Respire Medical
Respire Medical appears in FDA public data with 5 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1948-2018, Class II) was initiated on September 1, 2017. Its most recent 510(k) clearance was granted on May 31, 2022.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 3
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1948-2018 | Class II | Respire Pink+ Hard/Soft Oral Sleep Apnea Device | September 1, 2017 |
| Z-1947-2018 | Class II | Respire Pink Series EF+ Oral Sleep Apnea Device. | September 1, 2017 |
| Z-1951-2018 | Class II | Respire Pink H/S Oral Sleep Apnea Device | September 1, 2017 |
| Z-1949-2018 | Class II | Respire Pink+ Hard Oral Sleep Apnea Device | September 1, 2017 |
| Z-1950-2018 | Class II | Respire Pink H/S Oral Sleep Apnea Device | September 1, 2017 |