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 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list MAST Biosurgery USA, Inc. with 4 510(k) clearances, 1 device recall and 1 warning letter. The most recent is a warning letter dated Dec 17, 2025: Warning letter: Complaint handling, MDR reporting, 510(k) required.
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.
| Dec 17, 2025 | Warning letter: Complaint handling, MDR reporting, 510(k) requiredCDRH | Warning letters |
| Aug 26, 2014 | The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 Class II · The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The | Device recalls |
| Jan 7, 2010 | CARDIO-WRAPK090637 · DXZ | 510(k) clearances |
| Mar 7, 2007 | SURGI-WRAP MAST TENDON SHEETK063648 · FTL | 510(k) clearances |
| Sep 21, 2006 | SURGI-WRAP MAST BIORESORBABLE SHEETK061473 · FTL | 510(k) clearances |
| May 27, 2005 | SURGI-WRAP MAST BIORESORBABLE SHEETK050332 · 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
