| Cochlear Osia System (K240155) | Cochlear Americas | 2024-04-18 |
| Lyric4 Hearing Aid (K232999) | Sonova AG | 2024-04-11 |
| LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) (K233779) | MacroLux Medical Technology Co., Ltd. | 2024-04-05 |
| Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) (K240135) | Intuitive Surgical, Inc. | 2024-04-03 |
| SeptAlign (K233569) | Spirair, Inc. | 2024-03-22 |
| Otoport Pro (K240430) | Otodynamics, Ltd. | 2024-03-15 |
| Concha Sol Hearing Aids (CL-1001) (K233747) | Concha Labs | 2024-03-15 |
| hekaDrill (K233958) | Zethon, Ltd. | 2024-03-14 |
| Peace N Quiet (0.7.0) (K233435) | Pnq Health | 2024-02-27 |
| Biowy Tym Tube (TT) (K233658) | Biowy Corporation | 2024-02-16 |
| Bronchoscope System (K231107) | Hunan Endoso Life Technology Co., Ltd. | 2024-02-15 |
| WSA Self-Fitting Hearing Aid Gen 2 (K233464) | Wsaud A/S | 2024-02-09 |
| FUJIFILM Endoscope Model EB-710XT (K240075) | FUJIFILM Healthcare Americas Corporation | 2024-02-07 |
| EndoSign® Cell collection device (ES-CYT-102) (K233142) | Cyted Limited | 2024-01-19 |
| PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K232860) | Pentax of America, Inc. | 2024-01-18 |
| PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock (K231970) | Pentax of America, Inc. | 2024-01-12 |
| Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aView™ 2 Advance (K233671) | Ambu A/S | 2024-01-04 |
| Disposable Laryngeal Electrodes (K232888) | Suzhou Haishen Medical Device Associates Co., Ltd. | 2023-12-21 |
| Ion Endoluminal System (IF1000) (K232984) | Intuitive Surgical, Inc. | 2023-12-18 |
| ACCLARENT AERA Eustachian Tube Dilation System (K230742) | Acclarent, Inc. | 2023-12-13 |
| Sonu (DEN230045) | Sound Health Systems, Inc. | 2023-12-04 |
| Monarch Bronchoscope (K231473) | Auris Health, Inc., A Johnson and Johnson Family Company | 2023-11-28 |
| Tympanostomy Tubes (K232059) | Grace Medical, Inc. | 2023-11-24 |
| METIC™- Airway Balloon Catheter (K231818) | M/S Meril Life Sciences Pvt. , Ltd. | 2023-11-15 |
| Broncho Videoscope System (K231521) | Scivita Medical Technology Co., Ltd. | 2023-11-14 |
| hearOAE (K231545) | Hearx SA (Pty) , Ltd. | 2023-10-27 |
| Sontro® OTC Hearing Aids (AI) (K231550) | Soundwave Hearing, LLC | 2023-10-26 |
| NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube (K230320) | Medtronic Xomed, Inc. | 2023-10-26 |
| Lumen 155-SF (K223911) | Intricon Corporation | 2023-10-17 |
| EARP Nerve Cuff Electrode (K230853) | Nvision Biomedical Technologies, Inc. | 2023-10-06 |
| EndoCore (K230778) | Praxis Medical, LLC | 2023-09-25 |
| Self-Fitting hearing aids (K221052) | Huizhou Jinghao Medical Technology Co., Ltd. | 2023-09-25 |
| Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set (K232582) | Ambu A/S | 2023-09-20 |
| Intrisound™ Tuned Lumen® 155 Hearing Aids (K223848) | Tuned , Ltd. | 2023-09-08 |
| NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (K231580) | Medtronic Xomed, Inc. | 2023-08-30 |
| Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App (K231204) | Cochlear | 2023-08-18 |
| Spirair Nasal Septal Strap (K223167) | Spirair, Inc. | 2023-08-17 |
| Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 (K230428) | Ambu A/S | 2023-08-10 |
| TubaVent Balloon Dilatation System (K223542) | Spiggle & Theis Medizintechnik GmbH | 2023-08-03 |
| ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) (K232015) | Atmos Medizintechnik GmbH & Co. KG | 2023-08-03 |
| PatCom Distal Chip Endoscope (K222587) | H&A Mui Enterprises, Inc. | 2023-07-28 |
| Galen ES Cooperative Surgical Assistant Platform, Galen ES (DEN220047) | Galen Robotics | 2023-07-19 |
| Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) (K223694) | Duearity AB | 2023-06-30 |
| All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid (K230538) | Sonova AG | 2023-06-16 |
| EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 (K222861) | Olympus Medical Systems Corporation | 2023-06-15 |
| Single-use Flexible Rhinolaryngoscope; Digital Video Monitor (K230536) | Hunan Vathin Medical Instrument Co., Ltd. | 2023-06-14 |
| Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance (K223299) | Ambu A/S | 2023-06-01 |
| VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (K230065) | Fiagon GmbH | 2023-05-26 |
| BB 8 Sinus Dilation Kit (K230258) | Excelent, Inc. | 2023-05-25 |
| Vathin® Video Bronchoscope System (K223836) | Hunan Vathin Medical Instrument Co., Ltd. | 2023-05-15 |
