Widex Hearing Aid Co., Inc.
Lisle, IL, US
Widex Hearing Aid Co., Inc. appears in FDA device records in Lisle, IL. FDA records list 52 510(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
- 52
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 52FDA records hold 52 510(k) clearances for Widex Hearing Aid Co., Inc. between 1976 and 2008. The busiest year on record is 1993, with 8. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 2 |
| 1980 | 2 |
| 1982 | 2 |
| 1983 | 3 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 2 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 6 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 8 |
| 1994 | 8 |
| 1995 | 3 |
| 1996 | 2 |
| 1997 | 4 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K080955 | ZEN PROGRAM (MIND 440 HEARING AID) | KLW | Substantially Equivalent | |
| K971535 | WIDEX SENSO DIGITAL (MINI CANAL) | ESD | Substantially Equivalent | |
| K970904 | WIDEX SENSO DIGITAL (CIC) | ESD | Substantially Equivalent | |
| K965254 | WIDEX MODEL SENSO DIGITAL (C9) | ESD | Substantially Equivalent | |
| K965218 | SENSO DIGITAL (C18) | ESD | Substantially Equivalent | |
| K955879 | WIDEX MODEL SENSO DIGITAL (C16) | ESD | Substantially Equivalent | |
| K955878 | WIDEX MODEL SENSO DIGITAL (C8) | ESD | Substantially Equivalent | |
| K954526 | WIDEX SENSO DIGITAL (PX) | ESD | Substantially Equivalent | |
| K952229 | WIDEX MODEL LOGO 32 (L32) | ESD | Substantially Equivalent | |
| K946071 | LX-ITC | ESD | Substantially Equivalent | |
| K944518 | WIDEX MODEL LOGO 8S | ESD | Substantially Equivalent | |
| K945703 | WIDEX MODEL LOGO - L9 | ESD | Substantially Equivalent | |
| K943016 | ADOBE C.I.C | ESD | Substantially Equivalent | |
| K944097 | COMPASS SOFTWARE MODULE | ESD | Substantially Equivalent | |
| K944838 | WIDEX MODEL LX-ITE | ESD | Substantially Equivalent | |
| K943706 | AUDILENS LLK | ESD | Substantially Equivalent | |
| K941508 | WIDEX S-21 | ESD | Substantially Equivalent | |
| K935424 | WIDEX R.C. 2 (REMOTE CONTROL) | ESD | Substantially Equivalent | |
| K933644 | WIDEX MODEL LOGO 8 (L8) | ESD | Substantially Equivalent | |
| K933643 | WIDEX MODEL LOGO 6 (L6) | ESD | Substantially Equivalent | |
| K933640 | WIDEX MODEL LOGO 12 (L12) | ESD | Substantially Equivalent | |
| K931591 | ITC MODEL ADOBE 100 CANAL | ESD | Substantially Equivalent | |
| K931590 | ITE MODEL ADOBE 100 FULL CUSTOM | ESD | Substantially Equivalent | |
| K930715 | WIDEX MODEL DX HEARING AID | ESD | Substantially Equivalent | |
| K926085 | WIDEX MODEL D16 | ESD | Substantially Equivalent | |
| K926244 | WIDEX MODEL D8 (HEARING AID) | ESD | Substantially Equivalent | |
| K922708 | WIDEX MODEL D32 | ESD | Substantially Equivalent | |
| K912169 | WIDEX MODEL QX IN-THE-EAR HEARING AID | ESD | Substantially Equivalent | |
| K901642 | WIDEX HEARING AID MODEL THE DISCOVERY | ESD | Substantially Equivalent | |
| K897033 | WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE | ESD | Substantially Equivalent | |
| K901317 | WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL | ESD | Substantially Equivalent | |
| K901316 | WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL | ESD | Substantially Equivalent | |
| K895982 | WIDEX HEARING AID MODEL ES 10 ASP T | ESD | Substantially Equivalent | |
| K895981 | WIDEX HEARING AID MODELS ES9T AND ES9H | ESD | Substantially Equivalent | |
| K885128 | WIDEX BTE HEARING AID MODEL Q8 | ESD | Substantially Equivalent | |
| K884113 | HEARING AID WIDEX BTE | ESD | Substantially Equivalent | |
| K880273 | WIDEX HEARING AID MODEL C1 | ESD | Substantially Equivalent | |
| K872374 | WIDEX HEARING AID MODEL ES1 | ESD | Substantially Equivalent | |
| K872375 | WIDEX HEARING AID MODEL ES6 | ESD | Substantially Equivalent | |
| K864097 | WIDEX HEARING AID MODEL ES2 | ESD | Substantially Equivalent | |
| K853793 | WIDEX MODEL M1 | ESD | Substantially Equivalent | |
| K832376 | WIDEX HEARING AID MODEL L1 | ESD | Substantially Equivalent | |
| K832129 | HEARING AID G3H & G3T | ESD | Substantially Equivalent | |
| K830465 | WIDEX HEARING AID #G2H & G2T | ESD | Substantially Equivalent | |
| K823460 | MODELS G6H, G6T, G1H & G1T | ESD | Substantially Equivalent | |
| K823431 | HEARING AID #G6H & G6T | ESD | Substantially Equivalent | |
| K792567 | WIDEX HEARING AID MODEL 820 | ESD | Substantially Equivalent | |
| K792389 | WIDEX HEARING AID MODEL S10 | ESD | Substantially Equivalent | |
| K770689 | HEARING AID MODEL A8H AND A8T | ESD | Substantially Equivalent | |
| K770688 | HEARING AID MODEL F8H ANL F8T | ESD | 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
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Data as of , FDA export datePage updated Source: openFDA, public domain