FDA.report

MERIT MEDICAL SYSTEMS, INC

Matched from indexed company URL: Merit Medical

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
11257823002975287MERIT MEDICAL SYSTEMS, INC1N2026-01-0112701 Kingston Avenue Chester VA US 23836
17215041721504MERIT MEDICAL SYSTEMS, INC.1N2026-01-011600 WEST MERIT PKWY. South Jordan UT US 84095
20323383003295907Merit Medical Systems, Inc.1N2026-01-016 JOURNEY, SUITE 125 ALISO VIEJO CA US 92656
30106654333010665433Merit Medical Systems, Inc.1N2026-01-0114646 Kirby Drive Houston TX US 77047
30153096433015309643Merit Medical UK Limited1N2026-01-01Unit 27, Suttons Business Park Sutton Park Avenue Earley Reading GB RG6 1AW
25292521000121594Merit Medical Systems, Inc.1N2020-04-2565 GREAT VALLEY PKWY. Malvern PA US 19355

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
792181724216489P240023WRAPSODY® Cell-Impermeable EndoprosthesisPFV2024-12-19
3323371724216489P240023WRAPSODY® Cell-Impermeable EndoprosthesisPFV2024-12-19
792181160162634K994253VACLOK SYRINGEFMF2000-01-05
3323371160162634K994253VACLOK SYRINGEFMF2000-01-05
792181035490461K993341INTELLISYSTEM II COLOR MONITORMAV1999-10-25
792181990776746K992231FOUNTAIN Infusion Catheter and Occluding Guide WireQEY1999-07-23
3323371990776746K992231FOUNTAIN Infusion Catheter and Occluding Guide WireQEY1999-07-23
792181400122723K991619FOUNTAIN Infusion Catheter and Occluding Guide WireQEY1999-06-09
3323371400122723K991619FOUNTAIN Infusion Catheter and Occluding Guide WireQEY1999-06-09
792181360749086K990975IN-LINE HEMOSTASIS VALVEDYB2000-03-15
792181383750645K974570PERITONEAL DIALYSIS CATHETER CONNECTORFKO1998-02-27
3323371383750645K974570PERITONEAL DIALYSIS CATHETER CONNECTORFKO1998-02-27
3323371638338147K974374SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STVJKA1998-01-02
792181902321357K974067FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIREQEY1998-02-27
3323371902321357K974067FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIREQEY1998-02-27
792181161469967K973230MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)DXT1997-11-25
3323371161469967K973230MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)DXT1997-11-25
792181917151923K970159FLEX-NECK PD CATHETERFJS1997-09-05
3323371917151923K970159FLEX-NECK PD CATHETERFJS1997-09-05
792181827432717K962129CONTINUOUS FLUSH DEVICEKRA1997-04-15
792181372009656K96050918 GAUGE TRU-CUT BIOPSY NEEDLEKNW1996-04-04
3323371372009656K96050918 GAUGE TRU-CUT BIOPSY NEEDLEKNW1996-04-04
792181765451472K943739SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETERDQO1994-11-15
1670031765451472K943739SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETERDQO1994-11-15
3323371765451472K943739SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETERDQO1994-11-15
3323371293310046K941428EXACTA PERCUTANEOUS INTRODUCER SHEATHDYB1994-07-06
3323371750030742K936182CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KITKRB1994-03-25
792181457952433K936032TORQUE DEVICEDQX1994-03-15
3323371457952433K936032TORQUE DEVICEDQX1994-03-15
3323371890171816K935782DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIESDXN1994-08-01
792181269848180K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
3323371269848180K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
792181004689926K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVEDYB1994-01-21
1521221004689926K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVEDYB1994-01-21
