Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

103 results for "Resmed, Ltd."
1–24 of 103
Search insights Median review: 109d Cleared: 100% Top manufacturer: Resmed, Ltd. Lead specialty: Anesthesiology
Cleared May 07, 2019
Moore Park Mask
K183512 · BZD
Resmed, Ltd.
Anesthesiology · 140d
Cleared Jun 15, 2018
Scone Mask
K180497 · BZD
Resmed, Ltd.
Anesthesiology · 109d
Cleared CT Apr 26, 2018
Astral 100/150
K172875 · CBK
Resmed, Ltd.
Anesthesiology · 217d
Cleared Jan 03, 2018
AirFit F20
K170924 · BZD
Resmed, Ltd.
Anesthesiology · 280d
Cleared Sep 28, 2017
AirFit N20
K171212 · BZD
Resmed, Ltd.
Anesthesiology · 156d
Cleared CT Jan 19, 2017
Juno VPAP ST-A
K161492 · MNS
Resmed, Ltd.
Anesthesiology · 232d
Cleared CT Dec 15, 2016
Menai System
K160836 · BZD
Resmed, Ltd.
Anesthesiology · 265d
Cleared Nov 17, 2016
AirFit N20
K161978 · BZD
Resmed, Ltd.
Anesthesiology · 122d
Cleared CT Sep 09, 2016
VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
K161487 · MNS
Resmed, Ltd.
Anesthesiology · 101d
Cleared Sep 09, 2016
S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV
K160822 · BZD
Resmed, Ltd.
Anesthesiology · 169d
Cleared May 13, 2016
AirFit F20
K153563 · BZD
Resmed, Ltd.
Anesthesiology · 151d
Cleared May 13, 2016
Astral 100/150
K152068 · CBK
Resmed, Ltd.
Anesthesiology · 294d
Cleared May 02, 2016
AirFit N20
K153673 · BZD
Resmed, Ltd.
Anesthesiology · 133d
Cleared Apr 13, 2016
Juno VPAP ST-A
K153061 · MNS
Resmed, Ltd.
Anesthesiology · 175d
Cleared Nov 05, 2015
AirView
K151901 · CBK
Resmed, Ltd.
Anesthesiology · 118d
Cleared May 21, 2015
Darlinghurst Vented, Darlinghurst NV-AAV
K143603 · BZD
Resmed, Ltd.
Anesthesiology · 154d
Cleared Jul 31, 2014
S9 GREENHILLS
K140279 · BZD
Resmed, Ltd.
Anesthesiology · 178d
Cleared Jun 17, 2014
S9 WANDA VPAP ST
K140159 · BZD
Resmed, Ltd.
Anesthesiology · 146d
Cleared Jun 09, 2014
AIRSOFT F15
K132901 · BZD
Resmed, Ltd.
Anesthesiology · 266d
Cleared Jun 04, 2014
ASTRAL VENTILATOR
K133868 · CBK
Resmed, Ltd.
Anesthesiology · 166d
Cleared May 16, 2014
RESCAN
K140054 · BZD
Resmed, Ltd.
Anesthesiology · 127d
Cleared CT Jan 13, 2014
S9 CRONULLA FOR HER
K132606 · BZD
Resmed, Ltd.
Anesthesiology · 146d
Cleared Dec 20, 2013
AIRFIT N10
K132887 · BZD
Resmed, Ltd.
Anesthesiology · 95d
Cleared Nov 22, 2013
EASYCARE ONLINE
K132371 · MNS
Resmed, Ltd.
Anesthesiology · 115d