ESE
13 FDA 510(k) clearances · Product code
85 daysmedian time to decision
260 days90th percentile
13clearances measured
FDA profile
- Official device name
- Larynx, Artificial (Battery-Powered)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3375
- Medical specialty
- Ear, Nose, Throat
- Adverse events (MAUDE)
- 1995: 1 · 2007: 2 · 2010: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX (K934483) | Mountain Precision Mfg. Ltd. Co. | 1994-03-16 |
| DENRICK SPEECH AID (DR-1) (K931371) | Denrick Corp. | 1993-08-25 |
| LECTRO-LARYNX (K923648) | Bruce Medical Supply | 1993-04-07 |
| AMERICAN ARTIFICIAL LARYNX (K914816) | Ultravoice, Ltd. | 1993-02-12 |
| ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM (K901503) | Stanton Magnetics, Inc. | 1990-06-28 |
| VOX COMPANION (K860992) | Bloomfield Research and Development, Inc. | 1986-05-02 |
| P.O. VOX (K860993) | Bloomfield Research and Development, Inc. | 1986-04-25 |
| RESNICK EMITTER, ARTIFICIAL LARYNX (K854158) | Dynamed Audio, Inc. | 1985-12-13 |
| ELECTRO-PALATE (K840892) | Cisko Systems | 1984-05-22 |
| BEAR VENTI--VOICE (K834555) | Bear Medical Systems, Inc. | 1984-01-24 |
| VENTI-VOICE NASAL CATHETER (K834522) | Respiratory Support Products, Inc. | 1984-01-17 |
| INTRA-ORAL ARTIFICIAL LARYNX (K831127) | Xomed, Inc. | 1983-07-28 |
| SAY (K823118) | Kells Medical, Inc. | 1983-01-07 |
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