Atlas FDA

Ear, Nose, Throat

988 FDA 510(k) clearances · PMA advisory committee

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◉ Watch Ear, Nose, Throat

RecordFirmDate
HiResolution Bionic Ear System (P960058/S142)Advanced Bionics2019-08-27
Nucleus 24 Cochlear Implant System (P970051/S189)Cochlear Americas2019-08-27
HiResolution Bionic Ear System (P960058/S141)Advanced Bionics2019-08-23
Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Software (P000025/S112)Med-El Corp.2019-08-22
Propel Mini Sinus Implant (P100044/S038)Intersect Ent.2019-07-24
MED-EL Cochlear Implant System (P000025/S104)Med-El Corp.2019-07-19
HiResolution Bionic Ear System (P960058/S139)Advanced Bionics2019-07-18
HiResolution Bionic Ear System (P960058/S140)Advanced Bionics2019-07-03
+FLEX Active Electrode and Insertion Electrode (IE) FLEX (P000025/S106)Med-El Corp.2019-07-02
Nucleus 24 Cochlear Implant Sysstem (P970051/S186)Cochlear Americas2019-07-02
Nucleus Auditory Brainstem Implant System (P000015/S037)Cochlear Americas2019-07-02
Propel, Propel Mini and Propel Contour Sinus Implants (P100044/S042)Intersect Ent.2019-06-27
Cochlear Nucleus CI600 Series Cochlear Implants (P970051/S183)Cochlear Americas2019-06-14
MED-EL Cochlear Implant (P000025/S100)Med-El Corp.2019-06-07
Nucleus Hybrid Cochlear Implant System (P130016/S036)Cochlear Americas2019-06-05
Nucleus ABI541 Auditory Brainstem Implant (P000015/S034)Cochlear Americas2019-06-05
Nucleus 24 Cochlear Implant System (P970051/S182)Cochlear Americas2019-06-05
Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant (P000025/S110)Med-El Corp.2019-06-04
Propel Contour Sinus Implant (P100044/S041)Intersect Ent.2019-05-31
Propel Contour Sinus Implant (P100044/S040)Intersect Ent.2019-05-31
Propel, Propel Mini and Propel Contour Sinus Implants (P100044/S039)Intersect Ent.2019-05-23
AudioKey 1.0 and AudioLink (P000025/S109)Med-El Corp.2019-05-08
FineTuner Echo (P000025/S108)Med-El Corp.2019-05-08
HiResolution Bionic Ear System/AIM System (P960058/S133)Advanced Bionics2019-04-12
HiResolution Bionic Ear System (P960058/S138)Advanced Bionics2019-03-22
Chorus Sound Processor and SoundWave Professional Suite 3.2/HiResolution Bionic Ear System (P960058/S132)Advanced Bionics2019-03-12
Nucleus Auditory Brainstem Implant System (P000015/S035)Cochlear Americas2019-03-08
Nucleus 24 Cochlear Implant System (P970051/S184)Cochlear Americas2019-03-08
HiResolution Bionic Ear System (P960058/S136)Advanced Bionics2019-03-08
HiResolution Bionic Ear System (P960058/S137)Advanced Bionics2019-03-08
Nucleus Hybrid Implant System (P130016/S037)Cochlear Americas2019-03-08
Propel Contour Sinus Implant (P100044/S037)Intersect Ent.2019-02-28
MED-EL Cochlear Implant System (P000025/S107)Med-El Corp.2019-02-22
Mi1210 SYNCHRONY ST Cochlear Implant (P000025/S103)Med-El Corp.2019-01-22
HiResolution Bionic Ear System (P960058/S135)Advanced Bionics2019-01-11
Propel Family of Sinus Implants (P100044/S036)Intersect Ent.2019-01-10
HiResolution Bionic Ear System (P960058/S134)Advanced Bionics2019-01-09
Propel Sinus Implant, Propel Mini Sinus Implant, Propel Contour Sinus Implant (P100044/S035)Intersect Ent.2018-09-21
MED-EL Cochlear Implant System (P000025/S105)Med-El Corp.2018-09-19
Nucleus Hybrid Implant System (P130016/S035)Cochlear Americas2018-09-10
Nucleus Auditory Brainstem Implant System (P000015/S033)Cochlear Americas2018-09-10
Nucleus 24 Cochlear Implant System (P970051/S181)Cochlear Americas2018-09-10
Propel and Propel Mini Sinus Implants (P100044/S034)Intersect Ent.2018-09-07
HiRes Ultra 3D Cochlear Implant (P960058/S129)Advanced Bionics2018-08-28
HiResolution Bionic Ear System (P960058/S130)Advanced Bionics2018-08-13
MED-EL Cochlear Implant System (P000025/S102)Med-El Corp.2018-08-10
Esteem Totally Implantable Hearing Device (P090018/S037)Envoy Medical Corporation2018-07-31
MED-EL Cochlear Implant System (P000025/S101)Med-El Corp.2018-07-25
Maestro System Software 7.0 (P000025/S097)Med-El Corp.2018-07-24
