Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled 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 Q Core Medical Ltd. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Nov 19, 2020: Sapphire Infusion Pump, Sapphire administration sets.
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.
| Nov 19, 2020 | Sapphire Infusion Pump, Sapphire administration setsK192860 · FRN | 510(k) clearances |
| Mar 27, 2017 | Sapphire Infusion PumpK161667 · FRN | 510(k) clearances |
| Dec 11, 2014 | SAPPHIRE INFUSION PUMPK141389 · FRN | 510(k) clearances |
| Aug 5, 2014 | SAPPHIRE ADMINISTRATION SETK141834 · FPA | 510(k) clearances |
| Oct 17, 2013 | SAPPHIRE INFUSION PUMPK123049 · FRN | 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
