25 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Custom Procedure Kit
FDA UDI
MEDIVATORS INC.·40677964018167·Endo Carry-On Procedure Kit
UNIVERSAL PLUS
FDA UDI
Conmed Corporation·30653405040716·UNIVERSAL PLUS, SUMP CANNULA WITH SIDE HOLES, S...
MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW
FDA 510(k)
FDA Class 2
·Cardiovascular
WALLSTENT BILIARY ENDOPROSTHESIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
S-ROM M HEAD 36MM +6
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·March 20, 2014
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·March 20, 2014
ORTHONE
FDA Adverse Event
Injury
·ONI, INC.·Product code LNH·June 28, 2002
LIFESYNC ECG SYSTEM
FDA Adverse Event
Malfunction
·LIFESYNC CORPORATION·Product code DRT·December 14, 2007
D131 KIDS INFANT ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·May 20, 2026
LIFESYNC ECG SYSTEM
FDA Adverse Event
Malfunction
·LIFESYNC CORPORATION·Product code DRT·December 18, 2007
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·March 13, 2013
UNKNOWN DEPUY ASR 47 HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 18, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·February 22, 2008
LIFESYNC ECG SYSTEM
FDA Adverse Event
Malfunction
·LIFESYNC CORPORATION·Product code DRT·December 14, 2007
S-ROM*STM STD,36NK,16X11X150
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·July 8, 2014
S-ROM*SLEEVE PRX ZTT, 16B-SML
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·July 8, 2014
D131 KIDS INFANT ARTERIAL FILTER
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL.·Product code DTM·September 26, 2024
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTM·June 18, 2019
D131 DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE
FDA Adverse Event
SORIN GROUP ITALIA·Product code DTM·February 3, 2016