7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DUPONT THEOPHYLLINE DIT CALIBRATOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
FDA 510(k)
FDA Class 2
·Immunology
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
FDA 510(k)
FDA Class 2
·Dental
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 30, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·October 22, 2012
BAIR HUGGER
FDA Adverse Event
Malfunction
·ARIZANT HEALTHCARE INC.·Product code DWJ·September 11, 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