Terumo America, Inc.
United StatesFDA applicant, unverified
- Devices
- 31
What Terumo America, Inc. makes
Terumo America, Inc. manufactures urinary drainage systems, including the UROGARD urinary drainage bag, and intravenous administration sets such as the TERUFUSION blood administration set and HICALIQ IVH bag. Their portfolio also includes blood processing devices like the BLOOD FILTER with set, PLASMA FLEX, and TERUFUSION donor set, as well as hemodialysis components such as the CLIRANS TE15, CLIRANS TH15, and CLIRANS TE10 hollow fiber dialyzers. Additionally, they produce vascular access solutions like the AV fistula needle set and temperature monitoring devices, including the THERMO FINER CORETEMP.
The company’s devices are classified under FDA regulations as Class I and Class II, with most submissions recorded via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry, reflecting their authorised status under U.S. medical device regulations. Terumo America, Inc. is based in the United States.
Catalogue
Search and filter all 31 devicesFrequently asked questions
How many devices does Terumo America, Inc. have in the registry?
The registry currently lists 31 devices for Terumo America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Terumo America, Inc.'s devices?
Among its 31 most recently registered devices, Terumo America, Inc. has devices listed in FDA 510(k) (31 devices).
What risk classes do Terumo America, Inc.'s devices fall under?
Among its 31 most recently registered devices, the classes recorded for Terumo America, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Terumo America, Inc. in the registry?
The most recently registered devices listed for Terumo America, Inc. include UROGARD URINARY DRAINAGE BAG, TERUMO IMUGARD, BLOOD FILTER, W/SET and AV FISTULA NEEDLE SET.