Atlas FDA

Ear, Nose, Throat

988 FDA 510(k) clearances · PMA advisory committee

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◉ Watch Ear, Nose, Throat

RecordFirmDate
Propel Contour Sinus Implant (P100044/S049)Intersect Ent.2022-06-24
Neuro Cochlear Implant System (P200021/S014)Oticon Medical2022-06-17
Nucleus Hybrid L24 Implant System (P130016/S049)Cochlear Americas2022-06-16
Neuro Cochlear Implant System (NCIS) (P200021/S012)Oticon Medical2022-05-27
MED-EL CONCERT (PIN) Cochlear Implant (P000025/S123)Med-El Corp.2022-05-18
MAESTRO System Software 9.0 (P000025/S124)Med-El Corp.2022-05-17
Nucleus® Hybrid™ Implant System (P130016/S046)Cochlear Americas2022-04-29
Nucleus® 24 Cochlear™ Implant System (P970051/S208)Cochlear Americas2022-04-29
Neuro Cochlear Implant System (P200021/S011)Oticon Medical2022-03-15
Nucleus 24 Cochlear Implant System (P970051/S210)Cochlear Americas2022-03-11
Nucleus® 24 Cochlear Implant System (P970051/S209)Cochlear Americas2022-03-03
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S047)Cochlear Americas2022-03-03
Neuro Cochlear Implant System (P200021/S010)Oticon Medical2022-01-14
HiResolution Bionic Ear System (P960058/S154)Advanced Bionics2022-01-14
Nucleus 24 Cochlear Implant System (P970051/S205)Cochlear Americas2022-01-10
Nucleus® 24 Cochlear Implant System (P970051/S206)Cochlear Americas2021-12-07
Nucleus® Auditory Brainstem Implant System (P000015/S046)Cochlear Americas2021-12-07
Neuro Cochlear Implant System (P200021/S002)Oticon Medical2021-11-08
Neuro Cochlear Implant System (P200021/S009)Oticon Medical2021-11-04
Neuro Cochlear Implant System (P200021/S007)Oticon Medical2021-10-26
Neuro Cochlear Implant System (P200021/S006)Oticon Medical2021-10-26
Nucleus 24 Cochlear Implant System (P970051/S207)Cochlear Americas2021-10-08
Neuro Cochlear Implant System (“NCIS”) (P200021/S005)Oticon Medical2021-09-22
Neuro Cochlear Implant System (P200021/S004)Oticon Medical2021-09-10
Neuro Cochlear Implant System (P200021/S003)Oticon Medical2021-09-08
Tula System (P190016/S003)Tusker Medical, Inc.2021-09-08
MED-EL Cochlear Implant System (P000025/S122)Med-El Corp.2021-09-03
Neuro Cochlear Implant System (P200021/S001)Oticon Medical2021-08-20
SONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MAESTRO 9 (P000025/S120)Med-El Corp.2021-06-25
Neuro Cochlear Implant System (P200021)Oticon Medical2021-06-23
Nucleus ABI541 Auditory Brainstem Implant System (P000015/S040)Cochlear Americas2021-06-09
Nucleus Hybrid Implant System (P130016/S040)Cochlear Americas2021-06-09
Nucleus 24 Cochlear Implant System (P970051/S190)Cochlear Americas2021-06-09
Nucleus 22 Cochlear Implant System (P840024/S091)Cochlear Americas2021-06-09
Nucleus 22 Cochlear Implant System (P890027/S060)Cochlear Americas2021-06-09
HiResolution Bionic Ear System (P960058/S153)Advanced Bionics2021-04-29
HiResolution Bionic Ear System (P960058/S152)Advanced Bionics2021-04-23
Nucleus Cochlear Implant System (P970051/S203)Cochlear Americas2021-04-21
Propel and Propel Mini Sinus Implants (P100044/S048)Intersect Ent.2021-04-09
Nucleus 24 Cochlear Implant System (P970051/S204)Cochlear Americas2021-03-26
Nucleus Auditory Brainstem Implant System (P000015/S044)Cochlear Americas2020-12-30
Tula System (P190016/S002)Tusker Medical, Inc.2020-12-30
24 Cochlear Implant System (P970051/S200)Cochlear Americas2020-12-30
Hybrid Implant System (P130016/S044)Cochlear Americas2020-12-30
HiResolution Bionic Ear System (P960058/S151)Advanced Bionics2020-12-22
Nucleus 24 Cochlear Implant System (P970051/S202)Cochlear Americas2020-12-16
Nucleus Hybrid L24 Cochlear Implant System (P130016/S045)Cochlear Americas2020-12-08
Nucleus Auditory Brainstem Implant System (P000015/S045)Cochlear Americas2020-12-08
Nucleus 24 Cochlear Implant System (P970051/S201)Cochlear Americas2020-12-08
