8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CUPPED FORCEPS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
ADVIA Centaur EBV-EBNA IgG
FDA 510(k)
FDA Class 1
·Microbiology
BD MAX MRSA XT, BD MAX INSTRUMENT
FDA 510(k)
FDA Class 2
·Microbiology
THERMOPHORE HEATING PAD
FDA Adverse Event
BATTLE CREEK EQUIPMENT·Product code IRT·May 19, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 29, 2012
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·September 8, 2010
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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