Pmbs, LLC
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Pmbs, LLC makes
Pmbs, LLC manufactures sterilization systems designed for healthcare settings, including the MTS300 and MTS225 Multiple Tray Sterilization Systems. These devices are engineered to process multiple trays of medical instruments simultaneously using steam sterilization methods.
The company’s sterilization systems are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. These products are intended for use in the United States.
Catalogue
MTS300 Multiple Tray Sterilization System Ref K152014
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Pmbs, LLC, initiated on 2016-01-13. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 13 Jan 2016 Z-1266-2016 Class II Terminated Water retention issues. Units with filters that remain wet after the sterilization may compromised sterility.
Frequently asked questions
How many devices does Pmbs, LLC have in the registry?
The registry currently lists 2 devices for Pmbs, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pmbs, LLC's devices?
Among its 2 most recently registered devices, Pmbs, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Pmbs, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pmbs, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Pmbs, LLC?
FDA recall records list 1 recall initiated by Pmbs, LLC, the most recent initiated on 13 Jan 2016. 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 Pmbs, LLC in the registry?
The most recently registered devices listed for Pmbs, LLC include MTS300 Multiple Tray Sterilization System and MTS225 and MTS300 Multiple Tray Sterilization Systems.