TECFEN MEDICAL

FDA Device Registration & Listing · Santa Barbara, CA, US · Registration 3010487482

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010487482
FEI Number
3010487482
Entity Name
TECFEN MEDICAL
City/State/Country
Santa Barbara, CA, US
Establishment Address
6100 HOLLISTER AVENUE, Building 3, Unit 3A/3B, Santa Barbara, CA 93117, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
TECFEN MEDICAL (Owner Number: 10047971)
Owner / Operator Contact Address
6100 Hollister Avenue, Building 3, Unit 3A/3B, Santa Barbara, CA 93117, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Tecfen Laser Probes Tecfen Thermometer Tecfen Medical Face Shield Eye Shield Tecfen Medical goggles Tecfen Medical Tape Tecfen Trephine Tecfen Ophthalmic Knife Tecfen Medical Intranasal Septal Splint Tecfen Iris Retractor Tecfen Skin Marker Tecfen sponges, spears, wipes, wicks Tecfen PVA and Cellulose Product Tecfen Silicone Ear Plug Ophthalmic Patient Drape Tecfen Otological Ventilation Tube Tecfen Ophthalmic Cannula Tecfen Keratome Blade Tecfen Ophthalmic Hook

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQB Photocoagulator And Accessories Ophthalmic Class 2 886.4690 2020-11-23
FQZ Thermometer, Clinical Color Change General Hospital Class 1 880.2900 2015-03-17
LYU Accessory, Surgical Apparel General, Plastic Surgery Class 1 878.4040 2020-09-08
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2016-08-09
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2024-06-24
HRH Trephine, Manual, Ophthalmic Ophthalmic Class 1 886.4350 2015-03-17
HNN Knife, Ophthalmic Ophthalmic Class 1 886.4350 2014-12-03
LYA Splint, Intranasal Septal Ear, Nose, Throat Class 1 874.4780 2021-03-15
HOC Clip, Iris Retractor Ophthalmic Class 1 886.4350 2018-03-14
FZZ Marker, Skin General, Plastic Surgery Class 1 878.4660 2019-03-20
HOZ Sponge, Ophthalmic Ophthalmic Class 2 886.4790 2023-07-28
HOZ Sponge, Ophthalmic Ophthalmic Class 2 886.4790 2014-11-20
LDG Kit, Earmold, Impression Ear, Nose, Throat Class 1 874.3300 2015-04-28
HMT Drape, Patient, Ophthalmic General, Plastic Surgery Class 2 878.4370 2016-08-31
ETD Tube, Tympanostomy Ear, Nose, Throat Class 2 874.3880 2015-04-03
HMX Cannula, Ophthalmic Ophthalmic Class 1 886.4350 2015-04-28
HNO Keratome, Ac-Powered Ophthalmic Class 1 886.4370 2014-11-20
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2019-03-20

Official Correspondent

GENE EKONOMI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TECFEN MEDICAL
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K874057 Myocure, Inc. OPHTHALMIC TIP & BLADE SCALPELS 1987-12-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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-0026-04 Surgical Specialties Corp 1
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024 Alcon Research LLC Aspex Facility 1
20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024 Alcon Research LLC Aspex Facility 1
ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024 Alcon Research LLC Aspex Facility 1
ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

Similar Registrations

Registration Number Establishment Name Location
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2246552 Isomedix Operations Inc. S Plainfield, NJ, US
3010208880 Alcon Research, LLC Lake Forest, CA, US
3015456951 Alcon Laboratories Belgium Puurs-Sint-Amands Antwerpen, BE
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010487482. Last updated year: 2026. Please use registration number 3010487482 when referencing this establishment in official correspondence.
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