Data / Medical devices / Norway / Medistim Asa

Medistim Asa: FDA-registered device maker in Oslo, Norway, 3 510(k) clearances

Name: Medistim Asa FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medistim Asa is registered with the FDA (registration 9613067) in Oslo, Norway. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 27, 2010. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9613067
FEI number: 3010790133
Address: Oekernveien 94, Oslo, Norway, N-0579
Owner or operator: Medistim ASA (9038441)
Roles: Specification developer
First device listed: December 10, 2007
Registered through: 2026
Brand names listed: Medi-Stim Butterfly Flowmeter, Medistim Doppler Probe, Medistim Imaging probe, Medistim MiraQ system, Medistim Transit-Time Probe, Medistim VeriQ System, Medistim VeriQC system

Devices it lists

Device	Product code	Class	Role	Source
Computer, Blood-Pressure	DSK	2	Specification developer	accessdata.fda.gov
Flowmeter, Blood, Cardiovascular	DPW	2	Specification developer	accessdata.fda.gov
Probe, Blood-Flow, Extravascular	DPT	2	Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	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
December 27, 2010	K102595	MEDISTIM VERIQC SYSTEM	DPW	Substantially Equivalent	Medi-Stim Asa	accessdata.fda.gov
April 29, 2004	K040228	MEDI-STIM VERIQ SYSTEM, MODEL VQ1001 - VQ4122	DPW	Substantially Equivalent	Medi-Stim A/S	accessdata.fda.gov
September 8, 1999	K992305	MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004	ITX	Substantially Equivalent	Medi-Stim A/S	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 26, 2025	97707	Class II	Ongoing	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 intraoperativ	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.	accessdata.fda.gov
April 25, 2017	78973	Class II	Terminated	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.	accessdata.fda.gov

Compare with other makers

Updated October 29, 2025. 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.