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Device, Monitoring, Intracranial Pressure
FDA product code GWM · Class 2 · Neurology
650
Registered devices
6,841
Adverse events
52
Recalls
105
510(k) clearances
Devices with this code
N/A — MEDTRONIC PS MEDICAL, INC.CODMAN MICROSENSOR — Cerenovus, Inc.N/A — MEDTRONIC PS MEDICAL, INC.Exacta™ — MEDTRONIC PS MEDICAL, INC.CODMAN — Cerenovus, Inc.N/A — MEDTRONIC PS MEDICAL, INC.CODMAN — Cerenovus, Inc.Hummingbird® Parenchymal Catheter — Irras USA, Inc.Duet® — MEDTRONIC PS MEDICAL, INC.Exacta™ — MEDTRONIC PS MEDICAL, INC.NA — Medos International SàrlCODMAN — Cerenovus, Inc.Duet® — MEDTRONIC PS MEDICAL, INC.IRRAflow® Drainage Collection System — Irras USA, Inc.Camino® — INTEGRA LIFESCIENCES (IRELAND) LIMITEDAURA — Branchpoint & Aura Development LLCHummingbird® Patient Monitor — Irras USA, Inc.Duet® — MEDTRONIC PS MEDICAL, INC.Becker — MEDTRONIC PS MEDICAL, INC.Becker® — MEDTRONIC PS MEDICAL, INC.QFlow 500 Probe Dura Piercer and Introducer Kit — HEMEDEX, INCEDM — MEDTRONIC PS MEDICAL, INC.Licox® — Integra LifeSciences Switzerland SàrlCAMINO® — INTEGRA LIFESCIENCES CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-12 | Integra LifeSciences Corp. (NeuroSciences) | Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. |
| 2025-12-12 | Integra LifeSciences Corp. (NeuroSciences) | Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. |
| 2025-11-17 | Sophysa | Customer complaints of Pressio monitor rebooting. |
| 2024-11-01 | Medtronic Neurosurgery | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). |
| 2024-11-01 | Medtronic Neurosurgery | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device d |
| 2024-04-09 | Sophysa S.A. | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during impl |
| 2024-04-09 | Sophysa S.A. | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during impl |
| 2023-10-05 | Integra LifeSciences Corp. | Firm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated corrective a |
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