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PRIMED Medical Products, Inc. FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product
PRIMED AAMI Level 3 Open Back Gowns510(k)Sep 11, 2026General, Plastic Surgery
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)510(k)Sep 1, 2026General, Plastic Surgery
PRIMED Surgical and Procedure Masks510(k)Nov 4, 2025General, Plastic Surgery
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)510(k)Oct 7, 2024General Hospital
PRIMED Surgical Masks and PRIMED Procedure Masks510(k)Aug 26, 2024General, Plastic Surgery
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)510(k)May 24, 2024General Hospital
PRIMED Pediatric Facemask510(k)Nov 22, 2022General, Plastic Surgery

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