meddevicedb.com FDA Device Reference

Review Panel

Ear, Nose, Throat FDA 510(k) Clearances & Devices

Cleared Devices
3,803
Product Codes (page)
28
Latest Decision
2017-02-09

Clearances · page 5 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K162611 PeriFLEX Spiration, Inc. EOQ Class II 2017-02-09
K162624 Pre-Formed Penile Silicone Block International Medical Devices, Inc. MIB Class II 2017-02-01
K161514 Precision Thin Reciprocating Blade, 0.010in. Stryker Corporation EQJ Class I 2017-01-17
K162210 touchTymp Maico Diagnostics GmbH ETY Class II 2016-11-16
K161698 Relieva UltirraNav Sinus Balloon Catheter Acclarent, Inc. LRC Class I 2016-10-24
K161893 Neuromonitoring Kit SI-BONE, Inc. PDQ Class II 2016-10-18
K161671 Ponto 3, Ponto 3 Power and Ponto 3 SuperPower Oticon Medical AB LXB Class II 2016-09-29
K161562 Sound Options Tinnitus Treatment Sound Options Tinnitus Treatments, Inc. KLW Class II 2016-09-28
DEN150056 Acclarent Aera Eustachian Tube Balloon Dilation System Acclarent, Inc. PNZ Class II 2016-09-16
K153701 ULYSS Multi View Sinuscope Sopro-Comeg GmbH EOB Class II 2016-09-09
K161656 Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor Ambu A/S EOQ Class II 2016-09-01
K161392 Elation Pulmonary Balloon Dilation Merit Medical Systems, Inc. KTI Class II 2016-09-01
K161707 Madsen Zodiac Gn Otometrics ETY Class II 2016-09-01
K161376 DragonFly Surgical Drill System Grace Medical, Inc. ERL Class II 2016-08-25
K161331 HyperSound Tinnitus Module Turtle Beach Corporation KLW Class II 2016-08-23
K160101 SinuBand Bioinspire Technologies, Incorporated QJL Class I 2016-07-27
K153484 Dillard Airway Dilatation System Intuit Medical Products, LLC KTI Class II 2016-07-27
K160770 Vent-Os Sinus Dilation family Sinusys Corporation LRC Class I 2016-06-29
K161191 Latera Absorbable Nasal Implant Spirox, Inc. NHB Class II 2016-06-23
K161101 PolypVac Microdebrider (3.3mm and 4.0mm) Laurimed, LLC ERL Class II 2016-06-22
K153391 Sophono Bone Conduction Systems (S) Configuration and (M) Configuration Sophono, Inc. LXB Class II 2016-06-16
K152747 DSG Threaded Drill System Spineguard S.A. PDQ Class II 2016-06-10
K152744 DIEGO ELITE DRILL Gyrus Acmi, Inc. ERL Class II 2016-06-10
K152319 Auris Robotic Endoscopy System (ARES) Auris Surgical Robotics, Inc. EOQ Class II 2016-05-26
K161123 Baha 5 Power Sound Processor Cochlear Americas LXB Class II 2016-05-20
K152466 Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) Prosurg, Inc. EOQ Class II 2016-05-19
K161000 Biodesign Otologic Repair Graft Cook Biotech Incorporated KHJ Class II 2016-05-11
K152769 FREMAP ELECTRODE Ad-Tech Medical Instrument Corporation ETN Class II 2016-05-06
K152794 Cytosponge Cell Collection Device Covidien, LLC EOX Class II 2016-04-12
K153634 Wireless Earlens Light Driven Hearing Aid Earlens Corporation PLK Class II 2016-04-06
K153009 ULTRA Telescopes Olympus Winter & Ibe GmbH EOB Class II 2016-04-05
K153245 Baha 5 Super Power Sound Processor Cochlear Americas LXB Class II 2016-03-02
K160171 Illuminated Mediastinal Access Port Aegis Surgical, Ltd. EWY Class II 2016-02-26
K152922 ViziShot FLEX Spiration, Inc. KTI Class II 2016-02-19
K153341 Relieva Scout Multi-Sinus Dilation System Acclarent, Inc. LRC Class I 2016-02-12
K152505 C2 NerveMonitor System Inomed Medizintechnik GmbH ETN Class II 2016-02-01
K153686 SPIWay Endonasal Access Guide Spiway, LLC LYA Class I 2016-01-28
K152820 Ponto Bone Anchored Hearing System Oticon Medical AB MAH Class II 2016-01-22
K151558 Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System Neurotherapies Reset GmbH KLW Class II 2016-01-20
K152531 InstaClear Lens Cleaner Gyrus Acmi, Inc. EOB Class II 2016-01-15
K152942 NuVasiveNVM5 System Nu Vasive, Incorporated PDQ Class II 2016-01-13
K150969 Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces Karl Storz Endoscopy America, Inc. ERL Class II 2016-01-08
K151025 iHearTest Ihear Medical, Inc. EWO Class II 2015-12-29
K152958 INEX Absorbable Nasal Implant Spirox, Inc. NHB Class II 2015-12-04
K152121 NuVent EM Sinus Dilation System Medtronic Xomed, Inc. LRC Class I 2015-12-01
K152067 Ponto bone anchored hearing system Oticon Medical AB MAH Class II 2015-11-23
K152641 Pi Drive Plus Motor, Extender Stryker Corporation ERL Class II 2015-11-20
K152434 XprESS Multi-Sinus Dilation System Entellus Medical, Inc. LRC Class I 2015-11-20
K152435 PassAssist LED Light Fiber Entellus Medical, Inc. LRC Class I 2015-11-20
