| ULYSS Multi View Sinuscope (K153701) | Sopro-Comeg GmbH | 2016-09-09 |
| Elation Pulmonary Balloon Dilation (K161392) | Merit Medical Systems, Inc. | 2016-09-01 |
| 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 (K161656) | Ambu A/S | 2016-09-01 |
| Madsen Zodiac (K161707) | Gn Otometrics | 2016-09-01 |
| DragonFly Surgical Drill System (K161376) | Grace Medical, Inc. | 2016-08-25 |
| HyperSound Tinnitus Module (K161331) | Turtle Beach Corporation | 2016-08-23 |
| SinuBand (K160101) | Bioinspire Technologies, Incorporated | 2016-07-27 |
| Dillard Airway Dilatation System (K153484) | Intuit Medical Products, LLC | 2016-07-27 |
| Vent-Os Sinus Dilation family (K160770) | Sinusys Corporation | 2016-06-29 |
| Latera Absorbable Nasal Implant (K161191) | Spirox, Inc. | 2016-06-23 |
| PolypVac Microdebrider (3.3mm and 4.0mm) (K161101) | Laurimed, LLC | 2016-06-22 |
| Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (K153391) | Sophono, Inc. | 2016-06-16 |
| DSG Threaded Drill System (K152747) | Spineguard S.A. | 2016-06-10 |
| DIEGO ELITE DRILL (K152744) | Gyrus Acmi, Inc. | 2016-06-10 |
| Auris Robotic Endoscopy System (ARES) (K152319) | Auris Surgical Robotics, Inc. | 2016-05-26 |
| Baha 5 Power Sound Processor (K161123) | Cochlear Americas | 2016-05-20 |
| Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible) (K152466) | Prosurg, Inc. | 2016-05-19 |
| Biodesign Otologic Repair Graft (K161000) | Cook Biotech Incorporated | 2016-05-11 |
| FREMAP ELECTRODE (K152769) | Ad-Tech Medical Instrument Corporation | 2016-05-06 |
| Cytosponge Cell Collection Device (K152794) | Covidien, LLC | 2016-04-12 |
| Wireless Earlens Light Driven Hearing Aid (K153634) | Earlens Corporation | 2016-04-06 |
| ULTRA Telescopes (K153009) | Olympus Winter & Ibe GmbH | 2016-04-05 |
| Baha 5 Super Power Sound Processor (K153245) | Cochlear Americas | 2016-03-02 |
| Illuminated Mediastinal Access Port (K160171) | Aegis Surgical, Ltd. | 2016-02-26 |
| ViziShot FLEX (K152922) | Spiration, Inc. | 2016-02-19 |
| Relieva Scout Multi-Sinus Dilation System (K153341) | Acclarent, Inc. | 2016-02-12 |
| C2 NerveMonitor System (K152505) | Inomed Medizintechnik GmbH | 2016-02-01 |
| SPIWay Endonasal Access Guide (K153686) | Spiway, LLC | 2016-01-28 |
| Ponto Bone Anchored Hearing System (K152820) | Oticon Medical AB | 2016-01-22 |
| Desyncra for Tinnitus Therapy System, Desyncra for Tinnitus Pro System (K151558) | Neurotherapies Reset GmbH | 2016-01-20 |
| InstaClear Lens Cleaner (K152531) | Gyrus Acmi, Inc. | 2016-01-15 |
| NuVasiveNVM5 System (K152942) | Nu Vasive, Incorporated | 2016-01-13 |
| 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 (K150969) | Karl Storz Endoscopy America, Inc. | 2016-01-08 |
| iHearTest (K151025) | Ihear Medical, Inc. | 2015-12-29 |
| INEX Absorbable Nasal Implant (K152958) | Spirox, Inc. | 2015-12-04 |
| NuVent EM Sinus Dilation System (K152121) | Medtronic Xomed, Inc. | 2015-12-01 |
| Ponto bone anchored hearing system (K152067) | Oticon Medical AB | 2015-11-23 |
| Pi Drive Plus Motor, Extender (K152641) | Stryker Corporation | 2015-11-20 |
| XprESS Multi-Sinus Dilation System (K152434) | Entellus Medical, Inc. | 2015-11-20 |
| PassAssist LED Light Fiber (K152435) | Entellus Medical, Inc. | 2015-11-20 |
| Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle (K151315) | Boston Scientific Corporation | 2015-11-10 |
| PENTAX Medical EKP-i5010 Video Processor with EB Family (K143727) | Pentax of America, Inc. | 2015-10-29 |
| REVE134 (K151719) | Kw Ear Lab, Inc. | 2015-10-09 |
| EarLens Contact Hearing Device (DEN150002) | Earlens Corporation | 2015-09-29 |
| Hummingbird Tympanostomy Tube (K151830) | Preceptis Medical | 2015-09-21 |
| DEFENDO Bronchoscopy Suction Valve (K151522) | Medivators, Inc. | 2015-09-17 |
| Biodesign Otologic Repair Graft (K150594) | Cook Biotech Incorprated | 2015-09-16 |
| DSS Sinusplasty Balloon Catheter (K143738) | Intuit Medical Products, LLC | 2015-08-27 |
| XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole (K150728) | Medtronic Xomed, Inc. | 2015-08-14 |
| Serenity (K150014) | Sanuthera, Inc. | 2015-07-27 |
