Respironics, Inc. - FDA 510(k) Cleared Devices
172
Total
168
Cleared
0
Denied
172 devices
Cleared
Jan 22, 2010
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
Anesthesiology
130d
Cleared
Aug 05, 2009
BIPAP SYNCHRONY 2
Anesthesiology
30d
Cleared
Jul 23, 2009
OMNI 5 TOTAL O2 DELIVERY SYSTEM
Anesthesiology
104d
Cleared
May 15, 2009
RESPIRONICS SLEEPEASY CPAP SYSTEM
Anesthesiology
28d
Cleared
Mar 25, 2009
COMFORTLITE NASAL MASK
Anesthesiology
202d
Cleared
Nov 25, 2008
ENTERAL ONLY EXTENSION SET
Gastroenterology & Urology
74d
Cleared
Sep 19, 2008
GOLOX-93
Anesthesiology
88d
Cleared
Jul 28, 2008
HOMELOX
Anesthesiology
90d
Cleared
Mar 20, 2008
RESPIRONICS GOLOX
Anesthesiology
176d
Cleared
Dec 27, 2007
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM
Anesthesiology
64d
Cleared
Feb 22, 2007
BIPAP AUTOSV
Anesthesiology
90d
Cleared
Feb 20, 2007
BIPAP SYNCHRONY
Anesthesiology
90d
Cleared
Sep 22, 2006
ACTICAL
Neurology
171d
Cleared
Aug 31, 2006
VITALSENSE XHR
Neurology
59d
Cleared
Aug 02, 2006
SMARTMONITOR 2PS
Anesthesiology
90d
Cleared
Jun 28, 2006
L4 OXYGEN CONCENTRATOR
Anesthesiology
54d
Cleared
Jun 23, 2006
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
Anesthesiology
70d
Cleared
Feb 15, 2006
COMFORTLITE NASAL MASK
Anesthesiology
75d
Cleared
Dec 13, 2005
STARDUST II
Anesthesiology
85d
Cleared
Oct 20, 2005
M-SERIES PRO CPAP SYTEM
Anesthesiology
77d
Cleared
Sep 27, 2005
ACTIHEART
Neurology
15d
Cleared
Jun 15, 2005
BIPAP AUTO
Anesthesiology
83d
Cleared
Apr 11, 2005
PLIX
Anesthesiology
52d
Cleared
Feb 11, 2005
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
Anesthesiology
102d
Cleared
Jan 28, 2005
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
Anesthesiology
29d
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