Medical Device Manufacturer · US , Mchenry , IL

Codman & Shurtleff, Inc. - FDA 510(k) Cleared Devices

152 submissions · 151 cleared · Since 1976

Recent clearances: CERENOVUS Large Bore Catheter, CERENOVUS Large Bore Catheter, CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit

152

Total

151

Cleared

0

Denied

FDA 510(k) Regulatory Record - Codman & Shurtleff, Inc. Radiology ✕

4 devices

1-4 of 4

Cleared Dec 11, 1995

ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM

Radiology · 448d

Cleared Apr 13, 1992

OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID

Radiology · 221d

Cleared Sep 25, 1990

OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM

Radiology · 211d

Cleared Feb 19, 1987

INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER

Radiology · 423d