Implant, Orbital, Extra-Ocular

FDA product code HQX · Class II (moderate risk) · 21 CFR 886.3340 · Ophthalmic

16510(k) clearances
0PMA approvals
0recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K023481Microvision Scleral Buckling ComponentsHQX · Traditional Microvision, Inc.01/08/2003SE
K983581Ocu-Guard and Ocu-Guard SuppleHQX · Special Bio-Vascular, Inc.11/06/1998SE
K980816Retinal Detachment Implants, Including Bands, Strips (Rails) and SpongesHQX · Traditional Fci Ophthalmics, Inc.09/18/1998SE
K963219Retinal Detachment Implants; Including Bans, Strips, Tires, Sleeves, Cords and SpongesHQX · Traditional Fci Ophthalmics, Inc.10/28/1996SE
K950806Solid Dilicone Implants, Sdilicone Sponge ImplantsHQX · Traditional Mira, Inc.06/05/1996SE
K950599Stors Scleral Sponge II (Lincoff Design)HQX · Traditional Storz Ophthalmics, Inc.03/02/1995SE
K945172Visitec Silicone Retinal Implants/ExplantsHQX · Traditional Visitec Co.01/17/1995SE
K902308Tamcenan Ocular Explants and BandsHQX · Traditional Tamcenan Corp.06/19/1990SE
K901002O'Donnell, Socket Reconstruction ProsthesesHQX · Traditional Oculo Plastik, Inc.05/22/1990SE
K900929Putterman-Scott, Socket Reconstruction BilateralHQX · Traditional Oculo Plastik, Inc.05/18/1990SE
K900930Spivey-Allen Orbital Floor ImplantHQX · Traditional Oculo Plastik, Inc.05/15/1990SE
K900928Cox Malar Eminence ImplantsHQX · Traditional Oculo Plastik, Inc.05/15/1990SE
K900927Codere-Durette Orbital Floor ImplantHQX · Traditional Oculo Plastik, Inc.05/15/1990SE
K863946Porex(Tm) Extra-Ocular Orbital ImplantHQX · Traditional Porex Medical02/27/1987SE
K832481Scleral Buckling Implants Dif/TypesHQX · Traditional Storz Instrument Co.09/20/1983SE
K800140Silastic Scleral Sponge II W/Circling BDHQX · Traditional Dow Corning Corp. Healthcare Industries Materials03/03/1980SE