Catalina Biomedical Corp.
United StatesFDA applicant, unverified
- Devices
- 5
What Catalina Biomedical Corp. makes
Catalina Biomedical Corp. manufactures wound care dressings and intravenous site care products, including hydrogel-based wound gels, transparent film dressings for wounds or IV sites, and reusable wound care trays. Their portfolio includes moisture-retaining dressings designed for wound management and protective dressings for medical insertion sites.
The company’s products are regulated under FDA Class I, Class II, and Unclassified (U) devices, with many cleared via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database and are intended for use in the United States.
Catalogue
Biolex Wound Gel, Ref K920050
Regimes: 510(k) Registry: 510(k)Transparent Film I.V. Site/Wound Dressing Ref K896421
Regimes: 510(k) Registry: 510(k)Wound Care Tray B Ref K913479
Regimes: 510(k) Registry: 510(k)Vari/Moist Wound Dressing Ref K896358
Regimes: 510(k) Registry: 510(k)Wound Care Tray A Ref K913480
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Catalina Biomedical Corp. have in the registry?
The registry currently lists 5 devices for Catalina Biomedical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Catalina Biomedical Corp.'s devices?
Among its 5 most recently registered devices, Catalina Biomedical Corp. has devices listed in FDA 510(k) (5 devices).
What risk classes do Catalina Biomedical Corp.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Catalina Biomedical Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Catalina Biomedical Corp. in the registry?
The most recently registered devices listed for Catalina Biomedical Corp. include BIOLEX WOUND GEL,, TRANSPARENT FILM I.V. SITE/WOUND DRESSING, WOUND CARE TRAY B and VARI/MOIST WOUND DRESSING.