Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Glycar with 5 510(k) clearances and 2 device recalls. The most recent is a device recall dated Oct 9, 2025: SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PL….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 9, 2025 | SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENEClass I · The impacted lot may not meet the required tensile strength specification. | Device recalls |
| Oct 9, 2025 | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENEClass I · The impacted lot may not meet the required tensile strength specification. | Device recalls |
| Oct 31, 1997 | GLYCARTISSUE REPAIR PATCH FAMILY OF PRODUCTS; GLYCAR VASCULAR REPAIR PATCH ALTERNATIVE PROPRIETARY NAME POSSIBLEK963368 · DXZ | 510(k) clearances |
| Oct 31, 1997 | GLYCAR PERICARDIAL PATCHK963967 · DXZ | 510(k) clearances |
| Sep 23, 1996 | GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLINGK963175 · FTM | 510(k) clearances |
| Feb 14, 1996 | GLYCAR STAPLE STRIPSK954665 · FTL | 510(k) clearances |
| Dec 14, 1994 | GLYCAR TISSUE REPAIR PATCHK942911 · FTL | 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
