FDA.reportPublic FDA data

MERIT MEDICAL IRELAND, LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96166623000335778MERIT MEDICAL IRELAND, LTD1N2026-01-01Parkmore Business Park West Galway Galway(County) IE 0000

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
792371990776746K992231FOUNTAIN Infusion Catheter and Occluding Guide WireQEY1999-07-23
792371400122723K991619FOUNTAIN Infusion Catheter and Occluding Guide WireQEY1999-06-09
792371360749086K990975IN-LINE HEMOSTASIS VALVEDYB2000-03-15
792371902321357K974067FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIREQEY1998-02-27
792371827432717K962129CONTINUOUS FLUSH DEVICEKRA1997-04-15
792371710664973K961794FLUID ADMINISTRATION SET - CONTRAST MANAGERFPA1996-08-01
792371457952433K936032TORQUE DEVICEDQX1994-03-15
792371269848180K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
792371529948956K921702MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVIDQX1992-09-21
792371668957218K915678MERIT ADMINISTRATION SETFPA1992-07-30
792371983043194K913682MERIT CUSTOM KITDQO1991-11-15
792371445389584K850829WIRE, GUIDE, CATHETERDQY1985-06-26
792371161640314K850827GUIDE, WIRE, ANGIOGRAPHICDQX1985-06-26
792371378999649K822586TEFLON COATED GUIDE WIRES & CATHETERDQX1982-10-18
792372015045601K173621Advocate PTA CatheterLIT2017-12-13
792371149291551K150927Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiffOCY2015-05-27
792371105645913K141295MERIT HYDROPHILIC GUIDEWIREDQX2014-12-16
792371226494040K131710MERIT HYDROPHILIC GUIDE WIREDQX2013-07-29
792371209390303K130588MERIT HYDROPHILIC GUIDE WIREDQX2013-04-05
792372037902558K123609MERIT HYDROPHILIC GUIDE WIREDQX2013-01-16
792371539806290K120644MERIT HYDROPHILIC GUIDE WIREDQX2012-09-19
792371316408754K092343EN SNARE ENDOVASCULAR SNARE SYSTEMMMX2009-08-07
792372018707401K091310ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682GEI2010-08-11
792371720160293K090986STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)NDN2009-12-30
792371072921342K073035PRELUDE AND PRELUDE PRO SHEATH INTRODUCERSDRE2007-11-20
792371912732812K072496MODIFICATION TO SPACE CPSXL BONE CEMENTNDN2007-10-05
792371731671004K070159PRELUDE SHEATH INTRODUCERDRE2007-06-21
792371694361689K050962MERIT PRELUDE SHEATH INTRODUCERDRE2005-05-06
792371138631719K042060EASYPASS US Y-CONNECTOR HEMOSTATIC VALVEDTL2004-10-06
792371344378907K012758URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,FGB2002-04-09
792371021088375
792371101052529
792371126804209
792371142396868
792371149658667
792371186875133
792371197560232
792371197868765
792371199916908
792371202572382
792371204251543
792371227117137
792371228593879
792371291761395
792371314027738
792371381905025
792371384075970
792371414281377
792371431988591
792371437350721
792371516545199
792371522295050
792371551516661
792371590932649
792371617050044
792371629830330
792371629991784
792371672421510
792371690707039
792371704529908
792371715554232
792371725247423
792371729048806
792371733460950
792371744844353
792371757841586
792371771016343
792371808468521
792371822213113
792371861395945
792371877293097
792371887409229
792371888956301
792371913798554
792371966268161
792372000952041
792372003928322
792372050947485
792372057329724
792372064199038

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX102014-12-16
DRE32007-11-20
QEY31999-07-23
NDN22009-12-30
FPA21996-08-01
LIT12017-12-13
OCY12015-05-27
GEI12010-08-11
MMX12009-08-07
DTL12004-10-06
FGB12002-04-09
DYB12000-03-15
KRA11997-04-15
DQO11991-11-15
DQY11985-06-26