Merit Medical Systems, Inc.
Chester, VA, US
Merit Medical Systems, Inc. appears in FDA device records in Chester, VA. FDA records list 204 510(k) clearances between and , 5 PMA records and 4 registered establishments. As of , FDA records show 316 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Merit Medical Systems, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Thomas Medical Products, Inc.510(k), recall
510(k) clearance history
Showing 50 of 204FDA records hold 204 510(k) clearances for Merit Medical Systems, Inc. between 1988 and 2026. The busiest year on record is 1993, with 22. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 2 |
| 1990 | 2 |
| 1991 | 4 |
| 1992 | 4 |
| 1993 | 22 |
| 1994 | 3 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 4 |
| 2000 | 5 |
| 2001 | 5 |
| 2002 | 3 |
| 2003 | 3 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 5 |
| 2008 | 5 |
| 2009 | 7 |
| 2010 | 5 |
| 2011 | 4 |
| 2012 | 7 |
| 2013 | 11 |
| 2014 | 13 |
| 2015 | 8 |
| 2016 | 7 |
| 2017 | 13 |
| 2018 | 8 |
| 2019 | 4 |
| 2020 | 6 |
| 2021 | 6 |
| 2022 | 4 |
| 2023 | 6 |
| 2024 | 3 |
| 2025 | 6 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | DRE | Substantially Equivalent | |
| K262086 | PreludeSYNC™ Radial Compression Device | DXC | Substantially Equivalent | |
| K254073 | StatSeal Disc | FRO | Substantially Equivalent | |
| K251802 | STAR RF Ablation System | GXI | Substantially Equivalent | |
| K252892 | SCOUT MD Surgical Guidance System | NEU | Substantially Equivalent | |
| K250853 | Merit Syringe | FMF | Substantially Equivalent | |
| K251265 | Resilience Fully Covered Esophageal Stent System | ESW | Substantially Equivalent | |
| K250909 | Prelude Wave Hydrophilic Sheath Introducer | DYB | Substantially Equivalent | |
| K242873 | Ventrax™ Delivery System | DQY | Substantially Equivalent | |
| K242229 | Micro Ace Gold Advanced Micro Access System | DRE | Substantially Equivalent | |
| K241521 | Prelude Small O.D. Introducer Guide Wire | DQX | Substantially Equivalent | |
| K233268 | Impress Angiographic Catheter | DQO | Substantially Equivalent | |
| K240261 | Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027) | KRD | Substantially Equivalent | |
| K233813 | Bearing nsPVA Express™ | NAJ | Substantially Equivalent | |
| K230418 | Mighty Wire Guide Wire | DQX | Substantially Equivalent | |
| K232609 | Micro Ace™ Advanced Micro Access System | DRE | Substantially Equivalent | |
| K231246 | Ventrax™ Delivery System (VTR851) | DQY | Substantially Equivalent | |
| K212696 | Aspira Pleural Drainage System | DWM | Substantially Equivalent | |
| K223872 | Low Profile Companion Sheath | DYB | Substantially Equivalent | |
| K213845 | HeRO Graft | DSY | Substantially Equivalent | |
| K212882 | SCOUT BX Delivery System | NEU | Substantially Equivalent | |
| K213434 | Elation Pulmonary Balloon Dilation Catheter | KTI | Substantially Equivalent | |
| K212152 | Prelude IDeal 9F Hydrophilic Sheath Introducer | DYB | Substantially Equivalent | |
| K212675 | Aspira Peritoneal Drainage System | PNG | Unknown | |
| K212199 | ASAP Aspiration Catheter, ASAPLP Aspiration Catheter | QEZ | Substantially Equivalent | |
| K211405 | Prelude Guide Sheath | DYB | Substantially Equivalent | |
| K211525 | SwiftNINJA Steerable Microcatheter | KRA | Substantially Equivalent | |
| K203724 | HeRO Graft, HeRO Adapter | DSY | Substantially Equivalent | |
| K201674 | Cultura Collection and Transport System | JSM | Substantially Equivalent | |
| K202610 | Ventrax Delivery System | DQY | Substantially Equivalent | |
| K201595 | Merit Hydrophilic Guide Wire | DQX | Substantially Equivalent | |
| K201166 | Temno Elite Biopsy System | KNW | Substantially Equivalent | |
| K193082 | Fountain ValveTip Infusion Catheter | KRA | Substantially Equivalent | |
| K201907 | ClariVein IC | KRA | Substantially Equivalent | |
| K193507 | Merit ONE Snare System | MMX | Substantially Equivalent | |
| K192907 | Advocate PTA Catheter | LIT | Substantially Equivalent | |
| K191596 | Arcadia Balloon Catheter | HRX | Substantially Equivalent | |
| K191608 | Impress Angiographic Catheter | DQO | Substantially Equivalent | |
| K190175 | S-MAK XL | DRE | Substantially Equivalent | |
