Panels › Ophthalmic › Product code HRG · Class 1
Engine, Trephine, Accessories, Ac-Powered
Regulation 886.4070
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HRG
| Company | 510(k)s | Recalls |
|---|---|---|
| Bkg Opthalmics USA, Inc. | 1 | 0 |
| Edward Weck, Inc. | 1 | 0 |
| Intl. Ophthalmic Industries Corp. | 1 | 0 |
| Laser Center Dev. Corp. | 1 | 0 |
| Optical Systems Intl., Inc. | 1 | 0 |
| Scanlan Intl., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 14, 2001 | K013151 | ASMOTOM AUTOMATED TREPHINE SYSTEM Bkg Opthalmics USA, Inc. | HRG |
| Jun 23, 1998 | K981063 | AUTOMATED CORNEAL TREPHINE Laser Center Dev. Corp. | HRG |
| Jul 31, 1985 | K843957 | ULTRATHIN/SP LENS Optical Systems Intl., Inc. | HRG |
| Jun 5, 1984 | K841515 | SCANLAN VASCU-STATT II Scanlan Intl., Inc. | HRG |
| Jan 17, 1983 | K823901 | TREPHINE BLADES-VARIOUS MODELS Edward Weck, Inc. | HRG |
| Nov 5, 1979 | K791763 | (MICRO-KERATRON, MICRO DUCT TREPHINE) Intl. Ophthalmic Industries Corp. | HRG |
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