Dacomed Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 20
What Dacomed Corp. makes
Dacomed Corp. manufactures penile prostheses, including silicone-silver and inflatable models like the Eska Jonas and Omni Phase, along with sizing tools and vacuum erection devices. Their portfolio also includes external male continence devices and voice prostheses, such as the Eska-Herrmann. Retractors and measurement gauges for urological procedures are part of their product line.
The company’s devices are regulated under FDA classifications, including Class I, Class II, and Unclassified (U), with many authorised via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Search and filter all 20 devicesFrequently asked questions
How many devices does Dacomed Corp. have in the registry?
The registry currently lists 20 devices for Dacomed Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dacomed Corp.'s devices?
Among its 20 most recently registered devices, Dacomed Corp. has devices listed in FDA 510(k) (20 devices).
What risk classes do Dacomed Corp.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Dacomed Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dacomed Corp. in the registry?
The most recently registered devices listed for Dacomed Corp. include ESKA JONAS SILICONE-SILVER PENILE PROST, DACOMED PENILE PROSTHESIS SIZER, FORDER RETRACTOR and DACOMED SNAP-GAUGE.