Cardiac Pacemakers, Inc.
United StatesFDA applicant, unverified
- Devices
- 76
What Cardiac Pacemakers, Inc. makes
Cardiac Pacemakers, Inc. manufactures cardiac pacing devices, including bipolar pulse generators (programmable and demand), programmer systems for device programming and electrogram recording, and specialized tools like universal cutters and stylets. Their portfolio also includes chip revisions for existing pacemaker models and microthin bipolar pulse generators designed for precise cardiac stimulation.
The company’s devices are classified under FDA categories Class I, Class II, and Class III, with regulatory submissions supported via the 510(k) pathway. These products are listed in the FDA’s 510(k) registry, reflecting their authorised status for commercial distribution in the US.
Catalogue
Search and filter all 76 devicesShowing 1-50 of 76
Frequently asked questions
How many devices does Cardiac Pacemakers, Inc. have in the registry?
The registry currently lists 76 devices for Cardiac Pacemakers, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiac Pacemakers, Inc.'s devices?
Among its 50 most recently registered devices, Cardiac Pacemakers, Inc. has devices listed in FDA 510(k) (50 devices).
What risk classes do Cardiac Pacemakers, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Cardiac Pacemakers, 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 Cardiac Pacemakers, Inc. in the registry?
The most recently registered devices listed for Cardiac Pacemakers, Inc. include ACUITY UNIVERSAL CUTTER, PACEMAKER PROGRAMMER #2010, MICROTHIN-PII BIPOLAR PULSE GEN. #0623 and ASTRA 2, 3, 4 AND 6: CHIP REVISION.