Sorin Biomedica, Fiat, USA, Inc.
Country not established
- Devices
- 21
What Sorin Biomedica, Fiat, USA, Inc. makes
Sorin Biomedica manufactures implantable cardiac pacing leads, cardioplegia systems for heart surgery, and immunoassay kits for measuring hormones and biomarkers like cortisol, estradiol, and parathyroid hormone. Their portfolio also includes bubble sensors and control modules for cardioplegic perfusion systems, as well as diagnostic radioimmunoassay kits for clinical laboratory use.
The company’s devices are regulated under FDA pathways, including 510(k) clearances for Class I and II products and PMA authorizations for Class III devices. Their portfolio is listed in the FDA’s regulatory records, and the company is headquartered in the United States.
Catalogue
Search and filter all 21 devicesFrequently asked questions
How many devices does Sorin Biomedica, Fiat, USA, Inc. have in the registry?
The registry currently lists 21 devices for Sorin Biomedica, Fiat, USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sorin Biomedica, Fiat, USA, Inc.'s devices?
Among its 21 most recently registered devices, Sorin Biomedica, Fiat, USA, Inc. has devices listed in FDA 510(k) (20 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sorin Biomedica, Fiat, USA, Inc.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Sorin Biomedica, Fiat, USA, 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 Sorin Biomedica, Fiat, USA, Inc. in the registry?
The most recently registered devices listed for Sorin Biomedica, Fiat, USA, Inc. include S80 IMPLANTABLE CARDIAC PACING LEAD, BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS, DIRIA-PROGK IMMUNOASSAY and STOCKERT 1/4 BUBBLE SENSOR.