10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BTI CORTICAL BONE SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
GSI Novus
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·May 3, 2016
INRATIO2 PT/INR PROFESSIONAL TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·November 17, 2015
INRATIO2 PT/INR PROFESSIONAL TEST STRIP
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 13, 2015
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 3, 2016
TI ANTERIOR TENSION BAND PLATE
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code KWQ·February 15, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 24, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 31, 2014