Medical Device Manufacturer · US , Centercille , MA

Fci Ophthalmics, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1996

Recent clearances: RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES, TITANIUM PEG SYSTEM, PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Fci Ophthalmics, Inc. Ophthalmic ✕

13 devices

1-12 of 13

Cleared Aug 07, 2006

MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE

Ophthalmic · 80d

Cleared Jul 11, 2006

SNUG PLUG PUNCTUM PLUG

Ophthalmic · 53d

Cleared Nov 18, 2004

SELF RETAINING BICANALICULUS INTUBATION SET

Ophthalmic · 132d

Cleared Sep 17, 2003

BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)

Ophthalmic · 313d

Cleared Aug 22, 2003

FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT

Ophthalmic · 317d

Cleared Feb 26, 2003

DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES

Ophthalmic · 51d

Cleared Apr 19, 2000

BIOCERAMIC ORBITAL IMPLANT

Ophthalmic · 287d

Cleared Jul 08, 1999

FCI CRAWFORD PROBE INTUBATION SETS

Ophthalmic · 87d

Cleared Sep 18, 1998

RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES

Ophthalmic · 199d

Cleared Jul 09, 1998

TITANIUM PEG SYSTEM

Ophthalmic · 128d

Cleared Dec 20, 1996

PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS

Ophthalmic · 59d

Cleared Oct 28, 1996

RETINAL DETACHMENT IMPLANTS

Ophthalmic · 73d