Instrument, Microsurgical
Regulation 882.4525
0510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in GZX
| Company | 510(k)s | Recalls |
|---|---|---|
| Keeler Instruments, Inc. | 4 | 0 |
| Downs Surgical , Ltd. | 2 | 0 |
| American Russian Medical Services, Inc. | 1 | 0 |
| American V. Mueller | 1 | 0 |
| Clarus Medical Systems, Inc. | 1 | 0 |
| Cordis Corp. | 1 | 0 |
| Kinetic Medical Products | 1 | 0 |
| Medtronic Xomed, Inc. | 0 | 1 |
| O.R. Specialties, Inc. | 1 | 0 |
| Prothia USA, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2007 | Medtronic Xomed, Inc. AccuGuide Injection Needles (Surface electrodes)
The AccuGuide EMG Injection Needle, product 8263210, contains 5 individually packaged and sterilized injection needles and 10 nonsterile surface ele Terminated |
GZX | K990793 |
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