Fisher &Paykel Healthcare , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J), OptiPAP Junior Flexi Tube US (OPTIPAPFUS), F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A)
70
Total
70
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fisher &Paykel Healthcare , Ltd. Anesthesiology ✕
64 devices
Cleared
Dec 19, 2025
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
Anesthesiology
66d
Cleared
Nov 19, 2025
OptiPAP Junior Flexi Tube US (OPTIPAPFUS)
Anesthesiology
260d
Cleared
Sep 10, 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb...
Anesthesiology
61d
Cleared
Jul 14, 2025
F&P Optiflow Air/Oxygen Flow Source
Anesthesiology
206d
Cleared
Jun 25, 2025
Optiflow+ Nasal Cannula - Small (OPT942)
Anesthesiology
29d
Cleared
Aug 09, 2024
F&P Airvo 3 NIV (PT311US)
Anesthesiology
270d
Cleared
Aug 09, 2024
F&P Optiflow Flow Diverter
Anesthesiology
231d
Cleared
Aug 08, 2024
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility...
Anesthesiology
230d
Cleared
Jun 13, 2024
F&P Optiflow Oxygen Kit (AA451J)
Anesthesiology
195d
Cleared
Feb 07, 2024
F&P Optiflow+ Duet Nasal Cannula
Anesthesiology
219d
Cleared
Sep 05, 2023
F&P 820 Humidification System
Anesthesiology
271d
Cleared
Jun 29, 2023
F&P 950 Accessory Breathing Circuit Kits
Anesthesiology
408d
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