Pathkeeper Surgical Ltd
IsraelFDA applicant, unverified
Pathkeeper Surgical Ltd is a medical device manufacturer, with 29 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 29
Registry facts
- Registries
- FDA GUDID 28
- FDA 510(k) 1
- Device classes
- FDA Class II 29
- Sites and related companies
- Pathkeeper Surgical Ltd. Israel
- Identifiers
- DUNS 532374343
What Pathkeeper Surgical Ltd makes
PathKeeper Surgical Ltd manufactures optical surgical navigation device tracking systems, including drill reference frames (DRF) for precise intraoperative guidance, such as the PKS DRF 4-ID9.5x8 and PKS DRF 2-ID5.9. Their portfolio also includes surgical accessories kits, camera power supplies, and dongles for 3D optical tracking integration, such as the S3D OTI Camera DC Power Supply and PathKeeper Surgical Accessories Kit.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system.
Catalogue
Search and filter all 29 devicesCompany details
- DUNS number
- 532374343
Sites
- Pathkeeper Surgical Ltd. ILFEI 3027153110 0 devices
Frequently asked questions
How many devices does PATHKEEPER SURGICAL LTD have in the registry?
The registry currently lists 29 devices for PATHKEEPER SURGICAL LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list PATHKEEPER SURGICAL LTD's devices?
Among its 29 most recently registered devices, PATHKEEPER SURGICAL LTD has devices listed in FDA 510(k) (1 device) and FDA GUDID (28 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do PATHKEEPER SURGICAL LTD's devices fall under?
Among its 29 most recently registered devices, the classes recorded for PATHKEEPER SURGICAL LTD's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from PATHKEEPER SURGICAL LTD in the registry?
The most recently registered devices listed for PATHKEEPER SURGICAL LTD include PKS DRF 3-ID12.2 MAS0007, PKS DRF 4-ID9.5x8 MAS0006-01, PKS DRF 2-ID5.9 MAS0003 and PKS DRF 2 - ID 5.9 MAS0003.