Entire Medical, Ltd.
IsraelFDA 510(k) applicant, unverified FDA
- Devices
- 10
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Entire Medical, Ltd. makes
Entire Medical, Ltd. manufactures the ENTire IRE System, a device designed for irreversible electroporation (IRE) used in tissue ablation procedures, primarily for treating solid tumors in soft tissues.
The ENTire IRE System is classified as a Class II medical device in the U.S. and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
- GUDID
ENTire IRE System Ref K251996
510(k) 510(k)
Company details
- DUNS number
- 625930878
- [email protected]
- Phone
- 1-800-4080120
FDA establishments
- ENTIRE MEDICAL Ltd HERZLIYA Central · IL FEI 3043585137
Frequently asked questions
How many devices does Entire Medical, Ltd. have in the registry?
The registry currently lists 10 devices for Entire Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Entire Medical, Ltd.'s devices?
Among its 10 most recently registered devices, Entire Medical, Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (9 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Entire Medical, Ltd.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Entire Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Entire Medical, Ltd. in the registry?
The most recently registered devices listed for Entire Medical, Ltd. include ENTire IRE System Foot Pedal, ENTire IRE System Generator, ENTire IRE System Tonsil Handpiece and ENTire IRE System Nasal Handpiece.
Which FDA establishments are linked to Entire Medical, Ltd.?
1 FDA establishment is linked to Entire Medical, Ltd. in the registry; they are listed on the company page.