Gilardoni S.p.A.
ItalyFDA applicant, unverified FDA FEI 3009631751
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Gilardoni S.p.A. makes
Gilardoni S.P.A. manufactures the GRIDGIL, a medical device designed for use in surgical procedures, likely as a grid-based surgical instrument or mesh for tissue support or reinforcement.
The company’s portfolio is regulated under Class I medical devices in the United States, with the GRIDGIL authorised via the FDA’s 510(k) pathway. The manufacturer is based in the US.
Catalogue
Gridgil Ref K941626
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3009631751
- Address
- VIA ARTURO GILARDONI, 1, MANDELLO DEL LARIO Lecco
Frequently asked questions
How many devices does Gilardoni S.P.A. have in the registry?
The registry currently lists 1 device for Gilardoni S.P.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gilardoni S.P.A.'s devices?
Among its 1 most recently registered device, Gilardoni S.P.A. has devices listed in FDA 510(k) (1 device).
What risk classes do Gilardoni S.P.A.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Gilardoni S.P.A.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Gilardoni S.P.A. in the registry?
The most recently registered devices listed for Gilardoni S.P.A. include GRIDGIL.