Medtech Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Medtech Intl., Inc. makes
Medtech Intl., Inc. manufactures single-use medical textiles and accessories, including gauze, cotton sponges, surgical eye sponges, and cut-resistant surgical glove liners. Their portfolio also includes an IV insertion aid, a transcutaneous nerve stimulator, and a hypodermic needle equipped with a sensor for safety monitoring.
The company’s devices are regulated under FDA classifications, with products falling into Class I, Class II, and unclassified (U) categories. These items are listed via the FDA’s 510(k) pathway, and the manufacturer is based in the United States.
Catalogue
Gauze & Cotton Sponges Ref K790389
Regimes: 510(k) Registry: 510(k)Iv Mate Ref K853843
Regimes: 510(k) Registry: 510(k)Stimulator, Nerve, Transcutaneous Ref K781157
Regimes: 510(k) Registry: 510(k)Cut Resistant Gloves Or Surgical Glove Liner Ref K920876
Regimes: 510(k) Registry: 510(k)Surgical Eye Sponge Ref K790467
Regimes: 510(k) Registry: 510(k)Hyperdermic Needle With Sensor #514 Ref K791462
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtech Intl., Inc. have in the registry?
The registry currently lists 6 devices for Medtech Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtech Intl., Inc.'s devices?
Among its 6 most recently registered devices, Medtech Intl., Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Medtech Intl., Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Medtech Intl., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtech Intl., Inc. in the registry?
The most recently registered devices listed for Medtech Intl., Inc. include GAUZE & COTTON SPONGES, IV MATE, STIMULATOR, NERVE, TRANSCUTANEOUS and CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER.