FDA Product Code
FDA Product Code MOE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4750
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K944872 | BIO-COR COLLAGEN CORNEAL SHIELD | Bausch & Lomb Healthcare and Optics Worldwide | 1995-07-26 | Traditional | PDF ↗ |
| K915861 | MEDILENS-CS CORNEAL SHIELD | Chiron Ophthalmics | 1992-03-06 | Traditional | PDF ↗ |
| K914529 | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS | Oasis Medical, Inc. | 1991-11-13 | Traditional | PDF ↗ |
| K913148 | COLLAGEN SHIELD FOR ACUTE CARE | Vitaphore Corp. | 1991-10-15 | Traditional | PDF ↗ |
| K905825 | COLLAGEN SHIELD, VARIOUS MODELS | Chiron Ophthalmics | 1991-06-10 | Traditional | PDF ↗ |
| K902558 | COLLAGEN SHIELD FOR ACUTE CARE | Vitaphore Corp. | 1990-08-17 | Traditional | PDF ↗ |
| K901880 | MEDILENS(TM) CORNEAL SHIELD | Chiron Ophthalmics | 1990-07-02 | Traditional | PDF ↗ |
| K896449 | IM COLLAGEN SHIELD | Intermedical, Inc. | 1990-05-24 | Traditional | PDF ↗ |
| K884962 | ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA | Bausch & Lomb Pharmaceutical, Inc. | 1990-02-09 | Traditional | PDF ↗ |
| K885015 | COI 72 HR COLLAGEN SHIELD | Chiron Ophthalmics | 1989-06-23 | Traditional | PDF ↗ |
| K884961 | ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K884960 | ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1989-02-13 | Traditional | PDF ↗ |
| K885016 | COI 24 HR COLLAGEN SHIELD | Chiron Ophthalmics | 1989-02-01 | Traditional | PDF ↗ |
| K884363 | LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 | Traditional | PDF ↗ |
| K884364 | LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL | Bausch & Lomb Pharmaceutical, Inc. | 1988-11-29 | Traditional | PDF ↗ |
| K882762 | COLLAGEN SHIELD | Chiron Ophthalmics | 1988-09-12 | Traditional | PDF ↗ |
| K874224 | BIO-COR II COLLAGEN CORNEAL SHIELD | Bausch & Lomb, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K874225 | BIO-COR EXT COLLAGEN CORNEAL SHIELD | Bausch & Lomb, Inc. | 1988-01-22 | Traditional | PDF ↗ |
| K862315 | FYODOROV COLLAGEN CORNEAL SHIELD | Medical Technology Development Corp. | 1987-01-07 | Traditional | PDF ↗ |
Product code MOE · Class I · Ophthalmic. Data: openFDA.