9 results
·
27ms
·
Sources: EU EUDAMED, US FDA
SERACON-SRII
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lacrimal Probe
FDA UDI
KATENA PRODUCTS, INC.·00841668108710·MIYAKE LACRIMAL PROBE .75 AND .8MM
HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EZ-TRAX Containment Device
FDA 510(k)
FDA Class 2
·General Hospital
MINI QA+ #0 ETH OS-2 *EA
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HWC·May 9, 2018
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 16, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 31, 2013
ATTAIN STARFIX
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 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