Cosman Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 225
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Cosman Medical, Inc. makes
Cosman Medical, Inc. manufactures radiofrequency generators and related accessories for medical procedures, including the Cosman G4 Radiofrequency Generator (Model RFG-4) and the Cosman RF Lesion Generator (Model RFG-1A). The company also produces trigeminal electrode kits such as the Cosman Tew Trigeminal Electrode Kit and Cosman Tic Trigeminal Electrode Kit, fiducial markers, RF cannulas including the Cosman CSK RF Cannula, Cosman RFK RF Cannula, and LesionPoint RF Cannula, as well as RF injection electrodes in models CU, CUR, CCD, TCD, CP, CR, and CN.
All devices manufactured by Cosman Medical, Inc. are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in the United States.
Catalogue
Search and filter all 225 devicesShowing 1-50 of 225
FDA recalls
FDA recall records list 1 recall initiated by Cosman Medical, Inc., initiated on 2017-07-05. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination and manufacturing or quality process. 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 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 5 Jul 2017 Z-0687-2018 Class II Terminated After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.
Frequently asked questions
How many devices does Cosman Medical, Inc. have in the registry?
The registry currently lists 225 devices for Cosman Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cosman Medical, Inc.'s devices?
Among its 50 most recently registered devices, Cosman Medical, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Cosman Medical, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Cosman Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Cosman Medical, Inc.?
FDA recall records list 1 recall initiated by Cosman Medical, Inc., the most recent initiated on 5 Jul 2017. 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 Cosman Medical, Inc. in the registry?
The most recently registered devices listed for Cosman Medical, Inc. include cannulaRFK RFK-C151016S, electrodeEchoCU CU-6520U, electrodeCUR CUR-61022 and cannulaRFK RFK-C151020BZ.