Ivalon
Country not established
- Devices
- 3
What Ivalon makes
Ivalon manufactures absorbable surgical sponges for ophthalmic and external use, designed to aid in tissue management during procedures. The company also produces embolic particles for vascular interventions, intended to occlude blood vessels in interventional radiology.
Ivalon’s products are regulated under FDA’s Class I and Class II categories, with relevant devices listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Ivalon Ophthalmic Sponge Ref K946016
Regimes: 510(k) Registry: 510(k)Ivalon External Sponge Ref K946015
Regimes: 510(k) Registry: 510(k)Ivalon Embolization Particles Ref K913556
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ivalon have in the registry?
The registry currently lists 3 devices for Ivalon. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ivalon's devices?
Among its 3 most recently registered devices, Ivalon has devices listed in FDA 510(k) (3 devices).
What risk classes do Ivalon's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Ivalon's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ivalon in the registry?
The most recently registered devices listed for Ivalon include IVALON OPHTHALMIC SPONGE, IVALON EXTERNAL SPONGE and IVALON EMBOLIZATION PARTICLES.