9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
IRON PROCEDURE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SureSigns VM1
FDA UDI
Philips Medical Systems Hsg·00884838009691·SureSigns VM1 Patient Monitor: Sp02, C02, Recorder
Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument
FDA 510(k)
FDA Class 2
·Microbiology
3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC
FDA 510(k)
FDA Class 2
·Radiology
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2014
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·October 9, 2010
CAREASSIST BED
FDA Adverse Event
Malfunction
·HILL-ROM PLUVIGNER·Product code FNL·November 1, 2012
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·June 17, 2020
Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designed for fast and intuitive operation.
FDA Recall
Terminated
·Philips North America, LLC·Product code DPS·May 19, 2020