Bolton Medical Inc.
5 FDA 510(k) clearances · Recalling firm
| Record | Firm | Date |
|---|---|---|
| RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 2 recall (Z-2160-2026) | Bolton Medical Inc. | 2026-05-22 |
| RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU recall (Z-1383-2024) | Bolton Medical Inc. | 2024-03-27 |
| The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifica recall (Z-1689-2023) | Bolton Medical Inc. | 2023-06-06 |
| RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX recall (Z-0997-2023) | Bolton Medical Inc. | 2023-01-19 |
| RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX recall (Z-0998-2023) | Bolton Medical Inc. | 2023-01-19 |
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Every clearance here is in the API, with alerts when new ones post.