Grason-Stadler, Inc.
United StatesFDA applicant, unverified
- Devices
- 20
What Grason-Stadler, Inc. makes
Grason-Stadler, Inc. manufactures audiometric and middle ear analysis devices, including impedance audiometers, screening audiometers, and automated auditory brainstem response (ABR) screeners. Their portfolio includes otodynamic impedance analyzers, distortion product otoacoustic emission (DPOAE) systems, and clinical audiometers designed for hearing assessment. These devices support diagnostic and screening evaluations of hearing function across clinical and screening applications.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. These devices are intended for use in the United States, adhering to FDA compliance requirements for diagnostic and screening hearing instruments. The manufacturer is based in the US.
Catalogue
Search and filter all 20 devicesFrequently asked questions
How many devices does Grason-Stadler, Inc. have in the registry?
The registry currently lists 20 devices for Grason-Stadler, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Grason-Stadler, Inc.'s devices?
Among its 20 most recently registered devices, Grason-Stadler, Inc. has devices listed in FDA 510(k) (20 devices).
What risk classes do Grason-Stadler, Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Grason-Stadler, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Grason-Stadler, Inc. in the registry?
The most recently registered devices listed for Grason-Stadler, Inc. include MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER), MIDDLE EAR ANALYZER (IMPEDANCE AUDIO, MIDDLE EAR ANALYZER (IMPED. AUDIOMTR) and GSI Novus.