29 results
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28ms
·
Sources: EU EUDAMED, US FDA
EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3
FDA 510(k)
FDA Class 2
·Radiology
Accu-Patch Titanium with Clear tape
FDA UDI
SAKAMURA KENKYUSHO, K.K.·04955114013100·200 units in single package
Batrik In-Brush Twisted Wire Brushes
FDA UDI
Batrik Medical Manufacturing Inc·00690521005624·Brush\10Fraizier\BD-3.30mm\BL-38mm\OL-250mm - B...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450124277·
Matira
FDA UDI
Kalitec Direct LLC·B073DRK010029·Drill Guide, Variable, Attached Handle
Cosmolock
FDA UDI
Kalitec Direct LLC·B07310K0100290·Caddie Lid, MIS Rods and Caps
HOME HEALTH MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PROLONG, MODELS PL50, PL100, PL150
FDA 510(k)
FDA Class 2
·Anesthesiology
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·May 30, 2012
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 27, 2012
TSRH SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code MNI·April 16, 2013
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·April 3, 2014
ENDEAVOR RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code NIQ·March 19, 2013
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 1, 2011
PERC DC CONVENIENCE PACK
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code GEI·March 12, 2008
RESTORE
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 3, 2012
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·December 22, 2011
UNICEL® DXI 600 ACCESS IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·December 22, 2011