Kiltex Corp.
United Statesfrom the FDA registration address FDA FEI 1527493
Kiltex Corp. is a medical device manufacturer, with 9 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 14 Nov 2026.
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 8
- FDA 510(k) 1
- Device classes
- FDA Class II 9
- Identifiers
- FDA FEI 1527493
At a glance
Market reach
- United States
- FDA FEI
What Kiltex Corp. makes
Kiltex Corp. makes body-orifice ultrasound imaging transducer covers with image-enhancement properties.
These devices are classified as Class II and are listed in the FDA 510(k) and FDA UDI registries.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
Kiltex Probe Cover Ref K961029
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 1527493
- Address
- 2064 KILLIAN ROAD, Akron, OH, 44312
Frequently asked questions
How many devices does Kiltex Corp. have in the registry?
The registry currently lists 9 devices for Kiltex Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kiltex Corp.'s devices?
Among its 9 most recently registered devices, Kiltex Corp. has devices listed in FDA 510(k) (1 device) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Kiltex Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Kiltex Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kiltex Corp. in the registry?
The most recently registered devices listed for Kiltex Corp. include Kiltex Corporation 2.0UltrasoundProbeCover(500), Kiltex Corporation 3.5UltrasoundProbeCover(720), Kiltex Corporation 2.6UltrasoundProbeCover(100) and Kiltex Corpoartion 3.5UltrasoundProbeCover(500).