Primed Medical Products, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252964 | PRIMED Surgical and Procedure Masks | November 4, 2025 |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | October 7, 2024 |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | August 26, 2024 |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | May 24, 2024 |
| K213427 | PRIMED Pediatric Facemask | November 22, 2022 |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | November 4, 2016 |
| K092012 | PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-708 | September 25, 2009 |
| K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS | August 11, 2008 |