Shelhigh, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Shelhigh, Inc. - FDA 510(k) Cleared Devices
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.
FDA 510(k) Regulatory Record - Shelhigh, Inc.
8 devices
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