9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
COLLOID OSMOMETER 4400
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Legacy™2 Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307101703·Ø4.2 x 8 Platform 3.5mmD
IGE-QUANT DIAGNOSTIC TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
BETA-CAP D ADAPTER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·April 17, 2024
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 27, 2014
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 15, 2012
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·September 14, 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