Electrode, Depth
Regulation 882.1330
1510(k)s in 12 months (58 all time)
0recalls in 12 months (24 all time)
24recalls that name a 510(k)
Top companies in GZL
| Company | 510(k)s | Recalls |
|---|---|---|
| Ad-Tech Medical Instrument Corp | 13 | 8 |
| Dixi Medical | 2 | 9 |
| Alpha Omega Engineering , Ltd. | 8 | 1 |
| FHC, Inc. | 4 | 5 |
| Alpha Omega , Ltd. | 3 | 0 |
| Pmt Corp. | 3 | 0 |
| Progress Mankind Technology | 3 | 0 |
| Cyberkinetics Neurotechnology Systems, Inc. | 1 | 1 |
| Ice Neurosystems, Inc. | 2 | 0 |
| Neuroone Medical Technologies Corp. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 9, 1995 | K946018 | TENS-IT, FITTRONIC II, (MORE LATER) Ems, Inc. | GZL |
| Jan 20, 1995 | K944061 | CUEVA CRANIAL NERVE ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Sep 7, 1990 | K902976 | MEDI MODEL SBL502-B (LISS BODY STIMULATOR) ZERO DC Medical Consultants Intl. , Ltd. | GZL |
| Jul 27, 1989 | K891920 | AD-TECH'S DEPTH ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Aug 25, 1986 | K861031 | WYLER SPHENOIDAL ELECTRODE Ad-Tech Medical Instrument Corp | GZL |
| Nov 19, 1980 | K802249 | MICROLET FAMILY OF NEEDLE/DEPTH ELECT- Progress Mankind Technology | GZL |
| Nov 19, 1980 | K802152 | PMT DEPTHALON DEPTH #2102 Progress Mankind Technology | GZL |
| Nov 19, 1980 | K802151 | PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC Progress Mankind Technology | GZL |
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