Entific Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Entific Medical Systems, Inc. makes
Entific Medical Systems, Inc. manufactures bone-anchored hearing aid systems, including the BRANEMARK BAHA, BAHA Divino, and Cordelle II, along with accessories like the BAHA headband. These devices are designed for bilateral fitting to provide hearing solutions for patients with conductive or mixed hearing loss. The portfolio also includes surgical components for implanting the BAHA system.
The company’s devices are classified as Class II under FDA regulations and are 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
Branenmark Bone-Anchored-Hearing Aid (Baha) Ref K021837
Regimes: 510(k) Registry: 510(k)Baha Divino Ref K042017
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Headband For Baha Ref K002913
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Entific Medical Systems, Inc. have in the registry?
The registry currently lists 5 devices for Entific Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Entific Medical Systems, Inc.'s devices?
Among its 5 most recently registered devices, Entific Medical Systems, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Entific Medical Systems, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Entific Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Entific Medical Systems, Inc. in the registry?
The most recently registered devices listed for Entific Medical Systems, Inc. include BRANENMARK BONE-ANCHORED-HEARING AID (BAHA), BAHA DIVINO, BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II and HEADBAND FOR BAHA.