Berkley and Co.
Country not established
- Devices
- 3
What Berkley and Co. makes
Berkley and Co. manufactures hypodermic needles with stylets, as well as Filafex aesthetic orthodontic wires for dental applications. These products include both standard hypodermic needles and specialized orthodontic wires designed for precise dental adjustments.
The company’s portfolio is classified under FDA’s Class I medical devices, with relevant products listed via the 510(k) pathway. These devices are regulated under US jurisdiction and comply with applicable FDA requirements for low-risk medical instruments.
Catalogue
Hypodermic Needle And Stylet Ref K854579
Regimes: 510(k) Registry: 510(k)Filafex Esthetic Orthodinic Wire Ref K833788
Regimes: 510(k) Registry: 510(k)Filafex Tm, Esthetic Orthodontic Wire Ref K843171
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Berkley and Co. have in the registry?
The registry currently lists 3 devices for Berkley and Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Berkley and Co.'s devices?
Among its 3 most recently registered devices, Berkley and Co. has devices listed in FDA 510(k) (3 devices).
What risk classes do Berkley and Co.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Berkley and Co.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Berkley and Co. in the registry?
The most recently registered devices listed for Berkley and Co. include HYPODERMIC NEEDLE AND STYLET, FILAFEX ESTHETIC ORTHODINIC WIRE and FILAFEX TM, ESTHETIC ORTHODONTIC WIRE.