Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Shelhigh, Inc. with 8 510(k) clearances. The most recent is a 510(k) clearance dated Dec 19, 2003: SHELHIGH NO-REACT BIOCUFF.
| Date | Record | Source |
|---|---|---|
| Dec 19, 2003 | SHELHIGH NO-REACT BIOCUFFK032893 · FTL | 510(k) clearances |
| Jun 4, 2003 | SHELHIGH BIORINGK023940 · KRH | 510(k) clearances |
| May 2, 2000 | SHELHIGH NO-REACT DURA SHIELDK982101 · GXQ | 510(k) clearances |
| Jul 14, 1999 | SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.K991567 · FTM | 510(k) clearances |
| Oct 28, 1998 | SHELHIGH NO-REACT VASCUPATCHK982810 · DXZ | 510(k) clearances |
| Aug 5, 1998 | SHELHIGH NO-REACT PNEUMOPLEDGETSK981756 · FTL | 510(k) clearances |
| Jun 3, 1998 | SHELHIGH NO-REACT PERICARDIAL PATCHESK974914 · DXZ | 510(k) clearances |
| Sep 23, 1997 | SHELHIGH PERICARDIAL PATCHK964467 · DXZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
