| WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System (K220399) | OTU Medical, Inc. | 2022-06-16 |
| Zsquare ENT-Flex Endoscope (K220004) | Zsquare, Ltd. | 2022-06-14 |
| AMADEO, M-UK1015 (incl. attachments and accessories) (K213221) | W&H Dentalwerk Buermoss GmbH | 2022-05-26 |
| Pre-Formed Penile Silicone Block (K220760) | International Medical Devices, Inc. | 2022-05-13 |
| PosiSep EAR Fragmentable Ear Dressing (K210411) | Hemostasis, LLC | 2022-05-05 |
| Audion ET dilation system (K220027) | Entellus Medical, Inc. | 2022-04-12 |
| PediGuard Threaded (K220160) | Spineguard S.A. | 2022-03-31 |
| NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long (K213246) | Medtronic Xomed, Inc. | 2022-03-21 |
| Elation Pulmonary Balloon Dilation Catheter (K213434) | Merit Medical Systems, Inc. | 2022-03-08 |
| Vathin Video Bronchoscope System (K213635) | Hunan Vathin Medical Instrument Co., Ltd. | 2022-02-28 |
| Broncoflex Agile, Broncoflex Vortex, Screeni (K212886) | Axess Vision Technology | 2022-02-16 |
| VenSure LightGuide (K212774) | Intersect Ent. | 2022-02-04 |
| Celeris, Disposable Sinus Debrider (K212650) | Gyrus Acmi, Inc. | 2022-01-19 |
| Jabra Enhance Plus (K213424) | GN Hearing A/S | 2022-01-19 |
| Sunrise Sleep Disorder Diagnostic Aid (DEN210015) | Sunrise | 2022-01-07 |
| BHA100 Series Braun Clear Hearing Aid (K212609) | Kaz USA, Inc., A Helen of Troy Company | 2022-01-05 |
| Flexible Intubation Video Endoscope – Sterile (FIVE-S) (K212656) | Karl Storz Endoscopy America | 2021-12-29 |
| Ponto 5 SuperPower (K213733) | Oticon Medical AB | 2021-12-16 |
| Trachealator (K211894) | Disa Medinotec | 2021-11-24 |
| Bronchoscope System (K211169) | Shanghai AnQing Medical Instrument Co., Ltd. | 2021-11-24 |
| GlideScope BFlex 2.8 Single-Use Bronchoscope (K211947) | Verathon Medical (Canada) Ulc | 2021-11-03 |
| SPIWay Endonasal Access Guide (K213153) | Spiway, LLC | 2021-10-27 |
| PENTAX Medical Video Bronchoscope EB11-J10 (K210928) | Pentax of America, Inc. | 2021-10-21 |
| iotaSOFT Insertion System - Drive Unit, Controller and Accessories (DEN190055) | Iotamotion, Inc. | 2021-10-01 |
| Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App (K212136) | Cochlear Americas | 2021-09-29 |
| Single Use Guide Sheath Kit-401, K-402 (K212667) | Olympus Medical Systems Corp. | 2021-09-22 |
| Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large (K212355) | Checkpoint Surgical | 2021-08-26 |
| Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) (K212048) | Intuitive Surgical, Inc. | 2021-08-26 |
| NuVent Eustachian Tube Dilation Balloon (K210841) | Medtronic Xomed, Inc. | 2021-08-16 |
| Ponto 5 Mini (K211640) | Oticon Medical AB | 2021-08-10 |
| EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor (K211030) | Boston Scientific Corporation | 2021-08-09 |
| Broncho Videoscope System (K210379) | Scivita Medical Technology Co., Ltd. | 2021-07-28 |
| Peregrine Endoscopy System (K202727) | 3nt Medical , Ltd. | 2021-07-23 |
| Monarch Platform (K211493) | Auris Health, Inc. | 2021-07-09 |
| aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 (K210883) | Ambu A/S | 2021-06-17 |
| Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 (K211490) | Stryker Corporation | 2021-06-09 |
| HD Mediastinoscope (K202272) | Karl Storz Endoscopy America, Inc. | 2021-05-11 |
| Bose SoundControl Hearing Aids (K211008) | Bose Corporation | 2021-05-05 |
| EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) (K203450) | Capnostics, LLC | 2021-05-04 |
| Rescue Pulmonary Grasping Forceps (K202987) | Anrei Medical (Hangzhou) Co., Ltd. | 2021-04-29 |
| Neurosign V4 Intraoperative Nerve Monitor (K203684) | Magstim Company, Ltd. | 2021-03-17 |
| Monarch Bronchoscope (K203614) | Auris Health, Inc., A Johnson and Johnson Family Company | 2021-03-11 |
| ClearUP Sinus Relief (DEN200006) | Tivic Health Systems, Inc. | 2021-03-05 |
| Ponto Bone Anchored Hearing System, MONO Surgery Kit (K203807) | Oticon Medical AB | 2021-03-03 |
| Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App (K202048) | Cochlear Americas | 2021-02-23 |
| SPiN Vision Video Bronchoscope System (K202346) | Veran Medical Technologies, Inc. | 2021-02-19 |
| EsoCheck Cell Collection Device (K210137) | Lucid Diagnostics, Inc. | 2021-02-18 |
| DSG Connect Technology (K201454) | Spineguard S.A. | 2021-02-10 |
| Airway Mobilescope (K201300) | Olympus Medical Systems Corp. | 2021-01-26 |
| EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 (K201758) | Olympus Medical Systems Corp. | 2021-01-21 |
