Medical Modeling, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Medical Modeling, Inc. makes
Medical Modeling, Inc. manufactures the VSP System, a medical device designed for vascular surgical planning and simulation, supporting pre-operative visualization and training.
The VSP System is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Vsp System Ref K133907
Regimes: 510(k) Registry: 510(k)Vsp System Ref K120956
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Medical Modeling, Inc., initiated on 2022-05-17. By recorded status: 1 ongoing. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 17 May 2022 Z-1510-2022 Class II Ongoing Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Frequently asked questions
How many devices does Medical Modeling, Inc. have in the registry?
The registry currently lists 2 devices for Medical Modeling, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medical Modeling, Inc.'s devices?
Among its 2 most recently registered devices, Medical Modeling, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Medical Modeling, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Medical Modeling, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medical Modeling, Inc.?
FDA recall records list 1 recall initiated by Medical Modeling, Inc., the most recent initiated on 17 May 2022. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medical Modeling, Inc. in the registry?
The most recently registered devices listed for Medical Modeling, Inc. include VSP SYSTEM.