| MATRx plus (K200695) | Zephyr Sleep Technologies | 2020-08-24 |
| Cuffix (K192611) | Biovo Technologies , Ltd. | 2020-08-13 |
| EndoTool IV System (K201619) | Monarch Medical Technologies, LLC | 2020-08-07 |
| Invacare Perfecto2V Oxygen Concentrator (K200890) | Invacare Corporation | 2020-08-06 |
| Safey Pocket Spirometer (K201002) | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| Safey Peak Flow Meter (K200832) | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| Vitalograph Model 2120 In2itive eDiary (K200550) | Vitalograph Ireland, Ltd. | 2020-07-27 |
| Aer X (K200496) | 3B Medical, Inc. | 2020-07-24 |
| Rubicon SA System (K200654) | Dymedix Diagnostics, Inc. | 2020-07-22 |
| Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm (K192511) | Venner Medical (Singapore) Pte, Ltd. | 2020-07-22 |
| Owgels Oxygen Concentrator (K191875) | Guangzhou Life Light Electronic Technology Co., Ltd. | 2020-07-20 |
| AeroEclipse* ONE BAN (K200063) | Trudell Medical International | 2020-07-17 |
| DreamStation 2 System, DreamStation 2 Advanced System (K200480) | Respironics, Inc. | 2020-07-10 |
| Somnera System (K200698) | Fresca Medical, Inc. | 2020-06-29 |
| The C100 Contactless Breathing Monitor (K200445) | Circadia Technologies, Ltd. | 2020-06-24 |
| The NOxBOXi Nitric Oxide Delivery System (K201339) | Praxair, Inc. | 2020-06-19 |
| Servo-air 4.0 Ventilator System (K192604) | Maquet Critica Care AB | 2020-06-18 |
| InPen System (K201337) | Companion Medical, Inc. | 2020-06-18 |
| INOmax DSIR Plus (K200389) | Mallinckrodt Manufacturing, LLC | 2020-06-17 |
| F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model (K200089) | Fisher & Paykel Healthcare, Ltd. | 2020-06-02 |
| ProCell Surgical Sponge-Blood Recovery Unit (K193361) | Procell Surgical, Inc. | 2020-06-01 |
| Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff (K193077) | Covidien | 2020-06-01 |
| Stimuplex Onvision System (K192914) | Philips Medical Systems Nederland B.V. | 2020-05-27 |
| Maximus System (K200988) | Hill-Rom Services Pte, Ltd. | 2020-05-26 |
| CO2 Sidestream Module (K192488) | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-22 |
| CO2 Mainstream Module (K192446) | Beijing Kingst Commercial & Trade Co., Ltd. | 2020-05-21 |
| SonarMed AirWave Airway Monitoring System (K193058) | Sonarmed, Inc. | 2020-05-15 |
| Nuvo Nano Portable Oxygen Concentrator (K192693) | Nidek Medical Products, Inc. | 2020-05-07 |
| Hamilton-G5 (K193228) | Hamilton Medical AG | 2020-05-04 |
| GUS831 Compressor Nebulizer (K192633) | Globalcare Medical Technology Co., Ltd. | 2020-05-01 |
| Capnostream 35 Portable Respiratory Monitor (K200594) | Oridion Medical 1987 , Ltd. | 2020-04-27 |
| Percutaneous Introducer (K200624) | Epimed International, Inc. | 2020-04-27 |
| TwitchView System (K192958) | Blink Device Company | 2020-04-02 |
| Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French (K193027) | Deroyal Industries, Inc. | 2020-04-02 |
| BiWaze Cough (K191912) | Abmrc, LLC | 2020-03-27 |
| Propeller Sensor for Symbicort (K192724) | Reciprocal Labs Corporation | 2020-03-26 |
| Aluna (K193311) | Knox Medical Diagnostics, Inc. | 2020-03-25 |
| HepaShield Bacterial Viral Breathing System Filter (K191909) | Flexicare Medical Limited. | 2020-03-23 |
| F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) (K191818) | Fisher & Paykel Healthcare, Ltd. | 2020-03-19 |
| PulmoScan (K191876) | Cognita Labs, LLC | 2020-03-18 |
| Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (K191027) | Maquet Critical Care AB | 2020-03-18 |
| EndoTool IV 1.10 (K200443) | Monarch Medical Technologies, LLC | 2020-03-17 |
| Altera Filter and HME/Filter (K192713) | Meditera Tibbi Malzeme San VE Tic AS | 2020-03-16 |
| AeroNOx 2.0 Nitric Oxide Titration & Monitoring System (K193481) | International Biomedical | 2020-03-10 |
| F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version (K191624) | Fisher & Paykel Healthcare Limited | 2020-03-09 |
| NightOwl (K191031) | Ectosense NV | 2020-03-06 |
| Kingon P2 Oxygen Concentrator (K190304) | Qingdao Kingon Medical Science and Technology Co. | 2020-02-29 |
| Pylant Monitor (K191858) | Kal-Med, LLC | 2020-02-24 |
| D R Burton OxyPAP (K192000) | D R Burton Healthcare, LLC | 2020-02-19 |
| InPen Dose Calculator (K190487) | Companion Medical, Inc. | 2020-02-18 |
| Maximus System (K192143) | Hill-Rom Services Pte, Ltd. | 2020-02-14 |
| Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm (K192120) | Venner Medical (Singapore) Pte, Ltd. | 2020-02-14 |
| InPen System (K192841) | Companion Medical, Inc. | 2020-02-10 |
| Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors (K190800) | Cosmed Srl | 2020-02-06 |
| Ancora Nerve Block Catheter Set (K191290) | Ancora Medical Technology | 2020-02-06 |
| Linshom Respiratory Monitoring Device (LRMD) (K190734) | Linshom Management, LLC | 2020-01-30 |
| Proneb Max (K191270) | Pari Respiratory Equipment, Inc. | 2020-01-23 |
| Altera gas Sampling Lines (K192563) | Meditera Tibbi Malzeme San VE Tic AS | 2020-01-17 |
| Maxxi Snore Sensor (K191095) | Neurovirtual USA, Inc. | 2020-01-16 |
| Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff (K190878) | Salter Labs, Inc. | 2020-01-10 |
| Nihon Kohden NKV-550 Series Ventilator System (K192307) | Nihon Kohden Orangemed, Inc. | 2020-01-10 |
| Air Next (K183089) | Nuvoair AB | 2020-01-02 |
| The RHEA Vital Sign Vigilance System (K190775) | Shenzhen Fiber Medical Technology Co. , Ltd. | 2019-12-19 |
| BEACON Caresystem Model 00002144 (K192584) | Mermaid Care A/S | 2019-12-18 |
| Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric (K190824) | Bluepoint Medical GmbH & Co. KG | 2019-12-18 |
| ExSpiron 2Xi (K192595) | Respiratory Motion | 2019-12-17 |
| Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (K193133) | Cook Incorporated | 2019-12-12 |
| Endotracheal Tube with Evacuation Lumen (K182739) | Well Lead Medical Co., Ltd. | 2019-12-11 |
| Smart Peak Flow Meter (K191239) | Guangzhou Homesun Medical Technology Co., Ltd. | 2019-12-06 |
| Sheridan Spiral-Flex Endotracheal Tubes (K192324) | Teleflexmedical, Inc. | 2019-12-06 |
| Revitalair 430F (K171899) | Oxavita Srl | 2019-11-22 |
| MATRx Plus (K191925) | Zephyr Sleep Technologies | 2019-10-29 |
| C-CAT Anaesthesia Catheter kit (K191470) | Cimpax Aps | 2019-10-25 |
| Acapella Choice Blue Vibratory PEP Device (K181660) | Smiths Medical | 2019-10-24 |
| Servo Guard (K182862) | Maquet Critical Care AB | 2019-10-21 |
| Care Orchestrator Essence (K183226) | Respironics, Inc. | 2019-10-18 |
| SomnaPatch (K183625) | Respironics, Inc. | 2019-10-18 |
| Tetragraph Neuromuscular Transmission Monitor (K190795) | Senzime AB | 2019-10-18 |
| F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) (K190713) | Fisher & Paykel Healthcare, Ltd. | 2019-10-11 |
| Palladium High Flow Therapy System (K191010) | Vapotherm, Inc. | 2019-10-10 |
| SolidAIRity III Airway Stabilization System (K190630) | Securisyn Medical, LLC | 2019-10-09 |
| Asthma Monitor AM3 (K183479) | Eresearch Technology | 2019-10-03 |
| CATSmart (K192368) | Fresenius Kabi AG | 2019-09-27 |
| Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant (K180001) | Embla Systems | 2019-09-27 |
| SafeBreath Filter Mouthpiece (K190022) | MD Diagnostics Limited | 2019-09-25 |
| VORTRAN APM-Plus (K182292) | Vortran Medical Technology 1, Inc. | 2019-09-18 |
| CapMedic (K183586) | Cognita Labs, LLC | 2019-09-13 |
| Bellavista (K183364) | Imtmedical AG | 2019-09-13 |
| Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option (K191013) | Welch Allyn, Inc. | 2019-09-10 |
| Yikang Endotracheal Tube (K190213) | Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2019-09-06 |
| Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity (K191159) | Invacare Corporation | 2019-08-29 |
| Vyntus/SentrySuite Product Line (K183567) | Vyaire Medical | 2019-08-23 |
| Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit) (K190026) | Teleflex Medical | 2019-08-21 |
| Vyntus BODY (K190853) | Vyaire Medical, Inc. | 2019-08-16 |
| Combined Aerobika OPEP and VersaPAP device (K183108) | Trudell Medical International | 2019-08-16 |
| SleepImage System (K182618) | Mycardio, LLC Dba Sleepimage. | 2019-08-14 |
| Dr J Spinal and Epidural Needles (K183316) | Dr. Japan Co., Ltd. | 2019-08-12 |
| HAMILTON-T1, HAMILTON-C1 (K181216) | Hamilton Medical AG | 2019-08-02 |
| APA Oxy Blade (K191602) | Venner Medical (Singapore) Pte, Ltd. | 2019-08-02 |
| Hamilton-G5 (K180295) | Hamiton Medical AG | 2019-07-30 |