FDA Device Intelligence
HomeDevice types › HQX

Implant, Orbital, Extra-Ocular

FDA product code HQX · Class 2 · Ophthalmic

158
Registered devices
26
Adverse events
13
Recalls
16
510(k) clearances

Devices with this code

Scleral Buckling Products: Style 280, Asymmetrical Tire — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22Scleral Buckling Products: Style 275, Asymmetrical Tire — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22Scleral Buckling Products: Style 103, Meridional Implant – 15.0mm — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22MIRA IMEX Scleral Buckling Component — MIRA, INC.Scleral Buckling Products: Style 70, Silicone Sleeve — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22MIRA IMEX Scleral Buckling Component — MIRA, INC.Scleral Buckling Products: Style 240, 2.5mm Circling Band — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.Gelfilm — PHARMACIA & UPJOHN COMPANY LLCScleral Buckling Products: Style N/A, 5.0mm Silicone Strip — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.MIRA IMEX Scleral Buckling Component — MIRA, INC.Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22Scleral buckling device, non-bioabsorbable — FCI S A S FCI 20 22MIRA IMEX Scleral Buckling Component — MIRA, INC.NA — MICROVISION, INC.MIRA IMEX Scleral Buckling Component — MIRA, INC.MIRA IMEX Scleral Buckling Component — MIRA, INC.NA — MICROVISION, INC.MIRA IMEX Scleral Buckling Component — MIRA, INC.MIRA IMEX Scleral Buckling Component — MIRA, INC.

Recent recalls

DateFirmReason
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance
2002-11-29Gulden Ophthalmicslack of sterility assurance

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.