Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615745

FEI Number

3000314405

Entity Name

FCI SAS

City/State/Country

BESANCON Doubs, FR

Establishment Address

2 rue Carl Zeiss, BESANCON Doubs 25000, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Carl Zeiss Meditec AG (Jena) (Owner Number: 9053564)

Owner / Operator Contact Address

Goeschwitzer Strasse 51-52, Jena, DE-TH 07745, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K023400

PMA Number

N/A

All Registered Proprietary Names

NON-STERILE PLUGS, SLIM PLUGS 0.4MM SLIM MINI NON-STERILE PLUGS, SLANTED COLLARETTE PLUGS 0.7MM MINI NON-STERILE PLUGS, VARIETY PACK ASSORTED 6 PLUGS EACH NON-STERILE PLUGS, SLIM PLUGS 0.5MM SLIM PETITE Non-Sterile Plugs NON-STERILE PLUGS, SLANTED COLLARETTE PLUGS 0.6MM MICRO FCI External Eyelid Weight Blinkeze Eyelid Weight OCULID External Eyelid Weights Hypoallergenic Adhesive Strips OCULID Sizing Set Tantalum Eyelid Weight Sizing Set PERFORATED CONFORMERS, 26MM LARGE SILICONE CONFORMER SYMBLEPHARON RINGS, 25MM LARGE SYMBLEPHARON RINGS, 20MM SMALL SYMBLEPHARON RINGS, 22MM MEDIUM PERFORATED CONFORMERS, 23MM MEDIUM PERFORATED CONFORMERS, 20MM SMALL PVP PERFORATED PLUGS, MINI PLUG PVP PERFORATED PLUGS, MEDIUM PLUG PVP perforated plug OCULID Implantable Eyelid Weights OCULID Slim Implantable Eyelid Weights PLATINUM TAPERED WEIGHT EYELID IMPLANTS GOLD TAPERED WEIGHT EYELID IMPLANTS OCULID Sizing Set Gold and Platinum Tapered Weight Eyelid Implants RETILOCK, 25GA NON-VALVED CANNULAS RETILOCK, 23GA NON-VALVED CANNULAS RETILOCK, 25GA VALVED CANNULAS RETILOCK, 23GA VALVED CANNULAS REUSABLE DOUBLE DILATOR, FINE & MEDIUM TAPERS DISPOSABLE PUNCTUM DILATOR & PLUG INSERTER LACRIMAL DILATOR DISPOSABLE Disposable Punctum Dilator BOWMAN PROBE, BOWMAN PROBE SIZE 3 & 4 BOWMAN PROBE, BOWMAN PROBE SIZE 1 & 2 SIZER FOR SELF-RETAINING INTUBATION Sizer for LacriJet BOWMAN PROBE, BOWMAN PROBE SIZE 00 & 0 miLOOP SU MACKOOL HOOKS miLOOP reusable PUNCTAL GAUGES FOR READY-SET PLUGS, PUNCTAL GAUGE SET 6 GAUGE SIZES (3 INSTRUMENTS) INVITRIA INTRAVITREAL INJECTION ASSISTANT Goncalves Invitria Precivia Version I Precivia Version P Non-Sterile Precivia Version P Precivia Version I Non-Sterile Ritleng+ PVP Ritleng+ Silicone Orbital Implants Enucleation/evisceration implants ENUCLEATION/EVISCERATION DISPOSABLE SIZERS WIDE/MEDIUM COLLARETTE MONOKA, 3MM MEDIUM MONO-CRAWFORD, 3MM MEDIUM COLLARETTE BOX OF 1 WIDE/MEDIUM COLLARETTE MONOKA, 4MM WIDE MONO-CRAWFORD, 4MM WIDE COLLARETTE BOX OF 3 MONO-CRAWFORD, 3MM MEDIUM COLLARETTE BOX OF 3 MONO-CRAWFORD, 4MM PVP WIDE COLLARETTE BOX OF 1 MONO-CRAWFORD, 3MM PVP MEDIUM COLLARETTE BOX OF 3 MONO-CRAWFORD, 3MM PVP MEDIUM COLLARETTE BOX OF 1 MONO-CRAWFORD, 4MM WIDE COLLARETTE BOX OF 1 MONO-CRAWFORD, 4MM PVP WIDE COLLARETTE BOX OF 3 Merit Marquis Flow Switch SPHERE INTRODUCER Nunchaku 90 mm Nunchaku 105 mm Ptose-Up Ptose Up 3 