Panels › Ear, Nose, Throat › Product code ESE · Class 1
Larynx, Artificial (Battery-Powered)
Regulation 874.3375
0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in ESE
| Company | 510(k)s | Recalls |
|---|---|---|
| Bloomfield Research and Development, Inc. | 2 | 0 |
| Bear Medical Systems, Inc. | 1 | 0 |
| Bruce Medical Supply | 1 | 0 |
| Cisko Systems | 1 | 0 |
| Denrick Corp. | 1 | 0 |
| Dynamed Audio, Inc. | 1 | 0 |
| Kells Medical, Inc. | 1 | 0 |
| Mountain Precision Mfg. Ltd. Co. | 1 | 0 |
| Respiratory Support Products, Inc. | 1 | 0 |
| Stanton Magnetics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 16, 1994 | K934483 | NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX Mountain Precision Mfg. Ltd. Co. | ESE |
| Aug 25, 1993 | K931371 | DENRICK SPEECH AID (DR-1) Denrick Corp. | ESE |
| Apr 7, 1993 | K923648 | LECTRO-LARYNX Bruce Medical Supply | ESE |
| Feb 12, 1993 | K914816 | AMERICAN ARTIFICIAL LARYNX Ultravoice, Ltd. | ESE |
| Jun 28, 1990 | K901503 | ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM Stanton Magnetics, Inc. | ESE |
| May 2, 1986 | K860992 | VOX COMPANION Bloomfield Research and Development, Inc. | ESE |
| Apr 25, 1986 | K860993 | P.O. VOX Bloomfield Research and Development, Inc. | ESE |
| Dec 13, 1985 | K854158 | RESNICK EMITTER, ARTIFICIAL LARYNX Dynamed Audio, Inc. | ESE |
| May 22, 1984 | K840892 | ELECTRO-PALATE Cisko Systems | ESE |
| Jan 24, 1984 | K834555 | BEAR VENTI--VOICE Bear Medical Systems, Inc. | ESE |
| Jan 17, 1984 | K834522 | VENTI-VOICE NASAL CATHETER Respiratory Support Products, Inc. | ESE |
| Jul 28, 1983 | K831127 | INTRA-ORAL ARTIFICIAL LARYNX Xomed, Inc. | ESE |
| Jan 7, 1983 | K823118 | SAY Kells Medical, Inc. | ESE |
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