HiResolution Bionic Ear System (P960058/S149)Advanced Bionics2020-12-02
MAXUM System (P010023/S014)Ototronix, LLC2020-10-28
MED-EL Cochlear Implant System (P000025/S119)Med-El Corp.2020-10-21
MedEl EAS System (P000025/S115)Med-El Corp.2020-10-07
AudioStream and AudioKey 2.0 (P000025/S117)Med-El Corp.2020-09-25
Mi1260 SONATA 2 Cochlear Implant and Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant (P000025/S114)Med-El Corp.2020-09-25
MED-EL Cochlear Implant System (P000025/S118)Med-El Corp.2020-09-04
Nucleus Cochlear Implant System (P970051/S197)Cochlear Americas2020-08-31
MED-EL Cochlear Implant System (P000025/S116)Med-El Corp.2020-08-25
Nucleus Auditory Brainstem Implant System (P000015/S043)Cochlear Americas2020-08-13
Nucleus 24 Cochlear Implant System (P970051/S199)Cochlear Americas2020-08-13
Nucleus Hybrid L24 Implant System (P130016/S042)Cochlear Americas2020-07-28
HiResolution Bionic Ear System (P960058/S150)Advanced Bionics2020-07-22
Nucleus 22 Cochlear Implant Systems (P840024/S092)Cochlear Americas2020-07-02
Nucleus 24 Cochlear Implant Systems (P970051/S193)Cochlear Americas2020-07-02
Nucleus Hybrid Cochlear Implant (P130016/S041)Cochlear Americas2020-07-02
Nucleus Auditory Brainstem Implant (P000015/S041)Cochlear Americas2020-07-02
Propel Mini Sinus Implant (P100044/S046)Intersect Ent.2020-07-01
HiResolution Bionic Ear System (P960058/S148)Advanced Bionics2020-05-28
Nucleus 24 Cochlear Implant System (P970051/S198)Cochlear Americas2020-05-15
Tula SystemTube Delivery System (TDS) (P190016/S001)Tusker Medical, Inc.2020-05-06
Propel Family of Sinus Implants (P100044/S045)Intersect Ent.2020-04-24
HiResolution Bionic Ear System (P960058/S145)Advanced Bionics2020-04-03
Nucleus 24 Cochlear Implant (P970051/S188)Cochlear Americas2020-04-02
Nucleus Hybrid Cochlear Implant (P130016/S039)Cochlear Americas2020-04-02
Nucleus 24 Cochlear Implant System (P970051/S196)Cochlear Americas2020-03-18
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S172)Cochlear Americas2020-03-17
Propel (P100044/S043)Intersect Ent.2020-02-28
Esteem (P090018/S039)Envoy Medical Corporation2020-02-24
Nucleus Hybrid L24 Cochlear Implant System (P130016/S043)Cochlear Americas2020-02-21
Nucleus Cochlear Implant System (C124RE and C1500) (P970051/S195)Cochlear Americas2020-02-21
Nucleus CI624 Implant System (P970051/S191)Cochlear Americas2020-02-14
HiResolution Bionic Ear System (P960058/S147)Advanced Bionics2020-01-17
HiResolution Bionic Ear System (P960058/S144)Advanced Bionics2019-12-23
HiResolution Bionic Ear System (P960058/S146)Advanced Bionics2019-12-17
Nucleus 24 Cochlear Implant System (P970051/S194)Cochlear Americas2019-12-13
Nucleus ABI541 Auditory Brainstem Implant (P000015/S042)Cochlear Americas2019-12-13
Nucleus ABI541 Auditory Brainstem Implant (P000015/S038)Cochlear Americas2019-12-04
Hybrid L24 CI System (P130016/S038)Cochlear Americas2019-12-04
Nucleus 24 Cochlear Implant System (P970051/S187)Cochlear Americas2019-12-04
Tula® System (P190016)Tusker Medical, Inc.2019-11-25
Nucleus Auditory Brainstem Implant (P000015/S036)Cochlear Americas2019-11-08
Nucleus Cochlear Implant System (P970051/S185)Cochlear Americas2019-11-08
HiResolution Bionic Ear System (P960058/S143)Advanced Bionics2019-10-25
COMBI 40+ Cochlear Implant System (P000025/S113)Med-El Corp.2019-10-15
Propel, Propel Mini and Propel Contour (Propel Familly) Sinus Implants (P100044/S044)Intersect Ent.2019-10-08
Nucleus 24 Cochlear Implant System (EA22 Stiffener) (P970051/S192)Cochlear Americas2019-10-08
MAESTRO System Software 8.0 (P000025/S111)Med-El Corp.2019-09-27
Esteem System (P090018/S038)Envoy Medical Corporation2019-09-26
HiResolution Bionic Ear System (P960058/S131)Advanced Bionics2019-08-30
Nucleus Auditory Brainstem Implant System (P000015/S039)Cochlear Americas2019-08-27
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