14 results
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19ms
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Sources: EU EUDAMED, US FDA
ANKLE HOLDER W/ANKLE SUPPORT KIT FOR LEG HOLDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
JOBST Relief
FDA UDI
BSN MEDICAL, INC.·04042809690576·RELIEF 20-30 MM HG THIGH W/DOT BAND OPEN TOE SM...
IntelliVue MP5
FDA UDI
Philips Medizin Systeme Böblingen GmbH·00884838000230·IntelliVue MP5 Configured Patient Monitor with ...
Redemption
FDA UDI
VILEX LLC·00841731135513·3.3x650mm Ball Tip Guide Wire
MARQUEST QC-IV TONOMETER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BAKER CKMB REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INTELLIVUE MP5
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·August 12, 2015
INTELLIVUE MP5
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·December 14, 2015
TOTAL ASR FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·June 10, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS INNOVATION CENTER - SILICON VALLEY·Product code GEX·October 6, 2010
TBD
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code DXY·December 10, 2012
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment.
FDA Enforcement
Class II
·Ongoing·Philips Electronics North America Corporation·January 3, 2018
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·October 2, 2024
REUSE ELECTROCARDIGRAPHIC LEADS
FDA Adverse Event
Injury
·INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS·Product code MWI·March 8, 2022