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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
Jan 29, 1991K910099ELECTONE BTE MODEL AM 240 HF
Electone, Inc.
ESD
Jan 29, 1991K910096ELECTONE BTE MODEL AM900 PP
Electone, Inc.
ESD
Jan 28, 1991K910098ELECTONE BTE MODEL AM 240 PPI
Electone, Inc.
ESD
Jan 28, 1991K905692143 SERIES BTE
Gn Danavox, Inc.
ESD
Jan 28, 1991K905679133 SERIES BTE
Gn Danavox, Inc.
ESD
Dec 28, 1990K905483MEMORYMATE MODEL 8270 ITE HEARING AID
3M Company
ESD
Dec 21, 1990K903145HEARSET TELEPHONE HEARING SYSTEM
Starkey Laboratories, Inc.
ESD
Dec 17, 1990K904731QUALITONE ITE GENESIS
Qualitone
ESD
Dec 17, 1990K904020MEMORYMATE HEARING AID WITH PMC PROGRAMMER
3M Company
ESD
Dec 7, 1990K904730QUALITONE ULTRA CANAL GENESIS
Qualitone
ESD
Dec 7, 1990K904576HEARING AID, UNITRON MODEL UM60-UH
Unitron Industries, Inc.
ESD
Nov 9, 1990K903474BEST LABS MODEL C
Best Labs
ESD
Nov 9, 1990K903473BEST LABS MODEL S
Best Labs
ESD
Nov 9, 1990K903472BEST LABS MODEL M
Best Labs
ESD
Nov 9, 1990K903471BEST LABS MODEL P
Best Labs
ESD
Nov 1, 1990K904673OTICAON BTE MODEL E34P
Oticon Corp.
ESD
Oct 31, 1990K902846PRIZM HEARING SYSTEM
Audioscience, Inc.
ESD
Oct 9, 1990K903865ITE HEARING AID, SOUND MED AMETHYST MODEL
Improved Hearing Service, Inc.
ESD
Oct 9, 1990K903864ITE HEARING AID, PEARL MODEL
Improved Hearing Service, Inc.
ESD
Oct 9, 1990K903863ITE HEARING AID, SOUND MED OPAL MODEL
Improved Hearing Service, Inc.
ESD
Oct 9, 1990K903862ITE HEARING AID, SOUND MED RUBY MODEL
Improved Hearing Service, Inc.
ESD
Oct 9, 1990K903861ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL
Improved Hearing Service, Inc.
ESD
Oct 9, 1990K903860ITE HEARING AID, SAAPHIRE MODEL
Improved Hearing Service, Inc.
ESD
Oct 9, 1990K903859ITE HEARING AID, DIAMOND MODEL
Improved Hearing Service, Inc.
ESD
Oct 9, 1990K903583SERIES MCAXX (MODEL 851) ITE HEARING AID
Maico Hearing Instruments, Inc.
ESD
Oct 9, 1990K903479AUDIOTECH MODEL DB
Muskogee Regional Hearing Aid Lab
ESD
Oct 9, 1990K903478AUDIOTECH MODEL CL
Muskogee Regional Hearing Aid Lab
ESD
Oct 9, 1990K903415ITE HEARING AID, SOUND MED EMERALD MODEL
Improved Hearing Service, Inc.
ESD
Oct 9, 1990K902487MODIFIED HEARING AID (IN-THE-EAR)
Audio Hearing Aid Service
ESD
Oct 5, 1990K903760MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM
Siemens Hearing Instruments, Inc.
ESD
Sep 12, 1990K900632DYNASTY HEARING SYSTEMS INSTRUMENT
Alastair Granville-Jackson, Mfa, Ed.D.
ESD
Sep 5, 1990K903295ESCORT ITC
Hearing Tech, Inc.
ESD
Aug 10, 1990K902179VISTA - MODELS V12, V20, V23, V38, ITE HEARING AID
Vista Laboratories, Inc.
ESD
Aug 9, 1990K901833CE-8 CUSTOM IN-THE-EAR HEARING AIDS
Starkey Laboratories, Inc.
ESD
Aug 1, 1990K902290ITE HEARING AID MODEL PALOMINO
Improved Hearing Service, Inc.
ESD
Jul 27, 1990K903023HERITAGE III (HTC) ITC TYPE HEARING AID
Hearing Tech, Inc.
ESD
Jul 27, 1990K901341REXTON RX12 POWER PLUS W/DUAL RECEIVER
Rexton, Inc.
ESD
Jul 20, 1990K901860INTRA III AND INTRA IV HEARING AIDS
Starkey Laboratories, Inc.
ESD
Jul 9, 1990K902570ADAM MARK II CUSTOM IN-THE-EAR HEARING AID
Adams Hearing Aid Center
ESD
Jul 9, 1990K902559CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P
Oticon Corp.
ESD
Jun 14, 1990K902353CUSTOM ITE HEARING AID MODELS F AND L
Oticon Corp.
ESD
Jun 14, 1990K902352CUSTOM ITE HEARING AID MODEL: H
Oticon Corp.
ESD
Jun 14, 1990K902351CUSTOM ITE HEARING AID MODELS C AND M
Oticon Corp.
ESD
May 29, 1990K901783AUDIOTONE ITE HEARING AID MODEL ZA (MICRO)
Miracle-Ear, Inc.
ESD
May 29, 1990K901747AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE)
Miracle-Ear, Inc.
ESD
May 29, 1990K901746AUDIOTONE ITE HEARING AID MODEL ZD (XT)
Miracle-Ear, Inc.
ESD
May 29, 1990K901745AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST.
Miracle-Ear, Inc.
ESD
May 23, 1990K901642WIDEX HEARING AID MODEL THE DISCOVERY
Widex Hearing Aid Co., Inc.
ESD
May 23, 1990K900846MODEL 366 HEARING AID
Telex Communications, Inc.
ESD
May 23, 1990K900831BTE PICO SCD, PICO SC
Phonak, Inc.
ESD

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