| K182279 | Merit Syringe | FMF | Substantially Equivalent | |
| K182216 | Merit Syringe | FMF | Substantially Equivalent | |
| K181200 | AEROmini Tracheobronchial Stent System | JCT | Substantially Equivalent | |
| K180723 | PreludeSYNC DISTAL Radial Compression System | DXC | Substantially Equivalent | |
| K173548 | Merit Pursue Microcatheter | DQY | Substantially Equivalent | |
| K180450 | Corvocet Biopsy System | KNW | Substantially Equivalent | |
| K173750 | Prelude IDeal Hydrophilic Sheath Introducer | DYB | Substantially Equivalent | |
| K173601 | Merit Syringe | FMF | Substantially Equivalent | |
| K173621 | Advocate PTA Catheter | LIT | Substantially Equivalent | |
| K172637 | HeRO Graft | DSY | Substantially Equivalent | |
| K172117 | Prelude Pursuit Splittable Sheath Introducer | DYB | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1125782 | 3002975287 | MERIT MEDICAL SYSTEMS, INC | 12701 Kingston Avenue, Chester, VA 23836 US | 2026 | and 4 more, listed in full below |
| 1721504 | 1721504 | MERIT MEDICAL SYSTEMS, INC. | 1600 WEST MERIT PKWY., South Jordan, UT 84095 US | 2026 | and 112 more, listed in full below |
| 2032338 | 3003295907 | Merit Medical Systems, Inc. | 6 JOURNEY, SUITE 125, ALISO VIEJO, CA 92656 US | 2026 | |
| 3010665433 | 3010665433 | Merit Medical Systems, Inc. | 14646 Kirby Drive, Houston, TX 77047 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- DWMApparatus, Suction, Patient Care
- EXFBag, Bile Collecting
- BTCBag, Reservoir
- FQMBandage, Elastic
- FCGBiopsy Needle
- FCYBulb, Inflation, For Endoscope
- GEACannula, Surgical, General & Plastic Surgery
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- DXECatheter, Embolectomy
- DQOCatheter, Intravascular, Diagnostic
- GBXCatheter, Irrigation
- DQYCatheter, Percutaneous
- GBWCatheter, Peritoneal
- FKOCatheter, Peritoneal Dialysis, Single Use
- FJSCatheter, Peritoneal, Long-Term Indwelling
- DRACatheter, Steerable
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- DXCClamp, Vascular
- BZAConnector, Airway (Extension)
- FAJCystoscope And Accessories, Flexible/Rigid
- DWZDevice, Biopsy, Endomyocardial
- FDYDevice, Measuring, For Panendoscope
- GCCDilator, Catheter
- DREDilator, Vessel, For Percutaneous Catheterization
- FRODressing, Wound, Drug
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- CAHFilter, Bacterial, Breathing-Circuit
- GDFGuide, Needle, Surgical
- FZXGuide, Surgical, Instrument
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DXTInjector And Syringe, Angiographic
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- BZQMonitor, Breathing Frequency
- GAANeedle, Aspiration And Injection, Disposable
- DWONeedle, Biopsy, Cardiovascular
- GCBNeedle, Catheter
- ESWProsthesis, Esophageal
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- DTEPulse-Generator, Pacemaker, External
- FPASet, Administration, Intravascular
- FADStent, Ureteral
- FGEStents, Drains And Dilators For The Biliary Ducts
- DRBStylet, Catheter
- GAHStylet, Surgical, General & Plastic Surgery
- CCXSupport, Patient Position
- FMFSyringe, Piston
- FKXSystem, Peritoneal, Automatic Delivery
- BWNTable And Attachments, Operating-Room
- GAXTourniquet, Nonpneumatic
- DRSTransducer, Blood-Pressure, Extravascular
- DRCTrocar
- FPKTubing, Fluid Delivery
- GEHUnit, Cryosurgical, Accessories
- CBKVentilator, Continuous, Facility Use
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 316| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2517-2026 | Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669 00884450529690 REF: MSWSTDA35180 UDI-DI codes: 00884450529645 00884450529669 REF: MSWSTDA35260EX UDI-DI code: 00884450529683 REF: MSWSTDA3580 UDI-DI codes: 00884450529645 00884450529690 00884450529744 REF: MSWSTDS35150 UDI-DI codes: 00884450529690 00884450529744 REF: MSWSTFA35260EX UDI-DI code: 00884450529447 REF: MSWSTFA3580 UDI-DI code: 00884450529515 REF: MSWSTFS35150 UDI-DI code: 00884450529553 The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures. | Due to unsealed portions of pouches. | Class II | Open, Classified | |
| Z-2004-2026 | Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY | catheter may experience resistance when being advanced over the guidewire | Class II | Open, Classified | |
