Isramed, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Isramed, Inc. makes
Isramed, Inc. manufactures medical fixation devices, including the URIFIX, a surgical fixation system for spinal or orthopedic applications, and X-ray detectable bands, which are used to secure medical lines or tubes while remaining visible on radiographic imaging.
The company’s portfolio includes Class I and Class II devices, with products authorised via the FDA’s 510(k) pathway. These devices are listed under U.S. regulatory requirements and are based in the United States.
Catalogue
X-Ray Detectable Thread Ref K812018
Regimes: 510(k) Registry: 510(k)Urifix Ref K813537
Regimes: 510(k) Registry: 510(k)X-Ray Detectable Band Ref K812017
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isramed, Inc. have in the registry?
The registry currently lists 3 devices for Isramed, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isramed, Inc.'s devices?
Among its 3 most recently registered devices, Isramed, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Isramed, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Isramed, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Isramed, Inc. in the registry?
The most recently registered devices listed for Isramed, Inc. include X-RAY DETECTABLE THREAD, URIFIX and X-RAY DETECTABLE BAND.