MERIT MEDICAL IRELAND, LTD

FDA Device Registration & Listing · Galway, IE · Registration 9616662

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9616662
FEI Number
3000335778
Entity Name
MERIT MEDICAL IRELAND, LTD
City/State/Country
Galway, IE
Establishment Address
Parkmore Business Park West, Galway 0000, IE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Merit Medical Systems, Inc. (Owner Number: 1721504)
Owner / Operator Contact Address
1600 West Merit Parkway, --, South Jordan, UT 84095, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ShortStop Grandstand Temporary Sharps Holder ShortStop Advantage Temporary Sharps Holder MiniStop Plus Closed Waste Basin ShortStop Temporary Sharps Holder BackStop Plus Closed Waste Basin Kensington Guide Wire Bone Biopsy System Madison™ Perforating Bone Biopsy System with Drill Westbrook™ Bone Biopsy System Madison Mini™ Bone Biopsy System Bedford™ Guided Hard Bone Biopsy System Huntington Guided, Perforating Bone Biospy System with Drill One Snare Endovascular Snare System ONE1501 InQwire Guidewire with Palladium Tip Merit Hydrophilic Guide Wire Merit InQwire® Amplatz Super Stiff Guide Wire SteadySheath & Shortie Liberator Beacon Tip Locking Stylet basixCompak Analog Inflation Syringe basixTOUCH BIG60 basixTOUCH40 Inflation Syringe BIG60 ALPHA Inflation Devie basixSKY Inflation Device Prelude Sheath Introducer StabiliT ER2 Bone Cement and Saturate Mixing System StabiliT MX Fracture Kits StabiliT VP Vertebrosplasty Kit StabiliT VP Fracture Kits StabiliT MX Fracture Kits with PowerCURVE StabiliT Bone Cement and Saturate Mixing System Pinvise Torque Device SeaDragon Torque Device InQwire InQwire Guidewires Introducer Needle WithTrocar Stylet MAK-NV Non-Vascular InQwire Diagnostic (Support) Non-Vascular Guide Wire Osseoflex CD-H Hydraulic Cement Delivery System Osseoflex SB Straight Balloon (10ga) Fountain Infusion Catheter w/ Occluding Guide Wire Fountain Infusion System Straightline Osteotome, VerteCOR Midline Osteotome PowerCURVE Navigating Osteotome Evolution RL & Evolution Shortie RL InQwire Amplatz Super Stiff Guide Wire Osseoflex SB Steerable Balloon (10Ga) Siege Vascular Plug InQwire Super Stiff Guide Wire Prelude Plastic Jacketed Guide Wire Osseoflex SN Osseoflex SN+ Needle Osseoflex SN Needle Osseoflex Access Kit X-Change Cement Dispensing Syringe Hydraulic Assembly Osseon Bone Filler Device (BFD) StabiliT Cement Delivery Syringe Hydraulic-Master Syringe Assembly Purge Assist Master Syringe Assembly DiamondTOUCH Syringe Preston™ Transpedicular Introducer Preston™ Hard Bone Access Needle with Drill Preston Bone Filler Mighty Wire StabiliT Introducer and Delivery Instruments Maxxwire MultiPlex II Controller Activation Element, ERx bone cement Byrd Dilator Sheath Set Prelude Sheath Half Size (ACT) Prelude Sheath Introducer Rotating Adaptor Stopcock One Port Manifold Hemostasis Valve Adapter SafeSheath Sealing Adapter Merit Manifold DoublePlay Hemostasis Valve MYSHELL Hemostatic Valve FLO30 Honor hemostasis valve Passage Hemostasis Valve FLO40XR Merit Marquis Flow Switch Merit Marquis Stopcock Prelude Choice Hemostasis Valve Adapter PhD Hemostasis Valves & PhD Hemostasis Valves with Sidearm Tubing Access-9 H20 Torque Device AccessPLUS MBA Check Valve NeoVasc FLO50 10Fore Hemostasis Valve Guidewire Introducer MAP Torque Device & Introducer Fountain Catheter/Occluding Guide Wire VertecoR Bone Drill, 3 Osseoflex Straight Hand Drill Preston™ Transpedicular Drill Preston™ Hard Bone Introducer Preston™ Long Drill InQwire Diagnostic (Support) Non-Vascular Guide Wire EN Snare Endovascular Snare System Bulldog Lead Extender Contamination Sleeve, Cutter, Worley Slitter, Transavalvular Insertion Tool (TVI) One-Tie Compression Coil Lead Clippers InQwire Amplatz (IQA)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2001-07-14
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2020-01-20
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-10-17
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2009-11-09
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-06-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-04-07
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2026-02-23
DRB Stylet, Catheter Cardiovascular Class 2 870.1380 2026-03-04
PTM Syringe, Balloon Inflation, Exempt Cardiovascular Class 2 870.1650 2017-07-27
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2007-12-07
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2016-08-05
PTL Wire, Guide, Catheter, Exempt Cardiovascular Class 2 870.1330 2017-07-27
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2019-10-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2013-12-16
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 1992-07-14
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2017-07-27
HRX Arthroscope Orthopedic Class 2 888.1100 2017-07-27
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-07-27
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2007-12-07
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2007-12-07
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2016-08-05
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2025-12-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2017-03-06
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-07-27
LOD Bone Cement Orthopedic Class 2 888.3027 2017-07-27
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2014-11-19
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2024-05-06
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2026-02-03
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-12-18
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2017-07-27
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2013-11-11
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2018-12-21
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2023-11-20
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2009-06-11
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2016-08-05
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2016-08-05
GCC Dilator, Catheter General, Plastic Surgery Class 1 878.4200 2026-03-24
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-09-19
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2007-12-07
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Cardiovascular Class 2 870.4290 2015-10-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2007-12-07
QEY Mechanical Thrombolysis Catheter Cardiovascular Class 2 870.5150 2006-08-11
KRA Catheter, Continuous Flush Cardiovascular Class 2 870.1210 2006-08-11
DWO Needle, Biopsy, Cardiovascular General, Plastic Surgery Class 1 878.4800 2018-07-19
HTW Bit, Drill Orthopedic Class 1 888.4540 2016-08-05
OCY Endoscopic Guidewire, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-03-08
MMX Device, Percutaneous Retrieval Cardiovascular Class 2 870.5150 2015-07-03
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2013-01-17
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2026-05-28

Official Correspondent

No official correspondent registered.

US Agent Details

John Knorpp Business: MERIT MEDICAL SYSTEMS, INC. Email: jknorpp@merit.com Phone: (801) 2084389

Related Public Records

Same Entity

Merit Medical Systems, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3021179744 VIEW POINT MEDICAL, INC. Carlsbad, CA, US
3012276280 KA Medical Arden Hills, MN, US
2032338 Merit Medical Systems, Inc. ALISO VIEJO, CA, US
1125782 MERIT MEDICAL SYSTEMS, INC Chester, VA, US
9615728 BIOSPHERE MEDICAL, S.A. Roissy Val-d'Oise, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781371 Ferris Mfg. Corp. BONE MARROW ASPIRATION KIT 1978-09-20
K213494 ABBOTT MEDICAL Aveir Retrieval Catheter 2022-04-01
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2017 Merit Medical Systems, Inc. 2
Merit Inflation Syringe Kit. Catalog Number KOS-02857
Z-0026-2020 Merit Medical Systems, Inc. 2
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0027-2020 Merit Medical Systems, Inc. 2
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580
Z-0017-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023 Hobbs Medical, Inc. 1
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616662. Last updated year: 2026. Please use registration number 9616662 when referencing this establishment in official correspondence.
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