mm Width J.M. Ruban, M.D. Ptose Up 2 mm Width J.M. Ruban, M.D. Ptosis Sling Ptosis Strip TI/HA Peg and Sleeve System Large Size Ti/HA Peg & Sleeve System TI/HA Peg and Sleeve System Titanium peg and sleeve Egg Shaped Bioceramic Orbital Implant Bioceramic orbital implants DISPOSABLE TANO POLISHER, 20GA DISPOSABLE TANO POLISHER, 25GA DISPOSABLE TANO POLISHER, 23GA Crawford Bicanaliculus Intubation Transnasal Lacrimal Stent Becker Stent Single-Use Three-Mirrors Contact Lens 3 MIRRORS CONTACT LENS ( SINGLE USE ) Tissue Expander Hemisphere 0,9ml Tissue Expander Hemisphere 0,9ml/P Tissue Expander Sphere 1ml Tissue Expander Hemisphere 1,5ml Tissue Expander Sphere 4ml Tissue Expander Hemisphere 0,4ml Tissue Expander Sphere 5ml Tissue Expander Hemisphere 2ml Tissue Expander Sphere 2ml Tissue Expander Sphere 3ml STRAIGHT LASER PROBE, 27G QUANTEL STRAIGHT LASER PROBE, 27G DORC STRAIGHT LASER PROBE, 27G ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT ILLUM LASER PROBE,20G ALC/COH/ZEISS/ELLEX/OS4&19G N. FLEX CURVED LASER PROBE, 25G QUANTEL T.CURVED ILLUM LASER PROBE,23G QUANTEL & 19G NEEDLE 90 DEGREE ADJUSTABLE LASER PROBES, 23GA DORC CURVED LASER PROBE, 25G IRIDEX/B&L T.CURVED ILLUM LASER PROBE,25G IRIDEX/B&L & 19G NEEDLE FLEX CURVED LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4 CURVED ILLUM LASER PROBE,20G DORC & 19G NEEDLE STRAIGHT LASER PROBE, 25G QUANTEL STRAIGHT LASER PROBE, 20G DORC CURVED ILLUM LASER PROBE,20G NIDEK & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,20G NIDEK & 19G NEEDLE STRAIGHT LASER PROBE, 23G QUANTEL STRAIGHT ILLUM LASER PROBE,20G IRIDEX/B&L & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,27G IRIDEX/B&L & 19G NEEDLE FLEX CURVED LASER PROBE, 25G NIDEK CURVED LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4 90 DEGREE ADJUSTABLE LASER PROBES, 23GA NIDEK/LUMENIS NOVUS SPECTRA STRAIGHT ILLUM LASER PROBE,20G QUANTEL & 19G NEEDLE 90 Degree ADJUSTABLE LASER PROBE, 23G QUANTEL T.CURVED ILLUM LASER PROBE,23G ALC/COH/ZEISS/ELLEX/OS4&19G N. 90 DEGREE ADJUSTABLE LASER PROBES, 23GA ALCON/COHERENT/ZEISS/ELLEX/OS4 90 DEGREE ADJUSTABLE LASER PROBES, 25GA ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT ILLUM LASER PROBE,27G ALC/COH/ZEISS/ELLEX/OS4&19G N. STRAIGHT ILLUM LASER PROBE,23G ALC/COH/ZEISS/ELLEX/OS4&19G N. STRAIGHT LASER PROBE, 20G IRIDEX/B&L T.CURVED ILLUM LASER PROBE,25G DORC & 19G NEEDLE T.CURVED ILLUM LASER PROBE,25G NIDEK & 19G NEEDLE STRAIGHT LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4 FLEX CURVED LASER PROBE, 23G QUANTEL CURVED ILLUM LASER PROBE,20G IRIDEX/B&L & 19G NEEDLE CURVED LASER PROBE, 20G NIDEK T.CURVED ILLUM LASER PROBE,23G IRIDEX/B&L & 19G NEEDLE FLEX CURVED LASER PROBE, 23G IRIDEX/B&L STRAIGHT ILLUM LASER PROBE,23G NIDEK & 19G NEEDLE 90 DEGREE ADJUSTABLE LASER PROBES, 25GA DORC STRAIGHT LASER PROBE, 27G IRIDEX/B&L STRAIGHT LASER PROBE, 23G