HRJ
7 FDA 510(k) clearances · Product code
63 daysmedian time to decision
161 days90th percentile
7clearances measured
FDA profile
- Official device name
- Table, Instrument, Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4855
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MARCO H AND TS-1 INSTRUMENT TABLES (K930447) | Marco Ophthalmic, Inc. | 1993-07-06 |
| 910T MONTORIZED INSTRUMENT TABLE (K922242) | R.H. Burton Co. | 1992-09-30 |
| TBD, LENS MEASURING DEVICE (K912134) | Alcon Laboratories | 1991-07-25 |
| TECHNA VISION, INC.ELECTRIC TABLE (K853744) | Techna Vision | 1985-10-17 |
| RELIANCE 1379 (K853359) | Dentsply Intl. | 1985-09-24 |
| WOODLYN CLASSIC INSTRUMENT STAND (K841760) | Woodlyn, Inc. | 1984-06-19 |
| MACHEMER/TANO ROTATING (K833820) | Optical Micro Systems, Inc. | 1984-01-04 |
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Every clearance here is in the API, with alerts when new ones post.