Atlas FDA

Ear, Nose, Throat

988 FDA 510(k) clearances · PMA advisory committee

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◉ Watch Ear, Nose, Throat

RecordFirmDate
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051/S240)Cochlear Americas2025-12-19
MED-EL CI System (P000025/S134)Med-El Corp.2025-11-26
Propel Contour Sinus Implant (P100044/S058)Intersect Ent.2025-11-07
Tula® System (P190016/S010)Tusker Medical, Inc.2025-10-24
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S058)Cochlear Americas2025-10-16
Nucleus® 24 Cochlear Implant System (P970051/S236)Cochlear Americas2025-10-16
HiResolution™ Bionic Ear System (P960058/S172)Advanced Bionics2025-10-14
Nucleus® 24 Cochlear Implant System (P970051/S238)Cochlear Americas2025-09-26
Cochlear™ Nucleus® System (P970051/S237)Cochlear Americas2025-09-02
HiResolution™ Bionic Ear System (P960058/S171)Advanced Bionics2025-08-20
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
PROPEL, PROPEL MINI and PROPEL CONTOUR (P100044/S057)Intersect Ent.2025-06-18
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S135)Med-El Corp.2025-04-24
HiResolution Bionic Ear System (P960058/S168)Advanced Bionics2025-04-09
Nucleus 24 Cochlear Implant System (P970051/S233)Cochlear Americas2025-02-28
SONNET 3 (EAS) Audio Processor, MAESTRO 11 (P000025/S131)Med-El Corp.2025-02-13
Propel®, Propel® Mini, Propel® Contour Sinus Implants (P100044/S056)Intersect Ent.2025-02-12
Tula® System (P190016/S009)Tusker Medical, Inc.2025-01-31
HiResolution Bionic Ear System (P960058/S165)Advanced Bionics2025-01-29
HiResolution Bionic Ear System (P960058/S166)Advanced Bionics2024-12-18
Propel® Contour Sinus Implant (P100044/S055)Intersect Ent.2024-11-25
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
Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System, Propel Contor (P100044/S054)Intersect Ent.2024-10-11
MED-EL CI System (P000025/S129)Med-El Corp.2024-10-03
Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C (P100044/S053)Intersect Ent.2024-10-02
MED-EL Cochlear Implant System (P000025/S133)Med-El Corp.2024-09-13
Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS) (P100044/S052)Intersect Ent.2024-09-10
Cochlear™ Nucleus® CI632 cochlear implant with Slim Modiolar electrode, Cochlear™ Nucleus® CI532 cochlear implant with S (P970051/S228)Cochlear Americas2024-08-01
FLEX34 Active Electrode, Insertion Electrode (IE) FLEX34, Insertion Probe, Insertion Probe L and Auditory Nerve Test Sys (P000025/S127)Med-El Corp.2024-07-03
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
HiResolution Bionic Ear System (P960058/S164)Advanced Bionics2024-03-29
Tula® System (P190016/S007)Tusker Medical, Inc.2024-02-01
HiResolution Bionic Ear System (P960058/S162)Advanced Bionics2024-01-10
HiResolution Bionic Ear System (P960058/S163)Advanced Bionics2024-01-05
MED-EL Cochlear Implant System (P000025/S130)Med-El Corp.2023-12-22
Tula System (P190016/S008)Tusker Medical, Inc.2023-12-22
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
HiResolution Bionic Ear System (P960058/S159)Advanced Bionics2023-11-17
HearCare MED-EL, MAESTRO System Software 10.0 (P000025/S126)Med-El Corp.2023-11-05
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
MED-EL Cochlear Implant System (P000025/S128)Med-El Corp.2023-10-04
Nucleus CI522 Cochlear Implant, Nucleus CI532 Cochlear Implant, Nucleus CI622 Cochlear Implant, Nucleus CI624 Cochlear I (P970051/S219)Cochlear Americas2023-07-14
HiResolution Bionic Ear System (P960058/S160)Advanced Bionics2023-06-29
HiResolution Bionic Ear System (P960058/S161)Advanced Bionics2023-06-27
Nucleus 24 Cochlear Implant System (P970051/S218)Cochlear Americas2023-06-08
HiResolution Bionic Ear System (P960058/S158)Advanced Bionics2023-06-02
MED-EL Cochlear Implant System (P000025/S125)Med-El Corp.2023-05-05
Nucleus 24 Cochlear Implant System (P970051/S217)Cochlear Americas2023-04-24
Nucleus 24 Auditory Brainstem Implant System (P000015/S049)Cochlear Americas2023-04-24
HiResolution Bionic Ear System (P960058/S157)Advanced Bionics2023-03-22
Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C (P100044/S051)Intersect Ent.2022-12-22
Nucleus 24 Cochlear Implant System (P970051/S216)Cochlear Americas2022-12-15
Tula® System (P190016/S006)Tusker Medical, Inc.2022-12-15
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
Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C (P100044/S050)Intersect Ent.2022-11-04
Neuro Cochlear Implant System (NCIS) (P200021/S013)Oticon Medical2022-11-04
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
Vibrant Soundbridge System (P990052/S026)Med-El Elektromedizinische Gerate GmbH2022-10-11
Nucleus® 24 Cochlear™ Implant System (P970051/S212)Cochlear Americas2022-09-26
Tula® System (P190016/S005)Tusker Medical, Inc.2022-09-22
HiResolution Bionic Ear System (P960058/S156)Advanced Bionics2022-09-09
Esteem® Totally Implantable Hearing System (P090018/S041)Envoy Medical Corporation2022-08-24
HiResolution Bionic Ear System (P960058/S155)Advanced Bionics2022-08-11
Nucleus® 24 Cochlear Implant System (P970051/S213)Cochlear Americas2022-08-09
Nucleus® Hybrid™ L24 Cochlear Implant System (P130016/S050)Cochlear Americas2022-08-09
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Every clearance here is in the API, with alerts when new ones post.