7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
GLYCO-SPIN
FDA 510(k)
FDA Class 2
·Hematology
QUANTROLS HCG
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027
FDA 510(k)
FDA Unclassified
·Unknown
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW·Product code NXT·May 6, 2014
LAMITRODE 88C
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 11, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·August 10, 2010
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018