178 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SeQual Technologies Inc. Eclipse Oxygen System, Model 1000 Indicated for the administration of supplemental oxygen.
FDA Recall
Terminated
·Sequal Technologies Inc·Product code CAW·October 1, 2009
Rejuv O2 Home Oxygen Spa 98% + Pure, Non-pressurized Oxygen for Breathing. Benefits of Oxygen Therapy May Include: Increased Energy, Increased Mental Alertness, Increased Concentration and Memory, Increased Stamina, Improved Sleep, Relief of Stress and Anxiety. Portable Oxygen Delivery System: 98%+ pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 5 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Refill powders have a 2 year shelf life. Box Includes Reusable reaction chamber with dome assembly. 4 White Powder refills. 4 Black Powder refills. Reusable water bottle. Nasal cannula. Medium concentration mask. Canvas Carry Bag. Operating Instructions xxx, Directions: xxx, Caution: xxx, Applications: This system is designed expressly for cosmetic and nutraceutical applications. Manufactured by Oxygen Delivery Systems, LLC, 490 Mathis Airport Road, Suwanee, GA 30024.
FDA Recall
Terminated
·System 02 Inc
1090 Upper Hembree Rd
Roswell GA 300761140·Product code CAW·May 1, 2003
HomeFill Oxygen Compressor IOH200 Homefill, The serial numbers are as follows: 10JF034081, 10JF034082, 10JF034083, 10JF034084, 10JF034085, 10JF034086, 10JF034087, 10JF034088, 10JF034089, 10JF034090, 10JF034091, 10JF034092, 10JF034093, 10JF034094, 10JF034095, 10JF034096, 10JF034097, 10JF034098, 10JF034099, 10JF034100, 10JF034101, 10JF034102, 10JF034103, 10JF034104, 10JF034105, 10JF034106, 10JF034107, 10JF034108, 10JF034109, 10JF034111, 10JF034112, 10JF034113, 10JF034114, 10JF034115, 10JF034116, 10JF034117, 10JF034119, 10JF034120, 10JF034121, 10JF034122, 10JF034123, 10JF034124, 10JF034125, 10JF034126, 10JF034127, 10JF034128, 10JF034129, 10JF034130, 10JF034131, 10JF034132, 10JF034133, 10JF034134, 10JF034135, 10JF034136, 10JF034177, 10JF034178, 10JF034179, 10JF034180, 10JF034181, 10JF034182, 10JF034183, & 10JF034184. The IOH 200 Homefill is an electromechanical, prescription device designed for use in the home. Its intended function and use is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill cylinders for the patients personal ambulatory use.
FDA Recall
Terminated
·Invacare Corporation·Product code CAW·January 11, 2011
CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities.
FDA Recall
Terminated
·Caire, Inc.·Product code CAW·November 21, 2019
Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002
FDA Recall
Terminated
·Pacific Consolidated Industries LLC·Product code CAW·September 8, 2007
NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
FDA Recall
Terminated
·Nidek Medical Products Inc·Product code CAW·May 1, 2012
NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.
FDA Recall
Terminated
·Nidek Medical Products Inc·Product code CAW·May 1, 2012
INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
FDA Recall
Terminated
·Inovo, Inc·Product code CAW·July 21, 2016
Cobham AMOGS Advanced Medical Oxygen Generating System, 70309-03900-101. Concentrator, Oxygen, Molecular Sieve, S/A P/N: 70309-03900-101, Mfg P/N 3261165-0101. The firm name on the label is Carleton Life Support Systems Inc., Davenport, IA.
FDA Recall
Terminated
·Carleton Life Support Systems Inc·Product code CAW·July 24, 2009
OxySure Model 615 disposable replacement cartridges, for portable oxygen generator.
FDA Recall
Terminated
·Oxysure Systems, Inc.·Product code CAW·June 12, 2015
System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Box Includes Delivery system with Clear Base. 4 White Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry Case. Operating Instructions xxx, Directions: xxx, Caution: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.xxx, Applications: Unit is intended to provide oxygen for emergency use. Manufactured by System O2, Inc., 1090 Upper Hembree Road, Roswell, GA 30076-1140.
FDA Recall
Terminated
·System 02 Inc
1090 Upper Hembree Rd
Roswell GA 300761140·Product code CAW·May 1, 2003
Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
FDA Recall
Terminated
·Oxus America, Inc.·Product code CAW·January 14, 2013
SAROS Oxygen System Model 3000
FDA Recall
Terminated
·Caire, Inc.·Product code CAW·September 16, 2019
NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
FDA Recall
Terminated
·Nidek Medical Products Inc·Product code CAW·May 1, 2012
Portable Oxygen Generator
FDA Recall
Terminated
·Inogen, Inc·Product code CAW·August 1, 2005
Medline EndurO2 Oxygen Concentrator with Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS02; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.
FDA Recall
Terminated
·Medline Industries Inc·Product code CAW·March 4, 2008
Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.
FDA Recall
Terminated
·Invacare Corporation·Product code CAW·September 23, 2014
Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
FDA Recall
Terminated
·Invacare Corporation·Product code CAW·October 31, 2014
NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.
FDA Recall
Terminated
·Nidek Medical Products Inc·Product code CAW·May 1, 2012
Medline EndurO2 Oxygen Concentrator without Oxygen Monitor; Portable oxygen generator; Reorder Number: HCS021; Packaged in 1 unit per case; Product is an oxygen generator designed to provide oxygen to patient who has been prescribed oxygen therapy by a physician.
FDA Recall
Terminated
·Medline Industries Inc·Product code CAW·March 4, 2008