16 results
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20ms
·
Sources: EU EUDAMED, US FDA
EVOLUTION ESOPHAGEAL STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT-FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·March 25, 2015
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·March 12, 2015
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·November 12, 2014
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code ESW·November 27, 2014
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code ESW·November 24, 2014
Mapleson Anesthesia Breathing Circuit
FDA UDI
MERCURY ENTERPRISES, INC.·10641043803592·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450292655·
INNOVO
FDA 510(k)
FDA Class 2
·General Hospital
EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO
FDA 510(k)
FDA Class 2
·Radiology
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 12, 2018
MAYFIELD
FDA Adverse Event
Malfunction
·INTEGRA LIFE SCIENCE·Product code HBL·April 22, 2013
75MM SELECTABLE NEW TLC
FDA Adverse Event
Death
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 6, 2011
HS LONG 5MM CURVED SHEARS
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·July 24, 2008
ASR TAP SLV ADAP 12/14 -1
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·March 17, 2016
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014