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Ear, Nose, Throat

988 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
COCHLEAR IMPLANT SYSTEM (P970051/S050)Cochlear Americas2010-02-02
KARL STORZ AUTOFLUORESCENCE SYSTEM (P020008/S002)KARL STORZ Endoscopy-America, Inc.2009-12-23
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S052)Cochlear Americas2009-12-10
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S058)Cochlear Americas2009-12-02
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S011)Cochlear Americas2009-11-12
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S055)Cochlear Americas2009-11-12
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (P890027/S057)Cochlear Americas2009-11-12
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (P840024/S088)Cochlear Americas2009-11-12
MAXUM SYSTEM (P010023/S002)Ototronix, LLC2009-10-08
SONATATI100 IMPLANT (P000025/S043)Med-El Corp.2009-09-23
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S041)Med-El Corp.2009-09-03
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S048)Cochlear Americas2009-08-28
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S049)Cochlear Americas2009-08-24
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S051)Cochlear Americas2009-07-16
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S081)Advanced Bionics2009-06-12
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S075)Advanced Bionics2009-06-12
SONATATI100 IMPLANT (P000025/S042)Med-El Corp.2009-06-12
MED-EL COCHLEAR IMPLANT SYSTEMS (P000025/S039)Med-El Corp.2009-04-30
COMBI 40+ COCLEAR IMPLANT SYSTEM (P000025/S040)Med-El Corp.2009-03-25
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S079)Advanced Bionics2009-03-18
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S074)Advanced Bionics2009-03-11
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S078)Advanced Bionics2009-03-05
VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM (P990052/S020)Med-El Elektromedizinische Gerate GmbH2009-01-09
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S035)Med-El Corp.2008-12-19
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S073)Advanced Bionics2008-12-09
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S070)Advanced Bionics2008-10-31
VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM (P990052/S021)Med-El Elektromedizinische Gerate GmbH2008-10-24
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S038)Med-El Corp.2008-10-24
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S066)Advanced Bionics2008-10-15
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S037)Med-El Corp.2008-10-09
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S047)Cochlear Americas2008-09-05
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S046)Cochlear Americas2008-08-29
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S036)Med-El Corp.2008-08-27
COMBI 40+COCHLEAR IMPLANT SYSTEM (P000025/S017)Med-El Corp.2008-07-10
SONATA TI 100 COCHLEAR IMPLANT (P000025/S033)Med-El Corp.2008-06-20
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S034)Med-El Corp.2008-06-13
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S061)Advanced Bionics2008-04-21
COMBI 40+ COCHLEAR IMPLANT SYSTEM & MED EL C40+ COCHLEAR IMPLANT SYSTEM (P000025/S032)Med-El Corp.2008-04-18
MED EL C40+ COCHLEAR IMPLANT SYSTEM (P000025/S031)Med-El Corp.2008-04-18
COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH OPUS 2 SPEECH PROCESSOR (P000025/S029)Med-El Corp.2008-04-08
VIBRANT SOUNDBRIDGE EAR IMPLANT SYSTEM (P990052/S019)Med-El Elektromedizinische Gerate GmbH2008-03-25
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S026)Med-El Corp.2008-03-14
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S010)Cochlear Americas2007-12-31
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S045)Cochlear Americas2007-11-28
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S028)Med-El Corp.2007-10-24
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (P840024/S087)Cochlear Americas2007-10-16
NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (P890027/S056)Cochlear Americas2007-10-16
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S027)Med-El Corp.2007-09-25
COMBO 40+ COCHLEAR IMPLANT SYSTEM (P000025/S023)Med-El Corp.2007-09-24
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S043)Cochlear Americas2007-09-21
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S044)Cochlear Americas2007-09-21
NUCLEUS COCHLEAR IMPLANT SYSTEM (P970051/S041)Cochlear Americas2007-09-21
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S042)Cochlear Americas2007-09-21
PINPOINT ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (P950042/S004)Novadaq Technologies, Inc.2007-09-05
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S057)Advanced Bionics2007-07-27
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S025)Med-El Corp.2007-07-24
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S024)Med-El Corp.2007-07-24
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S058)Advanced Bionics2007-07-02
SONATATI100 COCHLEAR IMPLANT (P000025/S021)Med-El Corp.2007-06-22
VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM (P990052/S018)Med-El Elektromedizinische Gerate GmbH2007-06-13
VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD) (P990052/S016)Med-El Elektromedizinische Gerate GmbH2007-03-30
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S055)Advanced Bionics2007-02-26
VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD) (P990052/S014)Med-El Elektromedizinische Gerate GmbH2006-12-14
VIBRANT SOUNDBRIDGE (P990052/S015)Med-El Elektromedizinische Gerate GmbH2006-12-13
VIBRANT SOUNDBRIDGE (P990052/S013)Med-El Elektromedizinische Gerate GmbH2006-11-02
VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM (P990052/S012)Med-El Elektromedizinische Gerate GmbH2006-10-13
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (ABI) (P000015/S008)Cochlear Americas2006-10-05
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S039)Cochlear Americas2006-10-05
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S049)Advanced Bionics2006-08-17
HARMONY HIRESOLUTION BIONIC EAR SYSTEM (P960058/S054)Advanced Bionics2006-07-28
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S038)Cochlear Americas2006-06-14
COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM (P000025/S020)Med-El Corp.2006-05-31
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S037)Cochlear Americas2006-05-25
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S047)Advanced Bionics2006-04-11
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S053)Advanced Bionics2006-03-22
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (CI24R & CI24RE MODELS) (P970051/S036)Cochlear Americas2006-02-27
NUCLEUS 24-COCHLEAR IMPLANT SYSTEM (P970051/S035)Cochlear Americas2006-01-27
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S050)Advanced Bionics2006-01-17
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S043)Advanced Bionics2005-12-23
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S048)Advanced Bionics2005-12-05
VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (P990052/S011)Med-El Elektromedizinische Gerate GmbH2005-11-23
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S034)Cochlear Americas2005-10-21
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S042)Advanced Bionics2005-09-21
COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS (P000025/S019)Med-El Corp.2005-07-25
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S045)Advanced Bionics2005-07-25
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S046)Advanced Bionics2005-07-14
ONCO-LIFE ENDOSCOPIC LIGHT SOURCE AND VIDEO CAMERA (ONCO-LIFE) (P950042/S003)Novadaq Technologies, Inc.2005-06-30
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S031)Cochlear Americas2005-04-13
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S030)Cochlear Americas2005-03-30
NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM (P000015/S006)Cochlear Americas2005-03-30
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S040)Advanced Bionics2005-03-07
KARL STORZ AUTOFLURESCENCE SYSTEM (P020008/S001)KARL STORZ Endoscopy-America, Inc.2005-03-04
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S028)Cochlear Americas2005-03-01
MED-EL COMBI 40+/PULSAR COCHLEAR IMPLANT SYSTEM (P000025/S018)Med-El Corp.2005-02-28
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S029)Cochlear Americas2005-01-19
MENTOR POLYTEF PASTE FOR INJECTION (N16420/S007)Coloplast Corp.2005-01-03
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSARCI100 COCHLEAR IMPLANT (P000025/S014)Med-El Corp.2004-11-17
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S038)Advanced Bionics2004-08-24
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S036)Advanced Bionics2004-08-04
HIRESOLUTION BIONIC EAR SYSTEM (P960058/S037)Advanced Bionics2004-07-23
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