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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 23, 1990K900830BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4
Phonak, Inc.
ESD
May 23, 1990K900829BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
Phonak, Inc.
ESD
May 23, 1990K900675PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
Phonak, Inc.
ESD
May 23, 1990K897035MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID
Miracle-Ear, Inc.
ESD
May 23, 1990K897033WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE
Widex Hearing Aid Co., Inc.
ESD
May 21, 1990K893576SIEMENS MODEL 284 PP
Siemens Hearing Instruments, Inc.
ESD
May 21, 1990K893575SIEMENS MODEL 283 ASP
Siemens Hearing Instruments, Inc.
ESD
May 21, 1990K893574SIEMENS MODEL 284 PP-AGC
Siemens Hearing Instruments, Inc.
ESD
May 21, 1990K893573SIEMENS MODEL 284 PP-L
Siemens Hearing Instruments, Inc.
ESD
Apr 30, 1990K897154NICOLET DBTE HEARING AID: DIGITAL & PROGRAMMABLE
Nicolet Instrument Corp.
ESD
Apr 30, 1990K896995DISCRETION, IN THE CANAL HEARING INSTRUMENT
Gn Danavox, Inc.
ESD
Apr 27, 1990K901351SEARS MODEL 9098 ITE HEARING AID
Miracle-Ear, Inc.
ESD
Apr 27, 1990K901350SEARS MODEL 9094 ITE HEARING AID
Miracle-Ear, Inc.
ESD
Apr 18, 1990K901569BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
Unitron Industries, Inc.
ESD
Apr 18, 1990K901556AUDIOTONE MODEL FFI ITE HEARING AID
Miracle-Ear, Inc.
ESD
Apr 18, 1990K897024MODEL AUDINA ITE HEATING AID
Audina Hearing Instrument
ESD
Apr 18, 1990K891556EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.
Green Light Import Export Co., Inc.
ESD
Apr 16, 1990K901470SEARS MODEL JCS IN-THE-EAR HEARING INSTRUMENT
Miracle-Ear, Inc.
ESD
Apr 16, 1990K901469SEARS MODEL LF9096 IN-THE-EAR HEARING INSTRUMENT
Miracle-Ear, Inc.
ESD
Apr 16, 1990K901389SEARS MODEL LC9092 IN-THE-EAR HEARING INSTRUMENT
Miracle-Ear, Inc.
ESD
Apr 16, 1990K901388SEARS MODEL LM9091 IN-THE-EAR HEARING INSTRUMENT
Miracle-Ear, Inc.
ESD
Apr 16, 1990K901387SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT
Miracle-Ear, Inc.
ESD
Apr 16, 1990K895843AHAC ITE MODEL ENTENDRE
Aroostook Hearing Aid
ESD
Apr 13, 1990K901386SEARS MODEL LS9093 IN-THE-EAR HEARING INSTRUMENT
Miracle-Ear, Inc.
ESD
Apr 13, 1990K900862DAHLBERG MODEL JM IN-THE-EAR HEARING INSTRUMENT
Miracle-Ear, Inc.
ESD
Apr 10, 1990K901317WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL
Widex Hearing Aid Co., Inc.
ESD
Apr 10, 1990K901316WIDEX MODEL Q9, BTE W/QUATRO REMOTE CONTROL
Widex Hearing Aid Co., Inc.
ESD
Apr 10, 1990K901292OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44
Oticon Corp.
ESD
Apr 10, 1990K900968HEARING AID (ALL-IN-THE-EAR)
Audiology of Tulsa, Inc.
ESD
Apr 4, 1990K900861DAHLBERG MODEL JH IN-THE-EAR HEARING INSTRUMENT
Miracle-Ear, Inc.
ESD
Apr 4, 1990K900789HEARING AID (ALL-IN-THE-EAR)
Solar Aid Corp.
ESD
Mar 27, 1990K900636REXTON PP 142, PP 142-L
Rexton, Inc.
ESD
Mar 15, 1990K895982WIDEX HEARING AID MODEL ES 10 ASP T
Widex Hearing Aid Co., Inc.
ESD
Mar 15, 1990K895981WIDEX HEARING AID MODELS ES9T AND ES9H
Widex Hearing Aid Co., Inc.
ESD
Mar 14, 1990K900692DAHLBERG MODEL JMS IN-THE-EAR HEARING INSTRUMENT
Miracle-Ear, Inc.
ESD
Mar 14, 1990K900050MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID
Miracle-Ear, Inc.
ESD
Mar 14, 1990K893004HEARING AID (ALL-IN-THE-EAR)
Hearing Specialists of Nevada, Inc.
ESD
Mar 5, 1990K895368IN THE EAR HEARING AID
Hearing Crafters of America
ESD
Feb 22, 1990K900238MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID
Miracle-Ear, Inc.
ESD
Feb 22, 1990K900237MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID
Miracle-Ear, Inc.
ESD
Feb 8, 1990K896463RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1
Resound Corp.
ESD
Jan 23, 1990K893887BESTONE MODEL ITE & CANAL
Bestone Hearing Instruments
ESD
Jan 22, 1990K896159DAHLBERG MODEL LP BEHIND-THE-EAR HEARING AID
Dahlberg Electronics, Inc.
ESD
Jan 22, 1990K896158DAHLBERG MODEL LA BEHIND-THE-EAR HEARING AID
Dahlberg Electronics, Inc.
ESD
Jan 22, 1990K896157DAHLBERG MODEL LH BEHIND-THE-EAR HEARING AID
Dahlberg Electronics, Inc.
ESD
Jan 16, 1990K896057MINI PRIMO PLUS ASP BEHIND-THE-EAR HEARING AID
Rexton, Inc.
ESD
Jan 10, 1990K896056REXTON RX12D CUSTOM IN-THE-EAR HEARING AID
Rexton, Inc.
ESD
Jan 4, 1990K895590ITE HEARING AID MODEL PA
Best Aid, Inc.
ESD
Jan 4, 1990K895517AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC
Aural Technologies, Inc.
ESD
Jan 4, 1990K891914ITC PRESCRIPTION SERIES MODEL CA AND C
Us Hearing Centers, Inc.
ESD

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