Syntec, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Syntec, Inc. makes
Syntec, Inc. manufactures single-use optical fibers, including disposable bare-end fiber components for medical imaging and laser applications, as well as protective sheaths like the Phacogard for ocular procedures. The company also produces the Vitman, a device used in vitreoretinal surgery for precise vitreous management.
These products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance in the United States. Syntec, Inc. is headquartered in the US.
Catalogue
Syntec, Inc. Disposable Bare End Fiber Ref K971338
510(k) 510(k)Phacogard Ref K002932
510(k) 510(k)Syntec Vitman Ref K980480
510(k) 510(k)
Frequently asked questions
How many devices does Syntec, Inc. have in the registry?
The registry currently lists 3 devices for Syntec, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Syntec, Inc.'s devices?
Among its 3 most recently registered devices, Syntec, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Syntec, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Syntec, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Syntec, Inc. in the registry?
The most recently registered devices listed for Syntec, Inc. include SYNTEC, INC. DISPOSABLE BARE END FIBER, PHACOGARD and SYNTEC VITMAN.