Medical Device Manufacturer · US , Poway , CA

Resmed, Ltd.

103 submissions · 103 cleared · Since 1996
103
Total
103
Cleared
0
Denied

Resmed, Ltd. — FDA 510(k) Submissions

Resmed, Ltd. has submitted 103 FDA 510(k) premarket notifications since 1996, of which 103 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ventilator, Non-continuous (respirator), Ventilator, Continuous, Non-life-supporting, Ventilator, Continuous, Facility Use, Humidifier, Respiratory Gas, (direct Patient Interface), Ventilator, Continuous, Minimal Ventilatory Support, Facility Use . Use the specialty filter in the sidebar to narrow results.

103 devices
1–25 of 103
Moore Park Mask
K183512 · BZD Ventilator,... · Anesthesiology
May 2019 140d
Scone Mask
K180497 · BZD Ventilator,... · Anesthesiology
Jun 2018 109d
Astral 100/150
K172875 · CBK Ventilator, Continuous,... · Anesthesiology
Apr 2018 217d
AirFit F20
K170924 · BZD Ventilator,... · Anesthesiology
Jan 2018 280d
AirFit N20
K171212 · BZD Ventilator,... · Anesthesiology
Sep 2017 156d
Juno VPAP ST-A
K161492 · MNS Ventilator, Continuous,... · Anesthesiology
Jan 2017 232d
Menai System
K160836 · BZD Ventilator,... · Anesthesiology
Dec 2016 265d
AirFit N20
K161978 · BZD Ventilator,... · Anesthesiology
Nov 2016 122d
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
K160822 · BZD Ventilator,... · Anesthesiology
Sep 2016 169d
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
K161487 · MNS Ventilator, Continuous,... · Anesthesiology
Sep 2016 101d
Astral 100/150
K152068 · CBK Ventilator, Continuous,... · Anesthesiology
May 2016 294d
AirFit F20
K153563 · BZD Ventilator,... · Anesthesiology
May 2016 151d
AirFit N20
K153673 · BZD Ventilator,... · Anesthesiology
May 2016 133d
Juno VPAP ST-A
K153061 · MNS Ventilator, Continuous,... · Anesthesiology
Apr 2016 175d
AirView
K151901 · CBK Ventilator, Continuous,... · Anesthesiology
Nov 2015 118d
Darlinghurst Vented, Darlinghurst NV-AAV
K143603 · BZD Ventilator,... · Anesthesiology
May 2015 154d
S9 GREENHILLS
K140279 · BZD Ventilator,... · Anesthesiology
Jul 2014 178d
S9 WANDA VPAP ST
K140159 · BZD Ventilator,... · Anesthesiology
Jun 2014 146d
AIRSOFT F15
K132901 · BZD Ventilator,... · Anesthesiology
Jun 2014 266d
ASTRAL VENTILATOR
K133868 · CBK Ventilator, Continuous,... · Anesthesiology
Jun 2014 166d
RESCAN
K140054 · BZD Ventilator,... · Anesthesiology
May 2014 127d
S9 CRONULLA FOR HER
K132606 · BZD Ventilator,... · Anesthesiology
Jan 2014 146d
AIRFIT N10
K132887 · BZD Ventilator,... · Anesthesiology
Dec 2013 95d
EASYCARE ONLINE
K132371 · MNS Ventilator, Continuous,... · Anesthesiology
Nov 2013 115d
SWIFT AIR
K132013 · BZD Ventilator,... · Anesthesiology
Oct 2013 112d

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