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. Neurology ✕

24 devices

1-12 of 24

Cleared Sep 18, 1995

PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT

Neurology · 181d

Cleared May 03, 1994

PS MEDICAL CATHETER PLACEMENT KIT

Neurology · 116d

Cleared Apr 28, 1994

PS MEDICAL DELTA BURR HOLE VALVE

Neurology · 218d

Cleared Sep 10, 1993

PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER

Neurology · 217d

Cleared Mar 30, 1993

PS MEDICAL CSF-ACCESS DEVICE

Neurology · 608d

Cleared Dec 30, 1991

PS MEDICAL VENTRICULOSTOMY KIT

Neurology · 19d

Cleared Jun 28, 1991

PS MEDICAL BUTTON VALVE

Neurology · 88d

Cleared Oct 03, 1990

PS MEDICAL CRANIAL HAND DRILL

Neurology · 16d

Cleared Aug 08, 1990

PS MEDICAL DELTA CSF-FLOW CONTROL VALVE

Neurology · 43d

Cleared Apr 03, 1990

CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT

Neurology · 50d

Cleared Dec 21, 1989

PS MEDICAL CSF-ON/OFF FLUSHING RESERVOIR

Neurology · 57d

Cleared Sep 18, 1987

CSF-FLOW CONTROL VALVE, ULTRA SMALL

Neurology · 35d