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., part of Integra LifeSciencesLabelled 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 Integra Burlington MA, Inc. with 1 510(k) clearance and 1 device recall. The most recent is a device recall dated Mar 18, 2013: Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intr….
| Mar 18, 2013 | Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.Class II · If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such as static ele | Device recalls |
| Feb 22, 2012 | INTEGRA CUSA NXT INFERIOR FOWARD BONE TIPK113570 · LFL | 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