Nucleus C1532 Cochlear Implant (P970051/S180)Cochlear Americas2018-07-11
Propel Contour Sinus Implant (P100044/S033)Intersect Ent.2018-06-28
Nucleus Auditory Brainstem Implant (P000015/S027)Cochlear Americas2018-06-13
Nucleus Hybrid L24 Implant System (P130016/S032)Cochlear Americas2018-06-13
Nucleus Cochlear Implant System (P970051/S173)Cochlear Americas2018-06-13
Propel, Propel mini and Propel Contour Sinus Implants (P100044/S032)Intersect Ent.2018-06-01
Nucleus 24 Cochlear Implant System (Nucleus 7 Sound Processor) (P970051/S179)Cochlear Americas2018-05-24
RONDO 2 Audio Processor & WaterWear for RONDO 2 (P000025/S099)Med-El Corp.2018-05-15
Nucleus 24 Cochlear Implant System (P970051/S178)Cochlear Americas2018-05-11
Nucleus 24 Auditory Brainstem Implant (P000015/S032)Cochlear Americas2018-05-11
MED-EL Cochlear Implants (P000025/S098)Med-El Corp.2018-04-20
Nucleus Hybrid Cochlear Implant System (P130016/S034)Cochlear Americas2018-03-16
Nucleus 24 Cochlear Implant System (P970051/S177)Cochlear Americas2018-03-16
Nucleus AB1541 Auditory Brainstem Implant (P000015/S031)Cochlear Americas2018-03-16
HiResolution Bionic Ear System (P960058/S128)Advanced Bionics2018-03-14
COMBI 40+ COCHLEAR IMPLANT SYSTEM (P000025/S094)Med-El Corp.2018-03-07
Nucleus Auditory Brainstem Implant System (P000015/S030)Cochlear Americas2018-03-02
Nucleus 24 Cochlear Implant System (P970051/S176)Cochlear Americas2018-03-02
Nucleus 24 Cochlear Implant System (P970051/S170)Cochlear Americas2018-02-14
Nucleus Auditory Brainstem Implant System (P000015/S026)Cochlear Americas2018-02-14
Nucleus 24 Cochlear Implant System (P970051/S174)Cochlear Americas2018-02-01
Nucleus Auditory Brainstem Implant System (P000015/S029)Cochlear Americas2018-02-01
Nucleus Hybrid Implant System (P130016/S033)Cochlear Americas2018-02-01
Nucleus Auditory Brainstem Implant System (P000015/S028)Cochlear Americas2018-02-01
Necleus 24 Cochlear Implant System (P970051/S175)Cochlear Americas2018-02-01
Nucleus 24 Cochlear Implant System (P970051/S157)Cochlear Americas2017-12-14
Nucleus 22 Cochlear Implant System (P840024/S089)Cochlear Americas2017-12-14
Nucleus 22 Cochlear Implant System (P890027/S058)Cochlear Americas2017-12-14
HiResolution Bionic Ear System (P960058/S126)Advanced Bionics2017-11-21
Nucleus N22 Cochlear Implant Systems (P840024/S090)Cochlear Americas2017-11-17
Nucleus Hybrid L24 Implant System (P130016/S028)Cochlear Americas2017-11-17
Nucleus® Cochlear™ Implant System (P970051/S164)Cochlear Americas2017-11-17
Nucleus N22 Cochlear Implant Systems (P890027/S059)Cochlear Americas2017-11-17
HiFocus SlimJ Electrode (P960058/S121)Advanced Bionics2017-11-14
HiResolution Bionic Ear System (P960058/S122)Advanced Bionics2017-11-14
HiResolution Bionic Ear System - Universal Headpiece (UHP) 2.0 (P960058/S125)Advanced Bionics2017-10-26
Nucleus 24 Cochlear Implant System (P970051/S171)Cochlear Americas2017-10-25
HiResolution Bionic Ear System (P960058/S124)Advanced Bionics2017-10-25
PROPEL Contour SInus Implant (P100044/S031)Intersect Ent.2017-10-13
HiResolution Bionic Ear System (P960058/S123)Advanced Bionics2017-10-05
Mometasone Furoate Container Closure System (P100044/S030)Intersect Ent.2017-09-27
NUCLEUS HYBRID L24 IMPLANT SYSTEM (P130016/S021)Cochlear Americas2017-09-22
Nucleus 24 Cochlear Implant System (P970051/S166)Cochlear Americas2017-09-20
Nucleus Auditory Brainstem Implant System (P000015/S023)Cochlear Americas2017-09-20
Nucleus Hybrid Implant System (P130016/S030)Cochlear Americas2017-09-20
Necleus Auditory Brainstem Impant System (P000015/S025)Cochlear Americas2017-09-05
Nucleus 24 Cochlear Implant System (P970051/S169)Cochlear Americas2017-09-05
Nucleus Auditory Brainstem Implant (P000015/S024)Cochlear Americas2017-08-23
Nucleus 24 Cochlear Implant System (P970051/S168)Cochlear Americas2017-08-23
Nucleus 24 Cochlear Implant System (P970051/S167)Cochlear Americas2017-08-16
Nucleus Hybrid Cochlear Implant System (P130016/S031)Cochlear Americas2017-08-16
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