7 results
·
16ms
·
Sources: EU EUDAMED, US FDA
KODAK EKTACHEM 700 ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
EFLOW ELECTRONIC INHALER/NEBULIZER
FDA 510(k)
FDA Class 2
·Anesthesiology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 27, 2014
ASR XL TAP SLV ADAP 12/14+8
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 15, 2012
CIC PRO CLINICAL INFORMATION CENTER
FDA Adverse Event
Other
·GE HEALTHCARE·Product code DSI·September 8, 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