Panels › Ophthalmic › Product code HMY · Class 1
Keratome, Battery-Powered
Regulation 886.4370
0510(k)s in 12 months (12 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in HMY
| Company | 510(k)s | Recalls |
|---|---|---|
| Moria SA | 5 | 0 |
| Becton, Dickinson & CO | 2 | 0 |
| Insight Technologies Instruments, LLC | 2 | 0 |
| BD Opthalmic Systems | 0 | 1 |
| Becton Dickinson and Company | 0 | 1 |
| Codman & Shurtleff, Inc. | 1 | 0 |
| Industrial & Medical Design, Inc. | 1 | 0 |
| Visitec Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 2004 | K040297 | ONEUSE- PLUS MICROKERATOME Moria SA, FR | HMY |
| Oct 18, 2002 | K023092 | BD K-4000 MICROKERATOME SYSTEM Becton, Dickinson & CO | HMY |
| Oct 16, 2002 | K022637 | BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME Becton, Dickinson & CO | HMY |
| Sep 27, 2002 | K022560 | M2 SINGLE USE MICROKERTOME Moria SA, FR | HMY |
| Mar 9, 2001 | K003594 | CARRIAZO BARRAQUER SINGLE USE MICROKERATOME Moria, Inc., FR | HMY |
| Oct 12, 2000 | K002191 | CARRIAZO BARRAQUER II MICROKERATOME Moria, Inc., FR | HMY |
| Sep 24, 1999 | K992687 | MILLENIUM MICROKERATOME, MODEL IMD-001 Industrial & Medical Design, Inc. | HMY |
| May 14, 1999 | K984537 | KERATOME SYSTEM, MODEL K3000 Insight Technologies Instruments, LLC | HMY |
| Jul 24, 1998 | K981741 | CARRIAZO BARRAQUER MICROKERATOME Moria, Inc., FR | HMY |
| Jan 20, 1998 | K974243 | KERATOME SYSTEM Insight Technologies Instruments, LLC | HMY |
| Jul 31, 1990 | K902857 | VISI-DRAPE OPHTHALMIC DRAPES Visitec Co. | HMY |
| Oct 11, 1978 | K781412 | OSCILLATING KNIFE AND ACCESSORIES Codman & Shurtleff, Inc. | HMY |
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