Fci Ophthalmics, Inc.
Pembroke, MA, US
FCI OPHTHALMICS, INC. appears in FDA device records in Pembroke, MA. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Fci Ophthalmics, Inc. between 1996 and 2006. The busiest year on record is 1996, with 3. The most recent is 2006, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 3 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2003 | 3 |
| 2004 | 1 |
| 2006 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K061404 | MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE | OKS | Substantially Equivalent | |
| K061398 | SNUG PLUG PUNCTUM PLUG | LZU | Substantially Equivalent | |
| K041869 | SELF RETAINING BICANALICULUS INTUBATION SET | OKS | Substantially Equivalent | |
| K023758 | BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) | OKS | Substantially Equivalent | |
| K023400 | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | HPZ | Substantially Equivalent | |
| K030054 | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES | HJK | Substantially Equivalent | |
| K992294 | BIOCERAMIC ORBITAL IMPLANT | HPZ | Substantially Equivalent | |
| K991238 | FCI CRAWFORD PROBE INTUBATION SETS | OKS | Substantially Equivalent | |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | HQX | Substantially Equivalent | |
| K980822 | TITANIUM PEG SYSTEM | MQU | Substantially Equivalent | |
| K964774 | PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS | LZU | Substantially Equivalent | |
| K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | HQX | Substantially Equivalent | |
| K961909 | READY-SET PUNCTAL PLUGS | LZU | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1225124 | 3000210020 | FCI OPHTHALMICS, INC. | 30 Corporate Park Drive, Pembroke, MA 02359 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain