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PRIMED Medical Products, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K262007 PRIMED AAMI Level 3 Open Back GownsQPC2026-09-11 View
510(k) K261811 PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)QSO2026-09-01 View
510(k) K252964 PRIMED Surgical and Procedure MasksFXX2025-11-04 View
510(k) K242208 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG2024-10-07 View
510(k) K240286 PRIMED Surgical Masks and PRIMED Procedure MasksFXX2024-08-26 View
510(k) K233777 PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)FRG2024-05-24 View
510(k) K213427 PRIMED Pediatric FacemaskOXZ2022-11-22 View
510(k) K160361 PRIMAGARD Isolation Gown (AAMI PB70 Level 3)FYC2016-11-04 View
510(k) K092012 PRIMAGARD DELTA FIT 80,120, 160 SURGICAL FACE MASK (SMALL, MEDIUM, LARGE) MODEL PG4-7061,-7071,-7081, PG4-7062, 7072-70FXX2009-09-25 View
510(k) K081633 PRIMAGARD 80, 120, 160 FLUID RESISTANT PROCEDURE/SURGICAL FACE MASKSFXX2008-08-11 View
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