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Conformer, Ophthalmic

FDA product code HQN · Class 2 · Ophthalmic

132
Registered devices
2
Adverse events
1
Recalls
7
510(k) clearances

Devices with this code

SILICONE CONFORMER (FLEXIBLE) — FCI S A S FCI 20 22NA — Stryker Leibinger GmbH & Co. KGBilateral Conformer 18 Regular — Oculo-Plastik IncBio-Eye® — INTEGRATED ORBITAL IMPLANTS INCBio-Eye® — INTEGRATED ORBITAL IMPLANTS INCBio-Eye® — INTEGRATED ORBITAL IMPLANTS INCNA — INTEGRATED ORBITAL IMPLANTS INCNA — Stryker Leibinger GmbH & Co. KGBio-Eye® — INTEGRATED ORBITAL IMPLANTS INCPediatric Conformers — Oculo-Plastik IncAmbler Surgical — AMBLER SURGICAL CORP.Large Sterile Eye Conformer (PMMA) — Gulden Ophthalmics Inc.Soper Brothers Custom — Soper Brothers, IncorporatedBilateral Conformer 22 Small — Oculo-Plastik IncAmbler Surgical — AMBLER SURGICAL CORP.Medium Conformer (non-sterile) — Gulden Ophthalmics Inc.Bilateral Conformer 16 Regular, In Bulk — Oculo-Plastik IncBilateral Conformer 18 Regular — Oculo-Plastik IncUNIVERSAL CONFORMER LARGE — KATENA PRODUCTS, INC.SYMBLEPHARON RING 25 MM — FCI S A S FCI 20 22Ophthalmic Conformer — THE EYE CONCERN, INC.NA — Stryker Leibinger GmbH & Co. KGNA — Stryker Leibinger GmbH & Co. KGMEDPOR — Stryker Leibinger GmbH & Co. KG

Recent recalls

DateFirmReason
2008-03-28Porex Surgical, Inc.The Ocular Conformers were distributed with an expired expiration date.

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