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505 FDA 510(k) clearances · Product code

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RecordFirmDate
HAMILTON-C2 (K102775)Hamilton Medical AG2011-01-21
V200 VENTILATOR (K102054)Respironics California, Inc.2010-12-22
NEUMOVENT GRAPHNET MODEL 3179L1V (K101401)Tecme S.A.2010-12-07
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK (K101129)Respironics, Inc.2010-09-16
NEWPORT E360 VENTILATOR (K101803)Newport Medical Instruments, Inc.2010-09-08
FLIGHT 60 VENTILATOR, MODEL F-60 (K100753)Flight Medical , Ltd.2010-08-20
TRILOGY 202 VENTILATOR (K093905)Respironics, Inc.2010-05-12
VELA VENTILATOR (K093094)Cardinal Health 207, Inc.2010-05-11
ENGSTROM CARESTATION, ENGSTROM PRO (K093886)Datex-Ohmeda Inc., A Division of Instrumentarium C2010-05-03
INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE (K093632)Drager Medical AG & Co. Kgaa2010-04-05
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE (K093633)Draegerwerk AG & CO Kgaa2010-03-30
840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION (K092847)Covidien, Formerly Nellcor Puritan Bennett, Inc.2010-03-11
HAMILTON-C2 (K092148)Hamilton Medical AG2010-03-04
TRILOGY 200 VENTILATOR (K093416)Respironics, Inc.2010-01-29
ENDURAVENT-5 VENTILATOR (K092263)Providence Global Medical, Inc.2010-01-21
RESPIRONICS PERFORMAX SE TOTAL FACE MASK (K092648)Respironics Inc., Sleep & Home Respiratory Group2009-12-18
ATLANTIS HYPERBARIC CHAMBER VENTILATOR (K092264)Providence Global Medical, Inc.2009-12-17
MODIFICATION TO IVENT 101 (K092135)Versamed Medical Systems , Ltd.2009-11-23
NEWPORT HT70 FAMILY OF VENTILATORS (K090888)Newport Medical Instruments, Inc.2009-11-18
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+ (K091238)Impact Instrumentation, Inc.2009-08-13
HAMILTON-C2 (K090468)Hamilton Medical AG2009-06-15
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 (K083693)Covidien, Formerly Nellcor Puritan Bennett, Inc.2009-04-02
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR (K083688)Pulmonetic Systems, Inc.2009-03-18
IVENT101 (K081845)Versamed Medical Systems, Inc.2009-03-16
TRILOGY 100 VENTILATOR (K083526)Respironics Inc., Sleep & Home Respiratory Group2009-03-13
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041 (K083122)Fisher & Paykel Healthcare, Ltd.2009-03-04
NEPTUNE HYPERBARIC VENTILATOR (K082351)Level-5, Inc.2009-01-02
EVITE XL (K083050)Draeger Medical AG & Co. KG2008-12-29
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM (K082724)Newport Medical Instruments, Inc.2008-12-16
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV (K071526)Impact Instrumentation, Inc.2008-12-10
OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082) (K082600)Draeger Medical B.V.2008-11-26
PB 540 VENTILATOR (K082966)Covidien, Formerly Nellcor Puritan Bennett, Inc.2008-10-31
HELONTIX VENT (K072926)Linde Gas Therapeutics2008-10-15
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK (K081670)Cardinal Health 207, Inc.2008-10-09
ENGSTROM CARESTATION, ENGSTROM PRO (K081842)Datex-Ohmeda, Inc.2008-10-03
MODIFICATION TO HAMILTON-G5 (K081521)Hamilton Medical AG2008-09-25
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS (K081743)Draeger Medical AG & Co. KG2008-09-22
AVEA VENTILATOR (K081837)Cardinal Health 207, Inc.2008-08-13
MODIFICATION TO GALILEO GOLD (K080181)Hamilton Medical AG2008-06-24
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 (K073179)Maquet Critical Care AB2008-06-09
IVENT 2001 MRI CONDITIONAL (K073694)Versamed Medical Systems, Inc.2008-05-30
CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 (K072885)Draeger Medical AG & Co. KG2008-04-07
OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500 (K072412)Drager Medical AG & Co. Kgaa2008-02-06
MODIFICATION TO AVEA VENTILATOR (K073069)Viasys Respiratory Care, Inc.2008-01-25
INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM (K072590)Event Medical, Inc.2008-01-04
PERFORMAX SE TOTAL FACE MASK (K072588)Respironics Inc., Sleep & Home Respiratory Group2007-12-18
PURITAN BENNETT LEGENDAIR XL2 (K070899)Nellcor Puritan Bennett2007-12-13
ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 (K072450)Respironics California, Inc.2007-12-12
