American Medical Optics
Walker, MI, US
American Medical Optics appears in FDA device records in Walker, MI. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for American Medical Optics between 1982 and 1986. The busiest year on record is 1984, with 12. The most recent is 1986, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1984 | 12 |
| 1985 | 3 |
| 1986 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K860001 | BARRAQUER-KRUMEICH REFRACTIVE SET | HNO | Substantially Equivalent | |
| K851264 | AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS | HLI | Substantially Equivalent | |
| K851263 | AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP | HLI | Substantially Equivalent | |
| K851262 | AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA | HLI | Substantially Equivalent | |
| K844150 | MEDICAL OPTICS PHACOEMULSIFICATION KIT | HQC | Substantially Equivalent | |
| K843966 | ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS | HQB | Substantially Equivalent | |
| K843965 | ARGON LASER PHOTOCOAGULATOR SYS | HQF | Substantially Equivalent | |
| K842504 | AMER. MEDICAL OPTICS DIGITAL KERATO- | HQL | Substantially Equivalent | |
| K842197 | AMERICAN MEDICAL OPTICS I/A KIT- IRRIG | HQE | Substantially Equivalent | |
| K842127 | AMERICAN MEDICAL OPTICS IMAGING SYS | IYO | Substantially Equivalent | |
| K842251 | AMERI. MEDICAL OPTICS ARGON LASER PHOTO | HQF | Substantially Equivalent | |
| K842250 | AMER. MEDICAL OPTICS ARGON/KRYPTON LASE | HQF | Substantially Equivalent | |
| K842128 | AMERICAN MEDICAL OPTICS PHOTOKERATO | HJA | Substantially Equivalent | |
| K841855 | AMER. MED. OPTICS ARGON LASER PHOTO | HQF | Substantially Equivalent | |
| K841856 | AMER. MED. OPTICS ARGON/KRYPTON LASER | HQF | Substantially Equivalent | |
| K833405 | IRRIGATION ASPIRATION KIT | HQC | Substantially Equivalent | |
| K823222 | INTRAOCULAR LENS GUIDE | KYB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain