16 results
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26ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXIA RADIAL HEAD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Pedicle Screw System
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215027445·
TAMARIN BLUE PTCA RX DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·May 20, 2015
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 29, 2016
GENISTRONG
FDA Adverse Event
Malfunction
·GENICON·Product code GCJ·October 15, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 24, 2016
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
NI
FDA Adverse Event
Malfunction
·NI·Product code FPA·March 8, 2017
AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM - ANTERIOR
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·May 16, 2013
DURA STAR PTCA BALLOON CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code LOX·August 22, 2008
TRIMA ACCEL PLT, PLS, RBC, PAS, TLR SET
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·June 7, 2011
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
FDA Enforcement
Class II
·Terminated·Neurotherm, Inc.·April 20, 2016