| NightOwl (K220028) | Ectosense NV | 2022-02-24 |
| Optiflow Oxygen Kit (K211096) | Fisher & Paykel Healthcare, Ltd. | 2022-01-28 |
| Vitalograph Model 6000 Alpha (K212938) | Vitalograph Ireland, Ltd. | 2022-01-26 |
| iQ 2 Nasal Mask, Phantom 2 Nasal Mask (K211274) | Sleepnet Corporation | 2022-01-10 |
| Enlight 2100 (K211135) | Timpel S.A. | 2022-01-06 |
| Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM (K213316) | Nihon Kohden Corporation | 2021-12-29 |
| Altech® Exhalation Valve (Single Limb and Dual Limb) (K210992) | Meditera Tibbi Malzeme San VE Tic AS | 2021-12-23 |
| BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (K210978) | Becton, Dickinson and Company | 2021-12-22 |
| iCOquit® Smokerlyzer® (K211918) | Bedfont Scientific, Ltd. | 2021-12-21 |
| Wesper Lab (K203343) | Wesper, Inc. | 2021-12-21 |
| NightOwl (K213463) | Ectosense NV | 2021-12-16 |
| Airvo Nebulizer Adapter (K211560) | Fisher & Paykel Healthcare Limited | 2021-12-10 |
| Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% (K210126) | The Ritedose Corporation | 2021-12-03 |
| Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula (K210833) | Smiths Medical Asd, Inc. | 2021-11-26 |
| Breathe Easy Mobile Respiratory Monitor (MRM) (K211387) | Sound Life Sciences, Inc. | 2021-11-23 |
| Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger (K211286) | Pall Corporation | 2021-11-16 |
| LTV2 Series Ventilators (K201082) | Vyaire Medical, Inc. | 2021-11-10 |
| CARESCAPE R860 (K210384) | Datex-Ohmeda, Inc. | 2021-11-04 |
| EndoTool SubQ 2.1 (K211160) | Monarch Medical Technologies, LLC | 2021-10-28 |
| Tenax Laser Resistant Endotracheal Tube (K213028) | Bryan Medical, Inc. | 2021-10-21 |
| CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories (K211171) | GE Healthcare Finland Oy | 2021-10-21 |
| RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles (K203668) | Myco Medical Supplies, Inc. | 2021-09-29 |
| DiscCath Needle Set (K212328) | Disccath, LLC | 2021-09-26 |
| Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter (K202459) | Pharma System AB | 2021-09-26 |
| BreatheSuite MDI V1 (K203155) | Breathesuite, Inc. | 2021-09-17 |
| Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector (K203762) | Covidien | 2021-09-17 |
| BlueStar Rx (K203434) | Welldoc, Inc. | 2021-09-08 |
| Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain (K201305) | Atrium Medical Corporation | 2021-09-03 |
| Disposable Manual Resuscitator (K210288) | Xiamen Compower Medical Tech. Co., Ltd. | 2021-08-26 |
| HVT 2.0 (K203357) | Vapotherm, Inc. | 2021-08-25 |
| DreamWear Silicone Pillows Mask (K210844) | Respironics, Inc. | 2021-08-24 |
| Hailie Sensor NF0109 (K211233) | Adherium (Nz), Ltd. | 2021-08-18 |
| sOLVe Tube (K201026) | Hytek Medical, Inc. | 2021-08-10 |
| TRACOE vario (K203362) | Tracoe Medical GmbH | 2021-08-05 |
| Hemafuse System (K210862) | Sisu Global Health | 2021-07-29 |
| FlowSaver Blood Filter (K210176) | Inari Medical | 2021-07-22 |
| Magneto Nasal Mask (K210386) | Respironics, Inc. | 2021-07-12 |
| Nebulizer Kit (K192971) | Excellentcare Medical (Huizhou) , Ltd. | 2021-07-08 |
| AcuPebble SA (K210480) | Acurable Limited | 2021-07-06 |
| Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask (K203347) | Suzhou Yuyue Medical Technology Co., Ltd. | 2021-07-02 |
| Pulmogine Vibrating Mesh Nebulizer (K202171) | Hcmed Innovations Co., Ltd. | 2021-07-01 |
| Pivot Breath Sensor (K201206) | Carrot, Inc. | 2021-06-30 |
| Corrugated tube with mouthpiece accessory (K203400) | Trudell Medical International | 2021-06-14 |
| Ultrasonic Mesh Nebulizer (K201397) | Shenzhen Ivankaca Technology Co., Ltd. | 2021-06-14 |
| Spirometer (K201493) | Mehow Innovative, Ltd. | 2021-06-10 |
| Insulia Diabetes Management Companion (K202596) | Voluntis Sa. | 2021-06-04 |
| Peak flow meter (K203196) | Shanghai Sonmol Medical Equipment Co., Ltd. | 2021-05-26 |
| Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (K203749) | Ambu A/S | 2021-05-03 |
| Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (K201949) | Nihon Kohden Corporation | 2021-05-02 |
| Innova Nasal Non-Vented Mask (K203601) | Sleepnet Corporation | 2021-04-30 |
| Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (K202480) | Parker Hannifin | 2021-04-22 |
| Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 (K201874) | Maquet Critical Care AB | 2021-04-20 |
| F&P Visairo NIV Mask Range (K203449) | Fisher & Paykel Healthcare, Ltd. | 2021-04-14 |
| Invacare Platinum 5NXG Oxygen Concentrator (K203210) | Invacare Corporation | 2021-04-12 |
| Pulsehaler (K203378) | Respinova, Ltd. | 2021-03-31 |
| EMMA Capnograph (K201590) | Masimo Corporation | 2021-03-29 |
| A8, A9 Anesthesia System (K201957) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2021-03-26 |
| F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling (K201723) | Fisher & Paykel Healthcare, Ltd. | 2021-03-16 |
| wheezo WheezeRate Detector (K202062) | Respiri Limited | 2021-03-11 |
| Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation (K202018) | Hill-Rom, Inc. | 2021-03-04 |
| Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ (K210019) | Unimed Medical Supplies, Inc. | 2021-03-04 |
| X-PLO2R (K203086) | Belluscura, LLC | 2021-03-02 |
| Plastic LOR Syringe (K201356) | Jiangsu Caina Medical Co.,Ltd | 2021-02-12 |
| Electro Flo 6 Airway Clearance System (K201490) | Med Systems, Inc. | 2021-02-12 |
| CATSmart, Automated Blood Processing Autotransfusion System (K210089) | Fresenius Kabi AG | 2021-02-11 |
| VORTRAN GO2VENT with PEEP Valve (K202219) | Vortran Medical Technology 1, Inc. | 2021-02-11 |
| HAMILTON-C3 (K201306) | Hamilton Medical AG | 2021-02-05 |
| Luna® G3 BPAP 25A (K201620) | 3B Medical, Inc. | 2021-01-29 |
| Sunset Heated CPAP Tube (K201418) | Sunset Healthcare Solutions, Inc. | 2021-01-29 |
| Ventway Sparrow (K202970) | Inovytech Medical Solutions , Ltd. | 2021-01-29 |
| MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU (K202754) | Eresearchtechnology GmbH | 2021-01-28 |
| Vivo 45 LS (K193586) | Breas Medical AB | 2021-01-27 |
| Galapogos (K200565) | Resmed Corp | 2021-01-17 |
| AirPhysio Positive Expiratory Pressure (PEP) Device (K203209) | Airphysio Pty, Ltd. | 2021-01-15 |
| Puritan Bennett Cuff Pressure Manager (K202874) | Covidien, LLC | 2021-01-09 |
| E-Cath STIM acc. Tsui (K202699) | PAJUNK GmbH Medizintechnologie | 2020-12-29 |
| ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R (K200968) | Insung Medical Co., Ltd. | 2020-12-28 |
| S10 Kirra (K203126) | Resmed Pty , Ltd. | 2020-12-18 |
| Maxxi Flow Sensor (K201495) | Neurovirtual USA, Inc. | 2020-12-14 |
| Hamilton-C6 (K201658) | Hamilton Medical AG | 2020-12-11 |
| GoSpiro (K202837) | Monitored Therapeutics, Inc. | 2020-12-04 |
| Dynamic Gas Scavenging System 2 (DGSS - 2) (K193646) | Anesthetic Gas Reclamation, Inc. | 2020-12-04 |
| AireHealth NebulizerTM (K201167) | Airehealth, Inc. | 2020-12-03 |
| SysMed S/T (K192177) | Sysmed (China) Co., Ltd. | 2020-11-25 |
| CPR Face Shield (K192285) | Firstar Healthcare Company Limited (Guangzhou) | 2020-11-25 |
| Tenax Laser Resistant Endotracheal Tube (K200761) | Bryan Medical, Inc. | 2020-11-25 |
| Puritan Bennett 980 Series Ventilator System (K193056) | Covidien, LLC | 2020-11-20 |
| MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (K193191) | Weinmann Emergency Medical Technology GmbH + Co. KG | 2020-11-20 |
| Apogee (K200401) | Incoba Ltd D/B/A Dynaris | 2020-11-14 |
| SINGLE USE MANOMETER (K201666) | Flexicare Medical Limited. | 2020-11-13 |
| O2asis Personal Oxygen Humidifier (K193411) | Perma Pure, LLC | 2020-11-12 |
| ScalpelCric (K200190) | VBM Medizintechnik GmbH | 2020-10-30 |
| WiZARD 510 Nasal Mask (K193206) | Apex Medical Corp. | 2020-10-29 |
| Spirotrac (K201562) | Vitalograph Ireland, Ltd. | 2020-10-14 |
| BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle (K193131) | Becton, Dickinson and Company | 2020-09-29 |
| Portable Mesh Nebulizer (K182906) | Feellife Health, Inc. | 2020-09-27 |
| Ventilator, Non-continuous (Respirator) (K201439) | Respironics, Inc. | 2020-09-25 |
| Breezing Med (K200076) | Tf Health Co. | 2020-09-25 |
| SubQKath Catheter and Needle Set (K193664) | Hk Surgical | 2020-09-09 |
| NICU V'02 (K190561) | Cosmed Nordic Aps | 2020-09-04 |