Omnis Surgical, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Omnis Surgical, Inc. makes
Omnis Surgical, Inc. manufactures single-use surgical trays and kits, including an epidural anesthesia tray, a cardiotomy reservoir with integrated filter, and a Cohen-Warner testicular biopsy tray. The company also produces a hemoconcentrator kit designed for blood processing during surgical procedures.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Epidural Anesthesia Tray Ref K854518
Regimes: 510(k) Registry: 510(k)Cardiotomy Reservoir W/Filter Ref K843595
Regimes: 510(k) Registry: 510(k)Cohen-Warner Testicular Biopsy Tray 2N2720 Ref K844993
Regimes: 510(k) Registry: 510(k)Hemoconcentrator Kit Ref K850979
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omnis Surgical, Inc. have in the registry?
The registry currently lists 4 devices for Omnis Surgical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omnis Surgical, Inc.'s devices?
Among its 4 most recently registered devices, Omnis Surgical, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Omnis Surgical, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Omnis Surgical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omnis Surgical, Inc. in the registry?
The most recently registered devices listed for Omnis Surgical, Inc. include EPIDURAL ANESTHESIA TRAY, CARDIOTOMY RESERVOIR W/FILTER, COHEN-WARNER TESTICULAR BIOPSY TRAY 2N2720 and HEMOCONCENTRATOR KIT.