Atlas FDA

Fisher & Paykel Healthcare, Ltd.

8 FDA 510(k) clearances · Recalling firm

Sort:Newest firstOldest first

◉ Watch Fisher & Paykel Healthcare, Ltd.

RecordFirmDate
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual recall (Z-0158-2026)Fisher & Paykel Healthcare, Ltd.2025-10-15
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Ai recall (Z-3262-2024)Fisher & Paykel Healthcare, Ltd.2024-09-25
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US recall (Z-1823-2024)Fisher & Paykel Healthcare, Ltd.2024-05-15
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcar recall (Z-0210-2015)Fisher & Paykel Healthcare, Ltd.2014-11-13
Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack recall (Z-1539-2014)Fisher & Paykel Healthcare, Ltd.2014-05-20
Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON A recall (Z-1437-2013)Fisher & Paykel Healthcare, Ltd.2013-05-30
Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m recall (Z-0621-2013)Fisher & Paykel Healthcare, Ltd.2013-01-03
Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001 recall (Z-0485-2007)Fisher & Paykel Healthcare Ltd2007-01-11

Track Fisher & Paykel Healthcare, Ltd. automatically

Every clearance here is in the API, with alerts when new ones post.