ALCON/COHERENT/ZEISS/ELLEX/OS4 CURVED LASER PROBE, 25G QUANTEL CURVED LASER PROBE, 23G IRIDEX/B&L STRAIGHT LASER PROBE, 27G NIDEK STRAIGHT LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4 STRAIGHT ILLUM LASER PROBE,25G ALC/COH/ZEISS/ELLEX/OS4&19G N. STRAIGHT ILLUM LASER PROBE,27G QUANTEL & 19G NEEDLE CURVED LASER PROBE, 23G DORC STRAIGHT ILLUM LASER PROBE,25G NIDEK & 19G NEEDLE STRAIGHT LASER PROBE, 23G NIDEK STRAIGHT LASER PROBE, 25G DORC STRAIGHT ILLUM LASER PROBE,25G QUANTEL & 19G NEEDLE CURVED LASER PROBE, 23G NIDEK STRAIGHT ILLUM LASER PROBE,27G DORC & 19G NEEDLE STRAIGHT LASER PROBE, 23G DORC CURVED LASER PROBE, 23G QUANTEL CURVED LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4 FLEX CURVED LASER PROBE, 25G IRIDEX/B&L 90 DEGREE ADJUSTABLE LASER PROBE, 23G IRIDEX/B&L CURVED ILLUM LASER PROBE,20G QUANTEL & 19G NEEDLE FLEX CURVED LASER PROBE, 23G DORC STRAIGHT LASER PROBE, 25G NIDEK CURVED LASER PROBE, 20G DORC STRAIGHT ILLUM LASER PROBE,23G DORC & 19G NEEDLE T.CURVED ILLUM LASER PROBE,23G DORC & 19G NEEDLE STRAIGHT LASER PROBE, 20G QUANTEL STRAIGHT LASER PROBE, 25G IRIDEX/B&L FLEX CURVED LASER PROBE, 23G NIDEK CURVED LASER PROBE, 20G IRIDEX/B&L STRAIGHT ILLUM LASER PROBE,25G DORC & 19G NEEDLE T.CURVED ILLUM LASER PROBE,23G NIDEK & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,25G IRIDEX/B&L & 19G NEEDLE T.CURVED ILLUM LASER PROBE,25G QUANTEL & 19G NEEDLE STRAIGHT LASER PROBE, 20G NIDEK STRAIGHT ILLUM LASER PROBE,23G QUANTEL & 19G NEEDLE STRAIGHT ILLUM LASER PROBE,27G NIDEK & 19G NEEDLE STRAIGHT LASER PROBE, 23G IRIDEX/B&L STRAIGHT ILLUM LASER PROBE,23G IRIDEX/B&L & 19G NEEDLE CURVED LASER PROBE, 20G ALCON/COHERENT/ZEISS/ELLEX/OS4 T.CURVED ILLUM LASER PROBE,25G ALC/COH/ZEISS/ELLEX/OS4&19G N. CURVED LASER PROBE, 25G DORC STRAIGHT ILLUM LASER PROBE,20G DORC & 19G NEEDLE CURVED LASER PROBE, 20G QUANTEL 90 DEGREE ADJUSTABLE LASER PROBES, 25GA IRIDEX/B&L CURVED LASER PROBE, 25G NIDEK FLEX CURVED LASER PROBE, 25G ALCON/COHERENT/ZEISS/ELLEX/OS4 90 DEGREE ADJUSTABLE LASER PROBES, 25GA QUANTEL CURVED ILLUM LASER PROBE,20G ALC/COH/ZEISS/ELLEX/OS4&19G N. FLEX CURVED LASER PROBE, 25G DORC 90 DEGREE ADJUSTABLE LASER PROBES, 25GA NIDEK/LUMENIS NOVUS SPECTRA FIBER OPTIC CONNECTOR BAUSCH & LOMB STELLARIS® FCI Directional laser probes, 23G, 25G, Compatible with Alcon® / Coherent / Zeiss / Ellex / OS4® / Lightmed FCI Directional Extendable laser probes, 23G, 25G, Compatible with Nidek Thread FCI Directional laser probes, 23G, 25G, Compatible with Iridex / Bausch+Lomb FCI Directional laser probes, 23G, 25G, Compatible with Dorc DORC Revolver Illumination Adapter FIBER OPTIC CONNECTOR ZEISS VISALIS FIBER OPTIC CONNECTOR ALCON-ACCURUS® AND CONSTELLATION® FCI Directional laser probes, 23G, 25G, Compatible with Nidek Thread FCI Directional Extendable laser probes, 23G, 25G, Compatible with Iridex / Bausch+Lomb FIBER OPTIC CONNECTOR