Hemostasis, LLC
United StatesFDA applicant, unverified FDA FEI 3007225047
Hemostasis, LLC is a medical device manufacturer, with 33 devices listed in FDA GUDID and FDA 510(k) (FDA Unclassified, Class I and Class II) as of 13 Nov 2026.
- Devices
- 33
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 23
- FDA 510(k) 10
- Device classes
- FDA Unclassified 16
- FDA Class I 14
- FDA Class II 3
- Identifiers
- FDA FEI 3007225047
- DUNS 801380697
At a glance
Market reach
- United States
- FDA FEI
What Hemostasis, LLC makes
Hemostasis, LLC manufactures haemostatic agents and nasal splints for medical use, including chitosan-based dressings, plant polysaccharide dressings, and synthetic bone wax. Their products are designed to control bleeding in surgical and trauma settings, with some formulations also serving as intranasal splints for nasal fracture management. Examples include haemostatic dressings like PosiSep X and NexStat, as well as bone wax for surgical site sealing.
The company’s portfolio includes devices classified as Class I, Class II, and unclassified (U) under FDA regulations, with many authorised via the 510(k) pathway and listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in the United States, adhering to domestic regulatory standards for medical devices.
Catalogue
Search and filter all 33 devicesCompany details
- FDA FEI number
- 3007225047
- DUNS number
- 801380697
- Address
- 5000 Township Pkwy, Saint Paul, MN, 55110
- Phone
- +1 651-855-1466
Frequently asked questions
How many devices does Hemostasis, LLC have in the registry?
The registry currently lists 33 devices for Hemostasis, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hemostasis, LLC's devices?
Among its 33 most recently registered devices, Hemostasis, LLC has devices listed in FDA 510(k) (10 devices) and FDA GUDID (23 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hemostasis, LLC's devices fall under?
Among its 33 most recently registered devices, the classes recorded for Hemostasis, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hemostasis, LLC in the registry?
The most recently registered devices listed for Hemostasis, LLC include BleedArrest ER 9110264, PosiSep X 0.6 x 2.0 Hemostatic Dressing/Intranasal Splint 9210584, NexPak 9110524 and BoneSeal 2.5 gram Ingot 9550054.