Merit Medical Ireland L T D

FDA Filings

This page includes the latest FDA filings for Merit Medical Ireland L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9616662
FEI Number3000335778
NameMERIT MEDICAL IRELAND, LTD
Owner & OperatorMerit Medical Systems, Inc.
Contact Address1600 West Merit Parkway --
South Jordan UT 84095 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressParkmore Business Park West
Galway Galway, 0000 IE
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Go2Wire Guide Wire2020-04-09
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
One Snare Endovascular Snare System ONE15012020-01-20
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
InQwire2019-10-17
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
InQwire2019-10-17
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
InQwire2019-10-16
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Preston? Transpedicular Introducer2018-12-21
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Preston? Hard Bone Access Needle with Drill2018-12-21
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Preston Bone Filler2018-12-21
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
K23C Vein Accessory Kit2018-08-01
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
K22C Vein Tray2018-08-01
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
K19 Combination Packs2018-08-01
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
K12 Procedure Kit2018-08-01
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
K07 Syringe Kit (multiple K06)2018-08-01
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
K05 Inflation Kit2018-08-01
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
K02 Syringe Kit (multiple K01)2018-08-01
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Advocate PTA Catheter2017-12-15
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseoflex SB Straight Balloon (10ga)2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseoflex SB Straight Balloon (10ga)2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseoflex SB Steerable Balloon (10Ga)2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseoflex SB Steerable Balloon (10Ga)2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
basixTOUCH2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
basixTOUCH40 Inflation Syringe2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
basixTAU2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
basixCompak Analog Inflation Syringe2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
VerteMAX2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Guardian2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Cavimend2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
BIG602017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Arcadia High Pressure Inflation Syringe2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
SeaDragon Torque Device2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
SPINR High Performance Guidewire Catheter2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Pinvise Torque Device2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseoflex CD-H Hydraulic Cement Delivery System2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseoflex SN2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseoflex SN+ Needle2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseoflex SN Needle2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseoflex Access Kit2017-07-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Hydrophilic Guide Wire2017-06-27
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit InQwire? Amplatz Super Stiff Guide Wire2017-04-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
InQwire Amplatz Super Stiff Guide Wire2017-03-06
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
SpineSTAR Ablation Instruments2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
STAR Tumor Ablation Kit with PowerCURVE2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
STAR Tumor Ablation Kit and Accessories2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Activation Element, ERx bone cement2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Activation Element, ERx bone cement2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
StabiliT VP Vertebrosplasty Kit2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
StabiliT VP Fracture Kits2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
StabiliT MX Fracture Kits2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
StabiliT MX Fracture Kits with PowerCURVE2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
StabiliT ER2 Bone Cement and Saturate Mixing System2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
StabiliT Bone Cement and Saturate Mixing System2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Straightline Osteotome, VerteCOR Midline Osteotome2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
PowerCURVE Navigating Osteotome2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
ER2 Saturate Mixing System2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
VertecoR Bone Drill, 3.02016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Preston? Transpedicular Drill2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Preston? Long Drill2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Preston? Hard Bone Introducer2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseoflex Straight Hand Drill2016-08-05
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Stopcock One Port Manifold2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
SafeSheath Sealing Adapter2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Rotating Adaptor2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Prelude Choice Hemostasis Valve Adapter2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Passage Hemostasis Valve2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
NeoVasc2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Marquis Stopcock2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Marquis Flow Switch2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Manifold2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
MYSHELL Hemostatic Valve2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
MBA2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Honor hemostasis valve2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Hemostasis Valve Adapter2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
H20 Torque Device2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
FLO40XR2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
FLO302015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
DoublePlay Hemostasis Valve2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Check Valve2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
