Medical Device Manufacturer · US , Union , NJ

Shelhigh, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1997

Recent clearances: SHELHIGH NO-REACT BIOCUFF, SHELHIGH BIORING, SHELHIGH NO-REACT DURA SHIELD

View 8 510(k) Devices ↓

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Shelhigh, Inc. Cardiovascular ✕

4 devices

1-4 of 4

Cleared Jun 04, 2003

SHELHIGH BIORING

Cardiovascular · 190d

Cleared Oct 28, 1998

SHELHIGH NO-REACT VASCUPATCH

Cardiovascular · 78d

Cleared Jun 03, 1998

SHELHIGH NO-REACT PERICARDIAL PATCHES

Cardiovascular · 177d

Cleared Sep 23, 1997

SHELHIGH PERICARDIAL PATCH

Cardiovascular · 320d