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 14, 2026, FDA's public records list Sunscope International with 7 510(k) clearances. The most recent is a 510(k) clearance dated Nov 17, 2000: BIOSENSORS CENTRAL VENOUS CATHETER KITS.
| Nov 17, 2000 | BIOSENSORS CENTRAL VENOUS CATHETER KITSK002786 · FOZ | 510(k) clearances |
| Feb 5, 1999 | BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BPK983372 · DRS | 510(k) clearances |
| Sep 4, 1998 | BIOSENSORS EMBOLECTOMY CATHETERK973477 · DXE | 510(k) clearances |
| Aug 20, 1998 | BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXXK981747 · DRS | 510(k) clearances |
| Jul 17, 1998 | BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXXK981745 · DRS | 510(k) clearances |
| Oct 23, 1991 | HEPARIN COATED THERMODILUTION CATH & ACCESSORIESK911710 · DQO | 510(k) clearances |
| Sep 27, 1991 | SAFEWEDGE(TM) RELIEF VALVE DEVICEK912172 · KRB | 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
