Company ยท AU
William A. Cook Australia Pty. , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2018. 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 |
|---|---|---|---|
| May 18, 2018 | K173431 | Towako Transmyometrial Embryo Transfer Set William A. Cook Australia Pty. , Ltd., AU | MQF |
| Dec 15, 2017 | K171611 | Double Lumen Ovum Aspiration Needles William A. Cook Australia Pty. , Ltd., AU | MQE |
| Jun 13, 2017 | K160753 | COOK Vacuum Pump William A. Cook Australia Pty. , Ltd., AU | MQG |
| Feb 24, 2017 | K170257 | Sydney IVF Culture Oil William A. Cook Australia Pty. , Ltd., AU | MQL |
| Aug 15, 2016 | K153478 | Sydney IVF Gamete Buffer William A. Cook Australia Pty. , Ltd., AU | MQL |
| May 6, 2016 | K152717 | Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit William A. Cook Australia Pty. , Ltd., AU | MQL |
| Apr 22, 2016 | K160814 | Sydney IVF Sperm Cryopreservation Buffer William A. Cook Australia Pty. , Ltd., AU | MQL |
| Jan 27, 2016 | K153290 | Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Med William A. Cook Australia Pty. , Ltd., AU | MQL |
| Jan 27, 2016 | K151367 | Sydney IVF Hyaluronidase William A. Cook Australia Pty. , Ltd., AU | MQL |
| Dec 21, 2015 | K152782 | SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT William A. Cook Australia Pty. , Ltd., AU | MQL |
| Dec 3, 2015 | K152904 | SYDNEY IVF EMBRYO BIOPSY MEDIUM William A. Cook Australia Pty. , Ltd., AU | MQL |
| Aug 27, 2015 | K143724 | COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming Kit William A. Cook Australia Pty. , Ltd., AU | MQL |
| Aug 7, 2014 | K141365 | OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN William A. Cook Australia Pty. , Ltd., AU | MQE |
| Apr 29, 2009 | K082363 | COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS William A. Cook Australia Pty. , Ltd., AU | MQL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||