| Z-2003-2026 | Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY | catheter may experience resistance when being advanced over the guidewire | Class II | Open, Classified | |
| Z-2002-2026 | Philips Bridge Prep Kit REF: K12-09098B Sterile EO, Rx ONLY | catheter may experience resistance when being advanced over the guidewire | Class II | Open, Classified | |
| Z-1579-2026 | BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU, H965103028031/A, H965103028031/EU, H965103028041/A, H965103028041/EU, H965103028051/A, H965103028051/EU, H965103028061/A, H965103028061/EU, H965103028070/A, H965103028070/EU, H965103028080/A, H965103028080/EU, H965103028090/A, H965103028090/EU, H965103028161/A, H965103028181/A, H965103028191/A, H965103028191/EU, H965103028201/A, H965103028211/A, H965103028220/A, H965103028230/A, H965103028240/A, H965103038181/A | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. | Class I | Open, Classified | |
| Z-1578-2026 | DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A, H787103028031/A, H787103028035/A, H787103028041/A, H787103028045/A, H787103028051/A, H787103028055/A, H787103028061/A, H787103028075/A, H787103028085/A, H787103028095/A, H787103028165/A, H787103028181/A, H787103028185/A, H787103028191/A, H787103028195/A, H787103028205/A, H787103028215/A, H787103028225/A, H787103028235/A | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. | Class I | Open, Classified | |
| Z-1577-2026 | 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. | Class I | Open, Classified | |
| Z-1576-2026 | ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. | Class I | Open, Classified | |
| Z-1575-2026 | CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. | Class I | Open, Classified | |
| Z-1129-2026 | Allwell Angioplasty Pack REF: IS-30-B1/B | Inflation device handle may detach from the syringe during procedure. | Class II | Open, Classified | |
| Z-1128-2026 | Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B | Inflation device handle may detach from the syringe during procedure. | Class II | Open, Classified | |
| Z-1127-2026 | Merit Medical , Custom Manifold Kit REF: K09-13203A | Inflation device handle may detach from the syringe during procedure. | Class II | Open, Classified | |
| Z-1126-2026 | Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201 | Inflation device handle may detach from the syringe during procedure. | Class II | Open, Classified | |
| Z-1125-2026 | Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261 | Inflation device handle may detach from the syringe during procedure. | Class II | Open, Classified | |
| Z-1124-2026 | Allwell Inflation Device, for angiographic use REF: IS-30-A | Inflation device handle may detach from the syringe during procedure. | Class II | Open, Classified | |
| Z-1123-2026 | Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A | Inflation device handle may detach from the syringe during procedure. | Class II | Open, Classified | |
| Z-0533-2026 | PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802. | Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage. | Class II | Open, Classified | |
| Z-2553-2025 | 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices. | Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway. | Class II | Open, Classified | |
| Z-2296-2025 | Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. | Class II | Open, Classified | |
| Z-2295-2025 | Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. | Class II | Open, Classified | |
| Z-2294-2025 | Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. | Class II | Open, Classified | |
| Z-2293-2025 | High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. | Class II | Open, Classified | |
| Z-1641-2025 | Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. | Class II | Open, Classified | |
| Z-1640-2025 | Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly | Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. | Class II | Open, Classified | |
| Z-1434-2025 | Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D | Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain