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 Amedic USA with 10 510(k) clearances. The most recent is a 510(k) clearance dated Jan 4, 1990: EQUIP COVERS, STERILE.
| Jan 4, 1990 | EQUIP COVERS, STERILEK897120 · KKX | 510(k) clearances |
| Sep 5, 1989 | GENERAL IVT NEEDLE GUIDE KIT, STERILEK892070 · HGL | 510(k) clearances |
| Aug 8, 1989 | GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILEK892071 · KNW | 510(k) clearances |
| Aug 8, 1989 | EXTENDED COVERS, STERILEK892069 · FFF | 510(k) clearances |
| Aug 4, 1989 | TRT (ACUSON) NEEDLE GUIDE KIT, STERILEK892068 · FCG | 510(k) clearances |
| Aug 21, 1987 | BIOPSY NEEDLE GUIDE KIT, STERILEK871467 · FCG | 510(k) clearances |
| Jul 15, 1987 | ULTRASOUND TRANSDUCER SHEATHS, STERILEK871609 · ITX | 510(k) clearances |
| Jul 15, 1987 | ULTRASOUND TRANSDUCER GEL, STERILEK871565 · JOT | 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
