9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
B&F MEDICAL OXYGEN REG MECICAL OXY COMPRESS GAS REG
FDA 510(k)
FDA Class 1
·Anesthesiology
ORTHOFIX MODULSYSTEM
FDA UDI
ORTHOFIX SRL·18053800895795·SELFDRILLING XCALIBER CYLINDRICAL SCREW SS L260...
ORTHOFIX MODULSYSTEM
FDA UDI
ORTHOFIX SRL·18053800895603·SELFDRILLING XCALIBER CYLINDRICAL SCREW SS L260...
Avenue T TLIF Cage
FDA 510(k)
FDA Class 2
·Orthopedic
POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA, NATURAL WATER, SOLUBLE VITAMIN E AND VITAMIN C AND PROTEIN LABELING
FDA 510(k)
FDA Class 1
·General Hospital
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 4, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·December 30, 2010
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORPORATION·Product code DSQ·July 17, 2014
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