| EsoCheck CCD Cell Collection Device (K183262) | Lucid Diagnostics, Inc. | 2019-06-21 |
| Strome-Blitzer Cytology Balloon (K182159) | Adn International, LLC | 2019-06-13 |
| PENTAX Medical ENT Video Imaging System (K183691) | Pentax of America, Inc. | 2019-06-12 |
| PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus (K183654) | Pentax of America, Inc. | 2019-05-23 |
| Ambu aScope 4 RhinoLaryngo Slim (K191080) | Ambu A/S | 2019-05-22 |
| ATEC IOM Accessory Instruments (K182617) | Alphatec Spine, Inc. | 2019-05-09 |
| RELIEVA ULTIRRA Sinus Balloon Catheter (K190525) | Acclarent, Inc. | 2019-05-03 |
| Ponto 4 (K190540) | Oticon Medical AB | 2019-05-02 |
| Relieva Tract Balloon Dilation System (K183090) | Acclarent, Inc. | 2019-04-19 |
| PuraSinus (K183015) | 3-D Matrix, Inc. | 2019-04-12 |
| NAV PAK Needle, NIM NAV PAK Needle (K182662) | Boston Endo Surgical Tech, | 2019-04-10 |
| FUJIFILM Video Bronchoscopes (K182253) | Fujifilm Corporation | 2019-04-04 |
| CMOS Video-Rhino-Laryngoscope System (K182186) | KARL STORZ Endoscopy-America, Inc. | 2019-03-22 |
| CoreDx™ Pulmonary Mini-Forceps (K183085) | Boston Scientific Corporation | 2019-03-08 |
| Bonebridge (K183373) | Med-El Elektromedizinische Geraete GmbH | 2019-03-07 |
| Hearing Healthcare Pro (K183201) | Db Diagnostic Systems, Inc. | 2019-03-06 |
| FUJIFILM Ultrasonic Endoscope (K182825) | Fujifilm Corporation | 2019-02-22 |
| Ion Endoluminal System ; Flexision Biopsy Needle (K182188) | Intuitive Surgical | 2019-02-14 |
| RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 (K182102) | Olympus Medical Systems Corp. | 2019-02-06 |
| Earlens Contact Hearing Aid (K182480) | Earlens Corporation | 2019-01-25 |
| Pre-Formed Penile Silicone Block (K181387) | International Medical Devices, Inc. | 2019-01-23 |
| PENTAX Medical EPK-3000 Video Imaging System (K182846) | Pentax of America, Inc. | 2019-01-09 |
| GlideScope BFlex Single-Use Bronchoscope System (K183256) | Verathon Medical (Canada) Ulc | 2019-01-04 |
| Sinusway Dilation System (K181838) | 3nt Medical , Ltd. | 2018-12-20 |
| BA310 Abutment, BIA310 Implant/Abutment (K182116) | Cochlear Americas | 2018-12-19 |
| Tinnitus Sound Generator Module (K180495) | GN Hearing A/S | 2018-11-30 |
| Ambu aScope RLS Slim (K181286) | Ambu A/S | 2018-11-30 |
| ChitoZolve (K181696) | Gyrus Acmi, Inc. | 2018-11-30 |
| PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor (K181292) | Cogentix Medical, Inc. | 2018-11-15 |
| Neurosign V4 Intraoperative Nerve Monitor (K181559) | Magstim Company, Ltd. | 2018-11-09 |
| Silk Voice (K180631) | Sofregen Medical, Inc. | 2018-11-08 |
| Bose Hearing Aid (DEN180026) | Bose Corporation | 2018-10-05 |
| Rhino-Laryngo Fiberscope Olympus ENF-GP2 (K181240) | Olympus Medical Systems Corp. | 2018-10-04 |
| NIM PAK Needle; NIM XPAK Needle; NIM Pedicle Probe (K180542) | Boston Endo Surgical Tech, | 2018-08-22 |
| Cytosponge Cell Collection Device (K181020) | Covidien, LLC | 2018-08-16 |
| OptiPillows EPAP Mask (K181219) | Cpapnea Medical Supply | 2018-08-03 |
| Bonebridge (DEN170009) | Med-El Elektromedizinische Geraete GmbH | 2018-07-20 |
| PENTAX Medical VIVIDEO ENT Videoscope Solution (K171011) | Pentax Medical | 2018-07-18 |
| Tinnitus Sound Generator Module (K181586) | GN Hearing A/S | 2018-07-13 |
| PeriView FLEX (K181193) | Olympus Surgical Technologies America | 2018-07-03 |
| GSI Corti (K180287) | Grason-Stadler, Inc. | 2018-05-11 |
| EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D (K172726) | Olympus Medical Systems Corp. | 2018-04-30 |
| ADHEAR System (K172460) | Med-El Elektromedizinische Geraete GmbH | 2018-04-27 |
| LungVision Tool (K172955) | Bodyvision Medical , Ltd. | 2018-04-26 |
| Sharpsite AC Rigid Endsocope (K173855) | Medtronic Xomed, Inc. | 2018-04-20 |
| Reza Band, Reflux Band (K173934) | Somna Therapeutics, LLC | 2018-04-13 |
| PENTAX Medical EPK-3000 Video Imaging System (K172156) | Pentax Medical | 2018-04-05 |
| SENTIO MMG Gen 2 (K173526) | Medos International SARL | 2018-04-05 |
| 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 (K173727) | Ambu A/S | 2018-03-28 |
| OCM-G1 Attachment (K180063) | The Anspach Effort, Inc. | 2018-03-27 |
| Monarch Endoscopy Platform (Monarch Platform) (K173760) | Auris Surgical Robotics, Inc. | 2018-03-22 |
