Apdyne Medical Co.
Country not established
- Devices
- 2
What Apdyne Medical Co. makes
Apdyne Medical Co. manufactures medical devices including the APDYNE PHENOL APPLICATOR KIT, used for controlled phenol ablation procedures, and the HYGIENA-TRACH, a tracheostomy care product designed for hygiene maintenance.
The company’s portfolio includes Class I and Class II devices, all listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Apdyne Phenol Applicator Kit Ref K894369
Regimes: 510(k) Registry: 510(k)Hygiena-Trach Ref K911080
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Apdyne Medical Co. have in the registry?
The registry currently lists 2 devices for Apdyne Medical Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Apdyne Medical Co.'s devices?
Among its 2 most recently registered devices, Apdyne Medical Co. has devices listed in FDA 510(k) (2 devices).
What risk classes do Apdyne Medical Co.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Apdyne Medical Co.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Apdyne Medical Co. in the registry?
The most recently registered devices listed for Apdyne Medical Co. include APDYNE PHENOL APPLICATOR KIT and HYGIENA-TRACH.