Healthtronics Surgical Services, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Healthtronics Surgical Services, Inc. makes
Healthtronics Surgical Services, Inc. manufactures the TWINTRODE ELC 134 ELECTRODE, a surgical electrode used in electrocautery procedures, the HEALTHTRONIC OMEGA TRAC, a device for monitoring physiological parameters during surgery, and the HEALTHTRONICS LITHOTRON LITHOTRIPSY SYSTEM, an extracorporeal shock wave lithotripsy device for breaking kidney stones.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearances and a Premarket Approval (PMA). The company is based in the United States.
Catalogue
Twintrode Elc 134 Electrode Ref K012785
Regimes: 510(k) Registry: 510(k)Healthtronic Omega Trac Ref K881902
Regimes: 510(k) Registry: 510(k)Healthtronics Lithotron Lihtotripsy System Ref P970019
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Healthtronics Surgical Services, Inc. have in the registry?
The registry currently lists 3 devices for Healthtronics Surgical Services, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthtronics Surgical Services, Inc.'s devices?
Among its 3 most recently registered devices, Healthtronics Surgical Services, Inc. has devices listed in FDA 510(k) (2 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Healthtronics Surgical Services, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Healthtronics Surgical Services, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healthtronics Surgical Services, Inc. in the registry?
The most recently registered devices listed for Healthtronics Surgical Services, Inc. include TWINTRODE ELC 134 ELECTRODE, HEALTHTRONIC OMEGA TRAC and HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM.