Ots Medical, Ltd.
IsraelFDA applicant, unverified FDA
- Devices
- 8
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Ots Medical, Ltd. makes
Ots Medical, Ltd. manufactures the OTS 25 (100-1) and OTS 25-L (100-5) devices, which are designed for medical use in specific Class II applications.
These devices are regulated under the FDA’s 510(k) pathway as Class II medical devices and are listed in the U.S. regulatory system. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Ots 25 (100-1) Ref K233429
Regimes: 510(k) Registry: 510(k)Ots 25-L (100-5) Ref K251310
Regimes: 510(k) Registry: 510(k)Ots 25-L (100-5) Ref K241234
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 600883165
FDA establishments
- Ots-Medical Binyamina Haifa · IL FEI 3038185071
Frequently asked questions
How many devices does Ots Medical, Ltd. have in the registry?
The registry currently lists 8 devices for Ots Medical, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ots Medical, Ltd.'s devices?
Among its 8 most recently registered devices, Ots Medical, Ltd. has devices listed in FDA 510(k) (3 devices) and FDA GUDID (5 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Ots Medical, Ltd.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Ots Medical, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ots Medical, Ltd. in the registry?
The most recently registered devices listed for Ots Medical, Ltd. include RAPHAEL 25 Anchor 100-152, RAPHAEL 25 Anchor 100-161, RAPHAEL 25 Anchor 100-605 and RAPHAEL 25 Instrument Kit 100-162.
Which FDA establishments are linked to Ots Medical, Ltd.?
1 FDA establishment is linked to Ots Medical, Ltd. in the registry; they are listed on the company page.