Data / Medical devices / Italy / Medtronic Italia
Medtronic Italia: FDA-registered device maker in Rolo Reggio Emilia, Italy, 9 510(k) clearances
Medtronic Italia is registered with the FDA (registration 3013242701) in Rolo Reggio Emilia, Italy. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 8, 1995. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013242701
- Address
- Via Campogrande 43, Rolo Reggio Emilia, Italy, 42047
- Owner or operator
- Covidien llc (1282497)
- Roles
- Exporter to the US
- First device listed
- January 6, 1993
- Registered through
- 2026
- Brand names listed
- Airway Connector with Flex Tube, Barrierbac, Barrierbac S, Flexlife, HME for Tracheostomized Patients, Hybrobac S, Hygrobaby, Hygrobac and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Exporter to the US | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Exporter to the US | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Exporter to the US | 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 8, 1995 | K952036 | FLEXLIFE | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| September 8, 1994 | K944124 | SPIROBAC ADAPTERS | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| August 22, 1994 | K942794 | HYGROLIFE | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| August 22, 1994 | K942392 | AIRWAY CONNECTOR WITH FLEX TUBE | BZA | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| May 20, 1994 | K941676 | STERIVENT AND STERIVENT S | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 19, 1994 | K941585 | HYGROSTER | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 19, 1994 | K941536 | BARRIERBAC AND BARRIERBAC S | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 15, 1994 | K941535 | TRACHEOLIFE | BYD | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| April 15, 1994 | K941381 | HYGROBAC,S HYGROBOY AND HYGROBABY | CAH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Condenser, Heat And Moisture (Artificial Nose)
- All makers of Connector, Airway (Extension)
Updated June 8, 1995. 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.