American Edwards Laboratories
Country not established
- Devices
- 90
What American Edwards Laboratories makes
American Edwards Laboratories manufactures rigid and flexible endoscopes, including small-diameter and angiographic models, as well as thermodilution catheters for hemodynamic monitoring. The company also produces pressure gauges, balloon calibrators, and dilation/sheath sets for vascular and urological procedures. Infusion devices, cassette readers, and catheter covers are part of its portfolio, supporting diagnostic and interventional applications.
The portfolio includes devices classified as Class I, Class II, Class III, and unclassified (U) under US regulations. Products are authorised via FDA pathways, including 510(k) clearances and PMA submissions. The manufacturer operates from the United States.
Catalogue
Search and filter all 90 devicesShowing 1-50 of 90
Frequently asked questions
How many devices does American Edwards Laboratories have in the registry?
The registry currently lists 90 devices for American Edwards Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Edwards Laboratories's devices?
Among its 50 most recently registered devices, American Edwards Laboratories has devices listed in FDA 510(k) (50 devices).
What risk classes do American Edwards Laboratories's devices fall under?
Among its 50 most recently registered devices, the classes recorded for American 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 American Edwards Laboratories in the registry?
The most recently registered devices listed for American Edwards Laboratories include AMERICAN EDWARDS SMALL DIAMETER RIGID ENDOSCOPE, SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH, AMERICAN EDWARDS MINI-FLEX ANGIOSCOPE and EDSLAB PRESSURE GAUGE.