Welmed Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
What Welmed Systems, Inc. makes
Welmed Systems, Inc. produces single-use medical trays and kits for wound care, tracheostomy maintenance, and intravenous access. These include suture removal trays, tracheostomy care sets, suction catheter kits, TPN dressing change trays, and irrigation trays for catheter care. The company also offers IV starting kits designed for sterile insertion procedures.
The portfolio consists of Class I and Class II devices, with some products authorised via the FDA’s 510(k) pathway. These devices are listed under U.S. regulatory requirements, and the company operates from the United States.
Catalogue
Care + Plus Suture Removal Tray Ref K863283
Regimes: 510(k) Registry: 510(k)Tracheostomy Care Tray Ref K862663
Regimes: 510(k) Registry: 510(k)Suction Catheter Kit Ref K863497
Regimes: 510(k) Registry: 510(k)T.P.N. Dressing Change Tray Ref K862219
Regimes: 510(k) Registry: 510(k)I.V. Start Kit Ref K863284
Regimes: 510(k) Registry: 510(k)Care + Plus Catheter Care Tray Ref K863282
Regimes: 510(k) Registry: 510(k)Care + Plus Irregation Tray Ref K863281
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Welmed Systems, Inc. have in the registry?
The registry currently lists 7 devices for Welmed Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Welmed Systems, Inc.'s devices?
Among its 7 most recently registered devices, Welmed Systems, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Welmed Systems, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Welmed Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Welmed Systems, Inc. in the registry?
The most recently registered devices listed for Welmed Systems, Inc. include CARE + PLUS SUTURE REMOVAL TRAY, TRACHEOSTOMY CARE TRAY, SUCTION CATHETER KIT and T.P.N. DRESSING CHANGE TRAY.