| Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA) (K233829) | Fisher and Paykel Healthcare Limited | 2024-08-23 |
| iSage Rx (K242066) | Amalgam Rx, Inc. | 2024-08-21 |
| XTRA Collection sets; XTRA Sequestration set X (K241236) | Sorin Group Italia S.R.L. | 2024-08-16 |
| Family of DIMAR DMAX NIV masks (K232836) | Dimar S.P.A. | 2024-08-14 |
| VM-2000 (K240807) | Ventis Medical, Inc. | 2024-08-13 |
| F&P Airvo 3 NIV (PT311US) (K233643) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| F&P Optiflow Flow Diverter (K234053) | Fisher & Paykel Healthcare, Ltd. | 2024-08-09 |
| F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) (K234058) | Fisher & Paykel Healthcare, Ltd. | 2024-08-08 |
| Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) (K241268) | Exceleron Medical | 2024-08-02 |
| AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask (K233555) | Philips Respironics | 2024-07-31 |
| “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) (K233501) | Largan Medical Co., Ltd. | 2024-07-26 |
| Huxley SANSA Home Sleep Apnea Test (1000-00) (K240285) | Huxley Medical | 2024-07-15 |
| Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask (K241661) | Sleepnet Corporation | 2024-07-10 |
| DELTAWAVE Nasal Pillows System (K233415) | Remsleep Holdings | 2024-07-02 |
| Tyto Insights for Crackles Detection (K240555) | Tyto Care , Ltd. | 2024-07-02 |
| Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask (K241520) | Sleepnet Corporation | 2024-06-27 |
| MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter (K233553) | Thayer Medical Corporation | 2024-06-18 |
| iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask (K241469) | Sleepnet Corporation | 2024-06-15 |
| HFT150 (K233707) | Invent Medical Corporation | 2024-06-14 |
| F&P Optiflow Oxygen Kit (AA451J) (K233821) | Fisher & Paykel Healthcare, Ltd. | 2024-06-13 |
| Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line (K234032) | Medline Industries, LP | 2024-06-04 |
| SAM Model 9-10000 (K240100) | Snap Diagnostics, LLC | 2024-06-04 |
| EVOLVE Nitric Oxide Delivery System (K240410) | Malinckrodt Manufacturing, LLC | 2024-05-28 |
| SpiroSphere, SpiroSphereECG, CardioSphere (K223629) | Eresearchtechnology GmbH | 2024-05-28 |
| NOxBOXi Nitric Oxide Delivery System (K233251) | Linde Gas & Equipment, Inc. | 2024-05-23 |
| Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) (K233341) | Covidien, LLC | 2024-05-20 |
| Sentec Digital Monitoring System (SDMS) tCOM+ (K232516) | Sentec AG | 2024-05-17 |
| Aventus Clot Management System (K240426) | Inquis Medical | 2024-05-14 |
| Disposable Double Lumen Endobronchial Tube (K232529) | Shenzhen Insighters Medical Technology Co., Ltd. | 2024-05-13 |
| Aerogen®Solo Nebulizer System (K232507) | Aerogen, Ltd. | 2024-05-10 |
| F&P myAirvo 3 (K222292) | Fisher & Paykel Healthcare | 2024-05-08 |
| XTRA Autotransfusion System (with XTRA Bowl sets) (K240584) | Sorin Group Italia S.R.L. | 2024-04-29 |
| Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% (K232523) | Mankind Pharma Limited | 2024-04-10 |
| BiWaze Clear System (K231728) | Abmrc, LLC | 2024-04-08 |
| Pilling Tracheostomy Tubes (K233713) | Teleflex Medical | 2024-03-22 |
| The Vest APX System (PVAPX1) (K233441) | Baxter Healthcare Corportation | 2024-03-22 |
| Reach Needle (K240253) | Aerin Medical, Inc. | 2024-03-21 |
| Nihon Kohden NKV-550 Series Ventilator System (K231778) | Nihon Kohden Orangemed, LLC | 2024-03-01 |
| Electronic Peak Flow Meter (K230423) | Taian Dalu Medical Instrument Co., Ltd. | 2024-02-23 |
| Pulmonary Function Tester, Model: A9 (K231561) | Guangzhou Homesun Medical Technology Co., Ltd. | 2024-02-21 |
| Breathing circuit bacterial/viral filter (K222917) | Shaoxing Haitech Medical Products Co., Ltd. | 2024-02-15 |
| Aurora (K231355) | Ensodata | 2024-02-09 |
| F&P Optiflow+ Duet Nasal Cannula (K231956) | Fisher & Paykel Healthcare, Ltd. | 2024-02-07 |
| Sleep Apnea Feature (DEN230041) | Samsung Electronics Co., Ltd. | 2024-02-06 |
| AllPEP (K233855) | Enchant Tek Co. , Ltd. | 2024-02-02 |
| VerTouch Spinal Imaging Device (DEN220009) | Intuitap Medical, Inc. | 2024-01-19 |
| Air Next (NVD-02) (K231416) | Nuvoair AB | 2024-01-18 |
| Hudson RCI® AddiPak® Unit Dose Vial (K231058) | Medline Industries, LP | 2024-01-04 |
| TD-7301 Peak Flow meter (K222810) | Gostar Co., Ltd. | 2023-12-19 |
