Augustine Medical, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 25
What Augustine Medical, Inc. makes
The company manufactures patient warming systems, including forced-air thermal blankets (e.g., Bair Hugger Model 630, Model 600 units) and fluid warmers for intravenous and blood products. Additional products include temperature management systems (e.g., Model 750 Total Temperature Management System) and accessories like guide kits and stylets for procedural support. These devices are designed for intraoperative and perioperative thermal regulation in clinical settings.
The portfolio includes Class I and Class II devices, with several products authorised via FDA 510(k) clearance. The company’s products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 25 devicesFrequently asked questions
How many devices does Augustine Medical, Inc. have in the registry?
The registry currently lists 25 devices for Augustine Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Augustine Medical, Inc.'s devices?
Among its 25 most recently registered devices, Augustine Medical, Inc. has devices listed in FDA 510(k) (25 devices).
What risk classes do Augustine Medical, Inc.'s devices fall under?
Among its 25 most recently registered devices, the classes recorded for Augustine Medical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Augustine Medical, Inc. in the registry?
The most recently registered devices listed for Augustine Medical, Inc. include BAIR HUGGER MODEL 630 CARDIAC BLANKET, SYSTEM, THERMAL REGULATING 74-DWJ, BAIR HUGGER CUB BLANKET- SHORT MODEL 536 and AUGUSTINE GUIDE KIT.