15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LUXAR MODEL LX-20 CO2 LASER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNCHRON® CK 2 X 400
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CKA·May 10, 2011
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GWM·January 31, 2017
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GWM·January 31, 2017
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·June 16, 2006
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code GWM·December 16, 2016
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT - 10886704075486
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code GWM·April 20, 2016
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT - 10886704075486
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code GWM·April 20, 2016
CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBE·February 22, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIVISION·Product code FPO·December 28, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 1, 2014
ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT - 10886704075486
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code GWM·April 20, 2016
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016