17 results
·
38ms
·
Sources: EU EUDAMED, US FDA
WATER PIK AUTOMATIC TOOTHBRUSH
FDA 510(k)
FDA Class 1
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526159860·PROTECT.ACHI ANKLE SUPPORT GRAY V
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756017527·BUCKS TRACTION
9616240-2006-00344
FDA Adverse Event
Malfunction
·Product code KDI·June 14, 2006
9616240-2006-00342
FDA Adverse Event
Malfunction
·Product code KDI·June 14, 2006
9616240-2006-00330
FDA Adverse Event
Malfunction
·Product code FII·June 1, 2006
PRISMA SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL)
FDA 510(k)
FDA Class 2
·Orthopedic
9616240-2006-00349
FDA Adverse Event
Malfunction
·Product code FII·June 21, 2006
9616240-2006-00348
FDA Adverse Event
Malfunction
·Product code FDI·June 20, 2006
*
FDA Adverse Event
Malfunction
·Product code FII·June 1, 2006
CERELINK ICP PROBE BASIC KIT
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES MANSFIELD·Product code GWM·August 22, 2023
9616240-2006-00346
FDA Adverse Event
Malfunction
·Product code FII·June 14, 2006
INNOVA 3100-IQ
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code OWB·March 21, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code NVY·October 31, 2012
1644487-2008-00522
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 29, 2008
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