FDA Registration
Active
🇫🇷 France
FCI SAS
Reg #: 9615745
·
FEI: 3000314405
·
Expires 2026
Products
30
Proprietary Names
386
Establishment Types
4
Classifications
30
Registration Details
- Registration Name
- FCI SAS
- Registration Number
- 9615745
- FEI Number
- 3000314405
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 rue Carl Zeiss
- City
- BESANCON Doubs
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K964774
Owner / Operator
- Firm Name
- Carl Zeiss Meditec AG (Jena)
- Operator Number
- 9053564
- Address
- Goeschwitzer Strasse 51-52
- City
- Jena
- State
- Thuringia
- Postal Code
- 07745
- Country
- DE
US Agent
- Business Name
- CARL ZEISS MEDITEC USA, INC.
- Contact Name
- Paul Swift
- Address
- 5300 Central Pkwy
- City
- Dublin
- State
- CA
- ZIP
- 94568
- Country
- US
- [email protected]
- Phone
- 817 9258507
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plug, Punctum | LZU | Class U | Unknown | No | 2009-03-11 |
| Weights, Eyelid, External | MML | Class 2 | Ophthalmic | No | 2021-05-03 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 1999-10-05 |
| Weights, Eyelid, Implantable | NCB | Class 2 | Ophthalmic | No | 2021-07-26 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2013-03-05 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 1999-06-29 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 1999-10-05 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 1999-06-29 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 2003-04-04 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2010-04-11 |
| Lacrimal Stents And Intubation Sets | OKS | Class U | Unknown | No | 2021-03-12 |
| Implant, Eye Sphere | HPZ | Class 2 | Ophthalmic | No | 2009-03-11 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2016-03-02 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 1999-10-05 |
| Crutch, Ptosis | HJZ | Class 1 | Ophthalmic | No | 2002-01-29 |
| Ocular Peg | MQU | Class 2 | Ophthalmic | No | 2009-03-11 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2016-11-04 |
| Lens, Condensing, Diagnostic | HJL | Class 1 | Ophthalmic | No | 2016-08-02 |
| Expander, Tissue, Orbital | NFM | Class 2 | Ophthalmic | No | 2016-11-11 |
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2016-11-04 |
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2016-11-04 |
| Photocoagulator And Accessories | HQB | Class 2 | Ophthalmic | No | 2016-11-04 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1996-02-23 |
| Implant, Orbital, Extra-Ocular | HQX | Class 2 | Ophthalmic | No | 2009-03-11 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2018-09-05 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2020-01-31 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2016-11-04 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2012-12-13 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2009-03-11 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2009-03-11 |
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
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
MINI MONOKA
BIKA
Bika for DCR
Lacrimal Intubation Sets
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 (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
Bige II
Self-Retaining Bicanaliculus Intubation Set II
LacriJet
Painless Plug
Snug Plug
disposable infusion cannula
surgical knife
Disposable vitrectomy lens
DISPOSABLE SIZERS
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor
Complaint File Establishment per 21 CFR 820.198