Ultimed Incorporated
United StatesFDA applicant, unverified
- Devices
- 2
What Ultimed Incorporated makes
Ultimed Incorporated manufactures single-use safety syringes with removable needles and disposable pen needles designed for insulin administration and other injectable medications. These devices incorporate features to reduce needle-stick injuries and improve user safety during handling and disposal.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Ulticare Safety Syringe With Removable Needle Ref K140949
Regimes: 510(k) Registry: 510(k)UltiCare Disposable Pen Needles Ref K213407
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ultimed Incorporated have in the registry?
The registry currently lists 2 devices for Ultimed Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ultimed Incorporated's devices?
Among its 2 most recently registered devices, Ultimed Incorporated has devices listed in FDA 510(k) (2 devices).
What risk classes do Ultimed Incorporated's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ultimed Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ultimed Incorporated in the registry?
The most recently registered devices listed for Ultimed Incorporated include ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE and UltiCare Disposable Pen Needles.