Medistim ASA
HORTEN Vestfold, NO
MEDISTIM ASA appears in FDA device records in HORTEN Vestfold, NO. 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 |
|---|---|---|---|---|---|
| 3003647374 | 3003647374 | MEDISTIM ASA | BROMSVEIEN 17, HORTEN Vestfold 3183 NO | 2026 | |
| 9613067 | 3010790133 | MEDISTIM ASA | Oekernveien 94, OSLO N-0579 NO | 2026 |
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-0410-2026 | Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No | Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced. | Class II | Open, Classified | |
| Z-0719-2018 | MEDISTIM VERIQ SYSTEM, MODEL VQ4122 An intraoperative diagnostic system that utilizes ultrasonography to guide surgeons to successfully plan and accomplish surgical interventions. | A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain