Company ยท US
Grason-Stadler, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2020. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2020 | K193033 | GSI Audera Pro Grason Stadler | GWJ |
| May 11, 2018 | K180287 | GSI Corti Grason-Stadler, Inc. | EWO |
| Oct 20, 2017 | K172403 | GSI Novus Grason-Stadler, Inc. | EWO |
| Apr 12, 2000 | K000097 | GSI 2000 MIDDLE EAR ANALYZER Grason-Stadler, Inc. | ETY |
| Feb 10, 1998 | K974237 | GSI 70 AUDIOPATH SCREENER Grason-Stadler, Inc. | EWO |
| Jun 6, 1997 | K970324 | GSI SA60 DPOAE SYSTEM Grason-Stadler, Inc. | ETW |
| Oct 27, 1995 | K953684 | GSI 61 CLINICAL AUDIOMETER Grason-Stadler, Inc. | EWO |
| Jul 6, 1995 | K951759 | GSI 65 COMPUTERIZED AUDIOMETER Grason-Stadler, Inc. | EWO |
| Jul 13, 1990 | K902540 | GSI 17 SCREENING AUDIOMETER Grason-Stadler, Inc. | EWO |
| Jul 14, 1989 | K890124 | ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER Grason-Stadler, Inc. | EWO |
| Mar 13, 1987 | K870030 | THE SCREENER GSI 55 ABR SCREENER Grason-Stadler, Inc. | GWJ |
| Nov 3, 1986 | K863353 | MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) Grason-Stadler, Inc. | ETY |
| Dec 3, 1984 | K843618 | AUDIOMETER Grason-Stadler, Inc. | EWO |
| Apr 9, 1982 | K820715 | MIDDLE EAR ANALYZER (IMPEDANCE AUDIO Grason-Stadler, Inc. | EWO |
| Apr 29, 1981 | K810583 | AUDIOMETER Grason-Stadler, Inc. | EWO |
| May 17, 1979 | K790846 | MIDDLE EAR ANALYZER (IMPED. AUDIOMTR) Grason-Stadler, Inc. | EWO |
| Apr 10, 1979 | K790609 | AUDIOMETER Grason-Stadler, Inc. | EWO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||