16 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR
FDA 510(k)
FDA Class 3
·Cardiovascular
LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·September 25, 2018
EVONOS
FDA UDI
Gyrus ACMI, LLC·00821925012325·MCGEE INSTRUMENT CASE STAINLESS STEEL
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450315705·
COUGAR LS LATERAL CAGE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
FDA 510(k)
FDA Class 2
·Neurology
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·August 8, 2016
TRAUMA STRETCHER
FDA Adverse Event
Malfunction
·HILLROM DE MEXICO S DE RL DE CV·Product code FPO·March 26, 2013
UNKNOWN ZIMMER HIP
FDA Adverse Event
Injury
·ZIMMER INC·Product code JDI·June 13, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·ANIMAS CORP.·Product code LZG·August 19, 2008
Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 14, 2016
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·October 30, 2017
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 9, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·February 28, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Malfunction
·COOK INC·Product code GEX·February 8, 2018
H30 HOLMIUM LASER 30 WATT HOLMIUM LASER
FDA Adverse Event
Injury
·COOK INC·Product code GEX·April 25, 2018