Medical device makerLabelled by claude-haiku-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 Bio-Medical Devices with 7 510(k) clearances. The most recent is a 510(k) clearance dated Oct 18, 2004: MAXAIR SURGICAL HELMET SYSTEM.
| Oct 18, 2004 | MAXAIR SURGICAL HELMET SYSTEMK040485 · FYA | 510(k) clearances |
| Oct 15, 1998 | SMOKE-EVACK981888 · GEI | 510(k) clearances |
| Jan 24, 1996 | MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REELK955149 · BYY | 510(k) clearances |
| Jan 24, 1996 | MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATORK955151 · BYY | 510(k) clearances |
| Jan 23, 1996 | MAXI-FLOWK955150 · BYY | 510(k) clearances |
| Jun 7, 1994 | THE REEL THINGK940156 · GBX | 510(k) clearances |
| Apr 7, 1994 | TOP GUNK933742 · FQH | 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
