11 results
·
29ms
·
Sources: EU EUDAMED, US FDA
CT 5221 DOSE REDUCING COLLIMATORS
FDA 510(k)
FDA Class 2
·Radiology
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 4, 2016
WishBone Medical Plate and Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
INRATIO2 PT/INR TEST STRIP
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·March 30, 2016
INRATIO2 PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·April 25, 2016
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·April 22, 2014
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 5, 2012
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 19, 2015
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 12, 2015
6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 35MM THRD LENGTH
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MNH·October 10, 2018