COMPATIBLE WITH DORC FCI Directional Extendable laser probes, 23G, 25G, Compatible with Quantel Supra® / Vitra® FCI Directional laser probes, 23G, 25G, Compatible with Quantel Supra® / Vitra® FCI Directional Extendable laser probes, 23G, 25G, Compatible with Alcon® / Coherent / Zeiss / Ellex / OS4® / Lightmed FCI Directional Extendable laser probes, 23G, 25G, Compatible with DORC READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.8MM SMALL READY-SET PLUGS, SLIM PLUGS 0.4MM SLIM MINI READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.9MM MEDIUM READY-SET PLUGS, SLIM PLUGS 0.5MM SLIM PETITE READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.6MM MICRO READY-SET PLUGS, SLANTED COLLARETTE PLUGS 1MM LARGE READY-SET PLUGS, SLANTED COLLARETTE PLUGS 0.7MM MINI PRELOADED PUNCTAL PLUG (MINI US) - J.A. BERNARD TearSaver® 0.7 mm 2/box TearSaver® 0.6 mm 2/box PRELOADED PUNCTAL PLUG (EXTRA SMALL) - J.A. BERNARD PRELOADED PUNCTAL PLUG (SMALL) - J.A. BERNARD TearSaver® 0.4 mm 2/box TearSaver® 0.8 mm 2/box PRELOADED PUNCTAL PLUG STRAIGHT COLLARETTE (LARGE) PRELOADED PUNCTAL PLUG (MINI) - J.A. BERNARD PRELOADED PUNCTAL PLUG (REGULAR) - J.A. BERNARD PRELOADED PUNCTAL PLUG (LARGE) - J.A. BERNARD TearSaver® 0.5 mm 2/box PRELOADED PUNCTAL PLUG STRAIGHT COLLARETTE (SMALL) CRAWFORD Crawford Probe Disposable Sizers for Self-Retaining Stents RITLENG PROBE Ritleng Bicanaliculus Intubation SELF-THREADING MONOKA, 4MM WIDE SELF-THREADING MONOKA, 4MM WIDE PVP SELF-THREADING MONOKA, 3MM MEDIUM Ritleng bicanalicular intubation Watzke Sleeve Spreading Forceps ENDONASAL FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA SERRATED FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA END-GRASPING FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA ECKARDT (MACULORHEXIS) FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA SERRATED FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA TANO FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA ECKARDT (MACULORHEXIS) FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA TANO FORCEPS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA END-GRASPING FORCEPS Diamonized End-Gripping Vitreoretinal Forceps 25 GA Eckardt End-Gripping Forceps 20 GA PICK Vitreoretinal Forceps 25 GA Tano Assymmetrical End-Gripping Forceps 23 GA Vitreoretinal End-Gripping Forceps with Serrated Jaws 20 GA Flushing Adaptor (for vitreoretinal forceps/tips) ILM Vitreoretinal End-Gripping Forceps 20 GA Foreign Body Forceps 17 GA PICK Vitreoretinal Forceps 20 GA PICK Vitreoretinal Forceps 23 GA ILM Vitreoretinal End-Gripping Forceps 23 GA Angled Horizontal Subretinal Gripping Forceps 3 mm Tip 20 GA Diamonized End-Gripping Vitreoretinal Forceps 20 GA Eckardt End-Gripping Forceps 23 GA Eckardt End-Gripping Forceps 25 GA Tano Assymmetrical End-Gripping Forceps 25 GA Diamonized End-Gripping Vitreoretinal Forceps 