Device, Monitoring, Intracranial Pressure
Regulation 882.1620
1510(k)s in 12 months (105 all time)
3recalls in 12 months (52 all time)
47recalls that name a 510(k)
Top companies in GWM
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corporation | 8 | 26 |
| Codman & Shurtleff, Inc. | 9 | 12 |
| Innerspace, Inc. | 7 | 0 |
| Raumedic AG | 6 | 0 |
| Sophysa | 3 | 3 |
| Integra Neurosciences | 5 | 0 |
| Metatech Corp. | 5 | 0 |
| Camino Laboratories, Inc. | 4 | 0 |
| Cma Microdialysis AB | 4 | 0 |
| Camino Neurocare, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 31, 1980 | K802137 | CHEEK EPIDURAL SCREW Codman & Shurtleff, Inc. | GWM |
| Sep 16, 1980 | K802100 | INTRACRANIAL PRESSURING MONITORING SYST. Pudenz-Schulte Medical Research Corp. | GWM |
| Aug 13, 1980 | K801755 | MMI/GAELTEC CATHETER TIP PRESSURE Medical Measurements, Inc. | GWM |
| Aug 3, 1979 | K790920 | INTRACRANIAL PRESSURE MONITORING Codman & Shurtleff, Inc. | GWM |
| Jan 3, 1978 | K772063 | CATHETER, INTRACRANIAL PRESS. MONITOR. Cordis Corp. | GWM |
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