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Ear, Nose, Throat

988 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S013)Advanced Bionics2000-06-16
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) (P940022/S015)Advanced Bionics Corp.2000-06-16
PLATINUM SOUND PROCESSOR (COCHLEAR IMPLANT) (P940022/S013)Advanced Bionics Corp.2000-02-02
CLARION MULTI-STRATEGY COCHLEAR IMPLANT SYSTEM (P960058/S012)Advanced Bionics2000-02-02
NEUROCONTROL FREEHAND SYSTEM (P950035/S005)Biocontrol Technology, Inc.2000-01-13
SPRINT LONG RANGE COIL (P970051/S009)Cochlear Americas1999-12-23
ESPRIT22 SPEECH PROCESSOR (P840024/S079)Cochlear Americas1999-12-23
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE (P940022/S007)Advanced Bionics Corp.1999-12-23
ESPRIT22 SPEECH PROCESSOR (P890027/S048)Cochlear Americas1999-12-23
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S011)Advanced Bionics1999-11-18
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) (P940022/S012)Advanced Bionics Corp.1999-11-08
NECLEUS 24 COCHLEAR IMPLANT SYSTEM SOFTWARE (P970051/S007)Cochlear Americas1999-08-20
CLARION DEVICE FITTING SOFTWARE (SCLIN) (P960058/S010)Advanced Bionics1999-07-16
CLARION DEVICE FITTING SOFTWARE (SCLIN) (P940022/S011)Advanced Bionics Corp.1999-07-16
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S004)Cochlear Americas1999-06-09
NEUROCONTROL FREEHAND SYSTEM (P950035/S004)Biocontrol Technology, Inc.1999-05-18
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (2-METER INTRA-OPERATIIVE CABLE (P970051/S005)Cochlear Americas1999-05-12
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S006)Cochlear Americas1999-05-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (ADULT) (P840024/S078)Cochlear Americas1999-05-07
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (CHILDREN) (P890027/S047)Cochlear Americas1999-05-07
CLARION MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) (P940022/S010)Advanced Bionics Corp.1999-03-22
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S009)Advanced Bionics1999-03-22
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE (P940022/S008)Advanced Bionics Corp.1999-02-19
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S007)Advanced Bionics1999-02-19
MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S008)Advanced Bionics1999-01-19
NEUROCONTROL FREEHAND SYSTEM (P950035/S003)Biocontrol Technology, Inc.1999-01-19
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S076)Cochlear Americas1998-11-19
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S003)Cochlear Americas1998-11-19
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S045)Cochlear Americas1998-11-19
AUDALLION BEAMFORMER (P840024/S077)Cochlear Americas1998-09-25
AUDALLION BEAMFORMER (P890027/S046)Cochlear Americas1998-09-25
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S001)Cochlear Americas1998-09-21
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE (P960058/S005)Advanced Bionics1998-09-04
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE (P940022/S006)Advanced Bionics Corp.1998-09-04
NEUROCONTROL FREEHAND SYSTEM(R) (P950035/S002)Biocontrol Technology, Inc.1998-07-28
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S002)Cochlear Americas1998-07-22
XILLIX-LIFE-LUNG (P950042/S001)Novadaq Technologies, Inc.1998-07-21
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S072)Cochlear Americas1998-06-26
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S040)Cochlear Americas1998-06-26
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S041)Cochlear Americas1998-06-26
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S071)Cochlear Americas1998-06-26
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051)Cochlear Americas1998-06-25
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR (P960058/S002)Advanced Bionics1998-06-22
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE (P940022/S005)Advanced Bionics Corp.1998-05-28
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE (P960058/S004)Advanced Bionics1998-05-28
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S044)Cochlear Americas1998-04-01
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S075)Cochlear Americas1998-04-01
NEUROCONTROL FREEHAND SYSTEM(R) (P950035/S001)Biocontrol Technology, Inc.1998-03-20
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE (P940022/S004)Advanced Bionics Corp.1998-03-17
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) FLEX LEAD ELECTRODE (P960058/S003)Advanced Bionics1998-03-17
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S074)Cochlear Americas1998-03-06
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S043)Cochlear Americas1998-03-06
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S073)Cochlear Americas1998-01-12
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S042)Cochlear Americas1998-01-12
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S039)Cochlear Americas1997-12-28
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) S-SERIES TM SPEECH PROCESSOR (P960058/S001)Advanced Bionics1997-09-05
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) S-SERIES TM SPEECH PROCESSOR (P940022/S003)Advanced Bionics Corp.1997-09-05
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (P960058)Advanced Bionics1997-06-26
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P890027/S038)Cochlear Americas1997-06-11
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S070)Cochlear Americas1997-06-11
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S069)Cochlear Americas1997-05-15
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S068)Cochlear Americas1997-04-04
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S037)Cochlear Americas1997-04-01
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2 (P940022/S002)Advanced Bionics Corp.1997-01-10
PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042)Novadaq Technologies, Inc.1996-09-19
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S067)Cochlear Americas1996-09-10
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S036)Cochlear Americas1996-09-10
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S065)Cochlear Americas1996-09-09
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S034)Cochlear Americas1996-09-09
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S035)Cochlear Americas1996-08-28
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S066)Cochlear Americas1996-08-28
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT VERSION 1.2 (P940022/S001)Advanced Bionics Corp.1996-08-02
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S063)Cochlear Americas1996-06-20
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S064)Cochlear Americas1996-06-13
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S032)Cochlear Americas1996-06-13
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S033)Cochlear Americas1996-06-13
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S031)Cochlear Americas1996-05-20
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S062)Cochlear Americas1996-05-20
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S030)Cochlear Americas1996-04-04
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S061)Cochlear Americas1996-04-04
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S060)Cochlear Americas1996-03-26
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S029)Cochlear Americas1996-03-26
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (P940022)Advanced Bionics Corp.1996-03-22
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S055)Cochlear Americas1996-02-13
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S025)Cochlear Americas1996-02-13
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S058)Cochlear Americas1996-01-24
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S059)Cochlear Americas1995-12-11
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S028)Cochlear Americas1995-12-11
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S056)Cochlear Americas1995-08-31
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S026)Cochlear Americas1995-08-31
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S057)Cochlear Americas1995-08-24
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S027)Cochlear Americas1995-08-24
NUCLEUS 22 CHANNEL COCHLEAR (P840024/S046)Cochlear Americas1995-08-21
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S028)Cochlear Americas1995-07-28
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S023)Cochlear Americas1995-05-15
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S053)Cochlear Americas1995-04-17
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT (P890027/S022)Cochlear Americas1994-09-27
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM (P840024/S052)Cochlear Americas1994-09-27
MINI SPEECH PROCESSOR (P890027/S018)Cochlear Americas1994-04-28
MINI SPEECH PROCESSOR (P840024/S048)Cochlear Americas1994-04-28
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