3323371004689926K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVEDYB1994-01-21
792181529948956K921702MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVIDQX1992-09-21
3323371529948956K921702MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVIDQX1992-09-21
792181145189192K920977MERITRANS(TM) DISPOSABLE TRANSDUCERDRS1992-12-11
3323371145189192K920977MERITRANS(TM) DISPOSABLE TRANSDUCERDRS1992-12-11
792181668957218K915678MERIT ADMINISTRATION SETFPA1992-07-30
3323371668957218K915678MERIT ADMINISTRATION SETFPA1992-07-30
792181641249949K914208MERIT DISPOSAL DEPOT(TM)DQO1991-12-18
3323371641249949K914208MERIT DISPOSAL DEPOT(TM)DQO1991-12-18
792181983043194K913682MERIT CUSTOM KITDQO1991-11-15
792181856290612K912129DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBEKNS1991-08-07
792181847819263K902319BAUER TEMNO BIOPSY NEEDLEFCG1990-09-06
3323371847819263K902319BAUER TEMNO BIOPSY NEEDLEFCG1990-09-06
792181757841586K893480BYRD EXTRACTOR SETGCC1989-06-23
3323371266210610K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.DSK1989-01-25
792181675410076K884913MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)DXT1989-04-18
792181049947372K883718MERIT HI-FLEX(TM)FPK1989-01-30
3323371049947372K883718MERIT HI-FLEX(TM)FPK1989-01-30
3323371034006889K880740MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGEDQF1988-03-22
792181240318017K875196DISPOSABLE CORONARY CONTROL SYRINGE 12CCDXT1988-02-11
3323371240318017K875196DISPOSABLE CORONARY CONTROL SYRINGE 12CCDXT1988-02-11
3323371370245607K870261VIGGO EXACTA PRESSURE MONITORING SYSTEMFMG1987-04-01
3323371875185864K861092MODEL SP1465 CARDIAC OUTPUT COMPUTERDXG1986-08-18
3323371463919762K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATORDRS1986-02-26
792181161640314K850827GUIDE, WIRE, ANGIOGRAPHICDQX1985-06-26
3323371161640314K850827GUIDE, WIRE, ANGIOGRAPHICDQX1985-06-26
3323371157373759K850460VIGGO SECALON T CATHETERFOZ1985-04-11
3323371088156237K843969MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCERDXO1985-01-23
3323371263479928K830523CATHETER CONNECTION W/INTEGRAL INJECTATEDQO1983-03-16
792181087789026K823331PC-204 TUNNELORFKX1983-01-26
792181482901696K823330DIALATORS PC-203 & 202FKX1983-01-26
792181841358151K823303QUILL CATHETER GUIDEFKX1983-01-26
792181748736931K823297ST-610 NEEDLESCOPE STERILIZATION TRAYHET1983-05-06
792181853799956K823296PC-205 TENCKHOFF CATHETER ROD OBTURATORFKX1983-01-26
3323371853799956K823296PC-205 TENCKHOFF CATHETER ROD OBTURATORFKX1983-01-26
792181607410591K823295MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&HET1983-05-06
3323371851314269K821450PRESSURE TUBING-ADULT & PEDIATRICDRS1982-05-25
3323371203800903K811538MODELS TA 1017 & 1017T GRITIFLO DISPOSDRS1981-06-12
792181789492695K810924MEDRAD HIGH PRESSURE CONECTING TUBEDWE1981-04-17
792181178351986K810637COBE DISPOSABLE PRESSURE TRANSDUCERDRS1981-04-23
3323371297801761K801113DILATOR, VESSEL, FOR PERC. CATHETER.DRE1980-07-28
3323371346313540K791844CRITIFLO & CRITIFLO DOMEKRA1979-10-02
792181202572382K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX2026-01-31
792181684585127K252892SCOUT MD Surgical Guidance SystemNEU2025-12-19
3323371549754392K252674Solo Pace Fusion System (SOLOFUSE1)DQX2026-01-09
792181759837564K252527Surfacer Inside-Out Access Catheter SystemQJH2025-09-10
3323371759837564K252527Surfacer Inside-Out Access Catheter SystemQJH2025-09-10
792181227117137K251802STAR RF Ablation SystemGXI2026-02-13
3323371227117137K251802STAR RF Ablation SystemGXI2026-02-13
