Data / Medical devices / Sweden / Cardia Innovation AB
Cardia Innovation AB: FDA-registered device maker in Bromma Stockholm, Sweden, 1 510(k) clearance
Cardia Innovation AB is registered with the FDA (registration 3005555621) in Bromma Stockholm, Sweden. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 22, 2012. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005555621
- Address
- Gustavslundsvaegen 143, Bromma Stockholm, Sweden, SE-167 51
- Owner or operator
- CARDIA INNOVATION AB (9076128)
- Roles
- Exporter to the US, Specification developer
- First device listed
- November 27, 2012
- Registered through
- 2026
- Brand names listed
- CarbonAid, CarbonMini
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | 2 | Exporter to the US, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 22, 2012 | K112975 | CARBONAID C02 DIFFUSER | HIF | Substantially Equivalent | Cardia Innovation AB | accessdata.fda.gov |
Compare with other makers
Updated June 22, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.