| ORL Video NasoPharyngo-Larngoscope (K150248) | Jedmed Instrument Company | 2015-07-23 |
| Ventilation (Tympanostomy) Tubes (K151067) | Medtronic Xomed, Inc. | 2015-07-22 |
| Cordelle II Sound Processor (K150751) | Cochlear Americas | 2015-07-22 |
| Medrobotics Flex System (K150776) | Medrobotics Corporation | 2015-07-17 |
| AT235 (K151616) | Interacoustics A/S | 2015-07-15 |
| BA400 14mm Abutment (K150555) | Cochlear Americas | 2015-07-15 |
| aeris Balloon Dialation Catheter (K150951) | Bryan Medical, Inc. | 2015-06-25 |
| GSI TympStar Pro Middle Ear Analyzer (K151509) | Diagnostic Group, Dba Grason-Stadler | 2015-06-25 |
| CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved (K142934) | Covidien | 2015-06-17 |
| PulmoVia Working Channel (K150280) | Sanovas, Inc. | 2015-06-11 |
| Tinnitus Sound Generator Module (K150171) | Gn Resound A/S | 2015-05-14 |
| GenCut Core Biopsy System (K142839) | Covidien, LLC | 2015-04-29 |
| Flexible 19G EBUS Needle (K142909) | Spiration, Inc. | 2015-04-24 |
| HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS) (K142282) | Preceptis Medical | 2015-04-23 |
| Otowave 202 Portable Tympanometer (K150163) | Amplivox, Ltd. | 2015-04-23 |
| Relieva SpinPlus Balloon Sinuplasty System (K143541) | Acclarent, Inc. | 2015-04-22 |
| SoundCure Serenade Tinnitus Treatment System (K150065) | Soundcure, Inc. | 2015-04-13 |
| ACCLARENT SE Inflation Device (K150172) | Acclarent, Inc. | 2015-04-07 |
| Renu Gel (K150400) | Cytophil, Inc. | 2015-04-06 |
| NuVasive NVM5 System (K143641) | Nu Vasive, Incorporated | 2015-03-27 |
| ER36 Series OAE Test System (K150491) | Etymotic Research, Inc. | 2015-03-26 |
| Baha 5 Sound Processor (K142907) | Cochlear Americas | 2015-03-25 |
| NEURO-AUDIO (K141524) | Teleemg, LLC USA | 2015-03-12 |
| REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE (DEN130046) | Somna Therapeutics, LLC | 2015-03-06 |
| Nerve Monitoring Cable System (K142438) | Pioneer Surgical Technology, Inc. (Rti Surgical, Inc.) | 2015-03-05 |
| OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece (K143492) | Bien-Air Surgery SA | 2015-03-04 |
| CMOS Video Nasopharyngoscope System (K143673) | Schoelly Fiberoptic GmbH | 2015-03-04 |
| 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 (K143395) | Otodynamics, Ltd. | 2015-02-23 |
| Checkpoint, Checkpoint Head & Neck (K150005) | Ndi Medical, LLC | 2015-02-19 |
| SCHOELLY SINUSCOPE (K142249) | Schoelly Fiberoptic GmbH | 2015-01-27 |
| 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 (K143159) | Spineguard S.A. | 2015-01-23 |
| Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm (K142678) | Oticon Medical AB | 2015-01-21 |
| ILLUMINATED MEDIASTINOSCOPE (K141622) | Aegis Surgical, Ltd. | 2015-01-09 |
| MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES (K142022) | Medline Renewal | 2014-12-19 |
| VIDEO BRONCHOSCOPE SYSTEM (K141366) | Scholly Fiberoptic GmbH | 2014-12-17 |
| Cytosponge Cell Collection Device (K142695) | Covidien, LLC | 2014-11-26 |
| STIM PROBE (K133348) | Spes Medica Srl | 2014-11-21 |
| NUVASIVE NVM5 SYSTEM (K141968) | Nuvasive, Inc. | 2014-11-14 |
| HEMOPORE (K141816) | Polyganics B.V., | 2014-10-23 |
| XprESS Multi-Sinus Dilation Tool (K142252) | Entellus Medical, Inc. | 2014-10-17 |
| NOVASHIELD INJECTABLE NASAL PACKING AND STENT (K141704) | Medtronic, Inc. | 2014-10-06 |
| PROVOX FREEHANDS FLEXIVOICE (K141380) | Atos Medical AB | 2014-09-26 |
| STRYKER S2 DRILL (K141935) | Stryker Corporation | 2014-09-26 |
| PHANTOM XL INSULATED DILATORS (K140088) | Tedan Surgical Innovations, LLC | 2014-09-25 |
| PRECEPTIS TYMPANOSTOMY TUBE INSERTER (K133921) | Preceptis Medical | 2014-08-22 |
| NASOPORE-FD (K141423) | Polyganics B.V., | 2014-08-07 |
| PATHASSIST LED LIGHT FIBER (K141916) | Entellus Medical, Inc. | 2014-08-07 |
| LEVO TINNITUS MASKING SOFTWARE DEVICE (K140845) | Otoharmonics Corp | 2014-07-18 |
| ES2 NEUROMONITORING ACCESSORY INSTRUMENTS (K140400) | Stryker Corporation | 2014-07-01 |
| NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER (K140542) | Rhinosystems, Inc. | 2014-06-27 |