12 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COE COMFORT
FDA 510(k)
FDA Class 2
·Dental
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
FDA 510(k)
FDA Class 2
·Neurology
MASTERSCREEN CPX AND OXYCON CPX
FDA 510(k)
FDA Class 2
·Anesthesiology
ZILVER 518 BILIARY SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·September 21, 2017
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
PLATE BD CHROMAGAR O-157 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSI·August 10, 2021
PLATE BD CHROMAGAR O-157 20 EA
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code JSI·August 10, 2021
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·April 22, 2013
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code DHA·April 27, 2011
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·July 2, 2008
ZILVER 518 SELF-EXPANDING STENT
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FGE·October 26, 2012
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018