FDA.reportPublic FDA data

Glaucoma shunt

Definition
A sterile, non-bioabsorbable, implantable ocular device intended to create an artificial drainage channel for diversion of aqueous humour from the anterior chamber of the eye to reduce intraocular pressure (IOP) as an alternative to, or after failed, trabeculectomy, for the management of uncontrolled glaucoma. It consists of a tube which is introduced into the aqueous body (typically via limbal entry) and a distal episcleral plate intended to support a reservoir of aqueous humour; the shunt does not contain a valve.
GUDID devices
16
Last updated
2020-12-23 07:59:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
09419196000090Molteno3MOLTENO OPHTHALMIC LIMITEDGS-1752016-08-12
09419196000106Molteno3MOLTENO OPHTHALMIC LIMITEDGL-2302016-08-12
09419196000212Molteno3MOLTENO OPHTHALMIC LIMITEDSS-1852016-08-12
09419196000229Molteno3MOLTENO OPHTHALMIC LIMITEDSL-2452016-08-12
00810050243186NADOMICO MED-DEVICE, LLC90142020-09-24
00892064002188Ahmed™ Glaucoma ValveNEW WORLD MEDICAL, INCORPORATEDTE2020-08-12
00892064002348Ahmed™ ClearPathNEW WORLD MEDICAL, INCORPORATED2502019-01-23
00892064002355Ahmed™ ClearPathNEW WORLD MEDICAL, INCORPORATED3502019-01-23
10888628032439XEN Glaucoma Treatment SystemAllergan, Inc.5513-0012018-01-30
05050474512993BAERVELDT GLAUCOMA IMPLANT (350)JOHNSON & JOHNSON SURGICAL VISION, INC.BG1013502015-09-15
05050474513006BAERVELDT PARS PLANA GLAUCOMA IMPLANTJOHNSON & JOHNSON SURGICAL VISION, INC.BG1023502015-09-15
05050474513013BAERVELDT GLAUCOMA IMPLANT (250)JOHNSON & JOHNSON SURGICAL VISION, INC.BG1032502015-09-15
00380650704931EX-PRESS®Alcon Laboratories, Inc.P-502015-10-24
00380650704948EX-PRESS®Alcon Laboratories, Inc.P-2002015-10-24
00380657540075CypassAlcon Laboratories, Inc.80657540072018-07-19
10380657540034CyPassAlcon Laboratories, Inc.80657540032016-09-16