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 Bristol-Myers SquibbLabelled 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. See the Bristol Myers Squibb group view.
As of Nov 15, 2026, FDA's public records list Surgitek Medical Engineering with 11 510(k) clearances. The most recent is a 510(k) clearance dated Feb 18, 1992: CYTOLOGY BRUSH.
| Feb 18, 1992 | CYTOLOGY BRUSHK914504 · FDX | 510(k) clearances |
| Jan 30, 1992 | E.R.C.P. CATHETERK914495 · FGE | 510(k) clearances |
| Jan 3, 1992 | BIOPSY FORCEPSK914497 · FCL | 510(k) clearances |
| Dec 9, 1991 | STONE BASKETK914505 · FFL | 510(k) clearances |
| Dec 5, 1991 | SCLEROTHERAPY NEEDLEK914496 · FBK | 510(k) clearances |
| Dec 5, 1991 | GRASPING FORCEPSK914503 · OCZ | 510(k) clearances |
| Nov 19, 1991 | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENTK913928 · FAD | 510(k) clearances |
| Oct 4, 1991 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KITK913294 · GCA | 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