23 GA Angled Horizontal Diamonized Gripping Forceps 20 GA Tano Assymmetrical End-Gripping Forceps 20 GA Forceps FCI Prolong Plug EZYPOR Retinal Tire Eptfe Retinal implants ePTFE SPONGE 3 mm ePTFE DUCOURNAU ® BAND 2 x 7 mm 4 x 3 mm ePTFE SPONGE (CHAUVAUD) ePTFE BAND 2.1 x 5.5 mm ePTFE SPONGE 2 x 5 mm ePTFE SPONGE 3 x 5 mm ePTFE HALF-SPONGE 2.5 x 7.5 mm 9 mm ePTFE STRIP (DESIGNED BY O. LEQUOY) ePTFE SPONGE 5 mm ePTFE SPONGE 4 mm ePTFE DUCOURNAU ® BAND 2.5 x 5.5 mm Membrane Pick 23 GA Membrane Pick 25 GA Ocular Shield DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA HORIZONTAL SCISSORS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA HORIZONTAL SCISSORS DISPOSABLE VITREORETINAL INSTRUMENTS, 25GA VERTICAL SCISSORS DISPOSABLE VITREORETINAL INSTRUMENTS, 23GA VERTICAL SCISSORS Curved Vitreoretinal Scissors 25 GA ANGLED 70 Degree VERTICAL VITREORETINAL SCISSORS 23 GA Curved Vitreoretinal Scissors 20 GA ANGLED 45 Degree VERTICAL VITREORETINAL SCISSORS 25 GA Straight Vitreoretinal Scissors with Rounded Blades 20 GA Curved Vitreoretinal Scissors 23 GA ANGLED 70 Degree VERTICAL VITREORETINAL SCISSORS 20GA ANGLED HORIZONTAL VITREORETINAL 55 Degree SCISSORS 1.7mm Blades 20 GA Claus Lucke Vertical Retinotomy Scissors 20 GA ANGLED 45 Degree HORIZONTAL VITREORETINAL SCISSORS 20 GA INFANT BIKA WIDE/MEDIUM COLLARETTE MONOKA, 4MM WIDE MINI MONOKA BIKA Bika for DCR Lacrimal Intubation Sets WIDE/MEDIUM COLLARETTE MONOKA, 3MM MEDIUM SELF-RETAINING SET II (SRS II), 25MM SELF-RETAINING SET II (SRS II), 30MM SELF-RETAINING SET II (SRS II), 35MM Retinal Strip Retinal Sleeve Retinal Sponge Retinal Band Retinal bands & strips Retinal Tire Retinal Tire (Type 276) BAND FOR REINFORCING SCLERA AT THE BACK OF THE EYE OPTHACATH, 2MM AND 3MM UNILATERAL KIT 1X3MM BALLOON CATHETER & DISPOSABLE INFLATION DEVICE OPTHACATH, 2MM AND 3MM BILATERAL KIT 2X2MM BALLOON CATHETER & DISPOSABLE INFLATION DEVICE OPTHACATH, 2MM AND 3MM BILATERAL KIT 2X3MM BALLOON CATHETER & DISPOSABLE INFLATION DEVICE OPTHACATH, 2MM AND 3MM UNILATERAL KIT 1X2MM BALLOON CATHETER & DISPOSABLE INFLATION DEVICE MASTERKA Single Use Backflush Passive & Active Aspiration DISPOSABLE BACKFLUSH HANDPIECES, 23GA BRUSH TIP DISPOSABLE CANNULAS, 20GA DUAL BORE TIP REUSABLE BACKFLUSH HANDLES, ACTIVE HANDLE DISPOSABLE BACKFLUSH HANDPIECES, 20GA DIAMOND DUSTED SOFT TIP DISPOSABLE BACKFLUSH HANDPIECES, 25GA DIAMOND DUSTED SOFT TIP DISPOSABLE CANNULAS, 25GA BLUNT TIP DISPOSABLE BACKFLUSH HANDPIECES, 20GA BLUNT TIP DISPOSABLE CANNULAS, 20GA BLUNT TIP DISPOSABLE BACKFLUSH HANDPIECES, 23GA SOFT TIP DISPOSABLE CANNULAS, 23GA SUBRETINAL TIP DISPOSABLE BACKFLUSH HANDPIECES, 25GA SOFT TIP DISPOSABLE CANNULAS, 20GA BRUSH TIP DISPOSABLE CANNULAS, 25GA SOFT TIP DISPOSABLE BACKFLUSH HANDPIECES, 23GA BLUNT TIP DISPOSABLE CANNULAS, 25GA SUBRETINAL TIP DISPOSABLE BACKFLUSH HANDPIECES, 23GA DIAMOND DUSTED SOFT TIP