Kardium Inc
CanadaFDA applicant, unverified
Kardium Inc is a medical device manufacturer, with 13 devices listed in FDA GUDID, FDA 510(k) and FDA PMA (FDA Class II, III and I) and 2 FDA recalls as of 13 Nov 2026.
- Devices
- 13
- FDA recalls
- 2
Registry facts
- Registries
- FDA GUDID 11
- FDA 510(k) 1
- FDA PMA 1
- Device classes
- FDA Class II 7
- FDA Class III 4
- FDA Class I 2
- FDA recalls
- Sites and related companies
- KARDIUM Inc. Canada
- Identifiers
- DUNS 248480043
At a glance
Market reach
- United States
- FDA recalls
What Kardium Inc makes
Kardium, Inc. manufactures reusable electrical connection cables for medical devices, including specialized cardiac mapping systems such as computer workstations, reference patches, and electrode-based positioning systems. The company also produces cardiac irreversible electroporation systems, including generator units and catheter platforms designed for single-use procedures, as well as cable holders and introducer tools for catheter-based interventions.
The company’s portfolio includes devices classified under FDA categories Class I, Class II, and Class III, with regulatory submissions documented through 510(k), PMA, and UDI listings. These products are intended for use in the United States, where the manufacturer is based.
Catalogue
Search and filter all 13 devicesCompany details
- DUNS number
- 248480043
FDA recalls
2012
- 28 Aug 2012 Z-0054-2013 Class II Terminated The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use.
2010
- 31 Mar 2010 Z-1973-2010 Unclassified (pre-2012) Terminated A component of the device is installed incorrectly which can result in the component falling out of the device and into the patient during use.
Sites
- KARDIUM Inc. CAFEI 3007603855 0 devices
Frequently asked questions
How many devices does Kardium Inc have in the registry?
The registry currently lists 13 devices for Kardium Inc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kardium Inc's devices?
Among its 13 most recently registered devices, Kardium Inc has devices listed in FDA 510(k) (1 device), FDA PMA (1 device) and FDA GUDID (11 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Kardium Inc's devices fall under?
Among its 13 most recently registered devices, the classes recorded for Kardium Inc's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Kardium Inc?
FDA recall records list 2 recalls initiated by Kardium Inc, the most recent initiated on 28 Aug 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Kardium Inc in the registry?
The most recently registered devices listed for Kardium Inc include Globe® Loader Plug 601-01006, Globe® Controller 601-00048, Globe® Catheter Cable Support 601-00067 and Globe® Workstation 601-00064.