39 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·February 20, 2013
GE Healthcare Millennium MC
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·November 21, 2018
GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·November 21, 2018
GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·November 21, 2018
GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·February 20, 2013
GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·March 5, 2014
Giraffe OmniBed¿ and Giraffe Incubator p/n 6600-0723-700 (rev A and B) labeled in part: ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 U.S.A. www.gehealthcare.com***. GE Healthcare Giraffe Omnibed is a combination of an infant incubator and an infant warmer.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·April 17, 2013
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product Usage: The T-Piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·March 5, 2014
GE Healthcare - Giraffe and Panda Bag and Mask Resuscitation System;Giraffe Stand-alone Infant Resuscitation System. Product Usage: The Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant. These are clinical practices that represent the established standard of care.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·March 5, 2014
CARESCAPE Respiratory Module E-sCAiOV
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 22, 2020
CARESCAPE Respiratory Module E-sCO
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 22, 2020
Carestation 620/650/650c A2 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 29, 2020
Airway Gas Option N-CAiO
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 22, 2020
Carestation 620/650/650c A1 Product Usage: anesthesia systems are intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (pediatric and adult.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 29, 2020
CARESCAPE Respiratory Module E-sCOVX
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 22, 2020
CARESCAPE Respiratory Module E-sCAiOVE
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 22, 2020
CARESCAPE Respiratory Module E-sCAiO
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 22, 2020
CARESCAPE Respiratory Module E-sCAiOE
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 22, 2020
GE Healthcare, Aestiva/5 7900 SmartVent, anesthesia machine. Used in Datex-Ohmeda Aestiva/5 Anesthesia Systems.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·June 27, 2012
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·January 2, 2013