| Waypoint GPS (K222106) | Waypoint Orthopedics, Inc. | 2023-05-12 |
| ANDORATE® Suction Valve and ANDORATE® Biopsy Valve (K230280) | Ga Health Company Limited | 2023-05-11 |
| BFlex™ 2 Slim 3.8 Single-Use Bronchoscope (K230948) | Verathon Medical (Canada) Ulc | 2023-05-03 |
| Bronchoscope System (K222910) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-04-11 |
| Epi-Stop Nasal Gel/epistaxis pack (K230142) | Biomed Ent, Inc. | 2023-03-22 |
| Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application (K223137) | Hearx SA (Pty) , Ltd. | 2023-03-14 |
| Lenire Tinnitus Treatment Device (DEN210033) | Neuromod Devices Limited | 2023-03-06 |
| iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) (K221340) | Boston Scientific Corporation | 2023-03-02 |
| Galaxy System (K223144) | Noah Medical Corp. | 2023-03-01 |
| Multistage Balloon Dilatation Catheter (K222187) | Dongguan TT Medical, Inc. | 2023-03-01 |
| EsoCheck Cell Collection Device (K230339) | Lucid Diagnostics, Inc. | 2023-02-24 |
| TELIGEN System Peripheral Motor Nerve Stimulation Indications (K223438) | Medos International SARL | 2023-02-10 |
| Pre-Formed Silicone Block (K223051) | International Medical Devices, Inc. | 2023-02-03 |
| Tinnitogram Signal Generator (K221168) | Goldenear Company, Inc. | 2023-02-01 |
| C2 Xplore (K223254) | Inomed Medizintechnik GmbH | 2023-01-27 |
| Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set (K223782) | Ambu A/S | 2023-01-12 |
| SilentCloud (K221125) | Aureliym GmbH | 2023-01-04 |
| RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP (K221660) | Olympus Medical Systems Corp. | 2022-12-28 |
| ShiNeo Silicone Implant (K222748) | Shineo Technology Co., Ltd. | 2022-12-23 |
| Sunrise (K222262) | Sunrise SA | 2022-12-22 |
| PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System (K213235) | Pentax of America, Inc. | 2022-12-21 |
| Eargo 5 , Eargo 6 (K221698) | Eargo, Inc. | 2022-12-21 |
| PENTAX Medical Video Esophagoscope EE17-J10 (K223072) | Pentax of America, Inc. | 2022-12-02 |
| Single-Use Flexible Rhinolaryngoscope (K221581) | Hunan Vathin Medical Instrument Co., Ltd. | 2022-11-18 |
| PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 (K220465) | Pentax of America, Inc. | 2022-11-16 |
| PosiSep X BAM Hemostat Dressing/Intranasal Splint (K220326) | Hemostasis, LLC | 2022-11-14 |
| Mapping Suction Probe (K212164) | Inomed Medizintechnik GmbH | 2022-11-11 |
| FUJIFILM Endoscope Model EB-710P (K220957) | Fujifilm Corporaton | 2022-11-10 |
| ORiGO System (K221184) | Bien-Air Surgery SA | 2022-11-02 |
| Nuheara IQbuds 2 PRO Hearing Aid (K221064) | Nuheara Limited | 2022-10-30 |
| EsoCheck Cell Collection Device (K222366) | Lucid Diagnostics, Inc. | 2022-10-26 |
| AugMENTA Penile Implant (K200073) | Augmenta, LLC | 2022-09-30 |
| Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V (K221631) | Olympus Medical Systems Corp. | 2022-09-26 |
| ATEC IOM Accessory Instruments (K221821) | Alphatec Spine, Inc. | 2022-09-23 |
| Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 (K221638) | Olympus Medical Systems Corp. | 2022-09-19 |
| Phagenyx System (DEN220025) | Phagenesis Limited | 2022-09-16 |
| Compass Steerable Needle (K221206) | Serpex Medical, Inc. | 2022-08-25 |
| Recon Steerable Sheath (K221302) | Serpex Medical, Inc. | 2022-08-15 |
| Vibe SF Self-Fitting Hearing Aid (K220403) | Wsaud A/S | 2022-08-12 |
| MDHearingAid app, MDHearingAid Smart hearing aids (K220303) | Mdhearingaid | 2022-08-04 |
| EXALT Model B Single-Use Bronchoscope (K222014) | Boston Scientific Corporation | 2022-07-28 |
| Hummingbird Tympanostomy Tube System (K221254) | Preceptis Medical, Inc. | 2022-07-27 |
| Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit (K220922) | Cochlear Americas | 2022-07-27 |
| Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 (K220606) | Ambu A/S | 2022-07-25 |
| AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle (K213060) | Micro-Tech (Nanjing) Co., Ltd. | 2022-07-20 |
| Single-Use Video Bronchoscopes, Digital Controller (K213782) | Micro-Tech (Nanjing) Co., Lts | 2022-07-08 |
| ENT Nasopharyngoscope and Accessories (K214050) | Medimaging Integrated Solution, Inc (Miis) | 2022-07-01 |
| HD Mediastinoscope (K213194) | Karl Storz Endoscopy America, Inc. | 2022-06-23 |
| Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE (K213345) | Path Medical GmbH | 2022-06-22 |
| Ion Endoluminal System (IF1000) (K220299) | Intuitive Surgical, Inc. | 2022-06-16 |