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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2006 | Medex Inc MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch wit Terminated |
GWM | K822864 |
| Jan 6, 2006 | Integra Neuro Sciences NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit Terminated |
GWM | K050720 |
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