Telectronics, Inc.
United StatesFDA applicant, unverified
- Devices
- 108
What Telectronics, Inc. makes
Telectronics, Inc. manufactures implantable cardiac devices, including unipolar and bipolar endocardial pacing leads (e.g., Model 030-438, Model 030-324), programmable pulse generators (e.g., Model 030-446), and associated electrode assemblies. The portfolio also covers sterile packaging solutions for implantable electrodes and adaptors, as well as specialized tools like a hexagon driver wrench for device implantation.
The company’s devices are regulated under FDA pathways, with products classified as Class I, Class II, and Class III, and authorised via 510(k) clearances and Premarket Approval Applications (PMA). These devices are listed in the FDA’s regulatory records, and the manufacturer operates from the United States.
Catalogue
Search and filter all 108 devicesShowing 1-50 of 108
Frequently asked questions
How many devices does Telectronics, Inc. have in the registry?
The registry currently lists 108 devices for Telectronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Telectronics, Inc.'s devices?
Among its 50 most recently registered devices, Telectronics, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Telectronics, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Telectronics, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Telectronics, Inc. in the registry?
The most recently registered devices listed for Telectronics, Inc. include SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438, RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE, STERILE PACKAGING and IMPLANTABLE PROGRAMMABLE BIPOLAR CARDIAC.