Fci Ophthalmics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K061404MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICEAugust 7, 2006
K061398SNUG PLUG PUNCTUM PLUGJuly 11, 2006
K041869SELF RETAINING BICANALICULUS INTUBATION SETNovember 18, 2004
K023758BECKER TRANSNASAL LACRIMAL (INTUBATION SETS)September 17, 2003
K023400FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANTAugust 22, 2003
K030054DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSESFebruary 26, 2003
K992294BIOCERAMIC ORBITAL IMPLANTApril 19, 2000
K991238FCI CRAWFORD PROBE INTUBATION SETSJuly 8, 1999
K980816RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGESSeptember 18, 1998
K980822TITANIUM PEG SYSTEMJuly 9, 1998
K964774PUNCTUM PLUGS & READY-SET PUNCTAL PLUGSDecember 20, 1996
K963219RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGESOctober 28, 1996
K961909READY-SET PUNCTAL PLUGSJuly 25, 1996