Medical Device Manufacturer · US , Somerville , NJ

Pymah Corp. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 1988

Recent clearances: ATI ETHYLENE OXIDE STERILIZATION INDICATOR, ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION, ATI DISPOSABLE TEST PACK FOR EO GAS STERILIZATION

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pymah Corp. Cardiovascular ✕

6 devices

1-6 of 6

Cleared Jan 27, 1995

Cardiovascular · 213d

Cleared Nov 24, 1993

Cardiovascular · 89d

Cleared Jul 30, 1993

TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF

Cardiovascular · 259d

Cleared Apr 30, 1993

BALANCED(TM) NYLON BLADDER

Cardiovascular · 84d

Cleared Oct 19, 1990

PYMAH PRE-GAGED BALANCED TEMPA-KUFF

Cardiovascular · 81d

Cleared Jan 13, 1989

PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT

Cardiovascular · 85d