DISPOSABLE CANNULAS, 23GA BRUSH TIP DISPOSABLE BACKFLUSH HANDPIECES, 25GA BRUSH TIP DISPOSABLE BACKFLUSH HANDPIECES, 20GA SOFT TIP DISPOSABLE BACKFLUSH HANDPIECES, 27GA BLUNT TIP DISPOSABLE CANNULAS, 23GA DUAL BORE TIP DISPOSABLE BACKFLUSH HANDPIECES, 25GA BLUNT TIP DISPOSABLE CANNULAS, 23GA BLUNT TIP DISPOSABLE CANNULAS, 25GA DUAL BORE TIP DISPOSABLE CANNULAS, 25GA BRUSH TIP DISPOSABLE CANNULAS, 20GA SOFT TIP DISPOSABLE CANNULAS, 23GA SOFT TIP DISPOSABLE BACKFLUSH HANDPIECES, 20GA BRUSH TIP REUSABLE BACKFLUSH HANDLES, PASSIVE HANDLE Reusable Backflush Passive & Active Aspiration Replacement Reservoirs for Backflush STOPLOSS, 3.5MM 9MM STOPLOSS, 3.5MM 10MM STOPLOSS, 3.5MM 21MM STOPLOSS, 3.5MM 15MM STOPLOSS, 3.5MM 16MM STOPLOSS, 3.5MM 14MM STOPLOSS, 3.5MM 18MM STOPLOSS, 4MM 14MM STOPLOSS, 3.5MM 19MM STOPLOSS JONES TUBE INTRODUCER SET STOPLOSS, 4MM 15MM STOPLOSS, 3.5MM 12MM STOPLOSS, 3.5MM 22MM STOPLOSS, 3.5MM 17MM STOPLOSS, 3.5MM 11MM STOPLOSS, 4MM 16MM STOPLOSS, 4MM 13MM STOPLOSS, 3.5MM 13MM STOPLOSS, 4MM 22MM STOPLOSS, 4MM 19MM STOPLOSS, 4MM 21MM STOPLOSS, 4MM 9MM STOPLOSS, 4MM 18MM STOPLOSS, 4MM 17MM STOPLOSS, 4MM 11MM STOPLOSS, 4MM 10MM STOPLOSS JONES TUBE REMOVAL TOOL STOPLOSS, 4MM 12MM STOPLOSS, 3.5MM 20MM STOPLOSS, 4MM 20MM Mesh wrapped bioceramic orbital imp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZU	Plug, Punctum	Unknown	Class U	N/A	2009-03-11
MML	Weights, Eyelid, External	Ophthalmic	Class 2	886.5700	2021-05-03
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	1999-10-05
LZU	Plug, Punctum	Unknown	Class U	N/A	2009-03-11
NCB	Weights, Eyelid, Implantable	Ophthalmic	Class 2	886.5700	2021-07-26
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2013-03-05
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	1999-06-29
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	1999-10-05
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	1999-06-29
JYJ	Gauge, Measuring	Ear, Nose, Throat	Class 1	874.4420	2003-04-04
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2010-04-11
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2021-03-12
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2009-03-11
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-03-11
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2016-03-02
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	1999-10-05
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2016-11-04
HJZ	Crutch, Ptosis	Ophthalmic	Class 1	886.5600	2002-01-29
MQU	Ocular Peg	Ophthalmic	Class 2	886.3320	2009-03-11
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2009-03-11
MXY	Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal	Ophthalmic	Class 1	886.4350	2016-11-04
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2012-09-10
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-03-11
HJL	Lens, Condensing, Diagnostic	Ophthalmic	Class 1	886.1380	2016-08-02
