Resmed, Ltd.
Resmed, Ltd. holds FDA 510(k) medical device clearances, first cleared 1996, most recent 2019, with 11 FDA device recalls on record.
Top product codes for Resmed, Ltd.
FDA recalls by Resmed, Ltd.
10 most recent of 11- Z-2735-2026 — Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.
- Z-0536-2024 — AirFit N10 Nasal Masks and User Guide
- Z-0539-2024 — AirFit N20 Nasal Mask and User Guide
- Z-0540-2024 — AirTouch N20 Nasal Mask and User Guide
- Z-0537-2024 — AirFit F20 Full Face Mask and User Guide
- Z-0541-2024 — AirFit F30 Full Face Mask and User Guide
- Z-0538-2024 — AirTouch F20 Full Face Mask and User Guide
- Z-0542-2024 — AirFit F30i Full Face Mask and User Guide
- Z-0111-2024 — Astral 100 and Astral 150 ventilators
- Z-0915-2020 — ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Resmed, Ltd.
1–100 of 103- K183512 — Moore Park Mask
- K180497 — Scone Mask
- K172875 — Astral 100/150
- K170924 — AirFit F20
- K171212 — AirFit N20
- K161492 — Juno VPAP ST-A
- K160836 — Menai System
- K161978 — AirFit N20
- K160822 — S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
- K161487 — VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
- K152068 — Astral 100/150
- K153563 — AirFit F20
- K153673 — AirFit N20
- K153061 — Juno VPAP ST-A
- K151901 — AirView
- K143603 — Darlinghurst Vented, Darlinghurst NV-AAV
- K140279 — S9 GREENHILLS
- K140159 — S9 WANDA VPAP ST
- K132901 — AIRSOFT F15
- K133868 — ASTRAL VENTILATOR
- K140054 — RESCAN
- K132606 — S9 CRONULLA FOR HER
- K132887 — AIRFIT N10
- K132371 — EASYCARE ONLINE
- K132013 — SWIFT AIR
- K123789 — SWIFT FX NANO
- K123511 — S9 VPAP TX
- K123557 — EASYCARE ONLINE
- K123979 — QUATTRO AIR
- K122324 — VPAP S-A
- K121705 — GEO
- K113714 — VPAP TX
- K113780 — EASYCARE TX SYSTEM (CONNEXUNS)
- K113288 — VPAP ST-A
- K113815 — RESSCAN
- K113127 — MIRAGE QUATTRO
- K112914 — VPAP TX
- K112489 — SWIFT FX BELLA
- K112393 — TASMAN
- K102586 — S9 VPAP ADAPT WITH H5I
- K110444 — MIRAGE MICRO
- K102513 — S9 VPAP ST WITH H5I
- K102746 — MIRAGE FX
- K102224 — PIXI PEDIATRIC MASK
- K100772 — MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)
- K093731 — VPAP III ST-A
- K093684 — EASYCARE ONLINE
- K092186 — VPAP TX
- K092026 — EASYCARE TX, TX LINK
- K091947 — S8 ASPEN WITH H4I PLUS
- K091129 — QUATTRO LT
- K090244 — SWIFT FX
- K083816 — RES TRAXX ONLINE, MODEL: R14
- K082605 — VPAP AUTO WITH HUMIDAIRE 3I
- K082979 — S8 ADVANCE
- K082983 — RESSCAN-PRO
- K081321 — MODIFICATION TO MIRAGE MICRO
- K080797 — HUMIDAIRE 2I
- K080079 — S8 ESCAPE II
- K080131 — VPAP ST
- K073638 — SWIFT LT
- K072615 — TXCONTROL
- K072940 — MIRAGE MICRO
- K071808 — MIRAGE MICRO
- K070746 — RESTRAXX DATA CENTRE, MODEL R10
- K071171 — VPAP AUTO WITH H3I
- K063011 — MIRAGE LIBERTY FULL FACE MASK
- K063122 — MIRAGE QUATTRO FULL FACE MASK
- K062291 — VPAP MALIBU WITH H2I
- K061200 — PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
- K060105 — VPAP III ST-A/KIDSTA MASK SYSTEM
- K053205 — RES TRAXX DATA CENTER
- K051364 — VPAP ADAPT
- K051314 — RES TRAXX DATA CENTER
- K050775 — RESSCAN
- K050359 — ULTRA MIRAGE II MASK
- K050142 — RESMED MERIDIAN MASK
- K042403 — MIRAGE SWIFT
- K041362 — RESMED HOSPITAL FULL FACE MASK
- K041209 — RESMED S8 PIONEER CPAP SYSTEM
- K033276 — VPAP III ST-A
- K040944 — RESCONTROL II
- K034033 — RESCAN
- K033914 — OXYGEN DIVERTER VALVE
- K040566 — RESMED HOSPITAL NASAL MASK
- K033841 — RESMED S8 PRIME CPAP SYSTEM
- K032916 — MIRAGE ACTIVA MASK
- K032433 — NASAL JACKS MASK
- K032480 — AUTOSET SPIRIT SYSTEM
- K031047 — MIRAGE VISTA MASK
- K030843 — VPAP III
- K024191 — S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
- K030798 — MIRAGE ACTIVA MASK
- K023244 — MIRAGE FULL FACE MASK SERIES 2
- K023284 — MIRAGE FULL FACE MASK SERIES 2
- K023306 — MIRAGE FULL FACE MASK SERIES 2
- K984428 — SULLIVAN AUTOSET NASAL CPAP SYSTEM
- K982530 — SULLIVAN MIRAGE FULL FACE MASK
- K980721 — SULLIVAN AUTOSET
- K974539 — SULLIVAN VPAP II ST VENTILATORY SUPPORT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.