29
00817470006681Rapid RhinoSmith & Nephew, Inc.RR 750022015-08-29
00817470006698Rapid RhinoSmith & Nephew, Inc.RR 5512015-08-29
00817470006704Rapid RhinoSmith & Nephew, Inc.RR 5552015-08-29
00817470006711Rapid RhinoSmith & Nephew, Inc.RR 7512015-08-29
00817470006728Rapid RhinoSmith & Nephew, Inc.RR 7552015-08-29
00818501020669Invotec Ultra-StatINVOTEC INTERNATIONAL, INC.20-107002022-12-06
00818501020676Invotec Post StatINVOTEC INTERNATIONAL, INC.20-107102022-12-06
00818501020683Invotec Quick Pack Nasal Balloon PackingINVOTEC INTERNATIONAL, INC.20-107152022-12-06
00855364004115Rhino-Pak 45mmMAR-MED INC.RP-452025-02-06
00855364004139Rhino-Pak 75mmMAR-MED INC.RP-752025-02-06
04026704543953RUSCHTELEFLEX INCORPORATEDIPN0449852018-09-15
08906039319385OSSEOUSEON MEDITECH PRIVATE LIMITEDE310102024-05-13
08906039319392OSSEOUSEON MEDITECH PRIVATE LIMITEDE310312024-05-13
08906039319408OSSEOUSEON MEDITECH PRIVATE LIMITEDE310302024-05-13
10705031200555RELIEVA SPINACCLARENT, INC.RS0616F2016-10-01
10705031200562RELIEVA SPINACCLARENT, INC.RS0616M2016-10-01
10705031200586RELIEVA SPINACCLARENT, INC.RSF702016-10-01
10705031206021RELIEVA SPINACCLARENT, INC.RSS02016-10-01
10705031206038RELIEVA SPINACCLARENT, INC.RSM1102016-10-01
10705031206304RELIEVA SPINACCLARENT, INC.RS0516F2016-10-01
10705031206311RELIEVA SPINACCLARENT, INC.RS0516M2016-10-01
10705031227576RELIEVA SPINACCLARENT, INC.RSM110C2016-10-01
10705031230576RELIEVA SPINACCLARENT, INC.RS0516MFS2016-10-01
10705031230590RELIEVA SPINACCLARENT, INC.RS0616MFS2016-10-01
10705031232389RELIEVA SPINPLUSACCLARENT, INC.RSP0616MFS2016-10-01
10705031232839RELIEVA SPINPLUSACCLARENT, INC.RSP0516MFS2016-10-01
10705031232853RELIEVA SPINPLUSACCLARENT, INC.RSP0516F2016-10-01
10705031232877RELIEVA SPINPLUSACCLARENT, INC.RSP0516M2016-10-01
10705031232914RELIEVA SPINPLUSACCLARENT, INC.RSP0616F2016-10-01
10705031232938RELIEVA SPINPLUSACCLARENT, INC.RSP0616M2016-10-01
10705031233034RELIEVA SPINPLUSACCLARENT, INC.RSP05162016-10-01
10705031233058RELIEVA SPINPLUSACCLARENT, INC.RSP06162016-10-01
10705031238039RELIEVA SCOUTACCLARENT, INC.SCT0624MFS2016-10-01
14026704641403RUSCHTELEFLEX INCORPORATEDIPN0499302019-04-24
14063107101424Epi-Max™ Epistaxis Procedure PackBoston Medical Products, Inc.60-4022022-09-29
14063107101431Epi-Max™ Epistaxis Procedure PackBoston Medical Products, Inc.60-402L2022-09-29
14711182605466Silicone Nasal Epistaxis BalloonFORTUNE MEDICAL INSTRUMENT CORP.3101-08302021-11-24
14711182605473Silicone Nasal Epistaxis BalloonFORTUNE MEDICAL INSTRUMENT CORP.3102-20102021-12-15
14711182605480Silicone Nasal Epistaxis BalloonFORTUNE MEDICAL INSTRUMENT CORP.3103-09302021-12-15
00855364004122Rhino-Pak 55mmMAR-MED INC.RP-552025-02-06
10855364004112Rhino-Pak 45mmMAR-MED INC.RP-452025-02-06
10855364004136Rhino-Pak 75mmMAR-MED INC.RP-752025-02-06
08906039312430OSSEOUSEON MEDITECH PRIVATE LIMITEDE310102024-05-13
08906039312447OSSEOUSEON MEDITECH PRIVATE LIMITEDE310312024-05-13
08906039312454OSSEOUSEON MEDITECH PRIVATE LIMITEDE310302024-05-13
10818501020666Invotec Ultra-StatINVOTEC INTERNATIONAL, INC.20-107002022-12-06
10818501020673Invotec Post StatINVOTEC INTERNATIONAL, INC.20-107102022-12-06
10818501020680Invotec Quick Pack Nasal Balloon PackingINVOTEC INTERNATIONAL, INC.20-107152022-12-06
00763000340353EpistatMEDTRONIC XOMED, INC.15270312022-09-19
04711182605476Silicone Nasal Epistaxis BalloonFORTUNE MEDICAL INSTRUMENT CORP.3102-20102021-12-15
04711182605483Epistaxis balloon catheterSpiggle & Theis Medizintechnik GmbH3103-09302025-05-23
04711182605469Silicone Nasal Epistaxis BalloonFORTUNE MEDICAL INSTRUMENT CORP.3101-08302021-11-24
50749756142521DeRoyalDEROYAL INDUSTRIES, INC.34-2012021-07-12
50749756142538DeRoyalDEROYAL INDUSTRIES, INC.34-2022021-07-12