| Spirobank Oxi (K230501) | Mir Medical International Research USA | 2023-12-15 |
| Disposable Endobronchial Blocker Tube (K232580) | Shenzhen Insighters Medical Technology Co., Ltd. | 2023-12-14 |
| Tyto Insights for Wheeze Detection (K232237) | Tyto Care , Ltd. | 2023-12-13 |
| Insulia Bolus Companion (K232451) | Voluntis Sa. | 2023-12-12 |
| Evolve Nitric Oxide Delivery System (K222930) | Mallinckrodt Manufacturing, LLC | 2023-12-06 |
| Maxtec MaxBlend2+p (K231895) | Maxtec, LLC | 2023-12-04 |
| Somfit (K231546) | Compumedics Limited | 2023-11-30 |
| Portable (Ultrasonic) Nebulizer (K230379) | Dongguan Simzo Electronic Technology Co., Ltd. | 2023-11-27 |
| Oxy2Pro (K222511) | Southmedic, Inc. | 2023-11-21 |
| Oxygen Concentrator (K230969) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2023-11-09 |
| Hudson RCI® TurboMist™ Nebulizer System (K230602) | Medline Industries, LP | 2023-10-31 |
| Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) (K230559) | Medline Industries, Inc. | 2023-10-26 |
| EasyOne Sky Spirometer (K230178) | Ndd Medizintechnik AG | 2023-10-19 |
| Oran Park Mask (K230476) | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-10-19 |
| Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) (K230702) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2023-10-18 |
| BONHAWA Respiratory Humidifier (K223863) | Telesair, Inc. | 2023-10-13 |
| ORi (DEN200076) | Masimo Corporation | 2023-10-12 |
| ScanNav Anatomy Peripheral Nerve Block (K232787) | Intelligent Ultrasound Limited | 2023-10-06 |
| Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) (K223740) | Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. | 2023-10-05 |
| Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (K230483) | Passy-Muir, Inc. | 2023-09-16 |
| Perifix FX Catheter; Contiplex FX Catheter (K231242) | B.Braun Medical, Inc. | 2023-09-15 |
| FlowStar Analog Mixer Flowmeter (K230987) | Baldus Sedation GmbH & Co. KG | 2023-09-14 |
| Endure ETCO2/02 Nasal Cannula (K213767) | Endure Industries, Inc. | 2023-09-12 |
| F&P 820 Humidification System (K223684) | Fisher & Paykel Healthcare, Ltd. | 2023-09-05 |
| Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) (K230603) | Teleflex Medical | 2023-08-30 |
| Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) (K223130) | Covidien | 2023-08-30 |
| Ochsner Connected Inhaler Sensor (K223367) | Ochsner Clinic Foundation | 2023-08-30 |
| Alveoair Digital Spirometer (K222525) | Roundworks Technologies Private Limited | 2023-08-28 |
| Monaghan medical filtered mouthpiece kit (K220145) | Monaghan Medical Corporation | 2023-08-24 |
| Onera Sleep Test System (Onera STS) (K223573) | Onera B.V. | 2023-08-18 |
| eRapid Nebulizer System (K223840) | Pari Respiratory Equipment, Inc. | 2023-08-11 |
| NOxBOXi Nitric Oxide Delivery System (K231823) | Linde Gas & Equipment, Inc. | 2023-08-11 |
| AirLife DuoTherm™ Humidification System (K231380) | Vyaire Medical, Inc. | 2023-08-10 |
| Air Smart Extra Spirometer (K222443) | Feellife Health, Inc. | 2023-08-09 |
| Sterile Water for Inhalation in 1L Flexoval ® bottles. (K223551) | Hometa, Inc. | 2023-08-03 |
| Therapy Mask 3100 NC/SP (K231313) | Respironics, Inc. | 2023-07-28 |
| FlowStar Touch Digital Mixer Flowmeter (K222794) | Baldus Sedation GmbH & Co. KG | 2023-07-28 |
| BlueStar and BlueStar Rx (K230813) | Welldoc, Inc. | 2023-07-28 |
| Atlan (K230931) | Drägerwerk AG Co. Kgaa | 2023-07-23 |
| Oxygen concentrator (K222920) | Zhengzhou Olive Electronic Technology Co., Ltd. | 2023-07-20 |
| Panther 5 (K213098) | Origin Medical Devices | 2023-07-20 |
| FlowSaver Blood Return System (80-101) (K231782) | Inari Medical, Inc. | 2023-07-14 |
| ReddyPort Elbow (K231064) | Smd Manufacturing, LLC | 2023-07-13 |
| Servo-air Lite Ventilator System (K230173) | Maquet Critical Care AB | 2023-07-06 |
| Whitsundays Mask System (K223747) | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-07-06 |
| LungTrainer (MD2 & MD3) (K221058) | Lung Trainers, LLC | 2023-07-05 |
| Ulspira TS Nitric Oxide Therapy System (K212409) | Airgas Therapeutics | 2023-06-30 |
| Inogen Rove 6 (K230052) | Inogen, Inc. | 2023-06-30 |
| AirTom (K222466) | Bilab | 2023-06-30 |
| F&P 950 Accessory Breathing Circuit Kits (K221436) | Fisher & Paykel Healthcare, Ltd. | 2023-06-29 |
| Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) (K223100) | Medline Industries, Inc. | 2023-06-27 |