Device, Nerve Conduction Velocity Measurement
Regulation 882.1550
0510(k)s in 12 months (27 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JXE
| Company | 510(k)s | Recalls |
|---|---|---|
| Neurometrix, Inc. | 7 | 0 |
| Chalgren Enterprises, Inc. | 2 | 0 |
| Neurotron Medical | 2 | 0 |
| Bak Electronics | 1 | 0 |
| Biomet, Inc. | 0 | 1 |
| Cadwell Laboratories, Inc. | 1 | 0 |
| Excel Tech. , Ltd. | 1 | 0 |
| Grass Instrument Co. | 1 | 0 |
| Impulse Systems, Inc. | 1 | 0 |
| Insight Medical Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2012 | Biomet, Inc. Ultra-DriveTool, 6 MM Plug Puller, REF 423868. Recommended Power Setting 70 For Single Use Only, Sterile, Biomet Orthopedics, Warsaw, IN 46581
Incorrect Picture Label, Trochanter Plate (50-60 mm) Ma Terminated |
JXE | K031280 |
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