Kmi Kolster Methods, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Kmi Kolster Methods, Inc. makes
Kmi Kolster Methods, Inc. manufactures external ultrasound devices, power cannulas for surgical procedures, sterile solution warmers, extended aptos threads for tissue approximation, and suture anchors for soft tissue fixation. The company also produces an irrigation or infusion pump designed for controlled fluid delivery during medical procedures.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry, and the company is based in the United States.
Catalogue
Xub External Ultrasound Ref K010702
Regimes: 510(k) Registry: 510(k)STARS2000 Power Cannula Ref K012236
Regimes: 510(k) Registry: 510(k)Ssw-Sterile Solution Warmer Ref K002859
Regimes: 510(k) Registry: 510(k)Featherlift Extended Aptos Thread Ref K043591
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Irrigation Or Infusion Pump K Pump Ref K991203
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Kmi Kolster Methods, Inc. have in the registry?
The registry currently lists 6 devices for Kmi Kolster Methods, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kmi Kolster Methods, Inc.'s devices?
Among its 6 most recently registered devices, Kmi Kolster Methods, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Kmi Kolster Methods, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Kmi Kolster Methods, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kmi Kolster Methods, Inc. in the registry?
The most recently registered devices listed for Kmi Kolster Methods, Inc. include XUB EXTERNAL ULTRASOUND, STARS2000 POWER CANNULA, SSW-STERILE SOLUTION WARMER and FEATHERLIFT EXTENDED APTOS THREAD.