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Respironics, Inc.

53 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides recall (Z-2024-2012)Respironics, Inc.2012-07-23
Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institutio recall (Z-0296-2012)Respironics, Inc.2012-01-11
Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respiro recall (Z-1896-2010)Respironics, Inc.2010-06-24
SmartMonitor 2 Infant Apnea Monitor. The monitor is intended for use in the continuous mon recall (Z-1411-2009)Respironics, Inc.2009-05-19
PLV-100 Portable Lifecare Ventilator Life support ventilation The device is intended to me recall (Z-2344-2008)Respironics, Inc.2008-09-18
Power Board Kit for use with the PLV-100 Portable Lifecare repairs recall (Z-2345-2008)Respironics, Inc.2008-09-18
BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask, and/or accessories for sl recall (Z-1055-2008)Respironics, Inc.2008-04-24
Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model numb recall (Z-1056-2008)Respironics, Inc.2008-04-24
Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electr recall (Z-1057-2008)Respironics, Inc.2008-04-24
Inv Circuit Assembly Box 10 CE model number 652002. Filter, mask, and/or accessories for s recall (Z-1058-2008)Respironics, Inc.2008-04-24
M Series Heated Humidifier Domestic model number 1022257. Filter, mask, and/or accessories recall (Z-1059-2008)Respironics, Inc.2008-04-24
Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or accessories for slee recall (Z-1060-2008)Respironics, Inc.2008-04-24
Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories for sleep th recall (Z-1061-2008)Respironics, Inc.2008-04-24
PLV-102, 100V 50/60 HZ Japanese model number 87006. Filter, mask, and/or accessories for s recall (Z-1062-2008)Respironics, Inc.2008-04-24
Power Cord Accessory under the following brand names a) Power Cord W/C7 End Europe 5 ft mo recall (Z-1063-2008)Respironics, Inc.2008-04-24
Non-continuous ventilators accessories under the following brand names: a) REM Auto M. w/H recall (Z-1064-2008)Respironics, Inc.2008-04-24
Non-continuous ventilator accessories under the following brand names: a) REMStar (Tower) recall (Z-1065-2008)Respironics, Inc.2008-04-24
REMStar Heated Humidifier Pkg model number 1005792. Filter, mask, and/or accessories for s recall (Z-1066-2008)Respironics, Inc.2008-04-24
Non-continuous ventilator accessories under the following brand names: a) REMStar M US mod recall (Z-1067-2008)Respironics, Inc.2008-04-24
Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M U recall (Z-1068-2008)Respironics, Inc.2008-04-24
Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Dom recall (Z-1069-2008)Respironics, Inc.2008-04-24
Rotating Connector Packaged model number 302209. Filter, mask, and/or accessories for slee recall (Z-1070-2008)Respironics, Inc.2008-04-24
Non-continuous ventilator accessories under the following brand names: a) RP-L ComfortGel recall (Z-1071-2008)Respironics, Inc.2008-04-24
RP M Series Pollen Filter Kit 1 pack model number 1035443. Filter, mask, and/or accessorie recall (Z-1072-2008)Respironics, Inc.2008-04-24
Non-continuous ventilator accessories under the following brand names: a) RP-P ComfortGel recall (Z-1073-2008)Respironics, Inc.2008-04-24
Power Supply under the following brand names: a) RP, Power Supply Assembly model number H3 recall (Z-1074-2008)Respironics, Inc.2008-04-24
RP-Assy, Cover, DC-5 pack model number F35933. Filter, mask, and/or accessories for sleep recall (Z-1075-2008)Respironics, Inc.2008-04-24
Non-continuous ventilator accessories under the following brand names: a) RP-BIPAP Flow Pi recall (Z-1076-2008)Respironics, Inc.2008-04-24
RP-Cable DC 6 w/Ring PLV RBL POR model number FC07270. Filter, mask, and/or accessories fo recall (Z-1077-2008)Respironics, Inc.2008-04-24
RP C-Flex Mini Din Plug model number 1011220. Filter, mask, and/or accessories for sleep t recall (Z-1078-2008)Respironics, Inc.2008-04-24
Non-continuous ventilator accessories under the following brand names: a) RP-ComfortGel Ge recall (Z-1079-2008)Respironics, Inc.2008-04-24
RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or accessories for sleep t recall (Z-1080-2008)Respironics, Inc.2008-04-24
RP Duet LX/Pro Out Port w/Seal model number 622239. Filter, mask, and/or accessories for s recall (Z-1081-2008)Respironics, Inc.2008-04-24
RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or accessories for sleep recall (Z-1082-2008)Respironics, Inc.2008-04-24
RP-REM Auto w/C-FLEX/REM Pro Tubing Kit model number 1008492 and RP-REM Power Cord N. AMER recall (Z-1083-2008)Respironics, Inc.2008-04-24
RP-REMStar Plus Keypad model number 1006852. Filter, mask, and/or accessories for sleep th recall (Z-1084-2008)Respironics, Inc.2008-04-24
Continuous ventilator accessories under the following brand names: a) RP-Seal, Spring-5 pk recall (Z-1085-2008)Respironics, Inc.2008-04-24
APNEA monitor accessories under the following brand names: a) SM 2 PS/PSL, Prof. Operators recall (Z-1086-2008)Respironics, Inc.2008-04-24
Breathing Frequency Monitor Stardust 2 Domestic model number 1025720. Filter, mask, and/or recall (Z-1087-2008)Respironics, Inc.2008-04-24
Non-continuous ventilators under the following brand names: a) Sync S/T Lab, w/o modem US/ recall (Z-1088-2008)Respironics, Inc.2008-04-24
Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or accessories for recall (Z-1089-2008)Respironics, Inc.2008-04-24
ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or accessories for s recall (Z-1090-2008)Respironics, Inc.2008-04-24
Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or accessories fo recall (Z-1091-2008)Respironics, Inc.2008-04-24
Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for sleep ther recall (Z-1092-2008)Respironics, Inc.2008-04-24
Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or accessories for sl recall (Z-1093-2008)Respironics, Inc.2008-04-24
REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1 recall (Z-0446-2007)Respironics, Inc.2007-01-10
REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265 recall (Z-0447-2007)Respironics, Inc.2007-01-10
NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310 recall (Z-1191-06)Respironics, Inc.2006-07-01
NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous) recall (Z-0717-06)Respironics, Inc.2006-04-07
Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Seri recall (Z-1220-04)Respironics, Inc.2004-07-27
ComfortGel Nasal Mask size small recall (Z-0178-04)Respironics, Inc.2003-12-10
ComfortGel Nasal Mask size medium recall (Z-0179-04)Respironics, Inc.2003-12-10
ComfortGel Nasal Mask size large recall (Z-0180-04)Respironics, Inc.2003-12-10

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Every clearance here is in the API, with alerts when new ones post.