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Ear, Nose, Throat

988 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S034)Advanced Bionics2004-07-19
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH NUCLEUS 24 CONTOUR ADVANCE/SOFTIP II ELECTRODE AND INSERTION TOOL (P970051/S027)Cochlear Americas2004-05-18
HIRESOLUTION & CLARION CII BIONIC EAR SYSTEMS (P960058/S035)Advanced Bionics2004-05-14
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH MED-EL CI.STUDIO+ RELEASE VERSION 2.0 SOFTWARE (P000025/S012)Med-El Corp.2004-05-14
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S013)Med-El Corp.2004-02-25
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S033)Advanced Bionics2004-02-18
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S032)Advanced Bionics2003-12-16
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR ADVANCE (P970051/S025)Cochlear Americas2003-11-07
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH CONTOUR SOFTIP ELECTRODE (P970051/S026)Cochlear Americas2003-09-25
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S009)Med-El Corp.2003-08-27
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (ABI) (P000015/S005)Cochlear Americas2003-08-22
MED-EL COMBI 40+ (P000025/S010)Med-El Corp.2003-07-25
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S011)Med-El Corp.2003-07-22
HIRESOLUTION BIONIC EAR SYSTEM (HIRES 90K) (P960058/S030)Advanced Bionics2003-07-07
CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES (P960058/S031)Advanced Bionics2003-06-06
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS (P000025/S007)Med-El Corp.2003-06-05
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS) (P840024/S085)Cochlear Americas2003-04-02
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (CHILDREN) (P890027/S054)Cochlear Americas2003-04-02
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT (P000015/S004)Cochlear Americas2003-04-02
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S024)Cochlear Americas2003-04-02
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; MED-EL COMBI 40+ (STANDARD), COMBI 40+S (COMPRESSED), AND COMBI 40+ GB (SPLITS (P000025/S008)Med-El Corp.2003-03-25
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS (P000025/S006)Med-El Corp.2003-03-18
CLARION CII BIONIC EAR SYSTEM (P960058/S029)Advanced Bionics2003-02-04
NUCLEUS 22 COCHLEAR IMPLANT FOR CHILDREN (P890027/S055)Cochlear Americas2002-12-27
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS) (P840024/S086)Cochlear Americas2002-12-27
KARL STORZ AUTOFLUORESCENCE SYSTEM (P020008)KARL STORZ Endoscopy-America, Inc.2002-12-12
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS (P840024/S084)Cochlear Americas2002-12-09
NUCLEUS 22 COCHLEAR IMPLANT FOR CHILDREN (P890027/S053)Cochlear Americas2002-12-09
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S003)Cochlear Americas2002-12-09
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S023)Cochlear Americas2002-12-09
CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE (P960058/S028)Advanced Bionics2002-11-25
NUCLEUS 24 CONTOUR ADVANCE (P970051/S021)Cochlear Americas2002-11-22
CALRION CII BIONIC EAR SYSTEM (ADULT) (P940022/S027)Advanced Bionics Corp.2002-11-06
CLARION CII BIONIC EAR SYSTEM (PEDIATRIC) (P960058/S027)Advanced Bionics2002-11-06
CLARION CII BIONIC EAR SYSTEM (ADULT) (P940022/S026)Advanced Bionics Corp.2002-11-01
CLARION CII BIONIC EAR SYSTEM (PEDIATRIC) (P960058/S026)Advanced Bionics2002-11-01
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD) (P000025/S005)Med-El Corp.2002-10-29
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S022)Cochlear Americas2002-09-24
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM/CHILDREN (P890027/S052)Cochlear Americas2002-09-24
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM/ADULTS (P840024/S083)Cochlear Americas2002-09-24
BTE FIREFLY (PEDIATRIC) (P960058/S024)Advanced Bionics2002-09-23
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S025)Advanced Bionics2002-09-23
CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (P940022/S025)Advanced Bionics Corp.2002-09-23
BTE FIREFLY (ADULT) (P940022/S024)Advanced Bionics Corp.2002-09-23
CLARION CII BIONIC EAR, HIFOCUS ELECTRODE WITHOUT POSITIONER (MODEL AB-5100H-11A) & HIRES SOFTWARE (MODEL CI-6055) (P940022/S023)Advanced Bionics Corp.2002-09-09
CLARION CII BIONIC EAR SYSTEM (P960058/S023)Advanced Bionics2002-09-09
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S004)Med-El Corp.2002-09-04
SOUNDTEC DIRECT IPCA SYSTEM (P010023/S001)Ototronix, LLC2002-09-04
COMBI 40+COCHLEAR IMPLANT SYSTEM,C40+S(COMPRESSED)ELECTRODE ARRAY/C40+ GB (SPLIT) ELECTRODE ARRAY (P000025/S001)Med-El Corp.2002-07-29
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S002)Med-El Corp.2002-07-11
