Fertility Technology Resources, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Fertility Technology Resources, Inc. makes
Fertility Technology Resources, Inc. manufactures intrauterine insemination (IUI) catheters, embryo transfer catheters, and aspiration needles designed for assisted reproductive procedures. Their products include the MORTON IUI CATHETERS, MONA LISA ASPIRATION NEEDLE, and variants of the EMBRYO GLIDE and TUCKER EMBRYO CATHETER for embryo transfer.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Morton Iui Catheters Ref K041470
Regimes: 510(k) Registry: 510(k)Mona Lisa Aspiration Needle Ref K032208
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Tucker Embryo Catheter Ref K023017
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 6 recalls initiated by Fertility Technology Resources, Inc., initiated on 2007-09-13. By recorded status: 6 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 13 Sep 2007 Z-0662-2008 Unclassified (pre-2012) Terminated Expiration Date for Sterility; The 5 year dating could not be validated/supported for sterility assurance.
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- 13 Sep 2007 Z-0663-2008 Unclassified (pre-2012) Terminated Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.
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- 13 Sep 2007 Z-0664-2008 Unclassified (pre-2012) Terminated Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.
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- 13 Sep 2007 Z-0665-2008 Unclassified (pre-2012) Terminated Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.
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- 13 Sep 2007 Z-0666-2008 Unclassified (pre-2012) Terminated Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.
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- 13 Sep 2007 Z-0667-2008 Unclassified (pre-2012) Terminated Expiration Date for sterility; The 5 year dating could not be validated/supported for sterility assurance.
Full distribution text
- 13 Sep 2007 Z-0662-2008 Unclassified (pre-2012) Terminated Expiration Date for Sterility; The 5 year dating could not be validated/supported for sterility assurance.
Frequently asked questions
How many devices does Fertility Technology Resources, Inc. have in the registry?
The registry currently lists 4 devices for Fertility Technology Resources, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fertility Technology Resources, Inc.'s devices?
Among its 4 most recently registered devices, Fertility Technology Resources, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Fertility Technology Resources, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Fertility Technology Resources, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Fertility Technology Resources, Inc.?
FDA recall records list 6 recalls initiated by Fertility Technology Resources, Inc., the most recent initiated on 2007-09-13. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Fertility Technology Resources, Inc. in the registry?
The most recently registered devices listed for Fertility Technology Resources, Inc. include MORTON IUI CATHETERS, MONA LISA ASPIRATION NEEDLE, EMBRYO GLIDE EMBRYO TRANSFER CATHETER, EMBRYO GLIDE STYLE FOR EMBRYO TRANSFER CATHETER and TUCKER EMBRYO CATHETER.