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
2019-09-06

Clearances · page 4 of 39

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K183516 PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U Pentax of America, Inc. EOQ Class II 2019-09-06
K183419 EVIS EXERA III Bronchovideoscope Olympus BF-XT190 Olympus Medical Systems Corp. EOQ Class II 2019-09-05
K183607 FUJIFILM Bronchoscope Fujifilm Corporation EOQ Class II 2019-08-23
K191948 GlideScope BFlex 5.8 Single-Use Bronchoscope Verathon Medical (Canada) Ulc EOQ Class II 2019-08-21
K190293 Single Use Cytology Brush BC-205D Olympus Medical Systems Corp. BTG Class II 2019-08-02
K190163 ALARA Neuro Access Kit SurGenTec, LLC PDQ Class II 2019-07-16
K191372 Lyra Interacoustics A/S EWO Class II 2019-07-15
K190972 Ambu aScope 4 RhinoLaryngo Intervention Ambu A/S EOB Class II 2019-07-12
K190589 Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments Cochlear Americas PFO Class II 2019-07-03
K183262 EsoCheck CCD Cell Collection Device Lucid Diagnostics, Inc. EOX Class II 2019-06-21
K182159 Strome-Blitzer Cytology Balloon Adn International, LLC EOX Class II 2019-06-13
K183691 PENTAX Medical ENT Video Imaging System Pentax of America, Inc. EOB Class II 2019-06-12
K183654 PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus Pentax of America, Inc. EOQ Class II 2019-05-23
K191080 Ambu aScope 4 RhinoLaryngo Slim Ambu A/S EOB Class II 2019-05-22
K182617 ATEC IOM Accessory Instruments Alphatec Spine, Inc. PDQ Class II 2019-05-09
K190525 RELIEVA ULTIRRA Sinus Balloon Catheter Acclarent, Inc. LRC Class I 2019-05-03
K190540 Ponto 4 Oticon Medical AB LXB Class II 2019-05-02
K183090 Relieva Tract Balloon Dilation System Acclarent, Inc. QGK Class I 2019-04-19
K183015 PuraSinus 3-D Matrix, Inc. NHB Class II 2019-04-12
K182662 NAV PAK Needle, NIM NAV PAK Needle Boston Endo Surgical Tech, PDQ Class II 2019-04-10
K182253 FUJIFILM Video Bronchoscopes Fujifilm Corporation EOQ Class II 2019-04-04
K182186 CMOS Video-Rhino-Laryngoscope System KARL STORZ Endoscopy-America, Inc. EOB Class II 2019-03-22
K183085 CoreDx™ Pulmonary Mini-Forceps Boston Scientific Corporation EOQ Class II 2019-03-08
K183373 Bonebridge Med-El Elektromedizinische Geraete GmbH PFO Class II 2019-03-07
K183201 Hearing Healthcare Pro Db Diagnostic Systems, Inc. ETY Class II 2019-03-06
K182825 FUJIFILM Ultrasonic Endoscope Fujifilm Corporation EOQ Class II 2019-02-22
K182188 Ion Endoluminal System ; Flexision Biopsy Needle Intuitive Surgical EOQ Class II 2019-02-14
K182102 RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 Olympus Medical Systems Corp. EOB Class II 2019-02-06
K182480 Earlens Contact Hearing Aid Earlens Corporation PLK Class II 2019-01-25
K181387 Pre-Formed Penile Silicone Block International Medical Devices, Inc. MIB Class II 2019-01-23
K182846 PENTAX Medical EPK-3000 Video Imaging System Pentax of America, Inc. EOB Class II 2019-01-09
K183256 GlideScope BFlex Single-Use Bronchoscope System Verathon Medical (Canada) Ulc EOQ Class II 2019-01-04
K181838 Sinusway Dilation System 3nt Medical , Ltd. LRC Class I 2018-12-20
K182116 BA310 Abutment, BIA310 Implant/Abutment Cochlear Americas MAH Class II 2018-12-19
K181696 ChitoZolve Gyrus Acmi, Inc. LYA Class I 2018-11-30
K181286 Ambu aScope RLS Slim Ambu A/S EOB Class II 2018-11-30
K180495 Tinnitus Sound Generator Module GN Hearing A/S KLW Class II 2018-11-30
K181292 PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor Cogentix Medical, Inc. EOX Class II 2018-11-15
K181559 Neurosign V4 Intraoperative Nerve Monitor Magstim Company, Ltd. PDQ Class II 2018-11-09
K180631 Silk Voice Sofregen Medical, Inc. MIX Class II 2018-11-08
DEN180026 Bose Hearing Aid Bose Corporation QDD Class II 2018-10-05
K181240 Rhino-Laryngo Fiberscope Olympus ENF-GP2 Olympus Medical Systems Corp. EOB Class II 2018-10-04
K180542 NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe Boston Endo Surgical Tech, PDQ Class II 2018-08-22
K181020 Cytosponge Cell Collection Device Covidien, LLC EOX Class II 2018-08-16
K181219 OptiPillows EPAP Mask Cpapnea Medical Supply LWF Class I 2018-08-03
DEN170009 Bonebridge Med-El Elektromedizinische Geraete GmbH PFO Class II 2018-07-20
K171011 PENTAX Medical VIVIDEO ENT Videoscope Solution Pentax Medical EOB Class II 2018-07-18
K181586 Tinnitus Sound Generator Module GN Hearing A/S KLW Class II 2018-07-13
K181193 PeriView FLEX Olympus Surgical Technologies America KTI Class II 2018-07-03
K180287 GSI Corti Grason-Stadler, Inc. EWO Class II 2018-05-11
