POM Medical LLC
FDA Regulatory Profile
POM Medical LLC appears in FDA public data with 1 recall, 1 510(k) clearance, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0262-2020, Class II) was initiated on July 11, 2018. Its most recent 510(k) clearance was granted on April 19, 2018.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0262-2020 | Class II | POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM | July 11, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K172365 | Panoramic Oxygen Mask (POM) | April 19, 2018 |