Medical Device Manufacturer · US , Union , NJ

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

8 submissions · 8 cleared · Since 1997

Recent clearances: SHELHIGH NO-REACT DURA SHIELD, SHELHIGH NO-REACT VASCUPATCH, SHELHIGH NO-REACT PNEUMOPLEDGETS

8

Total

8

Cleared

0

Denied

Shelhigh, Inc. has 8 FDA 510(k) cleared medical devices. Based in Union, US.

Historical record: 8 cleared submissions from 1997 to 2003. Primary specialty: Cardiovascular.

Browse the FDA 510(k) cleared devices submitted by Shelhigh, Inc. Filter by specialty or product code using the sidebar.

Shelhigh, Inc. is one of 8017 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

8 devices

1-8 of 8

Cleared Dec 19, 2003

SHELHIGH NO-REACT BIOCUFF

General & Plastic Surgery · 93d

Cleared Jun 04, 2003

SHELHIGH BIORING

Cardiovascular · 190d

Cleared May 02, 2000

SHELHIGH NO-REACT DURA SHIELD

Neurology · 687d

Cleared Jul 14, 1999

SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.

General & Plastic Surgery · 70d

Cleared Oct 28, 1998

SHELHIGH NO-REACT VASCUPATCH

Cardiovascular · 78d

Cleared Aug 05, 1998

SHELHIGH NO-REACT PNEUMOPLEDGETS

General & Plastic Surgery · 79d

Cleared Jun 03, 1998

SHELHIGH NO-REACT PERICARDIAL PATCHES

Cardiovascular · 177d

Cleared Sep 23, 1997

SHELHIGH PERICARDIAL PATCH

Cardiovascular · 320d