Simpex, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Simpex, Inc. makes
Simpex, Inc. manufactures single-use medical fixation tools, including pins and wires for orthopedic procedures, as well as disposable oral and rectal thermometers for patient temperature monitoring. Their product line also includes latex examination gloves and sterile surgical dressings for wound care applications.
The company’s devices are regulated under FDA Class I and Class II classifications, with relevant products listed via the 510(k) pathway. These products are intended for use in the United States, where Simpex, Inc. is based.
Catalogue
Fixation Pin Ref K911452
Regimes: 510(k) Registry: 510(k)Simpex Inc. Oral And Rectal Thermometers Ref K913793
Regimes: 510(k) Registry: 510(k)Easy Touch Latex Eam Gloves Ref K920174
Regimes: 510(k) Registry: 510(k)Simpex Inc. Surgical Dressing Ref K913794
Regimes: 510(k) Registry: 510(k)Fixation Wire Ref K911505
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Simpex, Inc. have in the registry?
The registry currently lists 5 devices for Simpex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Simpex, Inc.'s devices?
Among its 5 most recently registered devices, Simpex, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Simpex, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Simpex, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Simpex, Inc. in the registry?
The most recently registered devices listed for Simpex, Inc. include FIXATION PIN, SIMPEX INC. ORAL AND RECTAL THERMOMETERS, EASY TOUCH LATEX EAM GLOVES and SIMPEX INC. SURGICAL DRESSING.