Irvine Scientific Sales Co., Inc.
United StatesFDA applicant, unverified
- Devices
- 38
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Irvine Scientific Sales Co., Inc. makes
Irvine Scientific Sales Co., Inc. manufactures media and solutions for assisted reproductive technologies, including human tubal fluid with serum substitutes, early cleavage media, sperm washing media, and buffered saline solutions. Their portfolio also covers lyophilized kits for vitrification and thawing, synthetic serum substitutes, and specialized basal media supplements for embryo culture. Additional products include phenol red stock solutions, hyaluronidase for sperm processing, and water specifically formulated for reproductive applications.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. These products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 38 devicesFDA recalls
FDA recall records list 1 recall initiated by Irvine Scientific Sales Co., Inc., initiated on 2008-10-23. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2008
- 23 Oct 2008 Z-0593-2009 Unclassified (pre-2012) Terminated Smiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.
Frequently asked questions
How many devices does Irvine Scientific Sales Co., Inc. have in the registry?
The registry currently lists 38 devices for Irvine Scientific Sales Co., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Irvine Scientific Sales Co., Inc.'s devices?
Among its 38 most recently registered devices, Irvine Scientific Sales Co., Inc. has devices listed in FDA 510(k) (38 devices).
What risk classes do Irvine Scientific Sales Co., Inc.'s devices fall under?
Among its 38 most recently registered devices, the classes recorded for Irvine Scientific Sales Co., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Irvine Scientific Sales Co., Inc.?
FDA recall records list 1 recall initiated by Irvine Scientific Sales Co., Inc., the most recent initiated on 23 Oct 2008. 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 Irvine Scientific Sales Co., Inc. in the registry?
The most recently registered devices listed for Irvine Scientific Sales Co., Inc. include HUMAN SERUM ALBUMIN (HSA), CONTINUOUS SINGLE CULTURE COMPLETE, OIL FOR EMBRYO CULTURE and HTF MEDIUM, MODIFIED HTF MEDIUM- HEPES, HTF POWDER (WITHOUT ANTIBIOTICS), MODIFIED HTG POWDER- HEPES (WITHOUT ANTIBODITI.