Company ยท CA
Primed Medical Products, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FXX | Mask, Surgical | 4 |
| FRG | Wrap, Sterilization | 2 |
| FYC | Gown, Isolation, Surgical | 1 |
| OXZ | Pediatric/Child Facemask | 1 |
| QPC | Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection | 1 |
| QSO | Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2026 | K262007 | PRIMED AAMI Level 3 Open Back Gowns PRIMED Medical Products, Inc., CA | QPC |
| Sep 1, 2026 | K261811 | PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PRIMED Medical Products, Inc., CA | QSO |
| Nov 4, 2025 | K252964 | PRIMED Surgical and Procedure Masks Primed Medical Products, Inc., CA | FXX |
| Oct 7, 2024 | K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) Primed Medical Products, Inc., CA | FRG |
| Aug 26, 2024 | K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks Primed Medical Products, Inc., CA | FXX |
| May 24, 2024 | K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) Primed Medical Products, Inc., CA | FRG |
| Nov 22, 2022 | K213427 | PRIMED Pediatric Facemask Primed Medical Products, Inc., CA | OXZ |
| Nov 4, 2016 | K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) Primed Medical Products, Inc., CA | FYC |
| Sep 25, 2009 | K092012 | PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 Primed Medical Products, Inc., CA | FXX |
| Aug 11, 2008 | K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS Primed Medical Products, Inc., CA | FXX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||