Data / Medical devices / France / Fci SAS
Fci SAS: FDA-registered device maker in BESANCON Doubs, France, 32 510(k) clearances
Fci SAS is registered with the FDA (registration 9615745) in BESANCON Doubs, France. It lists 30 device types. The FDA files 32 510(k) clearances under its listings, the newest dated June 24, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615745
- FEI number
- 3000314405
- Address
- 2 rue Carl Zeiss, BESANCON Doubs, France, 25000
- Owner or operator
- Carl Zeiss Meditec AG (Jena) (9053564)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- February 23, 1996
- Registered through
- 2026
- Brand names listed
- 3 MIRRORS CONTACT LENS ( SINGLE USE ), 4 x 3 mm ePTFE SPONGE (CHAUVAUD), 9 mm ePTFE STRIP (DESIGNED BY O. LEQUOY), 90 DEGREE ADJUSTABLE LASER PROBE, 23G IRIDEX/B&L, 90 DEGREE ADJUSTABLE LASER PROBES, 23GA ALCON/COHERENT/ZEISS/ELLEX/OS4, 90 DEGREE ADJUSTABLE LASER PROBES, 23GA DORC, 90 DEGREE ADJUSTABLE LASER PROBES, 23GA NIDEK/LUMENIS NOVUS SPECTRA, 90 DEGREE ADJUSTABLE LASER PROBES, 25GA ALCON/COHERENT/ZEISS/ELLEX/OS4 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 24, 2022 | K212741 | EZYPOR | HPZ | Substantially Equivalent | Fci (France Chirurgie Instrumentation) Sas | accessdata.fda.gov |
| June 11, 2021 | K203569 | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | NCB | Substantially Equivalent | Fci (France Chirurgie Instrumentation) Sas | accessdata.fda.gov |
| March 11, 2021 | K201892 | Ritleng®+ and Ritleng®+ PVP | OKS | Substantially Equivalent | Fci (France Chirurgie Instrumentation) Sas | accessdata.fda.gov |
| December 18, 2020 | K201606 | LacriJet® | OKS | Substantially Equivalent | Fci (France Chirurgie Instrumentation) Sas | accessdata.fda.gov |
| April 17, 2017 | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| November 3, 2016 | K161373 | Nunchaku | OKS | Substantially Equivalent | Fci (France Chirurgie Instrumentation) | accessdata.fda.gov |
| December 2, 2014 | K140290 | STOPLOSS JONES TUBE | OKS | Substantially Equivalent | Ljt Surgical, Ltd. | accessdata.fda.gov |
| December 4, 2013 | K130375 | SELF-RETAINING BICANALICULUS INTUBATON SET II | OKS | Substantially Equivalent | Fci Sas (France Chirurgie Instrumentation) | accessdata.fda.gov |
| July 29, 2013 | K123831 | OPHTACATH KIT | OKS | Substantially Equivalent | France Chirurgae Instrumentation | accessdata.fda.gov |
| September 17, 2012 | K121187 | KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES | HQF | Substantially Equivalent | Katalyst Surgical, LLC | accessdata.fda.gov |
| August 9, 2012 | K121142 | CRAWFORD BIOCANALICULUS INTUBATION | OKS | Substantially Equivalent | Fci Sas (France Chirurgie Instrumentation) | accessdata.fda.gov |
| August 3, 2012 | K113536 | MASTERKA 40 MASTERKA 35 MASTERKA 30 | OKS | Substantially Equivalent | Fci Sas (France Chirurgie Instrumentation) | accessdata.fda.gov |
| July 1, 2011 | K110643 | MERIT MARQUIS FLOW SWITCH | DQO | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| August 7, 2006 | K061404 | MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE | OKS | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| July 11, 2006 | K061398 | SNUG PLUG PUNCTUM PLUG | LZU | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| November 18, 2004 | K041869 | SELF RETAINING BICANALICULUS INTUBATION SET | OKS | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| September 17, 2003 | K023758 | BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) | OKS | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| August 22, 2003 | K023400 | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | HPZ | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| February 26, 2003 | K030054 | DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES | HJK | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| August 13, 2001 | K010852 | OSMED TISSUE EXPANDER | NFM | Substantially Equivalent | Iop, Inc. | accessdata.fda.gov |
| April 19, 2000 | K992294 | BIOCERAMIC ORBITAL IMPLANT | HPZ | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| July 8, 1999 | K991238 | FCI CRAWFORD PROBE INTUBATION SETS | OKS | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| September 18, 1998 | K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | HQX | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| July 9, 1998 | K980822 | TITANIUM PEG SYSTEM | MQU | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| December 20, 1996 | K964774 | PUNCTUM PLUGS & READY-SET PUNCTAL PLUGS | LZU | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| October 28, 1996 | K963219 | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | HQX | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| July 25, 1996 | K961909 | READY-SET PUNCTAL PLUGS | LZU | Substantially Equivalent | Fci Ophthalmics, Inc. | accessdata.fda.gov |
| March 6, 1996 | K955671 | RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.) | OKS | Substantially Equivalent | G.W.B. Intl., Ltd. | accessdata.fda.gov |
| October 5, 1995 | K954094 | OPHTA SIL- PUNCTAL PLUGS (MODIFICATION) | LZU | Substantially Equivalent | G.W.B. Intl., Ltd. | accessdata.fda.gov |
| May 4, 1994 | K940508 | OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET) | OKS | Substantially Equivalent | G.W.B. Intl., Ltd. | accessdata.fda.gov |
| June 18, 1991 | K911110 | OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS | HPZ | Substantially Equivalent | G.W.B. Intl., Ltd. | accessdata.fda.gov |
| May 1, 1991 | K911109 | OPHTA SIL (R), LACHRYMAL INTUBATION SETS | OKS | Substantially Equivalent | G.W.B. Intl., Ltd. | accessdata.fda.gov |
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Updated June 24, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.