Consumer health companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of BaxterLabelled by claude-sonnet-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 Bentley Laboratories LLC with 55 510(k) clearances and 1 warning letter. The most recent is a warning letter dated Sep 17, 2026: Warning letter: Cleaning validation, Process validation, Out-of-specification.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 17, 2026 | Warning letter: Cleaning validation, Process validation, Out-of-specificationCDER | Warning letters |
| Jul 13, 1993 | HE-30 GOLDK931967 · DTR | 510(k) clearances |
| Jan 17, 1992 | BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30K913956 · DTN | 510(k) clearances |
| Nov 15, 1991 | VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)K913692 · DTN | 510(k) clearances |
| Nov 9, 1990 | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000QK903641 · KDI | 510(k) clearances |
| Feb 28, 1990 | UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLFK894826 · DTZ | 510(k) clearances |
| Feb 2, 1988 | CATR(TM)-H CARDIOTOMY HOLDERK874867 · KPI | 510(k) clearances |
| Feb 2, 1988 | INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTERK874841 · DTZ | 510(k) clearances |
| Jan 19, 1988 | BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETERK874618 · DQR | 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
