DistributorLabelled 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., part of Sri Surgical ExpressLabelled 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 15, 2026, FDA's public records list Sri Surgical with 1 510(k) clearance and 1 device recall. The most recent is a 510(k) clearance dated May 29, 2009: SRI LEVEL II SURGICAL GOWN.
| May 29, 2009 | SRI LEVEL II SURGICAL GOWNK090383 · FYA | 510(k) clearances |
| Jul 16, 2008 | Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom proClass II · Distribution of a product that did not meet specifications. (labeling error) | Device recalls |
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