792181204251543K251385InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)DQX2026-01-21
792181737355045K251265Resilience Fully Covered Esophageal Stent SystemESW2025-07-23
3323371737355045K251265Resilience Fully Covered Esophageal Stent SystemESW2025-07-23
792181822213113K251181Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)DQX2025-08-29
792181116469686K250909Prelude Wave Hydrophilic Sheath IntroducerDYB2025-04-25
3323371116469686K250909Prelude Wave Hydrophilic Sheath IntroducerDYB2025-04-25
792181500456253K250853Merit SyringeFMF2025-11-04
3323371500456253K250853Merit SyringeFMF2025-11-04
792181323731005K242873Ventrax™ Delivery SystemDQY2025-01-15
3323371323731005K242873Ventrax™ Delivery SystemDQY2025-01-15
792181876098045K242229Micro Ace Gold Advanced Micro Access SystemDRE2025-01-15
3323371876098045K242229Micro Ace Gold Advanced Micro Access SystemDRE2025-01-15
3323371834052538K241781Solo Pace ControlDTE2025-01-10
792181227982546K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesODE2024-04-26
3323371227982546K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesODE2024-04-26
792181899877323K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)GEH2024-07-24
3323371899877323K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)GEH2024-07-24
792181771016343K240261Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)KRD2024-05-02
3323371771016343K240261Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vascular Plug (SVP6-0.027)KRD2024-05-02
792181160610720K233813Bearing nsPVA Express™NAJ2023-12-21
792181304852084K233268Impress Angiographic CatheterDQO2024-05-22
3323371304852084K233268Impress Angiographic CatheterDQO2024-05-22
792181007865637K232609Micro Ace™ Advanced Micro Access SystemDRE2023-09-27
3323371007865637K232609Micro Ace™ Advanced Micro Access SystemDRE2023-09-27
792181388918170K231468SCOUT MD Surgical Guidance SystemNEU2024-02-12
2247091388918170K231468SCOUT MD Surgical Guidance SystemNEU2024-02-12
3323371388918170K231468SCOUT MD Surgical Guidance SystemNEU2024-02-12
792181571817268K230636Maestro MicrocatheterKRA2023-03-30
3323371571817268K230636Maestro MicrocatheterKRA2023-03-30
792181437350721K230418Mighty Wire Guide WireDQX2023-10-28
3323371437350721K230418Mighty Wire Guide WireDQX2023-10-28
792181930057323K223872Low Profile Companion SheathDYB2023-01-19
3323371930057323K223872Low Profile Companion SheathDYB2023-01-19
3323371843515775K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesDRS2023-03-17
792182048761327K213845HeRO GraftDSY2022-08-15
3323372048761327K213845HeRO GraftDSY2022-08-15
792181835782116K213434Elation Pulmonary Balloon Dilation CatheterKTI2022-03-08

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DYB512025-04-25
DQX442026-01-31
DRE202025-01-15
DQO202024-05-22
KRA172023-03-30
FMF162025-11-04
MSD142016-04-04
FJS142012-05-21
DXT132017-06-15
JCT122018-09-21
NDN122015-04-09
DQY112025-01-15
KNW102020-08-28
NEU92025-12-19
MMX92020-01-17
FGE92019-03-14
DSY82022-08-15
DXC82018-04-17
QEY82016-10-31
DRS72023-03-17
ESW62025-07-23
QEZ62021-11-03
FCG62015-08-07
QSY62013-07-09
FKX51983-01-26
QJH42025-09-10
KRD42024-05-02
DWM42023-03-03
KTI42022-03-08
QBP42015-05-22
KNS42010-09-07
JAQ42010-07-12
FPA42008-12-23
PNG32021-12-14
DRA32016-02-24
DTL32010-04-28
DRC32002-05-02
GXI22026-02-13
GEH22024-07-24
ODE22024-04-26

PMN

S-MAK XL

2019-04-10

Merit Medical Systems Inc.

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