Tecfen Medical
Santa Barbara, CA, US
TECFEN MEDICAL appears in FDA device records in Santa Barbara, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010487482 | 3010487482 | TECFEN MEDICAL | 6100 HOLLISTER AVENUE, Santa Barbara, CA 93117 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- HMXCannula, Ophthalmic
- HOCClip, Iris Retractor
- HMTDrape, Patient, Ophthalmic
- KKXDrape, Surgical, Antimicrobial
- HNQHook, Ophthalmic
- HNOKeratome, Ac-Powered
- LDGKit, Earmold, Impression
- HNNKnife, Ophthalmic
- HQFLaser, Ophthalmic
- FZZMarker, Skin
- HQBPhotocoagulator And Accessories
- LZUPlug, Punctum
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- LYASplint, Intranasal Septal
- HOZSponge, Ophthalmic
- HQYSunglasses (Non-Prescription Including Photosensitive)
- KGXTape And Bandage, Adhesive
- FQZThermometer, Clinical Color Change
- HRHTrephine, Manual, Ophthalmic
- ETDTube, Tympanostomy
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1955-2025 | Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No | Sterility assurance for Ophthalmic knives. | Class II | Open, Classified | |
| Z-1954-2025 | Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent knife is used to create smooth, curved incisions for corneal transplant procedures, used in small incision cataract surgery and phacoemulsification to create self-sealing scleral tunnels, used for creating tunnel incisions in the sclera and cornea during procedures like trabeculectomy. Component: No | Sterility assurance for Ophthalmic knives. | Class II | Open, Classified | |
| Z-1953-2025 | Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport knives are used to create precision incisions in vitrectomy procedures. Component: No | Sterility assurance for Ophthalmic knives. | Class II | Open, Classified | |
| Z-1952-2025 | Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No | Sterility assurance for Ophthalmic knives. | Class II | Open, Classified | |
| Z-1951-2025 | Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No | Sterility assurance for Ophthalmic knives. | Class II | Open, Classified | |
| Z-1950-2025 | Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No | Sterility assurance for Ophthalmic knives. | Class II | Open, Classified | |
| Z-1949-2025 | Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Stab knives are used to make precise and fluid tight incisions during eye surgeries such as cataract procedures, vitreoretinal surgery, glaucoma surgery, corneal surgery, and oculoplastic procedures. Component: No | Sterility assurance for Ophthalmic knives. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain