Omnia SpA
Country not established FDA
Omnia SpA is a medical device manufacturer, with 204 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 204
- Registrations
- FDA
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 201
- EUDAMED 48
- FDA 510(k) 3
- Device classes
- FDA Class II 115
- FDA Class I 89
- FDA recalls
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Omnia SpA makes
Omnia Spa manufactures single-use surgical drapes, surgical gowns, surgical caps, and face masks for use in medical procedures. The company also produces polyolefin/fluoropolymer monofilament sutures, disposable surgical irrigation/aspiration systems, and dental suction system cannulas, all designed for one-time use in clinical settings.
These devices are classified as Class I or Class II medical devices and are listed in the FDA’s 510(k) and UDI registries.
Catalogue
Search and filter all 204 devicesShowing 1-50 of 204
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2021
- 30 Mar 2021 Z-1518-2021 Class II Terminated Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.
Full distribution text
- 30 Mar 2021 Z-1518-2021 Class II Terminated Omnia SRL received a notification from the contract manufacturer informing them of inadequate sterilization processes which have been taking place at their contracted sterilizing facility since 2016.
FDA establishments
- Omnia SRL FIDENZA Parma · IT FEI 3004361903
Frequently asked questions
How many devices does Omnia Spa have in the registry?
The registry currently lists 204 devices for Omnia Spa. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omnia Spa's devices?
Among its 50 most recently registered devices, Omnia Spa has devices listed in EUDAMED (19 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Omnia Spa's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Omnia Spa's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Omnia Spa?
FDA recall records list 1 recall initiated by Omnia Spa, the most recent initiated on 30 Mar 2021. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Omnia Spa in the registry?
The most recently registered devices listed for Omnia Spa include Basic Implant Set 12.S5621.00, Implantology Set 12.S4671.00, Oral Surgery Set 12.S4096.00 and Oral Surgery Pack 12.S8318.00.
Which FDA establishments are linked to Omnia Spa?
1 FDA establishment is linked to Omnia Spa in the registry; they are listed on the company page.