Medical Device Manufacturer · US , Mchenry , IL

Critikon Company, LLC - FDA 510(k) Cleared Devices

51 submissions · 51 cleared · Since 1979

51

Total

51

Cleared

0

Denied

FDA 510(k) Regulatory Record - Critikon Company, LLC General Hospital ✕

19 devices

1-12 of 19

Cleared Dec 14, 1993

CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH

General Hospital · 208d

Cleared Jun 03, 1991

RATEMINDER(TM) V INFUSION PUMP, MODIFICATION

General Hospital · 45d

Cleared Jul 26, 1990

RATEMINDER V INFUSION PUMP W/SECONDARY CAPABILITY

General Hospital · 78d

Cleared Nov 01, 1989

OPTICALLY CLEAR RADIOPAQUE CATHETER

General Hospital · 174d

Cleared May 11, 1988

General Hospital · 190d

Cleared Mar 29, 1988

RATEMINDER V INFUSION PUMP

General Hospital · 103d

Cleared Jan 14, 1988

J&J SCALP VEIN INFUSION SETS

General Hospital · 23d

Cleared Dec 29, 1987

RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET

General Hospital · 105d

Cleared Jul 22, 1986

CRITIKON 48-HOUR AIR ELIMINATING FILTER

General Hospital · 83d

Cleared Oct 17, 1985

JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL

General Hospital · 43d

Cleared Mar 07, 1985

CRITIKON I.V. ADMINISTRAION SET

General Hospital · 27d

Cleared Jun 28, 1984

CRITIKON I.V. FILTER

General Hospital · 36d