Edwards Laboratories
Country not established
- Devices
- 12
What Edwards Laboratories makes
Edwards Laboratories manufactures venous filter devices, including the Mobin-Uddin vena cava filters (models 7220, 7221, and 7321) designed for placement in the inferior vena cava to prevent pulmonary embolism. The company also produces cardiac monitoring and measurement tools such as the SpectraView (Model 100) for hemodynamic assessment, thermodilution cardiac output computers (Model 9520), and disposable holders for bioprosthetic heart valves. Additional offerings include angiography applicators, cardiac catheter probes, and accessories like flow-through temperature sensors (Model 9542) and AC adapters for medical devices.
The company’s products are classified under FDA’s Class I and Class II categories, with regulatory submissions documented via 510(k) clearances. These devices are listed in the FDA’s 510(k) registry, reflecting their authorised status under U.S. medical device regulations. The manufacturer is based in the United States.
Catalogue
Search and filter all 12 devicesFrequently asked questions
How many devices does Edwards Laboratories have in the registry?
The registry currently lists 12 devices for Edwards Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Edwards Laboratories's devices?
Among its 12 most recently registered devices, Edwards Laboratories has devices listed in FDA 510(k) (12 devices).
What risk classes do Edwards Laboratories's devices fall under?
Among its 12 most recently registered devices, the classes recorded for Edwards Laboratories's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Edwards Laboratories in the registry?
The most recently registered devices listed for Edwards Laboratories include FILTER (7220&7221 MOBIN-UDDIN VENA CAVA), MODEL 100 SPECTRAVIEW, AC ADAPTER:MODELS 9525, 9526, 9527 and CARPENTIER-EDWARDS FLEX. ANNULOPLASTY.