Carolina Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Carolina Medical, Inc. makes
Carolina Medical, Inc. manufactures the INFPUMP infiltration pump, designed for controlled fluid delivery in medical settings, and the PR3 ultrasound system, used for diagnostic imaging and procedural guidance.
The company’s portfolio consists of Class II devices, regulated under the FDA’s 510(k) clearance process. These products are listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Infpump Infiltration Pump Ref K050324
Regimes: 510(k) Registry: 510(k)PR3 Ultrasound System Ref K993978
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Carolina Medical, Inc. have in the registry?
The registry currently lists 2 devices for Carolina Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Carolina Medical, Inc.'s devices?
Among its 2 most recently registered devices, Carolina Medical, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Carolina Medical, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Carolina Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Carolina Medical, Inc. in the registry?
The most recently registered devices listed for Carolina Medical, Inc. include INFPUMP INFILTRATION PUMP and PR3 ULTRASOUND SYSTEM.