Medical Device Manufacturer · US , Poway , CA

Resmed, Ltd. - FDA 510(k) Cleared Devices

103 submissions · 103 cleared · Since 1996
103
Total
103
Cleared
0
Denied
103 devices
51-75 of 103
Cleared Aug 03, 2009
QUATTRO LT
K091129 · BZD
Anesthesiology · 105d
Cleared Apr 13, 2009
SWIFT FX
K090244 · BZD
Anesthesiology · 70d
Cleared Mar 20, 2009
RES TRAXX ONLINE, MODEL: R14
K083816 · BZD
Anesthesiology · 88d
Cleared Jan 13, 2009
VPAP AUTO WITH HUMIDAIRE 3I
K082605 · BZD
Anesthesiology · 127d
Cleared Jan 02, 2009
S8 ADVANCE
K082979 · BZD
Anesthesiology · 88d
Cleared Jan 02, 2009
RESSCAN-PRO
K082983 · BZD
Anesthesiology · 88d
Cleared Oct 09, 2008
MODIFICATION TO MIRAGE MICRO
K081321 · BZD
Anesthesiology · 150d
Cleared Jul 09, 2008
HUMIDAIRE 2I
K080797 · BTT
Anesthesiology · 111d
Cleared Apr 08, 2008
S8 ESCAPE II
K080079 · BZD
Anesthesiology · 88d
Cleared Apr 01, 2008
VPAP ST
K080131 · BZD
Anesthesiology · 74d
Cleared Mar 20, 2008
SWIFT LT
K073638 · BZD
Anesthesiology · 85d
Cleared Jan 04, 2008
TXCONTROL
K072615 · BZD
Anesthesiology · 109d
Cleared Dec 13, 2007
MIRAGE MICRO
K072940 · BZD
Anesthesiology · 57d
Cleared Oct 10, 2007
MIRAGE MICRO
K071808 · BZD
Anesthesiology · 100d
Cleared Jul 13, 2007
RESTRAXX DATA CENTRE, MODEL R10
K070746 · BZD
Anesthesiology · 116d
Cleared Jul 10, 2007
VPAP AUTO WITH H3I
K071171 · BZD
Anesthesiology · 74d
Cleared Feb 02, 2007
MIRAGE LIBERTY FULL FACE MASK
K063011 · BZD
Anesthesiology · 123d
Cleared Feb 02, 2007
MIRAGE QUATTRO FULL FACE MASK
K063122 · BZD
Anesthesiology · 113d
Cleared Sep 08, 2006
VPAP MALIBU WITH H2I
K062291 · BZD
Anesthesiology · 32d
Cleared Jul 20, 2006
PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
K061200 · BZD
Anesthesiology · 80d
Cleared Apr 07, 2006
VPAP III ST-A/KIDSTA MASK SYSTEM
K060105 · MNS
Anesthesiology · 84d
Cleared Feb 03, 2006
RES TRAXX DATA CENTER
K053205 · BZD
Anesthesiology · 79d
Cleared Aug 16, 2005
VPAP ADAPT
K051364 · MNS
Anesthesiology · 83d
Cleared Jul 15, 2005
RES TRAXX DATA CENTER
K051314 · BZD
Anesthesiology · 56d
Cleared May 10, 2005
RESSCAN
K050775 · BZD
Anesthesiology · 43d

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