10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CERNER PROVISION WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
CRAFT DUO-VAC SUCTION UNIT AND CRAFT SUCTION UNIT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
APC PLUS ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
SEE H10 NARRATIVE
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·September 11, 2017
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
UNKNOWN LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015
1.5MM DRILL BIT STRYKER J-LATCH/12MM STOP/82MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTW·April 22, 2013
RESOLUTION CLIP DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MND·July 3, 2008
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·April 18, 2011
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012