274 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code JAK·June 28, 2018
Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253
FDA Enforcement
Class II
·Terminated·Bayer Medical Care, Inc.·September 12, 2018
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
FDA Enforcement
Class II
·Terminated·Bayer Medical Care, Inc.·September 12, 2018
Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
FDA Recall
Terminated
·Bayer Medical Care, Inc.·Product code JAK·June 28, 2018
Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD
FDA Recall
Terminated
·Puritan Bennett Corporation·Product code MNT·August 31, 2006
BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
FDA Recall
Terminated
·Philips Respironics, Inc.·Product code MNT·April 6, 2021
Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
MVP-10 Pediatric/ Neonatal Volume Ventilator
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code MNT·November 7, 2003
Inv Circuit Assembly Box 10 CE model number 652002. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
FDA Recall
Terminated
·Respironics, Inc.·Product code MNT·October 15, 2007
Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Recall
Terminated
·Respironics California, LLC·Product code MNT·October 30, 2020
V60 Ventilator, Continuous Ventilator, Model# V60, PN 1056490 Product Usage: The V60 Ventilator is an assist Ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with respiratory failure, respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician. The V60 Ventilator is intended to support pediatric patients weighing 20kg (44 Ibs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. It is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.
FDA Recall
Terminated
·Respironics California Inc·Product code MNT·July 31, 2012
RESPIRONICS V60 VENTILATOR
FDA Recall
Terminated
·Respironics California Inc·Product code MNT·October 26, 2009
Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.
FDA Recall
Terminated
·Respironics California Inc·Product code MNT·July 2, 2010