Ohio Medical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 2
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1980-2025 | Class II | GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S | May 8, 2025 |
| Z-0482-2022 | Class II | Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (mod | November 16, 2021 |
| Z-2995-2018 | Class II | Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Mo | August 14, 2018 |
| Z-2410-2018 | Class II | Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regu | March 12, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K081185 | MOBLVAC W.C. | May 2, 2008 |
| K062610 | CARE-E-VAC 3 | September 28, 2006 |