Ear, Nose & Throat

FDA medical specialty panel: Ear, Nose & Throat. Product code prefix: EN.

10 companies · 66 devices
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66 devices

SilentCloud (K221125)

Class Class II K221125 KLW
2023-01-04

Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set (K223782)

Class Class II K223782 EOQ
2023-01-12

C2 Xplore (K223254)

Class Class II K223254 ETN
2023-01-27

Tinnitogram Signal Generator (K221168)

Class Class II K221168 KLW
2023-02-01

Pre-Formed Silicone Block (K223051)

Class Class II K223051 MIB
2023-02-03

TELIGEN System Peripheral Motor Nerve Stimulation Indications (K223438)

Class Class II K223438 PDQ
2023-02-10

EsoCheck Cell Collection Device (K230339)

Class Class II K230339 EOX
2023-02-24

Multistage Balloon Dilatation Catheter (K222187)

Class Class II K222187 KTI
2023-03-01

Galaxy System (K223144)

Class Class II K223144 EOQ
2023-03-01

iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) (K221340)

Class Class II K221340 EOQ
2023-03-02

Lenire Tinnitus Treatment Device (DEN210033)

Class Class II DEN210033 QVN
2023-03-06

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application (K223137)

Class Class II K223137 QUH
2023-03-14

BFlex™ 2 Slim 3.8 Single-Use Bronchoscope (K230948)

Class Class II K230948 EOQ
2023-05-03

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (K230280)

Class Class II K230280 KTI
2023-05-11

Waypoint GPS (K222106)

Class Class II K222106 QWP
2023-05-12

Vathin® Video Bronchoscope System (K223836)

Class Class II K223836 EOQ
2023-05-15

BB 8 Sinus Dilation Kit (K230258)

Class Class I K230258 LRC
2023-05-25

Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance (K223299)

Class Class II K223299 EOQ
2023-06-01

MISTI Silicone Implant (K241150)

Class Class II K241150 MIB
2024-07-24

EARP Nerve Cuff Electrode (K241917)

Class Class II K241917 ETN
2024-07-31

Hearing Aid Feature (HAF) (DEN230081)

Class Class II DEN230081 SCR
2024-09-12

MonoStereo (K234096)

Class Class II K234096 EOB
2024-09-19

Ion Endoluminal System (IF 1000) (K242070)

Class Class II K242070 EOQ
2024-09-24

Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) (K240289)

Class Class II K240289 EOQ
2024-10-23
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