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Ear, Nose, Throat

988 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
PROPEL AND PROPEL MINI SINUS IMPLANT (P100044/S007)Intersect Ent.2013-02-27
PROPEL MINI SINUS IMPLANT (P100044/S005)Intersect Ent.2013-01-17
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S093)Cochlear Americas2013-01-03
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, ECA MODULES M7, M8, M9 (P000025/S066)Med-El Corp.2012-12-04
MI1000 MED-EL CONCERT PIN COCHLEAR IMPLANT (P000025/S058)Med-El Corp.2012-11-21
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S098)Cochlear Americas2012-11-20
ESTEEM (P090018/S011)Envoy Medical Corporation2012-11-13
PROPEL MINI SINUS IMPLANT, 6011 (P100044/S003)Intersect Ent.2012-11-09
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S097)Cochlear Americas2012-11-09
MED-EL CONCERT IMPLANT (P000025/S064)Med-El Corp.2012-11-01
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S062)Med-El Corp.2012-10-26
COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR SYSTEM) (P000025/S065)Med-El Corp.2012-10-15
ESTEEM (P090018/S018)Envoy Medical Corporation2012-09-28
PROPEL MINI SINUS IMPLANT (P100044/S001)Intersect Ent.2012-09-21
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S095)Cochlear Americas2012-09-05
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S097)Advanced Bionics2012-08-24
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S092)Cochlear Americas2012-08-24
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S096)Advanced Bionics2012-08-20
PROPEL SINUS IMPLANT (P100044/S002)Intersect Ent.2012-08-10
ESTEEM (P090018/S016)Envoy Medical Corporation2012-06-22
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S095)Advanced Bionics2012-06-15
MAXUM SYSTEM (P010023/S007)Ototronix, LLC2012-05-10
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S057)Med-El Corp.2012-04-30
AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S091)Advanced Bionics2012-04-27
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S054)Med-El Corp.2012-04-20
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S094)Advanced Bionics2012-04-02
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S061)Med-El Corp.2012-03-28
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S064)Cochlear Americas2012-03-26
AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S093)Advanced Bionics2012-03-12
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S060)Med-El Corp.2012-03-05
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S089)Cochlear Americas2012-02-28
PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042/S007)Novadaq Technologies, Inc.2012-02-02
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S088)Cochlear Americas2011-12-20
MED-EL COCHLEAR IMPLANT SYSTEMS (P000025/S059)Med-El Corp.2011-12-16
ESTEEM (P090018/S017)Envoy Medical Corporation2011-12-14
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S086)Cochlear Americas2011-12-02
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S075)Cochlear Americas2011-11-29
AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S089)Advanced Bionics2011-11-17
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S087)Cochlear Americas2011-11-04
ESTEEM (P090018/S013)Envoy Medical Corporation2011-10-28
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S092)Advanced Bionics2011-10-26
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S085)Cochlear Americas2011-10-04
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S073)Cochlear Americas2011-09-27
ESTEEM (P090018/S010)Envoy Medical Corporation2011-09-23
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S056)Med-El Corp.2011-09-23
ESTEEM (P090018/S012)Envoy Medical Corporation2011-09-21
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S053)Med-El Corp.2011-09-15
AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S090)Advanced Bionics2011-09-12
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S055)Med-El Corp.2011-09-02
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S070)Cochlear Americas2011-08-30
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S074)Cochlear Americas2011-08-30
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S051)Med-El Corp.2011-08-26
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S082)Cochlear Americas2011-08-19
PROPEL (P100044)Intersect Ent.2011-08-11
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S080)Cochlear Americas2011-07-22
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S052)Med-El Corp.2011-07-22
MED - EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S050)Med-El Corp.2011-07-22
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S078)Cochlear Americas2011-07-21
MAXUM SYSTEM (P010023/S009)Ototronix, LLC2011-07-15
ESTEEM (P090018/S009)Envoy Medical Corporation2011-07-07
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S076)Cochlear Americas2011-06-15
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S077)Cochlear Americas2011-06-15
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S071)Cochlear Americas2011-06-15
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S069)Cochlear Americas2011-06-03
ESTEEM (P090018/S001)Envoy Medical Corporation2011-05-06
MAXUM SYSTEM (P010023/S004)Ototronix, LLC2011-04-08
COCHLEAR NUCLEUS 5 COCHLEAR IMPLANT SYSTEM (P970051/S068)Cochlear Americas2011-04-07
MAXUM SYSTEM (P010023/S008)Ototronix, LLC2011-03-02
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S067)Cochlear Americas2011-03-02
COCHLEAR NUCLEUS 24 IMPLANT SYSTEM (P970051/S065)Cochlear Americas2010-12-15
ESTEEM (P090018/S004)Envoy Medical Corporation2010-12-14
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S087)Advanced Bionics2010-12-14
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S063)Cochlear Americas2010-11-24
ESTEEM (P090018/S008)Envoy Medical Corporation2010-11-23
MAXUM SYSTEM (P010023/S006)Ototronix, LLC2010-11-05
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S048)Med-El Corp.2010-10-01
MAXUM SYSTEM (P010023/S003)Ototronix, LLC2010-09-30
ESTEEM (P090018/S007)Envoy Medical Corporation2010-09-21
COMBI 40+ COCHLEAR SYSTEM (MAESTRO COCHLER IMPLANT SYSTEM) (P000025/S049)Med-El Corp.2010-09-17
MAXUM SYSTEM (P010023/S005)Ototronix, LLC2010-09-10
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S076)Advanced Bionics2010-09-10
ESTEEM (P090018/S005)Envoy Medical Corporation2010-09-08
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM STERILE BLISTERS WITH INTERNAL ANTIBLOCK (P000025/S047)Med-El Corp.2010-09-03
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S046)Med-El Corp.2010-09-03
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S085)Advanced Bionics2010-08-24
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S059)Cochlear Americas2010-08-20
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S084)Advanced Bionics2010-08-20
ESTEEM (P090018/S002)Envoy Medical Corporation2010-08-16
ESTEEM (P090018/S003)Envoy Medical Corporation2010-08-16
VIBRANT SOUNDBRIDGE SYSTEM (P990052/S022)Med-El Elektromedizinische Gerate GmbH2010-07-27
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S045)Med-El Corp.2010-07-26
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S062)Cochlear Americas2010-07-22
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S080)Advanced Bionics2010-06-11
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S053)Cochlear Americas2010-06-03
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S057)Cochlear Americas2010-05-14
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S060)Cochlear Americas2010-04-23
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S082)Advanced Bionics2010-03-30
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S044)Med-El Corp.2010-03-26
ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM (P090018)Envoy Medical Corporation2010-03-17
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S054)Cochlear Americas2010-02-17
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