94 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·July 26, 2023
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·May 31, 2023
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·March 23, 2022
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.
FDA Enforcement
Class I
·Terminated·GE Healthcare·February 25, 2015
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
Replacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstr¿om Carestation and Engstr¿om PRO Ventilators.
FDA Enforcement
Class I
·Ongoing·GE Healthcare, LLC·June 15, 2022
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