Data / Medical devices / Italy / Adria SRL.
Adria SRL.: FDA-registered device maker in San Giovanni in Persiceto Bologna, Italy, 1 510(k) clearance
Adria SRL. is registered with the FDA (registration 3014200871) in San Giovanni in Persiceto Bologna, Italy. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 8, 2014. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014200871
- Address
- Via Modena n. 46, San Giovanni in Persiceto Bologna, Italy, 40017
- Owner or operator
- Adria Srl. (10062522)
- Roles
- Manufacturer
- First device listed
- February 6, 2020
- Registered through
- 2026
- Brand names listed
- Cement Injection Cannula - 495041420, Herniatome 5091715, 5091749, 5091745, Hollow Drill - 495930810, Kit of 2 Cement delivery instruments - 495041123, Litebag 500/0600, Vertebroplasty Canulated Needle - 493xx, T0604xx, Vertebroplasty Injector Kit - 49000001, Vertebroplasty Needle - 496xx, 498xx, 491xx, 490xx, 492xx, T0604xx and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Arthroscope | HRX | 2 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Manufacturer | accessdata.fda.gov |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 8, 2014 | K141557 | HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR | HRX | Substantially Equivalent | Gallini Medical Devices, Srl | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 17, 2021 | 88543 | Class II | Terminated | Herniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 5091715 | The recalling firm was notified by the contract sterilizer that the process parameters of the sterilization cycles were not followed. | accessdata.fda.gov |
Compare with other makers
- All makers of Bit, Drill
- All makers of Spinal Channeling Instrument, Vertebroplasty
- All makers of Collector, Urine, (And Accessories) For Indwelling Catheter
- All makers of Arthroscope
- All makers of Injector, Vertebroplasty (Does Not Contain Cement)
- All makers of Needle, Aspiration And Injection, Disposable
Updated December 8, 2014. 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.