31 results
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48ms
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Sources: EU EUDAMED, US FDA
PyloPlus+ Rapid Urease Test
FDA UDI
Arj Medical, Inc.·00860001810394·
PyloPlus+ Urea Breath Test Lab Analyzer
FDA UDI
Arj Medical, Inc.·00860001810387·
PyloPlus+ Urea Breath Test Pro Analyzer
FDA UDI
Arj Medical, Inc.·00860001810370·
PyloPlus+ Urea Breath Test Analyzer
FDA UDI
Arj Medical, Inc.·00860001810363·
PyloPlus+ Urea Breath Test Kit
FDA UDI
Arj Medical, Inc.·00860001810325·
ENTERPRISE 8000X
FDA Adverse Event
Malfunction
·ARJOHUNTLEIGH POLSKA SP. Z O.O.·Product code FNL·August 17, 2016
THERMOFLO NEO
FDA Adverse Event
Malfunction
·ARC MEDICAL, INC.·Product code BYD·August 6, 2012
6060A
FDA UDI
ARC MEDICAL INC.·00850015328053·
6120A
FDA UDI
ARC MEDICAL INC.·00850015328008·
6126A
FDA UDI
ARC MEDICAL INC.·00850015328015·
7056A
FDA UDI
ARC MEDICAL INC.·00850015328039·
6070A
FDA UDI
ARC MEDICAL INC.·00850015328060·
6000A
FDA UDI
ARC MEDICAL INC.·00850015328046·
6130A
FDA UDI
ARC MEDICAL INC.·00850015328022·
THERMOFLO FILTER PORT
FDA Adverse Event
Injury
·ARC MEDICAL, INC.·Product code JOJ·December 5, 2003
THERMOFLO FILTER
FDA Adverse Event
Death
·ARC MEDICAL, INC.·Product code DTR·January 28, 1992
HME THERMOFLO INLINE NEO
FDA Adverse Event
Malfunction
·ARC MEDICAL INC·Product code BYD·July 2, 2012
THERMOFLO 1/2 HCH MEDIA
FDA Adverse Event
Death
·ARC MEDICAL INC.·Product code BYD·August 22, 2001
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
FDA Recall
Terminated
·Arc Medical Inc·Product code BYD·February 19, 2015
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
FDA Enforcement
Class III
·Terminated·Arc Medical Inc·May 20, 2015