Medical Device Manufacturer · AU , Eight Mile Plains, Qld

William A. Cook Australia Pty. , Ltd.

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

William A. Cook Australia Pty. , Ltd. — FDA 510(k) Submissions

William A. Cook Australia Pty. , Ltd. has submitted 14 FDA 510(k) premarket notifications since 2009, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Media, Reproductive, Needle, Assisted Reproduction, Accessory, Assisted Reproduction, Catheter, Assisted Reproduction . Use the specialty filter in the sidebar to narrow results.

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