28 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRACTUS TISSUEMAPPER REVIEWER APPLICATION
FDA 510(k)
FDA Class 2
·Radiology
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564033376·Set Up, Minor Ortho
Leukomed®
FDA UDI
BSN medical GmbH·04042809594386·LEUKOMED SKIN SENSITIVE STERILE 8X10CM WHITE 20
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K1230010·Rod Holder, Straight, 5.5 mm
ADVIA Centaur® Sample Tips
FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414222608·Pipette tip
ALUMINA V40 FEMORAL HEADS
FDA 510(k)
FDA Class 2
·Orthopedic
HUMAN IGA CSF KIT FOR USE ON SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·January 15, 2016
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
PROMUS ELEMENT? PLUS
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 22, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 27, 2014
SYNCHRON® LX20 PRO CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 14, 2011
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·November 15, 2013
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·February 17, 2014