7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
NEURAL STIMULATOR MONITOR
FDA 510(k)
FDA Class 2
·Neurology
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
FDA 510(k)
FDA Class 2
·Clinical Toxicology
OSTEOFAB PATIENT SPECIFIC FACIAL DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
M2A-MAGNUM MOD HD SZ 42MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 27, 2014
BRILLIANCE 16
FDA Adverse Event
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code JAK·November 6, 2012
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·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