Tamabio
JapanFDA 510(k) applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Tamabio makes
Tamabio manufactures the PeriBeam® Pericardial Membrane, a synthetic pericardial substitute designed for cardiac surgical procedures to replace or reinforce the pericardium.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The product is listed in the FDA’s 510(k) database.
Catalogue
- GUDID
PeriBeam® Pericardial Membrane Ref K240775
510(k) 510(k)
FDA establishments
- Tamabio Co., Ltd. Musashino-shi Tokyo · JP FEI 3041851334
Frequently asked questions
How many devices does Tamabio have in the registry?
The registry currently lists 2 devices for Tamabio. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tamabio's devices?
Among its 2 most recently registered devices, Tamabio has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Tamabio's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Tamabio's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tamabio in the registry?
The most recently registered devices listed for Tamabio include PeriBeam® Pericardial Membrane P-090-1010 and PeriBeam® Pericardial Membrane.
Which FDA establishments are linked to Tamabio?
1 FDA establishment is linked to Tamabio in the registry; they are listed on the company page.