VIBRANT SOUNDBRIDGE SYSTEM (P990052/S008)Med-El Elektromedizinische Gerate GmbH2002-07-02
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM WITH STYLET REPLACEMENT TOOL (P970051/S020)Cochlear Americas2002-06-20
BTE (BEHIND-THE-EAR) SYSTEM SENSOR (ADULT) (P940022/S021)Advanced Bionics Corp.2002-06-06
CPI SWITCH BOX (P940022/S022)Advanced Bionics Corp.2002-06-06
BTE(BEHIND-THE-EAR)SYSTEM SENSOR (PEDIATRIC) (P960058/S022)Advanced Bionics2002-06-06
CLARION MULTI STRATEGY COCHLEAR IMPLANT SYSTEM (P960058/S021)Advanced Bionics2002-06-06
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN WITH CI 11=11=2M DOUBLE ARRAY COCHLEAR IMPLANT (P970051/S015)Cochlear Americas2002-06-06
BTE(BEHIND-THE-EAR)T-MIC (P960058/S020)Advanced Bionics2002-04-23
BTE(BEHIND-THE-EAR)T-MIC (P940022/S020)Advanced Bionics Corp.2002-04-23
VIBRANT SOUNDBRIDGE DIRECT DRIVE DEMONSTRATOR (P990052/S007)Med-El Elektromedizinische Gerate GmbH2002-04-17
COMBI 40 + COCHLEAR IMPLANT SYSTEM (P000025/S003)Med-El Corp.2002-04-12
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S019)Cochlear Americas2002-03-21
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS/ESPRIT 22 (P840024/S082)Cochlear Americas2002-02-19
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR CHILDREN/ESPRIT 22 (P890027/S051)Cochlear Americas2002-02-19
NEUROCONTROL FREEHAND II SYSTEM (P950035/S009)Biocontrol Technology, Inc.2002-01-18
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S002)Cochlear Americas2002-01-07
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S018)Cochlear Americas2002-01-07
MENTOR POLYTEF PASTE /FOR INJECTION (N16420/S006)Coloplast Corp.2001-11-21
VIBRANT SOUNDBRIDGE SYSTEM (P990052/S006)Med-El Elektromedizinische Gerate GmbH2001-10-26
NEUROCONTROL FREEHAND SYSTEM (P950035/S010)Biocontrol Technology, Inc.2001-09-13
SOUNDTEC DIRECT SYSTEM (P010023)Ototronix, LLC2001-09-07
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025)Med-El Corp.2001-08-20
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S001)Cochlear Americas2001-08-01
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S017)Cochlear Americas2001-08-01
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM FOR ADULTS (P840024/S081)Cochlear Americas2001-07-24
VIBRANT SOUNDBRIDGE SYSTEM (P990052/S004)Med-El Elektromedizinische Gerate GmbH2001-07-24
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (CHILDREN) (P890027/S050)Cochlear Americas2001-07-24
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM FOR ADULTS AND CHILDREN (P970051/S016)Cochlear Americas2001-07-24
POLYTEF PASTE FOR INJECTION (N16420/S005)Coloplast Corp.2001-05-30
VIBRANT D SOUNDBRIDGE SYSTEM (P990052/S003)Med-El Elektromedizinische Gerate GmbH2001-04-02
NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM (P970051/S013)Cochlear Americas2001-03-02
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (NUCLEUS 24 CONTOUR COCHLEAR IMPLANT (P970051/S014)Cochlear Americas2001-02-08
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM- ADULTS (P840024/S080)Cochlear Americas2001-01-16
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S012)Cochlear Americas2001-01-16
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM- CHILDREN (P890027/S049)Cochlear Americas2001-01-16
MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC) (P960058/S015)Advanced Bionics2001-01-12
MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (ADULT) (P940022/S016)Advanced Bionics Corp.2001-01-12
VIBRANT D SOUNDBRIDGE SYSTEM (P990052/S002)Med-El Elektromedizinische Gerate GmbH2001-01-03
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) HIFOCUS ELECTRODE (P960058/S014)Advanced Bionics2000-11-15
NEUROCONTROL FREEHAND SYSTEM (P950035/S008)Biocontrol Technology, Inc.2000-11-14
NUCLEUS 24 CONTOUR COCHLEAR IMPLANT SYSTEM (P970051/S011)Cochlear Americas2000-11-01
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015)Cochlear Americas2000-10-20
VIBRANT P SOUNDBRIDGE/VIBRANT D SOUNDBRIDGE SYSTEM (P990052/S001)Med-El Elektromedizinische Gerate GmbH2000-09-21
CLARION MULTI-STRATEGY COCHLEAR IMPLANT (PEDIATRIC) (P960058/S006)Advanced Bionics2000-09-05
VIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM (P990052)Med-El Elektromedizinische Gerate GmbH2000-08-31
CI24R(ST) COCHLEAR IMPLANT (P970051/S010)Cochlear Americas2000-08-21
CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE (P940022/S014)Advanced Bionics Corp.2000-07-13
NUCLEUS N24 COCHLEAR IMPLANT SYSTEM (P970051/S008)Cochlear Americas2000-07-11
NEUROCONTROL FREEHAND SYSTEM (P950035/S006)Biocontrol Technology, Inc.2000-07-05
NEUROCONTROL FREEHAND SYSTEM (P950035/S007)Biocontrol Technology, Inc.2000-06-23
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