Sonesta Medical AB
Stockholm, SE
SONESTA MEDICAL AB appears in FDA device records in Stockholm, SE. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010496070 | 3010496070 | SONESTA MEDICAL AB | Industrivagen 7, Stockholm 114 46 SE | 2026 | |
| 3010517377 | 3010517377 | SONESTA MEDICAL, INC. | 2 De Bush Ave Unit C3, Middleton, MA 01949 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0460-2026 | Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 - Procedure table designed for full fluoroscopic imaging of the urinary tract during video Urodynamics procedures. Component: N/A | Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping. | Class II | Open, Classified | |
| Z-1894-2017 | Sonesta S2; Article numbers: 525-S2-110V and 525S2-220V | The user / service manual for the Sonesta S2 Chair contain wrong information concerning the maximum patient weight. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain