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ESD

1,367 FDA 510(k) clearances · Product code

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RecordFirmDate
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC (K964451)Rexton, Inc.1996-11-27
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4) (K964510)Unitron Industries, Inc.1996-11-27
PRIMOFOCUS COMPACT (K963788)Oticon Corp.1996-11-27
UNITRON MODEL SOUND F/X +4 (K964503)Unitron Industries, Inc.1996-11-27
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4) (K964511)Unitron Industries, Inc.1996-11-27
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS (K964244)Starkey Laboratories, Inc.1996-11-27
UNITRON MODEL SOUND F/XP +4 (K964502)Unitron Industries, Inc.1996-11-27
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS (K964214)Starkey Laboratories, Inc.1996-11-27
UNITRON MODEL ICON AOHPL +4 (K964504)Unitron Industries, Inc.1996-11-27
AHS OMEGA DEQ (K963873)Authorized Hearing Systems, Inc.1996-11-26
MODEL WMR BTE HEARING INSTRUMENT (MODEL WMR) (K963745)Hearing Innovations, Inc.1996-11-26
AHS DELTA 22 (K963879)Authorized Hearing Systems, Inc.1996-11-26
AHS OMEGA PP (K963876)Authorized Hearing Systems, Inc.1996-11-26
AUDIO 'D' SOUND SELECTOR POWER (SSP) (K964180)Hearing Solutions, Inc.1996-11-26
AHS DELTA 22 T (K963881)Authorized Hearing Systems, Inc.1996-11-26
AHS OMEGA AGC (K963874)Authorized Hearing Systems, Inc.1996-11-26
TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION (K963915)Telex Communications, Inc.1996-11-08
RESOUND CC4 PERSONAL HEARING SYSTEM (K964115)Resound Corp.1996-11-04
OVATION AGC-3 (K963822)Orsonique, Inc.1996-10-28
OVATION AGC-1 (K963821)Orsonique, Inc.1996-10-28
OVATION LINEAR (K963820)Orsonique, Inc.1996-10-28
OVATION ASP (K963819)Orsonique, Inc.1996-10-28
OVATION AGC-2 (K963818)Orsonique, Inc.1996-10-28
DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION (K963604)Midwest City Hearing Aid Center1996-09-27
EUROLINE A-675 SERIS (K963519)Starkey Laboratories, Inc.1996-09-27
HORIZON 1 AND 2 PROGRAMABLE FULL SHELL AND IN THE CANAL (K963607)Midwest City Hearing Aid Center1996-09-20
IN THE EAR HEARING AID (K962388)Unique Hearing Technology, Inc.1996-09-16
AIR-CONDUCTION HEARING INSTRUMENTS: MODELS = 227, 229, 232, 216, 216P, 123, 219 (MODIFY) (K963047)Fenwick Hearing Instruments1996-09-10
AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS (K962798)Hearing Solutions, Inc.1996-09-09
UNITRON MODEL ICON KR (K963122)Unitron Industries, Inc.1996-09-06
RIONET HB-55S (K963153)Authorized Hearing Systems, Inc.1996-09-05
RIONET HB-54AS (K963154)Authorized Hearing Systems, Inc.1996-09-05
RIONET HB-55AS (K963152)Authorized Hearing Systems, Inc.1996-09-05
MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT (K962228)Ototech Intl., Inc.1996-08-28
MT10P, MT60-PP, MT60-AGC0, AND MT60 (K962847)Micro-Tech Hearing Instruments1996-08-09
PHILIPS 71 SERIES (K961770)Philips Hearing Instruments Co.1996-08-02
SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP (K962170)Siemens Hearing Instruments, Inc.1996-07-25
IN-THE-EAR (K961827)Qualitone1996-07-03
RIONET HEARING AID HB53-K (K961907)Authorized Hearing Systems, Inc.1996-07-03
ARGOSY PROGRAMMABLE (K961729)Argosy Electronics1996-05-29
PHONAK SONA P2 (K961653)Phonak, Inc.1996-05-29
PHONAK PICONET2 P2 AZ (K961622)Phonak, Inc.1996-05-17
CLARITY (K961670)Seig Technologies, Inc.1996-05-14
TECHNA TONE (K961082)Techna Tone1996-05-07
DIGIFOCUS COMPACT (K961059)Oticon, Inc.1996-05-07
COMFORTONE PHS (K960741)Comfortone America'S Value Hearing Aid Line1996-05-07
AUDIO 'D' INTIMA CIC (K961308)Hearing Solutions, Inc.1996-05-07
TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40 (K961143)Telex Communications, Inc.1996-05-07
AM 400 (K961084)Electone, Inc.1996-04-18
HEARING AID - AIR CONDUCTION (K960684)Resound Corp.1996-04-10
RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, & EDR-P1 (K960680)Resound Corp.1996-04-10
MIRACLE EAR & AUDIOTONE MODEL ITE/ITC/CIC (K960804)Miracle-Ear, Inc.1996-04-05
PERFECT EAR PE/PE-AGC/PE-B/PE-PWR (K960410)Perfect Ear1996-04-04
AUDIO 'D' 2N SERIES HEARING AIDS(FULL SHELL ITE,HALF SHELL ITE, MINI CANAL, CANAL) (K960935)Hearing Solutions, Inc.1996-04-03
LONG LIFE RX-12 (K960295)Rexton, Inc.1996-03-22
RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 (K960052)Resound Corp.1996-03-12
UNITRON MODEL SOUND F/XP (K960155)Unitron Industries, Inc.1996-03-07
AUDIOFLEX 120 (K960031)Maico Hearing Instruments, Inc.1996-03-07
OTICON /PRIMOFOCUS (PF) (K960284)Oticon, Inc.1996-03-07
EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS (K960494)Starkey Laboratories, Inc.1996-03-01
BELTONE COMPOSER 2000 BTE HP (K955930)Beltone Electronics Corp.1996-03-01
WIDEX MODEL SENSO DIGITAL (C16) (K955879)Widex Hearing Aid Co., Inc.1996-02-27
SONATA U-01 (K955702)Electone, Inc.1996-02-22
DYNAMEQ-II OPTION (K955466)Qualitone1996-02-13
WIDEX MODEL SENSO DIGITAL (C8) (K955878)Widex Hearing Aid Co., Inc.1996-02-12
HEARING AID IMPRESSION MATERIAL (K955288)Crown Delta Corp.1996-02-02
RESOUND PERSONAL HEARING SYSTEM BT247 (K955867)Resound Corp.1996-02-02
FINETONE FSC, (K955692)Finetone Hearing Instruments1996-02-02
MIRACLE EAR MIRAGE (K954119)Miracle-Ear, Inc.1996-01-24
REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTS (K954922)Rexton, Inc.1996-01-17
MIRACLE EAR AND AUDIOTONE (K954941)Miracle-Ear, Inc.1995-12-22
RESOUND PERSONAL HEARING SYSTEM BTP W/DAI (K955574)Resound Corp.1995-12-22
CYBER III OPTION UM, UC312, UC10, UCIC (K955359)Qualitone1995-12-19
TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION (K954579)Telex Communications, Inc.1995-12-08
FACEPLATE (HEARING AID KIT) (K954236)Truetone Hearing Systems, Inc.1995-12-06
BELTONE ULTIMA 80 OTOSONIC POWER PAS (K954936)Beltone Electronics Corp.1995-12-06
HEARING TODAY HEARING AID (K953603)Hearing Today Laboratory, Inc.1995-11-13
OTICON (K954794)Oticon, Inc.1995-11-13
COAST HEARING CHS (CUSTOM HEARING SYSTEM) (K954937)Coast Hearing Services1995-11-13
WIDEX SENSO DIGITAL (PX) (K954526)Widex Hearing Aid Co., Inc.1995-10-18
UNITRON MODEL SOUND F/X II (K954516)Unitron Industries, Inc.1995-10-07
UNITRON MODEL IKON AOHPD (K953727)Unitron Industries, Inc.1995-10-07
UNITRON MODEL SOUND F/XD (K953932)Unitron Industries, Inc.1995-10-07
MIRACLE - EAR MODEL PBP (K954528)Miracle-Ear, Inc.1995-10-07
UNITRON MODEL SOUND F/X (K954430)Unitron Industries, Inc.1995-10-06
3M MODEL 8295 (K954067)3M Company1995-09-28
MAICO PRODIGY CIC SERIES (K954054)Maico Hearing Instruments, Inc.1995-09-28
REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY (K953770)Rexton, Inc.1995-09-18
AMENDMENTS TO MULTIFOCUS (K951002)Oticon A/S1995-09-18
PHONAK 9900 CIC (K953921)Phonak, Inc.1995-09-18
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT (K954038)Argosy Electronics1995-09-18
HEARING AID (ALL-IN-THE-EAR) (K951712)Omega Hearing Aid Center1995-09-12
HEARING AID (ALL-IN-THE-EAR) (K953960)Audina Hearing Instrument1995-09-12
K AMP FULL SHELL AND IN THE EAR (K953729)Midwest City Hearing Aid Center1995-09-12
RX12 LINEAR FULL SHELL AND IN THE CANAL (K953728)Midwest City Hearing Aid Center1995-09-12
UNITRON MODEL IKON AOHPL (K953646)Unitron Industries, Inc.1995-08-28
SNIP INPUT COMPRESSION CLASS A (K953631)Midwest City Hearing Aid Center1995-08-28
PHONAK PICONET 232X-AZ HEARING INSTRUMENT (K945439)Phonak, Inc.1995-08-23
3M MODEL 8200P MULTIPRO BTE (K953543)3M Company1995-08-23
Z20 (K953047)Electone, Inc.1995-08-22
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