MAUDE manufacturer profile
RANIR LLC · OBR
MAUDE profile for Mouthguard, Over-The-Counter
Key facts
| Manufacturer | RANIR LLC |
|---|---|
| Manufacturer group | RANIR LLC |
| Product code | OBR |
| Product code name | Mouthguard, Over-The-Counter |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Break, Adverse Event Without Identified Device or Use Problem, No Code Available, Insufficient Information, Swelling, Patient-Device Incompatibility, Reaction 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