| EasyPath RF Introducer Sheath (K200702) | Broncus Medical, Inc. | 2021-01-14 |
| ENTity WiFi Video Nasopharyngoscope System (K200609) | Optim, LLC | 2021-01-13 |
| Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L (K200342) | Olympus Medical Systems Corp. | 2020-12-17 |
| Novapak Nasal Sinus Packing and Stent (K202623) | Medtronic Xomed | 2020-12-08 |
| Ion Endoluminal System (K202370) | Intuitive Surgical, Inc. | 2020-11-16 |
| StimSite (K200886) | Allotrope Medical, Inc. | 2020-11-10 |
| UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece (K200318) | KARL STORZ Endoscopy-America, Inc. | 2020-10-22 |
| Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 (K202180) | Axess Vision Technology | 2020-10-22 |
| SINUSPRIME Dilation System (K201398) | Stryker Ent | 2020-10-15 |
| BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) (K201983) | Med-El Elektromedizinische Geraete GmbH | 2020-10-09 |
| Next Generation Balloon Dilation System (K201115) | Acclarent, Inc. | 2020-08-27 |
| VenSure Balloon Device, VenSure Nav Balloon Device (K201472) | Fiagon GmbH | 2020-08-26 |
| HD Video Rhino Laryngoscope (K200740) | KARL STORZ Endoscopy-America, Inc. | 2020-08-11 |
| PENTAX Medical Video Bronchoscope EB-J10 Series (K200678) | Pentax of America, Inc. | 2020-07-30 |
| BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote (K200504) | Med-El Elektromedizinische Geraete GmbH | 2020-07-29 |
| BioSiCar Silicone Implant (K193392) | Metalware Technology Corp. | 2020-07-20 |
| Ion Endoluminal System (K201146) | Intuitive Surgical, Inc. | 2020-06-26 |
| Multiflex Tinnitus Technology (K201370) | Starkey Laboratories, Inc. | 2020-06-19 |
| Hummingbird Tympanostomy Tube System (K200952) | Preceptis Medical, Inc. | 2020-06-05 |
| StarPore (K200532) | Anatomics Pty, Ltd. | 2020-06-02 |
| Single Use Biopsy Forceps FB-456D (K200397) | Olympus Medical Systems Corp. | 2020-04-24 |
| Monarch Platform (K193534) | Auris Health, Inc. | 2020-04-15 |
| ViziShot 2 FLEX (K193517) | Olympus Surgical Technologies America | 2020-03-18 |
| Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR (K192164) | Olympus Medical Systems Corp. | 2020-03-06 |
| Colibri Endoscopy System (K192305) | 3nt Medical , Ltd. | 2020-02-27 |
| Tinnitus Sound Generator Module (K193303) | GN Hearing A/S | 2020-02-20 |
| Vathin Video Bronchoscope System (K191828) | Hunan Vathin Medical Instrument Co., Ltd. | 2020-02-13 |
| Pulmonary Cytology Brush (K182927) | Hobbs Medical, Inc. | 2020-02-07 |
| CMOS Video Rhino-Laryngoscope SSU (K192090) | Karl Storz SE & CO. KG | 2020-01-27 |
| CMOS Video Esophagoscope SSU (K192523) | Karl Storz SE & CO. KG | 2020-01-24 |
| GlideScope BFlex 3.8 Single-Use Bronchoscope (K193488) | Verathon Medical (Canada) Ulc | 2020-01-16 |
| Dillard Nasal Balloon Catheter (K181546) | Intuit Medical Products, LLC | 2020-01-03 |
| EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand (K190715) | Interscope, Inc. | 2019-12-13 |
| Single Use Aspiration Needle (K190239) | Olympus Medical Systems Corp. | 2019-12-10 |
| Ion Endoluminal System (K192367) | Intuitive Surgical, Inc. | 2019-11-26 |
| Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments (K191921) | Cochlear Americas | 2019-11-15 |
| LATERA Absorbable Nasal Implant System (K192661) | Entellus Medical, Inc. (Aka Stryker Ent) | 2019-11-10 |
| ATEC IOM Accessory Instruments (K191723) | Alphatec Spine, Inc. | 2019-10-18 |
| BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) (K191457) | Med-El Elektromedizinische Geraete GmbH | 2019-09-18 |
| Precision S 4K Sinuscope (K191102) | Stryker | 2019-09-06 |
| PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K183516) | Pentax of America, Inc. | 2019-09-06 |
| Rhino-Laryngo Videoscope Olympus ENF-VT3 (K183416) | Olympus Medical Systems Corp. | 2019-09-06 |
| EVIS EXERA III Bronchovideoscope Olympus BF-XT190 (K183419) | Olympus Medical Systems Corp. | 2019-09-05 |
| FUJIFILM Bronchoscope (K183607) | Fujifilm Corporation | 2019-08-23 |
| GlideScope BFlex 5.8 Single-Use Bronchoscope (K191948) | Verathon Medical (Canada) Ulc | 2019-08-21 |
| Single Use Cytology Brush BC-205D (K190293) | Olympus Medical Systems Corp. | 2019-08-02 |
| ALARA Neuro Access Kit (K190163) | SurGenTec, LLC | 2019-07-16 |
| Lyra (K191372) | Interacoustics A/S | 2019-07-15 |
| Ambu aScope 4 RhinoLaryngo Intervention (K190972) | Ambu A/S | 2019-07-12 |
| Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments (K190589) | Cochlear Americas | 2019-07-03 |