Equidyne Systems, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 5
What Equidyne Systems, Inc. makes
Equidyne Systems, Inc. manufactures needle-free injection systems, including the INJEX 30 and INJEX 50 models, as well as jet injectors like the HYPEX and Jet Syringe Model-100500. These devices are designed for high-pressure fluid delivery without traditional needles, used in medical and clinical settings for vaccinations, drug administration, and other injections.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Injex 30 Needle Free Injection System Ref K022148
510(k) 510(k)- 510(k) 510(k)
Injex 50 System Ref K003864
510(k) 510(k)Hypex(Tm) Jet Injector Ref K945873
510(k) 510(k)Jet Syringe Model-100500 Ref K003741
510(k) 510(k)
Frequently asked questions
How many devices does Equidyne Systems, Inc. have in the registry?
The registry currently lists 5 devices for Equidyne Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Equidyne Systems, Inc.'s devices?
Among its 5 most recently registered devices, Equidyne Systems, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Equidyne Systems, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Equidyne Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Equidyne Systems, Inc. in the registry?
The most recently registered devices listed for Equidyne Systems, Inc. include INJEX 30 NEEDLE FREE INJECTION SYSTEM, INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000, INJEX 50 SYSTEM and HYPEX(TM) JET INJECTOR.