28 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ARTHROSCOPY PUMP, MODEL A107
FDA 510(k)
FDA Class 2
·Orthopedic
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489004028·PowerChem Neoprene Exam Gloves, Small
Latitude™ EV
FDA UDI
TORNIER, INC.·00846832002795·Humeral Stem - Coated
LEONE SPA
FDA UDI
LEONE SPA·08033707065661·INTRAORAL ELASTICS 2,5 oz 5/16" blue
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0104020·Caddie, Large, 30mm
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0104020·Caddie, Large, 30mm
WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
FDA 510(k)
FDA Class 2
·General Hospital
SCREENERS PHENCYCLIDINE (PCP) TEST, DRUGSCREEN DIP PHENCYCLIDINE (PCP) TEST
FDA 510(k)
FDA Unclassified
·Unknown
C21617 DE LIFE SYSTEMS $PHISIO
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 24, 2013
COBAS® WNV NUCLEIC ACID TEST FOR USE ON THE COBAS® 6800/8800 SYSTEMS
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 29, 2025
INFUSE BONE GRAFT DEVICE (RHBMP2)
FDA Adverse Event
Injury
·MEDTRONIC INC.·Product code NEK·March 28, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 9, 2011
CONTOUR TEST STRIPS (10)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·April 15, 2008
CP82200 I MIRANDOLA
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·April 6, 2012
CP85341 FR PARIS
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·July 15, 2011
PLUM LS PRIM. 225 CM CLAVE PORT DISTA
FDA Adverse Event
Injury
·HOSPIRA COSTA RICA LTD.·Product code FPA·March 22, 2013
EMORY/CL/KNNSTN ATLANTA GA1
FDA Adverse Event
Other
·SORIN GROUP USA·Product code DWF·August 19, 2010
DUKE UNIV DURHAM NC 1
FDA Adverse Event
Other
·SORIN GROUP USA, INC.·Product code DWF·July 15, 2011
COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
Death
·SORIN GROUP ITALIA SRL·Product code KFM·November 23, 2016
COBE CARDIOVASCULAR REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
FDA Adverse Event
SORIN GROUP ITALIA·Product code KFM·February 29, 2016