7 results
·
35ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OSMOMETER STANDARD SOLUTIONS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SOPIX 2
FDA 510(k)
FDA Class 2
·Dental
Blue Latex Examination Powder Free Gloves
FDA 510(k)
FDA Class 1
·General Hospital
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·June 24, 2014
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·November 30, 2012
UNK DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·November 2, 2010
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015