HAMILTON-G5 (K070513)Hamilton Medical AG2007-11-26
RAPHAEL COLOR ASV VENTILATOR (K071194)Hamilton Medical AG2007-10-18
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 (K070594)Pulmonetic Systems, Inc.2007-08-01
ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 (K071212)Respironics California, Inc.2007-07-30
SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED (K063806)Sleepnet Corporation2007-05-17
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 (K063650)Puritan Bennett Corp.2007-02-15
SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800 (K063404)Maquet Critical Care AB2007-02-15
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION (K062793)Maquet Critical Care AB2007-02-07
GE DATEX-OHMEDA ENGSTROM CARESTATION (K062710)Datex-Ohmeda, Inc.2006-12-08
OXYLOG 3000 (K062267)Drager Medical B.V.2006-10-31
AVEA VENTILATOR (K062093)Viasys Respiratory Care, Inc.2006-09-20
RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD (K062019)Innomed Technologies, Inc./Respcare, Inc.2006-08-17
NEWPORT E500 WAVE VENTILATOR (K061094)Newport Medical Instruments, Inc.2006-07-28
GALILEO GOLD ASV (K061090)Hamilton Medical AG2006-07-17
MODIFICATION TO I VENT 201 (K061627)Versamed Medical Systems, Inc.2006-06-29
CARINA HOME (K060705)Draeger Medical B.V.2006-06-14
GE DATEX-OHMEDA ENGSTROM CARESTATION (K060862)Datex-Ohmeda, Inc.2006-06-05
LTV 1200 VENTILATOR (K060647)Pulmonetic Systems, Inc.2006-05-25
AUTOMOBILE LIGHTER POWER CORD (K060549)Pulmonetic Systems, Inc.2006-05-04
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION (K053388)Puritan Bennett Corp.2006-04-04
IVENT 201 (K053270)Versamed Medical Systems, Inc.2006-01-27
NEWPORT E360 VENTILATOR (K053502)Newport Medical Instruments, Inc.2006-01-10
RAPHAEL COLOR (K052863)Hamilton Medical AG2006-01-06
GE DATEX-OHMEDA ENGSTROM CARESTATION (K051895)Datex-Ohmeda, Inc.2005-09-27
AV-S ANAESTHESIA VENTILATOR (K051222)Penlon Limited2005-09-23
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR (K052554)Versamed Medical Systems, Inc.2005-09-23
LTV 1000 VENTILATOR (K051767)Pulmonetic Systems, Inc.2005-07-29
EVITAXL WITH OPTION SMARTCARE (K051263)Drager Medical AG & Co. Kgaa2005-07-12
INSPIRATION VENTILATOR SYSTEM (K051550)eVent Medical, Ltd.2005-07-12
ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 (K051262)Respironics California, Inc.2005-07-08
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR (K050860)Datex-Ohmeda, Inc.2005-06-21
GE DATEX-OHMEDA ENGSTROM CARESTATION (K050597)Datex-Ohmeda, Inc.2005-03-25
MODIFICATION TO: PNEUTON VENTILATOR (K043085)Airon Corporation2004-12-20
IVENT 201 PORTABLE VENTILATOR (K042468)Versamed Medical Systems, Inc.2004-11-17
GALILEO GOLD (K040574)Hamilton Medical, Inc.2004-10-27
GE DATEX-OHMEDA ENGSTROM CARESTATION (K041775)Datex-Ohmeda, Inc.2004-10-26
CLARISSA INFANT NCPAP CANNULA (K032922)Airways Ltd., Inc.2004-09-22
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM (K041524)Datex-Ohmeda, Inc.2004-09-20
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K041223)Maquet Critical Care AB2004-07-29
ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 (K041412)Respironics California, Inc.2004-06-18
MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS (K040790)Pulmonetic Systems, Inc.2004-06-03
LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA (K040642)Draeget Medical AG & Co. Kgaa2004-06-02
MODIFICATION TO LTV 1000 VENTILATOR (K040540)Pulmonetic Systems, Inc.2004-04-29
BIRD TBIRD VELA VENTILATOR (K032451)Bird Products Corp.2004-03-17
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K040221)Maquet Critical Care AB2004-02-20
NEWPORT E500 WAVE VENTILATOR (K030780)Newport Medical Instruments, Inc.2004-01-23
ESPRIT VENTILATOR, MODEL V1000 (K034040)Respironics, Inc.2004-01-21
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM (K030341)eVent Medical, Ltd.2004-01-16
RAPHAEL (K022679)Hamilton Medical AG2003-10-22
LTV-1000 VENTILATOR (K032226)Pulmonetic Systems, Inc.2003-10-16
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS (K023366)Datex-Ohmeda, Inc.2003-10-07
PNEUTON VENTILATOR (K024344)Airon Corporation2003-06-03
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