NFM	Expander, Tissue, Orbital	Ophthalmic	Class 2	886.3320	2016-11-11
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2016-11-04
MPA	Endoilluminator	Gastroenterology, Urology	Class 2	876.1500	2016-11-04
HQB	Photocoagulator And Accessories	Ophthalmic	Class 2	886.4690	2016-11-04
LZU	Plug, Punctum	Unknown	Class U	N/A	2009-02-20
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-02-20
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-03-11
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-03-11
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1996-02-23
LZU	Plug, Punctum	Unknown	Class U	N/A	2019-07-17
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2022-06-24
HQX	Implant, Orbital, Extra-Ocular	Ophthalmic	Class 2	886.3340	2009-03-11
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-09-05
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-01-31
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-11-04
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-03-11
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2009-03-11
HQX	Implant, Orbital, Extra-Ocular	Ophthalmic	Class 2	886.3340	2009-03-11
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2013-09-25
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2012-09-10
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-12-13
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2015-10-22
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2009-03-11

Official Correspondent

No official correspondent registered.

US Agent Details

Paul Swift Business: CARL ZEISS MEDITEC USA, INC. Email: fdaagent.med.us@zeiss.com Phone: (817) 9258507

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Same Entity

Carl Zeiss Meditec AG (Jena)

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015534077	Carl Zeiss Meditec Digital Innovations Inc	Temple, TX, US
3032734659	Carl Zeiss Meditec (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
3010126268	Carl Zeiss Meditec Production, LLC.	Ontario, CA, US
2918630	CARL ZEISS MEDITEC INC	DUBLIN, CA, US
9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE

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K230411	ABBOTT MEDICAL	Dragonfly OpStar Imaging Catheter	2023-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0308-2026	Alcon Research LLC	1	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-0012-2007	Integrated Orbital Implants Inc	2	Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S
Z-0307-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000252 UNITY 27 GA CHANDELIER 8065000253 UNITY 27+DS WIDE ANGLE LIGHT PROBE Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-0581-2026	Alcon Research LLC	2	CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615745. Last updated year: 2026. Please use registration number 9615745 when referencing this establishment in official correspondence.