Pharmaceutical Innovations, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 5
- Inspections
- 5
- Compliance Actions
- 3
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2830-2020 | Class II | Ultra/Phonic Focus BP Conforming Gel Pads, UDI 00300361301021 (Primary); 10300361301028 (Package) - | August 13, 2020 |
| Z-1970-2019 | Class II | ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution. | June 19, 2019 |
| Z-1971-2019 | Class II | ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution. | June 19, 2019 |
| Z-1969-2019 | Class II | ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution. | June 19, 2019 |
| Z-1968-2019 | Class II | Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray so | June 19, 2019 |
| Z-1972-2019 | Class II | Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray | June 19, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K163026 | Ultra/Phonic Scanning Gel | January 9, 2018 |
| K163027 | Ultra/Phonic Free Conductivity Gel | January 9, 2018 |
| K163023 | Other-Sonic Transmission Gel | January 8, 2018 |
| K163024 | Ultra/Phonic Conductivity Gel | January 8, 2018 |
| K961222 | EVRON GEL | June 26, 1996 |