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 Integer HoldingsLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Lake Region Manufacturing with 42 510(k) clearances. The most recent is a 510(k) clearance dated Feb 26, 2010: TRAILRUNNER GUIDEWIRES.
| Feb 26, 2010 | TRAILRUNNER GUIDEWIRESK092965 · DQX | 510(k) clearances |
| Dec 9, 2008 | FREEWAY AND RAILRUNNER GUIDEWIRESK082922 · DQX | 510(k) clearances |
| Aug 26, 2008 | TAXI ENDOSCOPIC GUIDEWIREK081708 · OCY | 510(k) clearances |
| Feb 26, 2008 | MANDREL GUIDEWIRES OR M-WIRESK080144 · DQX | 510(k) clearances |
| Jan 28, 2008 | PEGASUS STEERABLE (PTCA) GUIDEWIREK073655 · DQX | 510(k) clearances |
| Mar 24, 2006 | TITAN GUIDEWIREK060454 · DQX | 510(k) clearances |
| Feb 17, 2006 | TITAN STEERABLE (PTCA) GUIDEWIREK052347 · DQX | 510(k) clearances |
| Sep 16, 2004 | CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIREK042338 · DQX | 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