| SENTIO MMG Pedicle Access Needles (K173134) | Medos International SARL | 2018-03-22 |
| SOFTXIL (K171851) | Bistool | 2018-03-16 |
| Captura Disposable Bronchoscope Biopsy Forceps (K163377) | Wilson-Cook Medical, Inc. | 2018-02-21 |
| SPIWay Endonasal Access Guide (K180141) | Spiway, LLC | 2018-02-16 |
| Sera (K173567) | Interacoustics A/S | 2018-02-14 |
| KARL STORZ Slim Nasopharyngolaryngoscope (K171402) | KARL STORZ Endoscopy-America, Inc. | 2018-02-02 |
| PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope (K173554) | Pentax of America, Inc. | 2018-01-19 |
| FUJIFILM Bronchoscope Model EB-530P (K171291) | Fujifilm Medical Systems U.S.A, Inc. | 2018-01-19 |
| ACCLARENT AERA Eustachian Tube Balloon Dilation System (K171761) | Acclarent, Inc. | 2018-01-16 |
| PoreStar Patient Specific Implant (K171037) | Anatomics Pty, Ltd. | 2017-12-27 |
| Composite Removable Sinus Stent System (K170913) | Sts Medical | 2017-12-15 |
| MESIRE - Balloon Sinus Dilatation System (K172737) | M/S. Meril Life Sciences Private Limited | 2017-12-12 |
| B7 2C Occlusion Balloon (K171492) | Spiration, Inc. | 2017-11-20 |
| GSI Novus (K172403) | Grason-Stadler, Inc. | 2017-10-20 |
| audifon Tinnitus-Module (K171243) | Audiofon USA, Inc. | 2017-10-19 |
| Medrobotics Flex Robotic System (K170453) | Medrobotics Corporation | 2017-10-19 |
| Chitogel Endoscopic Sinus Surgery Kit (K172179) | Chitogel, Ltd. | 2017-10-17 |
| PeriView FLEX (K171232) | Olympus Surgical Technologies America | 2017-09-21 |
| Stryker Consolidated Operating Room Equipment (CORE) 2 Console (K171840) | Stryker Corporation | 2017-09-15 |
| Relieva SpinPlus Nav Balloon Sinuplasty System (K171687) | Acclarent, Inc. | 2017-09-05 |
| Easyscreen (K171506) | Maico Diagnostics GmbH | 2017-08-29 |
| ShenDa Sinuscope (K161298) | Shenyang Shenda Endoscope Co., Ltd. | 2017-08-25 |
| Hearing Healthcare Pro (K171038) | Db Diagnostic Systems, Inc. | 2017-08-02 |
| AED Sinuscope (K170285) | National Advanced Endoscopy Devices, Inc. | 2017-08-01 |
| Otowave 302 Portable Tympanometer (K171265) | Amplivox, Ltd. | 2017-07-28 |
| ES2 Neuromonitoring Accessory Instruments (K171807) | Stryker Corporation | 2017-07-18 |
| Aegis Transit System (K170757) | Boston-Biomedical Associates | 2017-07-14 |
| TULA Tube Delivery System (K171239) | Tusker Medical | 2017-06-28 |
| CRE Pulmonary Balloon Dilatation Catheter (K170759) | Boston Scientific Corporation | 2017-06-23 |
| Cochlear Baha SoundArc (K171088) | Cochlear Americas | 2017-06-07 |
| TinniLogic Mobile Tinnitus Management Device (K163094) | Jiangsu Betterlife Medical Co., Ltd. | 2017-05-17 |
| Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga (K163537) | Covidien, LLC | 2017-04-21 |
| PENTAX Medical ENT Video Imaging System (K162151) | Pentax of America, Inc. | 2017-04-20 |
| ViziShot 2 FLEX (K163469) | Olympus Surgical Technologies America | 2017-04-06 |
| XprESS ENT Dilation System (K163509) | Entellus Medical, Inc. | 2017-04-05 |
| Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K163248) | Boston Scientific Corporation | 2017-03-27 |
| NuVasive Next Generation NVM5 System (K162313) | Nu Vasive, Incorporated | 2017-03-16 |
| 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider (K163247) | Laurimed, LLC | 2017-03-09 |
| TIPCAM 1S 3D System (K162410) | Karl Storz Endoscopy America, Inc. | 2017-03-02 |
| 3NT endoscopy system (K162916) | 3nt Medical , Ltd. | 2017-02-24 |
| PeriFLEX (K162611) | Spiration, Inc. | 2017-02-09 |
| Pre-Formed Penile Silicone Block (K162624) | International Medical Devices, Inc. | 2017-02-01 |
| Precision Thin Reciprocating Blade, 0.010in. (K161514) | Stryker Corporation | 2017-01-17 |
| touchTymp (K162210) | Maico Diagnostics GmbH | 2016-11-16 |
| Relieva UltirraNav Sinus Balloon Catheter (K161698) | Acclarent, Inc. | 2016-10-24 |
| Neuromonitoring Kit (K161893) | SI-BONE, Inc. | 2016-10-18 |
| Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (K161671) | Oticon Medical AB | 2016-09-29 |
| Sound Options Tinnitus Treatment (K161562) | Sound Options Tinnitus Treatments, Inc. | 2016-09-28 |
| Acclarent Aera Eustachian Tube Balloon Dilation System (DEN150056) | Acclarent, Inc. | 2016-09-16 |