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. General & Plastic Surgery ✕

3 devices

1-3 of 3

Cleared Dec 19, 2003

SHELHIGH NO-REACT BIOCUFF

General & Plastic Surgery · 93d

Cleared Jul 14, 1999

SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.

General & Plastic Surgery · 70d

Cleared Aug 05, 1998

SHELHIGH NO-REACT PNEUMOPLEDGETS

General & Plastic Surgery · 79d