41 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
FDA 510(k)
FDA Class 2
·Immunology
REPROCESSED DISPOSABLE TROCARS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
URS-1K (KETONE TESST)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JLW·February 2, 2016
VITROS ECI IMMUNODIAGNOSTIC SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code KHO·February 2, 2016
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·August 4, 2015
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 1, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 16, 2014
UNKNOWN SPINAL CORD STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LGW·May 13, 2011
FOOTPRINT ULTRA PK SUTURE ANCHOR, 4.5
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBI·July 28, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·September 11, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·September 14, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 3, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·February 4, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·October 8, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·April 17, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 25, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·August 27, 2015
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·November 6, 2014
INRATIO2 PT MONITORING SYSTEM
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·August 27, 2015