| 2026-04-13 |
K254078 |
Vapotherm, Inc.
|
HVT 2.0 |
| 2026-01-16 |
K251448 |
Flexicare Medical Limited.
|
FL-10000U Respiratory Humidifier |
| 2026-01-14 |
K251419 |
Laboratorios Biogalenic S.A. DE C.V.
|
Laboratorios Biogalenic Sterile Water for Inhalation, USP |
| 2025-12-19 |
K253479 |
Fisher & Paykel Healthcare, Ltd.
|
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) |
| 2025-07-02 |
K250312 |
Medline Industries, LP
|
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small |
| 2025-06-25 |
K251611 |
Fisher & Paykel Healthcare, Ltd.
|
Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) |
| 2025-01-30 |
K242717 |
Laboratorios Biogalenic S.A. DE C.V.
|
Laboratorios Biogalenic Sterile Water for Inhalation, USP |
| 2024-12-19 |
K241778 |
Medline Industries, LP
|
Hudson RCI Comfort Flo® CubCannula |
| 2024-09-27 |
K240163 |
Medline Industries, LP
|
Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula |
| 2024-08-08 |
K234058 |
Fisher & Paykel Healthcare, Ltd.
|
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) |
| 2024-06-14 |
K233707 |
Invent Medical Corporation
|
HFT150 |
| 2024-06-13 |
K233821 |
Fisher & Paykel Healthcare, Ltd.
|
F&P Optiflow Oxygen Kit (AA451J) |
| 2024-05-08 |
K222292 |
Fisher & Paykel Healthcare
|
F&P myAirvo 3 |
| 2024-02-07 |
K231956 |
Fisher & Paykel Healthcare, Ltd.
|
F&P Optiflow+ Duet Nasal Cannula |
| 2023-10-26 |
K230559 |
Medline Industries, Inc.
|
Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) |
| 2023-10-13 |
K223863 |
Telesair, Inc.
|
BONHAWA Respiratory Humidifier |
| 2023-09-05 |
K223684 |
Fisher & Paykel Healthcare, Ltd.
|
F&P 820 Humidification System |
| 2023-08-10 |
K231380 |
Vyaire Medical, Inc.
|
AirLife DuoTherm Humidification System |
| 2023-08-03 |
K223551 |
Hometa, Inc.
|
Sterile Water for Inhalation in 1L Flexoval ® bottles. |
| 2023-06-16 |
K220703 |
Fisher & Paykel Healthcare
|
F&P 950 Respiratory Humidifier |
| 2023-04-06 |
K222197 |
Fisher & Paykel Healthcare, Ltd.
|
F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range |
| 2022-12-21 |
K222351 |
Vincent Healthcare Products Limited
|
inspired VHB20 Heated Humidifier |
| 2022-04-22 |
K212031 |
Fisher & Paykel Healthcare, Ltd.
|
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit |
| 2022-01-28 |
K211096 |
Fisher & Paykel Healthcare, Ltd.
|
Optiflow Oxygen Kit |
| 2021-08-25 |
K203357 |
Vapotherm, Inc.
|
HVT 2.0 |