AllStar Hemostasis Valve2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
AccessPLUS2015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Access-92015-10-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
EN Snare Endovascular Snare System2015-07-03
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Convenience Kits2015-05-18
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Prelude Plastic Jacketed Guide Wire2014-12-18
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
InQwire Guidewires2013-12-16
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
X-Change Cement Dispensing Syringe2013-11-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
StabiliT Cement Delivery Syringe2013-11-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Purge Assist2013-11-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Osseon Bone Filler Device (BFD)2013-11-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Master Syringe Assembly2013-11-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Hydraulic-Master Syringe Assembly2013-11-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Hydraulic Assembly2013-11-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
DiamondTOUCH Syringe2013-11-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
PORT SEAL / BPS-Y2013-09-19
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Laureate Hydrophilic Guide Wire2013-08-01
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Laureate Hydrophilic Guide Wire2013-04-16
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Laureate Hydrophilic Guide Wire2013-01-29
MERIT MEDICAL IRELAND, LTD.
BASIXCONPAK ANALOG INFLATION SYRINGE2012-12-19
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
OneSnare Endovascular Snare System2012-12-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Heparin Coated Guide Wire2012-12-12
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Laureate Hydrophilic Guide Wire2012-09-21
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
EN Snare Endovascular Snare System2009-11-09
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Guidewire with Palladium Tip2009-11-09
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Honor Hemostasis Valve2009-11-09
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Hemostatic Valve2009-11-09
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
EASYPASS US Y-Connector2009-11-09
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Honor Hemostasis Valve2009-11-09
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Hemostatic Valve2009-11-09
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
EASYPASS US Y-Connector2009-11-09
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
StabiliT Introducer and Delivery Instruments2009-06-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Maxxwire2009-06-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
In-Line Hemostasis Valve2007-12-19
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
FLO302007-12-19
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Fountain 4F Catheter & Occluding GW2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Fountain Infusion System2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Continuous Flush Device2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Contrast Management System2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
PinVise Torque Device2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
MAP Torque Device & Introducer2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Guidewire Introducer2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Administration Set2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
CT Transfer Set2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Prelude Sheath Introducer2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Prelude Sheath Introducer2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Prelude Sheath Half Size (ACT)2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Prelude Sheath Introducer2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit S-MAK (Stiffened Mini Access Kit)2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit PAK2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit MAK (Mini Access Kit)2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
InQwire Guidewire-Prelude Introducer2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
InQwire Guidewire w/o Ringmaster2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
InQwire Guidewire w/ Ringmaster2007-12-07
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Fountain Catheter/Occluding Guide Wire2006-08-11
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Westbrook? Bone Biopsy System2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
ShortStop Temporary Sharps Holder2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
ShortStop Grandstand Temporary Sharps Holder2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
ShortStop Advantage Temporary Sharps Holder2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
MiniStop Plus Closed Waste Basin2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Madison? Perforating Bone Biopsy System with Drill2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Madison Mini? Bone Biopsy System2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Kensington Guide Wire Bone Biopsy System2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Huntington Guided, Perforating Bone Biospy System with Drill2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Bedford? Guided Hard Bone Biopsy System2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
BackStop Plus Closed Waste Basin2001-07-14
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Merit Custom Kit1999-03-10
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Angiographic Procedure Packs1999-03-10
MERIT MEDICAL IRELAND, LTD [Merit Medical Systems, Inc.]
Access Safety Kit (ASK)1999-03-10

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092641412Anvers,Belgium -> Norfolk, VirginiaMEDICAL SUPPLIES 90183900 392310001000 BOX
2020092678200Southhampton,United Kingdom -> Oakland, CaliforniaMEDICAL SUPPLIES 392310001411 BOX
2020092562758Southhampton,United Kingdom -> Oakland, CaliforniaMEDICAL SUPPLIES 392310001411 BOX
2020091429313Rotterdam,Netherlands -> Norfolk, VirginiaDISPOSABLE MEDICAL PRODUCTS1222 BOX
202009142076Southhampton,United Kingdom -> Oakland, CaliforniaMEDICAL SUPPLIES1677 BOX
2020091241316Anvers,Belgium -> Norfolk, VirginiaMEDICAL SUPPLIES HS: 392310 90018391116 BOX
20200828361Rotterdam,Netherlands -> Norfolk, VirginiaDISPOSABLE MEDICAL PRODUCTS HS:392310101099 BOX
202008192450Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaDISPOSABLE MEDICAL DEVICE HS 392310101116 BOX

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.