Medical Device Manufacturer · AU , Eight Mile Plains, Qld

William A. Cook Australia Pty. , Ltd. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2009
14
Total
14
Cleared
0
Denied

William A. Cook Australia Pty. , Ltd. has 14 FDA 510(k) cleared obstetrics & gynecology devices. Based in Eight Mile Plains, Qld, AU.

Historical record: 14 cleared submissions from 2009 to 2018.

Browse the complete list of FDA 510(k) cleared obstetrics & gynecology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - William A. Cook Australia Pty. , Ltd.

14 devices
1-14 of 14
Cleared May 18, 2018
Towako Transmyometrial Embryo Transfer Set
K173431 · MQF
Obstetrics & Gynecology · 197d
Cleared Dec 15, 2017
Double Lumen Ovum Aspiration Needles
K171611 · MQE
Obstetrics & Gynecology · 197d
Cleared Jun 13, 2017
COOK Vacuum Pump
K160753 · MQG
Obstetrics & Gynecology · 452d
Cleared Feb 24, 2017
Sydney IVF Culture Oil
K170257 · MQL
Obstetrics & Gynecology · 28d
Cleared Aug 15, 2016
Sydney IVF Gamete Buffer
K153478 · MQL
Obstetrics & Gynecology · 257d
Cleared May 06, 2016
Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit
K152717 · MQL
Obstetrics & Gynecology · 228d
Cleared Apr 22, 2016
Sydney IVF Sperm Cryopreservation Buffer
K160814 · MQL
Obstetrics & Gynecology · 29d
Cleared Jan 27, 2016
Sydney IVF Hyaluronidase
K151367 · MQL
Obstetrics & Gynecology · 251d
Cleared Jan 27, 2016
Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF...
K153290 · MQL
Obstetrics & Gynecology · 75d
Cleared Dec 21, 2015
SYDNEY IVF SPERM MEDIUM, SYDNEY IVF SPERM GRADIENT KIT, SYDNEY IVF SPERMIENT
K152782 · MQL
Obstetrics & Gynecology · 87d
Cleared Dec 03, 2015
SYDNEY IVF EMBRYO BIOPSY MEDIUM
K152904 · MQL
Obstetrics & Gynecology · 63d
Cleared Aug 27, 2015
COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst...
K143724 · MQL
Obstetrics & Gynecology · 241d
Cleared Aug 07, 2014
OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
K141365 · MQE
Obstetrics & Gynecology · 76d
Cleared Apr 29, 2009
COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000)...
K082363 · MQL
Obstetrics & Gynecology · 254d
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