International Medical Industries, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0925-2023 | Class II | Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarde | September 16, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231095 | Tamper Evident Cap | September 4, 2024 |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip Caps | December 16, 2020 |
| K193192 | Tamper Evident Cap | January 31, 2020 |
| K190305 | Additive Cap | April 30, 2019 |
| K182545 | Tamper Evident Cap with Male Luer Lock | January 11, 2019 |
| K173577 | Guarded Luer Connector | June 7, 2018 |
| K170672 | Tamper Evident Cap For use with ENFit Syringes | October 6, 2017 |