Grason-Stadler, Inc.
Milford, NH, US
Grason-Stadler, Inc. appears in FDA device records in Milford, NH. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Grason-Stadler, Inc. between 1979 and 2020. The busiest year on record is 1979, with 2. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1981 | 1 |
| 1982 | 1 |
| 1984 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| 1998 | 1 |
| 2000 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193033 | GSI Audera Pro | GWJ | Substantially Equivalent | |
| K180287 | GSI Corti | EWO | Substantially Equivalent | |
| K172403 | GSI Novus | EWO | Substantially Equivalent | |
| K000097 | GSI 2000 MIDDLE EAR ANALYZER | ETY | Substantially Equivalent | |
| K974237 | GSI 70 AUDIOPATH SCREENER | EWO | Substantially Equivalent | |
| K970324 | GSI SA60 DPOAE SYSTEM | ETW | Substantially Equivalent | |
| K953684 | GSI 61 CLINICAL AUDIOMETER | EWO | Substantially Equivalent | |
| K951759 | GSI 65 COMPUTERIZED AUDIOMETER | EWO | Substantially Equivalent | |
| K902540 | GSI 17 SCREENING AUDIOMETER | EWO | Substantially Equivalent | |
| K890124 | ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER | EWO | Substantially Equivalent | |
| K870030 | THE SCREENER GSI 55 ABR SCREENER | GWJ | Substantially Equivalent | |
| K863353 | MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) | ETY | Substantially Equivalent | |
| K843618 | AUDIOMETER | EWO | Substantially Equivalent | |
| K820715 | MIDDLE EAR ANALYZER (IMPEDANCE AUDIO | EWO | Substantially Equivalent | |
| K810583 | AUDIOMETER | EWO | Substantially Equivalent | |
| K790846 | MIDDLE EAR ANALYZER (IMPED. AUDIOMTR) | EWO | Substantially Equivalent | |
| K790609 | AUDIOMETER | EWO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain