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Fisher & Paykel Healthcare, Ltd. FDA Approvals
0 new drug approvals and 19 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)510(k)Dec 19, 2025Anesthesiology |
| OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun510(k)Nov 19, 2025Anesthesiology |
| F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full510(k)Sep 10, 2025Anesthesiology |
| F&P Optiflow Air/Oxygen Flow Source510(k)Jul 14, 2025Anesthesiology |
| 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)510(k)Jun 25, 2025Anesthesiology |
| F&P Optiflow Flow Diverter510(k)Aug 9, 2024Anesthesiology |
| F&P Airvo 3 NIV (PT311US)510(k)Aug 9, 2024Anesthesiology |
| F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)510(k)Aug 8, 2024Anesthesiology |
| F&P Optiflow Oxygen Kit (AA451J)510(k)Jun 13, 2024Anesthesiology |
| F&P Optiflow+ Duet Nasal Cannula510(k)Feb 7, 2024Anesthesiology |
| F&P 820 Humidification System510(k)Sep 5, 2023Anesthesiology |
| F&P 950 Accessory Breathing Circuit Kits510(k)Jun 29, 2023Anesthesiology |
| F&P Solo Mask Range510(k)May 17, 2023Anesthesiology |
| F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range510(k)Apr 6, 2023Anesthesiology |
| F&P 850 AirSpiral Adult NIV and NHF Circuit Kit510(k)Apr 22, 2022Anesthesiology |
| F&P Evora Full Face Mask510(k)Mar 18, 2022Anesthesiology |
| Optiflow Oxygen Kit510(k)Jan 28, 2022Anesthesiology |
| F&P Visairo NIV Mask Range510(k)Apr 14, 2021Anesthesiology |
| F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling510(k)Mar 16, 2021Anesthesiology |