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 National Custom Enterprises with 12 510(k) clearances. The most recent is a 510(k) clearance dated Oct 10, 2001: MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC.
| Oct 10, 2001 | MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWCK012264 · DPS | 510(k) clearances |
| Oct 10, 2001 | MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024K012263 · DPS | 510(k) clearances |
| Sep 12, 2001 | MEDFUSION 2001 & 2010, MODEL N7215IWCK012259 · MRZ | 510(k) clearances |
| Sep 12, 2001 | SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2K012266 · MRZ | 510(k) clearances |
| Sep 12, 2001 | BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WCK012262 · MRZ | 510(k) clearances |
| Sep 10, 2001 | SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WCK012229 · FMT | 510(k) clearances |
| Nov 4, 1994 | REPLACEMENT BATTERIESK943632 · FCO | 510(k) clearances |
| Nov 4, 1994 | NCE REPLACEMENT BATTERIESK943680 · FCO | 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