Syntex Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 10
What Syntex Corp. makes
Syntex Corp. makes surgical loops, fiber optic handpieces, dental amalgam alloys, and computerized tomography scanners including the S-100 CT scanner and System 6000. They also produce assay modifications such as the TXIT D.A.U. barbiturate assay, fiber optic system options like the Opus I Fiber Optic L System, and sensitivity options for imaging devices such as the Hi-Sensitivity Mode Option for S60-1A.
The devices in Syntex Corp.'s portfolio are classified as Class I and Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Surgipress Surgical Loop Ref K843593
510(k) 510(k)Txit D.A.U. Barbiturate Assay (Modification) Ref K920314
510(k) 510(k)Fiber Optic Handpiece Ref K780483
510(k) 510(k)S-100 Ct Scanner Ref K780769
510(k) 510(k)Hi-Sensitivity Mode Option For S60-1A Ref K761332
510(k) 510(k)Amalgam Alloy Ref K780997
510(k) 510(k)Syntex System 6000 Ref K761330
510(k) 510(k)Opus I Option - Fiber Optic L System Ref K761331
510(k) 510(k)Computerized Tomography Scanner Ref K761033
510(k) 510(k)Options For Star Dental Opus I Ref K761264
510(k) 510(k)
Frequently asked questions
How many devices does Syntex Corp. have in the registry?
The registry currently lists 10 devices for Syntex Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Syntex Corp.'s devices?
Among its 10 most recently registered devices, Syntex Corp. has devices listed in FDA 510(k) (10 devices).
What risk classes do Syntex Corp.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Syntex Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Syntex Corp. in the registry?
The most recently registered devices listed for Syntex Corp. include SURGIPRESS SURGICAL LOOP, TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION), FIBER OPTIC HANDPIECE and S-100 CT SCANNER.