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Panels › Ear, Nose, Throat › Product code ESD · Class 1

Hearing Aid, Air-Conduction, Prescription

Regulation 874.3300

0510(k)s in 12 months (1,367 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
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Top companies in ESD

Company510(k)sRecalls
Unitron Industries, Inc.690
Miracle-Ear, Inc.640
Electone, Inc.630
Oticon Corp.630
Widex Hearing Aid Co., Inc.510
Rion Acoustic Instruments, Inc.470
Starkey Laboratories, Inc.390
Telex Communications, Inc.390
Phonak, Inc.370
Beltone Electronics Corp.360
Decided510(k)Device and applicantCode
May 9, 1991K911182NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS
Magnatone Hearing Aid Corp.
ESD
May 9, 1991K911174NHS 2009SP HEARING AID
Magnatone Hearing Aid Corp.
ESD
May 7, 1991K911579STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS
Starkey Laboratories, Inc.
ESD
Apr 19, 1991K911504ULTRA & ULTRA LITE II, MODIFICATION
Qualitone
ESD
Apr 19, 1991K911499ELEGANCE - DEO, MODIFICATION
Qualitone
ESD
Apr 19, 1991K911498ADJUSTRETTE - DAO, MODIFICATION
Qualitone
ESD
Apr 19, 1991K911497CUSTOM PERSONAL EAR - CPE
Qualitone
ESD
Apr 17, 1991K911211PHONAK 9100 SC-AF ITE HEARING INSTRUMENT
Phonak, Inc.
ESD
Apr 17, 1991K911210PHONAK 9800 SC-AF ITE HEARING INSTRUMENT
Phonak, Inc.
ESD
Apr 15, 1991K911209PHONAK 9300 SC-AF ITE HEARING INSTRUMENT
Phonak, Inc.
ESD
Apr 15, 1991K910325AHL, ITE MODEL AMERICAN
Bob Bare Hearing Aid Repair
ESD
Apr 9, 1991K905516MODEL FT40 TRANSONIC(TM) HEARING AID
Sonovation, Inc. Dba Avr Sonovation
ESD
Apr 3, 1991K910097ELECTONE ITE MODEL PREMIER
Electone, Inc.
ESD
Apr 3, 1991K905740RESORBABLE BONE PLUG
Zimmer, Inc.
ESD
Mar 21, 1991K911096DAHLBERG MODEL LZ BTE HEARING AID
Miracle-Ear, Inc.
ESD
Mar 21, 1991K911064DAHLBERG MODEL LG BTE HEARING AID
Miracle-Ear, Inc.
ESD
Mar 21, 1991K911063DAHLBERG MODEL LU BTE HEARING AID
Miracle-Ear, Inc.
ESD
Mar 21, 1991K910979DAHLBERG MODEL LT BTE HEARING AID
Miracle-Ear, Inc.
ESD
Mar 21, 1991K910809DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID
Miracle-Ear, Inc.
ESD
Mar 18, 1991K910314C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID
Ototech, Ltd.
ESD
Mar 18, 1991K910313ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID
Ototech, Ltd.
ESD
Mar 18, 1991K910312C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID
Ototech, Ltd.
ESD
Mar 18, 1991K910311ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID
Ototech, Ltd.
ESD
Mar 18, 1991K905784CUSTOM ITE HEARING AID
Hearing Aid Co.
ESD
Mar 15, 1991K905371ITE HEARING AID
Audicare Hearing Center
ESD
Mar 15, 1991K904756MATRICS
Kerr Corporation (Danbury)
ESD
Mar 13, 1991K9106903M MODEL 8240 ITE HEARING AID
3M Company
ESD
Mar 8, 1991K910028POST AURICULAR HEARING AID MODEL PICO SC-H
Phonak, Inc.
ESD
Mar 8, 1991K905680543 SERIES BTE
Hearing Tech, Inc.
ESD
Feb 28, 1991K9107633M MODEL 8245 ITE HEARING AID
3M Company
ESD
Feb 28, 1991K9107623M MODEL 8244 ITE HEARING AID
3M Company
ESD
Feb 28, 1991K9107613M MODEL 8243 ITE HEARING AID
3M Company
ESD
Feb 28, 1991K9107603M MODEL 8242 ITE HEARING AID
3M Company
ESD
Feb 28, 1991K9107593M MODEL 8241 ITE HEARING AID
3M Company
ESD
Feb 28, 1991K910744PHILIPS MODEL S46-O BTE HEARING AID
Philips Hearing Instruments Co.
ESD
Feb 28, 1991K910743PHILIPS MODEL S46-OL BTE HEARING AID
Philips Hearing Instruments Co.
ESD
Feb 28, 1991K910705ACTIVE MODEL AHX HELIX ITE HEARING AID
Active Electronics, Inc.
ESD
Feb 28, 1991K910704ACTIVE MODEL AMC MINI CANAL ITE HEARING AID
Active Electronics, Inc.
ESD
Feb 28, 1991K910703ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID
Active Electronics, Inc.
ESD
Feb 28, 1991K910702ACTIVE MODEL AHS HALF SHELL ITE HEARING AID
Active Electronics, Inc.
ESD
Feb 28, 1991K910701ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID
Active Electronics, Inc.
ESD
Feb 28, 1991K910700ACTIVE MODEL AST CUSTOM ITE HEARING AID
Active Electronics, Inc.
ESD
Feb 28, 1991K910018POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC
Phonak, Inc.
ESD
Feb 28, 1991K910012PHONAK MODEL PICO C-S-H-T, BTE HEARING AID
Phonak, Inc.
ESD
Feb 5, 1991K910206PHILIPS MODEL S47 BTE HEARING AID
Philips Hearing Instruments Co.
ESD
Jan 29, 1991K910148AM130 AGC-O (BEHIND THE EAR) HEARING AID
Electone, Inc.
ESD
Jan 29, 1991K910103ELECTONE BTE MODEL AM 130 HF
Electone, Inc.
ESD
Jan 29, 1991K910102ELECTONE BTE MODEL AM 240 PPL
Electone, Inc.
ESD
Jan 29, 1991K910101ELECTONE BTE MODEL AM 130 PP
Electone, Inc.
ESD
Jan 29, 1991K910100ELECTONE BTE MODEL AM 130 D
Electone, Inc.
ESD

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