Hem Con Medical Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
What Hem Con Medical Technologies, Inc. makes
Hem Con Medical Technologies, Inc. manufactures hemostatic dressings and wound care products, including variations of ChitoGauze (such as 2×2 inch, 4×4 inch, and 4×8 inch 8-ply versions), ChitoGauze Fusion, and HemCon Bandage modifications (including over-the-counter versions). The company also produces specialized dressings like ChitoFlex PRO, HemCon Patch PRO, and Prometheus ChitoGauze XR PRO, designed for rapid blood clotting in traumatic or surgical settings. Additional products include GuardaCare and first-aid variants like HemCon Strip First Aid PRO.
These products are classified as Class II medical devices under U.S. regulations and are listed in the FDA’s 510(k) registry. The company operates from the United States, where its devices are subject to FDA clearance requirements for market authorization.
Catalogue
- Regimes: 510(k) Registry: 510(k)
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO Ref K150916
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Chitogauze Ref K102546
Regimes: 510(k) Registry: 510(k)Chitogauze Fusion Ref K111163
Regimes: 510(k) Registry: 510(k)Prometheus ChitoGauze XR PRO Ref K153582
Regimes: 510(k) Registry: 510(k)Guardacare Ref K103641
Regimes: 510(k) Registry: 510(k)Chitogauze, Models 130, 131, 263, 264, 265, 266 Ref K090026
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hem Con Medical Technologies, Inc. have in the registry?
The registry currently lists 9 devices for Hem Con Medical Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hem Con Medical Technologies, Inc.'s devices?
Among its 9 most recently registered devices, Hem Con Medical Technologies, Inc. has devices listed in FDA 510(k) (9 devices).
What are the newest devices from Hem Con Medical Technologies, Inc. in the registry?
The most recently registered devices listed for Hem Con Medical Technologies, Inc. include MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC, HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO, CHITOGAUZE, 2 IN X 2 IN, 8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 and CHITOGAUZE.