Primed Medical Products Inc.
Edmonton Alberta, CA
PRIMED MEDICAL PRODUCTS INC. appears in FDA device records in Edmonton Alberta, CA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Primed Medical Products Inc. between 2008 and 2025. The busiest year on record is 2024, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2009 | 1 |
| 2016 | 1 |
| 2022 | 1 |
| 2024 | 3 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252964 | PRIMED Surgical and Procedure Masks | FXX | Substantially Equivalent | |
| K242208 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | FRG | Substantially Equivalent | |
| K240286 | PRIMED Surgical Masks and PRIMED Procedure Masks | FXX | Substantially Equivalent | |
| K233777 | PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) | FRG | Substantially Equivalent | |
| K213427 | PRIMED Pediatric Facemask | OXZ | Substantially Equivalent | |
| K160361 | PRIMAGARD Isolation Gown (AAMI PB70 Level 3) | FYC | Substantially Equivalent | |
| K092012 | PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70 | FXX | Substantially Equivalent | |
| K081633 | PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKS | FXX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615270 | 3002750002 | PRIMED MEDICAL PRODUCTS INC. | 200, 2003 - 91 Street SW, Edmonton Alberta T6X0W8 CA | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- FYFCap, Surgical
- FXPCover, Shoe, Operating-Room
- FYEDress, Surgical
- FMEGown, Examination
- FYCGown, Isolation, Surgical
- MDMInstrument, Manual, Surgical, General Use
- FXXMask, Surgical
- OEANon-Surgical Gown
- OXZPediatric/Child Facemask
- LZAPolymer Patient Examination Glove
- KPYShield, Protective, Personnel
- LRPTray, Surgical
- FRGWrap, Sterilization
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain