Nitto Denko America, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Nitto Denko America, Inc. makes
Nitto Denko America, Inc. manufactures surgical tapes and adhesive electrodes, including non-woven, cloth, and plastic-backed tapes for medical use, as well as clip-on diagnostic electrodes for electrocardiogram monitoring.
The company’s products are regulated under FDA Class I and Class II designations, with some devices listed via the 510(k) pathway. These items are distributed in the United States.
Catalogue
Nitto Surgical Paper Tape St-310 Ref K853647
Regimes: 510(k) Registry: 510(k)Electrode Rte-3, Clip-On Diagnostic Electrode Ref K871441
Regimes: 510(k) Registry: 510(k)Nitto Surgical Non-Woven Tape St-320 Ref K853646
Regimes: 510(k) Registry: 510(k)Nitto Surgical Plastic Tape St-356 Ref K853644
Regimes: 510(k) Registry: 510(k)Nitto Surgical Cloth Tape St-330 Ref K853645
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nitto Denko America, Inc. have in the registry?
The registry currently lists 5 devices for Nitto Denko America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nitto Denko America, Inc.'s devices?
Among its 5 most recently registered devices, Nitto Denko America, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Nitto Denko America, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Nitto Denko 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 Nitto Denko America, Inc. in the registry?
The most recently registered devices listed for Nitto Denko America, Inc. include NITTO SURGICAL PAPER TAPE ST-310, ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE, NITTO SURGICAL NON-WOVEN TAPE ST-320 and NITTO SURGICAL PLASTIC TAPE ST-356.