Panels › Ophthalmic › Product code HJB · Class 1
Instrument, Measuring, Corneal Radius
Regulation 886.1450
0510(k)s in 12 months (5 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in HJB
| Company | 510(k)s | Recalls |
|---|---|---|
| Haag-Streit USA Inc | 0 | 2 |
| Acufex Microsurgical, Inc. | 1 | 0 |
| Heidelberg Instruments | 1 | 0 |
| Kera Corp. | 1 | 0 |
| Marco Ophthalmic, Inc. | 1 | 0 |
| R.H. Burton Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 9, 1993 | K930444 | MARCO STANDARD KERATOMETERS Marco Ophthalmic, Inc. | HJB |
| Apr 5, 1993 | K924779 | BURTON KERATOMETER - MODLE 2040 R.H. Burton Co. | HJB |
| Dec 15, 1986 | K864369 | LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER Heidelberg Instruments | HJB |
| Nov 13, 1986 | K864037 | KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER Kera Corp. | HJB |
| Sep 11, 1985 | K852424 | ACUFEX COMPARATIVE SURGICAL KERATOMETER Acufex Microsurgical, Inc. | HJB |
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