Company · DK
Origio A/S
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2020. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 25, 2020 | K200815 | VitriGuard Origio A/S, DK | MQK |
| May 4, 2018 | K180740 | VitriGuard Origio A/S, DK | MQK |
| Mar 2, 2018 | K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311) Origio A/S, DK | MQL |
| Oct 13, 2017 | K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS Origio A/S, DK | MQL |
| Mar 9, 2017 | K161547 | Transem and EchoGen Embryo Transfer Catheters Origio A/S, DK | MQF |
| Feb 16, 2017 | K162833 | VitriGuard Origio A/S, DK | MQK |
| Jul 22, 2016 | K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash Origio A/S, DK | MQL |
| Feb 29, 2016 | K152932 | BlastGen Origio A/S, DK | MQL |
| Jun 16, 2014 | K140317 | EMBRYOGEN Origio A/S, DK | MQL |
| May 14, 2014 | K133912 | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO Origio A/S, DK | MQL |
| Apr 29, 2014 | K133387 | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED Origio A/S, DK | MQL |
| Apr 16, 2014 | K133707 | SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS Origio A/S, DK | MQL |
| Sep 26, 2012 | K120136 | EMBRYOGEN Origio A/S | MQL |
| Aug 27, 2010 | K100367 | MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 Origio A/S | MQL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||