13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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METHA SHORT STEM HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014606361·MIDMARK 7100 5.25" DELUXE GEL
NA
FDA UDI
STRYKER CORPORATION·07613327058482·Insert, Single-Action Atraumatic Grasper
N2000 BASE STATION; N2001 NURSE STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 26, 2013
ENDURANT ABDOMINAL STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·April 22, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2008
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE, INC.·Product code JPA·May 20, 2009
Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
FDA Enforcement
Class III
·Terminated·Spinal Elements, Inc·May 15, 2013
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE, INC.·Product code JPA·May 5, 2009
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INC.·Product code JPA·April 2, 2009
INRATIO
FDA Adverse Event
Injury
·BIOSITE INC.·Product code JPA·May 19, 2009