Fisher & Paykel Healthcare Limited is one of 14 FDA 510(k) medical device manufacturers from New Zealand in the dataset, ranked by real submission volume.
Fisher & Paykel Healthcare Limited - FDA 510(k) Cleared Devices
Recent clearances: F&P Nova Nasal Mask, Airvo Nebulizer Adapter, F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version
8
Total
8
Cleared
0
Denied
Fisher & Paykel Healthcare Limited has 8 FDA 510(k) cleared medical devices. Based in Auckland, NZ.
Latest FDA clearance: Jun 2025. Active since 2012. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Fisher & Paykel Healthcare Limited Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Fisher & Paykel Healthcare Limited
8 devices
Cleared
Jun 18, 2025
F&P Nova Nasal Mask
Anesthesiology
210d
Cleared
Dec 10, 2021
Airvo Nebulizer Adapter
Anesthesiology
204d
Cleared
Mar 09, 2020
F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve...
Anesthesiology
265d
Cleared
Apr 05, 2019
OJR215 Pressure Relief Manifold
Anesthesiology
480d
Cleared
Sep 20, 2016
F&P Eson 2 Nasal Mask
Anesthesiology
288d
Cleared
Jun 05, 2013
F&P SIMPLUS FULL FACE MASK
Anesthesiology
114d
Cleared
Oct 02, 2012
ESON NASAL MASK
Anesthesiology
124d
Cleared
Feb 23, 2012
PILAIRO NASAL PILLOWS MASK
Anesthesiology
51d