Woodlyn, Inc.
Mchenry, IL, US
Woodlyn, Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(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
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Woodlyn, Inc. between 1984 and 1993. The busiest year on record is 1984, with 12. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 12 |
| 1987 | 1 |
| 1989 | 1 |
| 1990 | 3 |
| 1992 | 1 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K931303 | WOODLYN OPERATION MICROSCOPE | FSO | Substantially Equivalent | |
| K920861 | WOODLYN CLASSIC LENSMETER | HLM | Substantially Equivalent | |
| K900478 | WOODLYN FULL APERTURE TRIAL LENS SET | HPC | Substantially Equivalent | |
| K900477 | WOODLYN CLASSIC SLIT LAMP MODEL SMM | HJO | Substantially Equivalent | |
| K900476 | WOODLYN SLIT LAMP MODEL HR-1 | HJO | Substantially Equivalent | |
| K890992 | WOODLYN OPHTHALMIC PROJECTOR | HOS | Substantially Equivalent | |
| K874900 | WOODLYN CLASSIC REFRACTOR, PHOROPTOR | HKN | Substantially Equivalent | |
| K843812 | WOODLYN CLASSIC CATARACT ACUITY TEST | HLI | Substantially Equivalent | |
| K841767 | WOODLYN CLASSIC KERATOMETER | HLI | Substantially Equivalent | |
| K841765 | WOODLYN STANDARD SLIT LAMP HSSL-ST | HLQ | Substantially Equivalent | |
| K841764 | WOODLYN CLASSIC JAVAL OPHTHALMOMETER | HLI | Substantially Equivalent | |
| K841761 | WOODLYN CLASSIC SLIT LAMP HSSL-CL | HLI | Substantially Equivalent | |
| K841763 | WOODLYN SLIT LAMP HSSL-EC | HLI | Substantially Equivalent | |
| K841762 | WOODLYN APPLANATION TONOMETER | HKX | Substantially Equivalent | |
| K842045 | WOODLYN CLASSIC EXAM. CHAIR | HME | Substantially Equivalent | |
| K841760 | WOODLYN CLASSIC INSTRUMENT STAND | HRJ | Substantially Equivalent | |
| K841768 | WOODLYN LIGHTWEIGHT TRIAL FRAME | HPA | Substantially Equivalent | |
| K841766 | WOODLYN CLASSIC TRIAL LENS SET | HPC | Substantially Equivalent | |
| K841759 | OPHTHALMIC TABLE | HMG | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- HMEChair, Ophthalmic, Ac-Powered
- HPAFrame, Trial, Ophthalmic
- HLMInstrument, Measuring, Lens, Ac-Powered
- HLQKeratoscope, Ac-Powered
- FSOMicroscope, Surgical, General & Plastic Surgery
- HLIOphthalmoscope, Ac-Powered
- HOSProjector, Ophthalmic
- HKNRefractor, Manual, Non-Powered, Including Phoropter
- HPCSet, Lens, Trial, Ophthalmic
- HMGStand, Instrument, Ophthalmic, Non-Powered
- HRJTable, Instrument, Powered, Ophthalmic
- HKXTonometer, Ac-Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain
