| Virtus Metabolic Monitor (K222982) | Virtus Technology Aps | 2023-06-23 |
| Hudson RCI Variable concentration Large Volume Nebulizer (1770) (K220955) | Medline Industires, Inc. | 2023-06-23 |
| Portable Oxygen Concentrator (Model: P2-E7, P2-E) (K223379) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023-06-22 |
| tremoflo C2 Airwave Oscillometry System (K221024) | Thorasys Thoracic Medical Systems, Inc. | 2023-06-20 |
| F&P 950 Respiratory Humidifier (K220703) | Fisher & Paykel Healthcare | 2023-06-16 |
| Mindray SV600 Ventilator, Mindray SV800 Ventilator (K220107) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023-06-16 |
| TNI Clear-Guard™ 3 angled breathing filter (1545020) (K223258) | Intersurgical , Ltd. | 2023-06-15 |
| VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) (K222822) | Draegerwerk AG & CO Kgaa | 2023-06-14 |
| SpiroHome Personal, SpiroHome Clinic (K213754) | Inofab Saglik Teknolojileri A.S | 2023-06-12 |
| Breathe+ (K222018) | Peep Medical, LLC Dba Go2 Devices | 2023-06-02 |
| Oxus Sieve Beds (K211056) | Oxus, Inc. | 2023-05-31 |
| Nihon Kohden NKV-440 Ventilator System (K222644) | Nihon Kohden Orangemed, Inc. | 2023-05-31 |
| Model 9160 VitaloQUB (K223818) | Vitalograph Ireland, Ltd. | 2023-05-25 |
| Oxymag - Transport and Emergency Ventilator (K221634) | Magnamed Tecnologia Medica S/A | 2023-05-24 |
| F&P Solo Mask Range (K223696) | Fisher & Paykel Healthcare, Ltd. | 2023-05-17 |
| Evita V800, Evita V600 (K222024) | Draegerwerk AG & CO Kgaa | 2023-05-16 |
| Babylog VN800, Babylog VN600 (K222207) | Draegerwerk AG & CO Kgaa | 2023-05-16 |
| Revitalair 430+ (K220290) | Us Hyperbaric Network | 2023-05-04 |
| Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A (K213825) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2023-04-28 |
| Inomax DSIR (K211153) | Mallinckrodt Manufacturing, LLC | 2023-04-20 |
| TrachCuff Cuff Controller (K220854) | Aw Technologies Aps | 2023-04-14 |
| F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range (K222197) | Fisher & Paykel Healthcare, Ltd. | 2023-04-06 |
| CO2 Mainstream Sensor (K221118) | Draegerwerk AG & CO Kgaa | 2023-04-05 |
| Maxtec MaxO2 ME+p (K221734) | Maxtec, LLC | 2023-04-01 |
| Masimo SafetyNet (DEN200011) | Masimo Corporation | 2023-03-31 |
| Carestation 750/750c (K213867) | Datex-Ohmeda, Inc. | 2023-03-28 |
| EOlife® (K221841) | Archeon | 2023-03-18 |
| Digital Routines (K221924) | Gnc Holdings, LLC | 2023-03-15 |
| Wesper Lab (K221816) | Wesper, Inc. | 2023-03-09 |
| Respiree Cardio-Respiratory Monitor (K223681) | Respiree Pte, Ltd. | 2023-03-08 |
| Enlight 2100 (K222897) | Timpel S.A. | 2023-03-07 |
| Nitronox Scavenger Plus (K223452) | Parker Hannifin Corporation | 2023-03-05 |
| TytoCare Lung Sounds Analyzer (K221614) | Tyto Care , Ltd. | 2023-02-24 |
| Belun Sleep System BLS-100 (K222579) | Belun Technology Company Limited | 2023-02-23 |
| FlowSaver Blood Return System (K221483) | Inari Medical, Inc. | 2023-02-17 |
| PMD-200 (DEN210022) | Medasense Biometrics , Ltd. | 2023-02-17 |
| Arrow 0.2 Micron Flat Filter, GVS (K222341) | Arrow International, LLC | 2023-02-13 |
| Filter and HME/Filter (K221472) | Ningbo Huakun Medical Equipment Co., Ltd. | 2023-02-08 |
| Hailie Sensor NF0110 (K222247) | Adherium (Nz), Ltd. | 2023-02-08 |
| AcuPebble OX100 (K222950) | Acurable Limited | 2023-02-03 |
| XChange Device, XChange System (K210112) | Pneuma Therapeutics, Inc. | 2023-01-30 |
| F&P Airvo 3 (K221338) | Fisher & Paykel Healthcare | 2023-01-27 |
| Quality Mix Blender, Oxymixer (K221494) | Dehas Medical Systems GmbH | 2023-01-23 |
| WatchPAT ONE (WP1) (K223675) | Itamar Medical , Ltd. | 2023-01-06 |
| AG100s (K221477) | Hospitech Respiration , Ltd. | 2022-12-29 |
| BiWaze Clear System (K213564) | Abmrc, LLC | 2022-12-21 |
| inspired™ VHB20 Heated Humidifier (K222351) | Vincent Healthcare Products Limited | 2022-12-21 |
| BresoDX1 (K220012) | Bresotec, Inc. | 2022-12-21 |
| Proxima (K220591) | Dynasthetics, LLC | 2022-12-15 |
| Dozee VS (K221555) | Turtle Shell Technologies Private Limited | 2022-12-15 |
| HVT 2.0 (K221318) | Vapotherm, Inc. | 2022-12-13 |
| Inogen Rove 4 Portable Oxygen Concentrator (K222086) | Inogen | 2022-12-09 |
| Oxygen Concentrator, Model JAY-5AW (K213210) | Longfian Scitech Co., Ltd. | 2022-12-08 |
| Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (K221836) | Drägerwerk AG & Co. KGaA | 2022-12-07 |
| BPAP System (K213169) | BMC Medical Co., Ltd. | 2022-12-05 |
| Chartis Precision Catheter (K222340) | Pulmonx Corporation | 2022-12-01 |
| EasyOne Filter (K221250) | Ndd Medizintechnik AG | 2022-11-22 |
| Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense (K223246) | Baxter Healthcare Corproration | 2022-11-18 |
| Electromed SmartVest Airway Clearance System (K222496) | Electromed, Inc. | 2022-11-18 |
| Endoscopy Oxygen Mask (K220533) | Engineered Medical Systems, Inc. | 2022-11-16 |
| Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (K221722) | Haemonetics Corporation | 2022-11-15 |
| Vapotherm Aerosol Adapter AAA-2 (K220869) | Vapotherm, Inc. | 2022-10-28 |
| Hudson RCI Triflo II Incentive Deep Breathing Exerciser (K220565) | Medline Industries, Inc. | 2022-10-25 |
| ScanNav Anatomy Peripheral Nerve Block (DEN220024) | Intelligent Ultrasound Limited | 2022-10-18 |
| Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile (K221014) | Effortless Oxygen, LLC | 2022-10-17 |
| STIMPOD NMS450 Nerve Stimulator (K213049) | Xavant Technology (Pty), Ltd. | 2022-10-16 |
| RespiraSense (K220111) | Pmd Solutions | 2022-10-07 |
| VISIONAIR (K221892) | Pacificmd Biotech, LLC | 2022-10-05 |
| Hailie Sensor NF0107 & NF0108 (K221994) | Adherium (Nz), Ltd. | 2022-10-04 |
| WatchPAT300 (WP300) (K222331) | Itamar Medical , Ltd. | 2022-09-14 |
| Percent Oxygen Sensors (K213933) | Careox, LLC | 2022-08-19 |
| Sotair Device (K212905) | Safe Bvm Corporation | 2022-08-18 |
| Tetragraph Neuromuscular Transmission Monitor (K220530) | Senzime AB | 2022-08-17 |
| Medispine - Spinal Needle, Glospine - Spinal Needle (K212982) | Global Medikit Limited | 2022-07-29 |
| Microstream CO2 NanoPod (K213911) | Covidien, LLC | 2022-07-29 |
| Life Scope PT BSM-1700 Series Bedside Monitor (K220976) | Nihon Kohden Corporation | 2022-07-21 |
| Wei Nasal Jet Tube (K211543) | Well Lead Medical Co., Ltd. | 2022-07-21 |
| Hailie Sensor NF0106 (K220622) | Adherium (Nz), Ltd. | 2022-07-15 |
| Model 9100 PFT/DICO (K221030) | Vitalograph Ireland, Ltd. | 2022-07-15 |
| ComPAS2 (K213872) | Morgan Scientific, Inc. | 2022-07-15 |
| ANNE Sleep (K220095) | Sibel, Inc. | 2022-07-11 |
| SleepCheckRx (K213360) | Resapp Health | 2022-07-05 |
| Nihon Kohden NKV-330 Ventilator System (K213521) | Nihon Kohden Orangemed, Inc. | 2022-07-01 |
| BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle (K211085) | Becton, Dickinson and Company | 2022-07-01 |
| Portable Oxygen Concentrator, model: P2-E6 (K210371) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2022-06-03 |
| BD Epilor Syringe (K210983) | Becton, Dickinson and Company | 2022-05-19 |
| Neuromuscular Transmission Monitor TOF3D (K212434) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2022-05-05 |
| NOxBOXi Nitric Oxide Delivery System (K220898) | Linde Gas & Equipment, Inc. | 2022-04-27 |
| F&P 850 AirSpiral Adult NIV and NHF Circuit Kit (K212031) | Fisher & Paykel Healthcare, Ltd. | 2022-04-22 |
| CARESCAPE CO2 Microstream parameter (K213518) | Covidien, LLC | 2022-04-12 |
| Oxygen Concentrator (K202389) | Foshan Mic Medical Technology Co., Ltd. | 2022-04-08 |
| Onera Sleep Test System (Onera STS) (K210593) | Onera B.V. | 2022-04-06 |
| LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber (K210558) | Thayer Medical Corporation | 2022-04-01 |
| GGM Breathing Circuit Bacterial Filter (K210352) | Great Group Medical Co, Ltd. | 2022-03-27 |
| Nebulizer (K212395) | Shenzhen Homed Medical Device Co., Ltd. | 2022-03-25 |
| Luna G3 BPAP System (K212263) | 3B Medical, Inc. | 2022-03-25 |
| WatchPAT200U (WP200U) (K203839) | Itamar Medical , Ltd. | 2022-03-21 |
| F&P Evora Full Face Mask (K212371) | Fisher & Paykel Healthcare, Ltd. | 2022-03-18 |
| OxyMinder (K213948) | Bio-Med Devices, Inc. | 2022-03-17 |
| Auto CPAP System (K211155) | BMC Medical Co., Ltd. | 2022-03-09 |