MAUDE manufacturer profile
INSIGHTEC LTD. · POH
MAUDE profile for Mr-Guided Focused Ultrasound System
Key facts
| Manufacturer | INSIGHTEC LTD. |
|---|---|
| Manufacturer group | INSIGHTEC LTD. |
| Product code | POH |
| Product code name | Mr-Guided Focused Ultrasound System |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Insufficient Information, Ambulation Difficulties, Numbness, Muscle Weakness/Atrophy, Balance Problems, Speech Disorder, No Code Available Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1