8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
HEPCOL SYSTEM B-10 & B-10-P
FDA 510(k)
FDA Class 2
·Hematology
WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BONE WIRE
FDA 510(k)
FDA Class 2
·Orthopedic
ABBOCATH-T 20G 1-1/4
FDA Adverse Event
Malfunction
·AMSINO MEDICAL CO., LTD·Product code FOZ·April 27, 2009
RESTORE ADVANCED
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 13, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 23, 2014
GYNECARE THERMACHOICE III
FDA Adverse Event
Malfunction
·ETHICON·Product code MKN·August 31, 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