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.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Scholten Surgical Instruments with 8 510(k) clearances. The most recent is a 510(k) clearance dated Oct 3, 2007: NOVATOME, MODEL: SU101-50.
| Oct 3, 2007 | NOVATOME, MODEL: SU101-50K072051 · DWZ | 510(k) clearances |
| Mar 1, 1990 | SCHOLTEN FRAMEK900405 · JEB | 510(k) clearances |
| Aug 1, 1986 | SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHICK852331 · IZI | 510(k) clearances |
| Sep 15, 1985 | TEMPORARY PACEMAKER GROUND WIREK852119 · DTB | 510(k) clearances |
| Jul 2, 1985 | TABLE ACCESSORIES, OPERATING ROOMK852332 · BWN | 510(k) clearances |
| Jul 2, 1985 | FORCEPS, BIOPSY(NON RIGID)K852120 · GEN | 510(k) clearances |
| Jun 27, 1985 | RETRACTOR, SURGICALK852330 · GAD | 510(k) clearances |
| Jun 14, 1985 | STAND, OPERATING ROOMK852329 · FOX | 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