Medical Device Manufacturer · US , Mchenry , IL

Pudenz-Schulte Medical Research Corp. - FDA 510(k) Cleared Devices

40 submissions · 39 cleared · Since 1980

40

Total

39

Cleared

0

Denied

FDA 510(k) Regulatory Record - Pudenz-Schulte Medical Research Corp. General Hospital ✕

10 devices

1-10 of 10

Cleared Sep 30, 1996

MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 &...

General Hospital · 270d

Cleared Dec 18, 1995

PS MEDICAL IPI VASCULAR ACCESS CATHETER

General Hospital · 89d

Cleared Jul 14, 1994

IPI DUAL LUMEN PORT

General Hospital · 321d

Cleared Jul 14, 1994

IPI LOW PROFILE IMPORT

General Hospital · 281d

Cleared Feb 25, 1994

PS MEDICAL IPI ACCESS KIT

General Hospital · 406d

Cleared Nov 20, 1992

General Hospital · 183d

Cleared Jul 18, 1991

IPI ALGO-LINE CATHETER

General Hospital · 112d

Cleared Feb 11, 1988

P-S MEDICAL VENTRICULAR ACCESS PORT

General Hospital · 101d

Cleared Feb 11, 1988

CSF-VENTRICULOSTOMY RESERVOIR

General Hospital · 101d

Cleared May 25, 1984

P-S MEDICAL CSF ACCESS DEV 15MM/25MM

General Hospital · 205d