HRH
12 FDA 510(k) clearances · Product code
40 daysmedian time to decision
108 days90th percentile
12clearances measured
FDA profile
- Official device name
- Trephine, Manual, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1994: 1 · 1998: 3 · 1999: 2 · 2002: 1 · 2004: 2 · 2010: 4
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 |
|---|---|---|
| GAYHEART CORNEAL EXCISION DEVICE (K022843) | Stephens Instruments | 2002-11-01 |
| ARTHROSCOPE (K931792) | Intramed Laboratories, Inc. | 1994-06-13 |
| HEAD & CHIN RESTS (K873918) | Richmond Products, Inc. | 1987-10-28 |
| BARRON ROTARY BLADE TREPHINE USING HESSBURG-BARRON (K864520) | Precision Instruments, Inc. | 1987-01-20 |
| DEKNATEL (R) TREPHINE (K862524) | Deknatel, Inc. | 1986-08-11 |
| CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE (K861825) | Storz Instrument Co. | 1986-06-09 |
| BARRON TWIN BLADE TREPHINE FOR EPPIKARATOPHAKIA (K860648) | Precision Instruments, Inc. | 1986-03-25 |
| STEINWAY MICRO-KERATO-TREPHINE (K843646) | Steinway Instrument Co., Inc. | 1985-01-03 |
| RING SUPPORTED TREPHINE FOR CORNEA TRANS (K843048) | Precision Instruments, Inc. | 1984-10-05 |
| PEARCE CORNEAL TREPHINE (K812723) | Visitec Co. | 1981-10-13 |
| CORNEAL CUTTER AND ACCESSORIES (K781411) | Codman & Shurtleff, Inc. | 1978-09-20 |
| TROUTMAN CORNEAL PUNCH (K771866) | Edward Weck, Inc. | 1977-11-09 |
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Every clearance here is in the API, with alerts when new ones post.