K172726 EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D Olympus Medical Systems Corp. EOQ Class II 2018-04-30
K172460 ADHEAR System Med-El Elektromedizinische Geraete GmbH LXB Class II 2018-04-27
K172955 LungVision Tool Bodyvision Medical , Ltd. EOQ Class II 2018-04-26
K173855 Sharpsite AC Rigid Endsocope Medtronic Xomed, Inc. EOB Class II 2018-04-20
K173934 Reza Band, Reflux Band Somna Therapeutics, LLC PKA Class II 2018-04-13
K172156 PENTAX Medical EPK-3000 Video Imaging System Pentax Medical EOB Class II 2018-04-05
K173526 SENTIO MMG Gen 2 Medos International SARL PDQ Class II 2018-04-05
K173727 Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor Ambu A/S EOQ Class II 2018-03-28
K180063 OCM-G1 Attachment The Anspach Effort, Inc. ERL Class II 2018-03-27
K173760 Monarch Endoscopy Platform (Monarch Platform) Auris Surgical Robotics, Inc. EOQ Class II 2018-03-22
K173134 SENTIO MMG Pedicle Access Needles Medos International SARL PDQ Class II 2018-03-22
K171851 SOFTXIL Bistool MIB Class II 2018-03-16
K163377 Captura Disposable Bronchoscope Biopsy Forceps Wilson-Cook Medical, Inc. EOQ Class II 2018-02-21
K180141 SPIWay Endonasal Access Guide Spiway, LLC LYA Class I 2018-02-16
K173567 Sera Interacoustics A/S EWO Class II 2018-02-14
K171402 KARL STORZ Slim Nasopharyngolaryngoscope KARL STORZ Endoscopy-America, Inc. EOB Class II 2018-02-02
K173554 PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope Pentax of America, Inc. EOQ Class II 2018-01-19
K171291 FUJIFILM Bronchoscope Model EB-530P Fujifilm Medical Systems U.S.A, Inc. EOQ Class II 2018-01-19
K171761 ACCLARENT AERA Eustachian Tube Balloon Dilation System Acclarent, Inc. PNZ Class II 2018-01-16
K171037 PoreStar Patient Specific Implant Anatomics Pty, Ltd. JOF Class II 2017-12-27
K170913 Composite Removable Sinus Stent System Sts Medical LYA Class I 2017-12-15
K172737 MESIRE - Balloon Sinus Dilatation System M/S. Meril Life Sciences Private Limited LRC Class I 2017-12-12
K171492 B7 2C Occlusion Balloon Spiration, Inc. EOQ Class II 2017-11-20
K172403 GSI Novus Grason-Stadler, Inc. EWO Class II 2017-10-20
K171243 audifon Tinnitus-Module Audiofon USA, Inc. KLW Class II 2017-10-19
K170453 Medrobotics Flex Robotic System Medrobotics Corporation EOB Class II 2017-10-19
K172179 Chitogel Endoscopic Sinus Surgery Kit Chitogel, Ltd. LYA Class I 2017-10-17
K171232 PeriView FLEX Olympus Surgical Technologies America KTI Class II 2017-09-21
K171840 Stryker Consolidated Operating Room Equipment (CORE) 2 Console Stryker Corporation ERL Class II 2017-09-15
K171687 Relieva SpinPlus Nav Balloon Sinuplasty System Acclarent, Inc. LRC Class I 2017-09-05
K171506 Easyscreen Maico Diagnostics GmbH EWO Class II 2017-08-29
K161298 ShenDa Sinuscope Shenyang Shenda Endoscope Co., Ltd. EOB Class II 2017-08-25
K171038 Hearing Healthcare Pro Db Diagnostic Systems, Inc. ETY Class II 2017-08-02
K170285 AED Sinuscope National Advanced Endoscopy Devices, Inc. EOB Class II 2017-08-01
K171265 Otowave 302 Portable Tympanometer Amplivox, Ltd. NAS Class II 2017-07-28
K171807 ES2 Neuromonitoring Accessory Instruments Stryker Corporation PDQ Class II 2017-07-18
K170757 Aegis Transit System Boston-Biomedical Associates EWY Class II 2017-07-14
K171239 TULA Tube Delivery System Tusker Medical ETD Class II 2017-06-28
K170759 CRE Pulmonary Balloon Dilatation Catheter Boston Scientific Corporation KTI Class II 2017-06-23
K171088 Cochlear Baha SoundArc Cochlear Americas LXB Class II 2017-06-07
K163094 TinniLogic Mobile Tinnitus Management Device Jiangsu Betterlife Medical Co., Ltd. KLW Class II 2017-05-17
K163537 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga Covidien, LLC EOQ Class II 2017-04-21
K162151 PENTAX Medical ENT Video Imaging System Pentax of America, Inc. EOB Class II 2017-04-20
K163469 ViziShot 2 FLEX Olympus Surgical Technologies America KTI Class II 2017-04-06
K163509 XprESS ENT Dilation System Entellus Medical, Inc. PNZ Class II 2017-04-05
K163248 Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Boston Scientific Corporation EOQ Class II 2017-03-27
K162313 NuVasive Next Generation NVM5 System Nu Vasive, Incorporated PDQ Class II 2017-03-16
K163247 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider Laurimed, LLC ERL Class II 2017-03-09
K162410 TIPCAM 1S 3D System Karl Storz Endoscopy America, Inc. EOB Class II 2017-03-02
K162916 3NT endoscopy system 3nt Medical , Ltd. EOB Class II 2017-02-24

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