K151315 Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Boston Scientific Corporation EOQ Class II 2015-11-10
K143727 PENTAX Medical EKP-i5010 Video Processor with EB Family Pentax of America, Inc. EOQ Class II 2015-10-29
K151719 REVE134 Kw Ear Lab, Inc. KLW Class II 2015-10-09
DEN150002 EarLens Contact Hearing Device Earlens Corporation PLK Class II 2015-09-29
K151830 Hummingbird Tympanostomy Tube Preceptis Medical ETD Class II 2015-09-21
K151522 DEFENDO Bronchoscopy Suction Valve Medivators, Inc. KTI Class II 2015-09-17
K150594 Biodesign Otologic Repair Graft Cook Biotech Incorprated KHJ Class II 2015-09-16
K143738 DSS Sinusplasty Balloon Catheter Intuit Medical Products, LLC LRC Class I 2015-08-27
K150728 XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole Medtronic Xomed, Inc. ERL Class II 2015-08-14
K150014 Serenity Sanuthera, Inc. KLW Class II 2015-07-27
K150248 ORL Video NasoPharyngo-Larngoscope Jedmed Instrument Company EQN Class II 2015-07-23
K150751 Cordelle II Sound Processor Cochlear Americas LXB Class II 2015-07-22
K151067 Ventilation (Tympanostomy) Tubes Medtronic Xomed, Inc. ETD Class II 2015-07-22
K150776 Medrobotics Flex System Medrobotics Corporation EOB Class II 2015-07-17
K151616 AT235 Interacoustics A/S ETY Class II 2015-07-15
K150555 BA400 14mm Abutment Cochlear Americas MAH Class II 2015-07-15
K151509 GSI TympStar Pro Middle Ear Analyzer Diagnostic Group, Dba Grason-Stadler ETY Class II 2015-06-25
K150951 aeris Balloon Dialation Catheter Bryan Medical, Inc. KTI Class II 2015-06-25
K142934 CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved Covidien EOQ Class II 2015-06-17
K150280 PulmoVia Working Channel Sanovas, Inc. EOQ Class II 2015-06-11
K150171 Tinnitus Sound Generator Module Gn Resound A/S KLW Class II 2015-05-14
K142839 GenCut Core Biopsy System Covidien, LLC EOQ Class II 2015-04-29
K142909 Flexible 19G EBUS Needle Spiration, Inc. EOQ Class II 2015-04-24
K150163 Otowave 202 Portable Tympanometer Amplivox, Ltd. NAS Class II 2015-04-23
K142282 HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) Preceptis Medical ETD Class II 2015-04-23
K143541 Relieva SpinPlus Balloon Sinuplasty System Acclarent, Inc. LRC Class I 2015-04-22
K150065 SoundCure Serenade Tinnitus Treatment System Soundcure, Inc. KLW Class II 2015-04-13
K150172 ACCLARENT SE Inflation Device Acclarent, Inc. LRC Class I 2015-04-07
K150400 Renu Gel Cytophil, Inc. MIX Class II 2015-04-06
K143641 NuVasive NVM5 System Nu Vasive, Incorporated PDQ Class II 2015-03-27
K150491 ER36 Series OAE Test System Etymotic Research, Inc. EWO Class II 2015-03-26
K142907 Baha 5 Sound Processor Cochlear Americas LXB Class II 2015-03-25
K141524 NEURO-AUDIO Teleemg, LLC USA EWO Class II 2015-03-12
DEN130046 REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE Somna Therapeutics, LLC PKA Class II 2015-03-06
K142438 Nerve Monitoring Cable System Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) PDQ Class II 2015-03-05
K143492 OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece Bien-Air Surgery SA ERL Class II 2015-03-04
K143673 CMOS Video Nasopharyngoscope System Schoelly Fiberoptic GmbH EOB Class II 2015-03-04
K143395 Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit Otodynamics, Ltd. EWO Class II 2015-02-23
K150005 Checkpoint, Checkpoint Head & Neck Ndi Medical, LLC ETN Class II 2015-02-19
K142249 SCHOELLY SINUSCOPE Schoelly Fiberoptic GmbH EOB Class II 2015-01-27
K143159 Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS Spineguard S.A. PDQ Class II 2015-01-23
K142678 Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm Oticon Medical AB MAH Class II 2015-01-21
K141622 ILLUMINATED MEDIASTINOSCOPE Aegis Surgical, Ltd. EWY Class II 2015-01-09
K142022 MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES Medline Renewal NLY Class I 2014-12-19
K141366 VIDEO BRONCHOSCOPE SYSTEM Scholly Fiberoptic GmbH EOQ Class II 2014-12-17
K142695 Cytosponge Cell Collection Device Covidien, LLC EOX Class II 2014-11-26
K133348 STIM PROBE Spes Medica Srl ETN Class II 2014-11-21
K141968 NUVASIVE NVM5 SYSTEM Nuvasive, Inc. PDQ Class II 2014-11-14
K141816 HEMOPORE Polyganics B.V., LYA Class I 2014-10-23
K142252 XprESS Multi-Sinus Dilation Tool Entellus Medical, Inc. LRC Class I 2014-10-17
K141704 NOVASHIELD INJECTABLE NASAL PACKING AND STENT Medtronic, Inc. LYA Class I 2014-10-06

3,803 clearances in the Ear, Nose, Throat panel. Data: openFDA.