Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in DenmarkLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of The Cooper CompaniesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Origio with 16 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jul 17, 2020: Synvitro Hyadase.
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.
| Jul 17, 2020 | Synvitro HyadaseK200680 · MQL | 510(k) clearances |
| Jun 25, 2020 | VitriGuardK200815 · MQK | 510(k) clearances |
| May 4, 2018 | VitriGuardK180740 · MQK | 510(k) clearances |
| Mar 2, 2018 | ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)K173624 · MQL | 510(k) clearances |
| Oct 13, 2017 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSK172197 · MQL | 510(k) clearances |
| Mar 9, 2017 | Transem and EchoGen Embryo Transfer CathetersK161547 · MQF | 510(k) clearances |
| Feb 16, 2017 | VitriGuardK162833 · MQK | 510(k) clearances |
| Jul 22, 2016 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashK153267 · MQL | 510(k) clearances |
| Jun 20, 2014 | Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PLClass II · Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration | Device recalls |
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
