I M, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 41
What I M, Inc. makes
I M, Inc. manufactures medical devices including umbilical cord clamps for obstetric use, prefilled syringes containing sterile water, and reusable hemostats for surgical applications. The company also produces diagnostic reagents such as Coccidioides mycelial antigen, Blastomyces yeast antigen, and latex-based reagent tests for fungal infections. Additionally, it supplies feeding units and tubes for patient nutrition, as well as urine bag systems for urinary collection.
The company’s portfolio includes Class I and Class II devices, with several products authorised via the FDA’s 510(k) pathway. These devices are listed under U.S. regulatory requirements, and the company operates from the United States.
Catalogue
Search and filter all 41 devicesFrequently asked questions
How many devices does I M, Inc. have in the registry?
The registry currently lists 41 devices for I M, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list I M, Inc.'s devices?
Among its 41 most recently registered devices, I M, Inc. has devices listed in FDA 510(k) (41 devices).
What risk classes do I M, Inc.'s devices fall under?
Among its 41 most recently registered devices, the classes recorded for I M, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from I M, Inc. in the registry?
The most recently registered devices listed for I M, Inc. include UMBILICAL CORD CLAMP, SYRINGE PREFILLED WITH WATER, SETS & TRAYS and HEMOSTATS.