9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ENZYGNOST ANTI-VZV IGG TEST
FDA 510(k)
FDA Class 2
·Microbiology
SureSigns VM8SE
FDA UDI
Philips Medical Systems Hsg·00884838050464·SureSigns VM8 Special Edition Patient Monitor
DISP. HYPERINFLATION BAG SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
ELECTROmatic
FDA 510(k)
FDA Class 1
·Dental
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2014
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 9, 2010
INTEGRITY RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MAF·December 10, 2012
Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature
FDA Enforcement
Class II
·Ongoing·Philips Electronics North America Corporation·August 29, 2018
Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 863287 863288 863289 The SureSigns VM4, VM6, and VM8 patient monitors are for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Standard and optional parameters include: " ECG " Respiration " NBP " S2pO " IBP " CO2 " Temperature
FDA Recall
Open, Classified
·Philips Electronics North America Corporation·Product code MHX·July 13, 2018