11 results
·
29ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Mini-Dalbo®
FDA UDI
Cendres+Métaux SA·07640166513865·Mini-Dalbo®
Male part C
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900
FDA 510(k)
FDA Class 2
·Radiology
FATHOM GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - FREMONT·Product code DQX·June 16, 2011
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·April 10, 2013
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code HQL·April 4, 2011
FATHOM GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·February 23, 2010
FATHOM GUIDEWIRE
FDA Adverse Event
Injury
·SALT LAKE CITY·Product code DQX·February 23, 2010
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012