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 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Sartorius and its 3 subsidiaries with 13 510(k) clearances and 1 device recall. The most recent is a device recall dated Mar 11, 2022: Virus Counter Platform with Model Name VC3100.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Sartorius and its 3 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Mar 11, 2022 | Virus Counter Platform with Model Name VC3100Class II · The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in solution. | Device recalls |
| Aug 2, 1991 | DUAL COMPARTMENT TPN BAG 3 LITERK911567 · KPE | 510(k) clearances |
| Oct 27, 1989 | AUTOMIX COMPOUNDER VENTED SPIKE ADAPTORK890204 · LHI | 510(k) clearances |
| Oct 27, 1989 | AUTOMIX COMPOUNDER Y - ADAPTOR SETK890205 · LHI | 510(k) clearances |
| Aug 19, 1985 | SARTORIUS MINI-SART FH 16555K851817 · FPB | 510(k) clearances |
| Aug 19, 1985 | SARTORIUS MINISART FH 16534K851816 · FPB | 510(k) clearances |
| Aug 19, 1985 | SARTORIUS MINI SART FH 16592K851818 · FPB | 510(k) clearances |
| Jun 4, 1985 | SARTORIUS AQUASART SM 40035 - DIALYSATE SYSK850435 · FKR | 510(k) clearances |
| Jan 22, 1985 | INFUSARTK844227 · FLN | 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
