Atlas FDA

Cochlear Americas

501 FDA 510(k) clearances · PMA applicant

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◉ Watch Cochlear Americas

RecordFirmDate
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S240)Cochlear Americas2025-12-19
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S058)Cochlear Americas2025-10-16
Nucleus® 24 Cochlear Implant System (P970051/S236)Cochlear Americas2025-10-16
Nucleus® 24 Cochlear Implant System (P970051/S238)Cochlear Americas2025-09-26
Cochlear™ Nucleus® System (P970051/S237)Cochlear Americas2025-09-02
Nucleus® 24 Cochlear Implant System (P970051/S235)Cochlear Americas2025-08-06
Nucleus® 24 Cochlear Implant System (P970051/S234)Cochlear Americas2025-07-24
Nucleus® 22 Cochlear Implant System (P890027/S064)Cochlear Americas2025-07-03
Nucleus® 24 Cochlear Implant System (P970051/S225)Cochlear Americas2025-07-03
Nucleus® 22 Cochlear Implant System (P840024/S096)Cochlear Americas2025-07-03
Nucleus® 24 Auditory Brainstem Implant System (P000015/S053)Cochlear Americas2025-07-03
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S056)Cochlear Americas2025-07-03
Nucleus 24 Cochlear Implant System (P970051/S233)Cochlear Americas2025-02-28
Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant (P970051/S231)Cochlear Americas2024-11-15
Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant (P970051/S232)Cochlear Americas2024-11-13
Cochlear™ Slimline™ Coil, Cochlear™ Slimline™ Coil (5(I)), Nucleus® 7 Aqua+ Coil (5(I)), Nucleus 7 Aqua+ Coil (P970051/S230)Cochlear Americas2024-10-25
Nucleus 24 Cochlear Implant System (P970051/S229)Cochlear Americas2024-10-25
Cochlear™ Nucleus® CI632 cochlear implant with Slim Modiolar electrode, Cochlear™ Nucleus® CI532 cochlear implant with S (P970051/S228)Cochlear Americas2024-08-01
Cochlear™ Nucleus® CI522 cochlear implant with Slim Straight electrode, Cochlear™ Nucleus® CI532 cochlear implant with S (P970051/S227)Cochlear Americas2024-06-17
Nucleus® 22 Cochlear Implant System (P890027/S065)Cochlear Americas2024-05-31
Nucleus® 24 Cochlear Implant System (P970051/S226)Cochlear Americas2024-05-31
Nucleus® 24 Auditory Brainstem Implant System (P000015/S054)Cochlear Americas2024-05-31
Nucleus® 22 Cochlear Implant System (P840024/S097)Cochlear Americas2024-05-31
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S057)Cochlear Americas2024-05-31
Nucleus 24 Cochlear Implant System (P970051/S220)Cochlear Americas2024-05-08
Nucleus® Hybrid Cochlear Implant (P130016/S055)Cochlear Americas2023-12-13
Nucleus® 24 Cochlear Implant System (P970051/S224)Cochlear Americas2023-12-13
Nucleus® Auditory Brainstem Implant (P000015/S052)Cochlear Americas2023-12-13
Nucleus® 24 Cochlear Implant System (P970051/S223)Cochlear Americas2023-11-29
Nucleus Hybrid L24 Cochlear Implant System (P130016/S052)Cochlear Americas2023-11-17
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S054)Cochlear Americas2023-10-25
Nucleus® 24 Auditory Brainstem Implant System (P000015/S051)Cochlear Americas2023-10-25
Nucleus® 24 Cochlear Implant System (P970051/S222)Cochlear Americas2023-10-25
Nucleus® 22 Cochlear Implant System (P840024/S095)Cochlear Americas2023-10-13
Nucleus® 24 Auditory Brainstem Implant System (P000015/S050)Cochlear Americas2023-10-13
Nucleus® 22 Cochlear Implant System (P890027/S063)Cochlear Americas2023-10-13
Nucleus® 24 Cochlear Implant System (P970051/S221)Cochlear Americas2023-10-13
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S053)Cochlear Americas2023-10-13
Nucleus CI522 Cochlear Implant, Nucleus CI532 Cochlear Implant, Nucleus CI622 Cochlear Implant, Nucleus CI624 Cochlear I (P970051/S219)Cochlear Americas2023-07-14
Nucleus 24 Cochlear Implant System (P970051/S218)Cochlear Americas2023-06-08
Nucleus 24 Cochlear Implant System (P970051/S217)Cochlear Americas2023-04-24
Nucleus 24 Auditory Brainstem Implant System (P000015/S049)Cochlear Americas2023-04-24
Nucleus 24 Cochlear Implant System (P970051/S216)Cochlear Americas2022-12-15
Nucleus 24 Auditory Brainstem Implant System (P000015/S048)Cochlear Americas2022-12-06
Nucleus Hybrid L24 Cochlear Implant System (P130016/S051)Cochlear Americas2022-12-06
Nucleus 24 Cochlear Implant System (P970051/S214)Cochlear Americas2022-12-06
Nucleus 22 Cochlear Implant System (P890027/S061)Cochlear Americas2022-12-06
Nucleus® 24 Cochlear Implant System (P970051/S215)Cochlear Americas2022-12-06
Nucleus 22 Cochlear Implant System (P840024/S093)Cochlear Americas2022-12-06
Nucleus Auditory Brainstem Implant (P000015/S047)Cochlear Americas2022-10-31
Nucleus Cochlear Implant Systems (P970051/S211)Cochlear Americas2022-10-31
Nucleus Cochlear Implant Systems (P890027/S062)Cochlear Americas2022-10-31
Nucleus Hybrid Cochlear Implant (P130016/S048)Cochlear Americas2022-10-31
Nucleus Cochlear Implant Systems (P840024/S094)Cochlear Americas2022-10-31
Nucleus® 24 Cochlear™ Implant System (P970051/S212)Cochlear Americas2022-09-26
Nucleus® 24 Cochlear Implant System (P970051/S213)Cochlear Americas2022-08-09
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S050)Cochlear Americas2022-08-09
Nucleus Hybrid L24 Implant System (P130016/S049)Cochlear Americas2022-06-16
Nucleus® Hybrid™ Implant System (P130016/S046)Cochlear Americas2022-04-29
Nucleus® 24 Cochlear™ Implant System (P970051/S208)Cochlear Americas2022-04-29
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
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
Nucleus 24 Cochlear Implant System (P970051/S207)Cochlear Americas2021-10-08
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
Nucleus Cochlear Implant System (P970051/S203)Cochlear Americas2021-04-21
Nucleus 24 Cochlear Implant System (P970051/S204)Cochlear Americas2021-03-26
Nucleus Auditory Brainstem Implant System (P000015/S044)Cochlear Americas2020-12-30
24 Cochlear Implant System (P970051/S200)Cochlear Americas2020-12-30
Hybrid Implant System (P130016/S044)Cochlear Americas2020-12-30
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
Nucleus Cochlear Implant System (P970051/S197)Cochlear Americas2020-08-31
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
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
Nucleus 24 Cochlear Implant System (P970051/S198)Cochlear Americas2020-05-15
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
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
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
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Every clearance here is in the API, with alerts when new ones post.