FDA.report

MERIT MEDICAL SYSTEMS, INC.

Matched from indexed company URL: Merit Medical Systems, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
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
25292521000121594Merit Medical Systems, Inc.1N2020-04-2565 GREAT VALLEY PKWY. Malvern PA US 19355

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
792181724216489P240023
792181160162634K994253VACLOK SYRINGEFMF2000-01-05
792181035490461K993341INTELLISYSTEM II COLOR MONITORMAV1999-10-25
792181990776746K992231FOUNTAIN Infusion Catheter and Occluding Guide WireQEY1999-07-23
792181400122723K991619FOUNTAIN Infusion Catheter and Occluding Guide WireQEY1999-06-09
792181360749086K990975IN-LINE HEMOSTASIS VALVEDYB2000-03-15
792181383750645K974570PERITONEAL DIALYSIS CATHETER CONNECTORFKO1998-02-27
792181902321357K974067FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIREQEY1998-02-27
792181161469967K973230MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)DXT1997-11-25
792181917151923K970159FLEX-NECK PD CATHETERFJS1997-09-05
792181827432717K962129CONTINUOUS FLUSH DEVICEKRA1997-04-15
792181372009656K96050918 GAUGE TRU-CUT BIOPSY NEEDLEKNW1996-04-04
1670031765451472K943739SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETERDQO1994-11-15
792181765451472K943739SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETERDQO1994-11-15
792181457952433K936032TORQUE DEVICEDQX1994-03-15
792181269848180K935170CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSDQX1994-03-31
1521221004689926K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVEDYB1994-01-21
792181004689926K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVEDYB1994-01-21
792181529948956K921702MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVIDQX1992-09-21
792181145189192K920977MERITRANS(TM) DISPOSABLE TRANSDUCERDRS1992-12-11
792181668957218K915678MERIT ADMINISTRATION SETFPA1992-07-30
792181641249949K914208MERIT DISPOSAL DEPOT(TM)DQO1991-12-18
792181983043194K913682MERIT CUSTOM KITDQO1991-11-15
792181856290612K912129DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBEKNS1991-08-07
792181847819263K902319BAUER TEMNO BIOPSY NEEDLEFCG1990-09-06
792181757841586K893480BYRD EXTRACTOR SETGCC1989-06-23
792181675410076K884913MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)DXT1989-04-18
792181049947372K883718MERIT HI-FLEX(TM)FPK1989-01-30
792181240318017K875196DISPOSABLE CORONARY CONTROL SYRINGE 12CCDXT1988-02-11
792181161640314K850827GUIDE, WIRE, ANGIOGRAPHICDQX1985-06-26
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
792181607410591K823295MEDIGROUP 2.2MM NEEDLESCOPE CANNULA&HET1983-05-06
792181789492695K810924MEDRAD HIGH PRESSURE CONECTING TUBEDWE1981-04-17
792181178351986K810637COBE DISPOSABLE PRESSURE TRANSDUCERDRS1981-04-23
792181202572382K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX2026-01-31
792181684585127K252892SCOUT MD Surgical Guidance SystemNEU2025-12-19
792181759837564K252527Surfacer Inside-Out Access Catheter SystemQJH2025-09-10
792181227117137K251802STAR 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
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
792181500456253K250853Merit SyringeFMF2025-11-04
792181323731005K242873Ventrax™ Delivery SystemDQY2025-01-15
792181876098045K242229Micro Ace Gold Advanced Micro Access SystemDRE2025-01-15
792181227982546K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesODE2024-04-26
792181899877323K240457C2 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
792181160610720K233813Bearing nsPVA Express™NAJ2023-12-21
792181304852084K233268Impress Angiographic CatheterDQO2024-05-22
792181007865637K232609Micro Ace™ Advanced Micro Access SystemDRE2023-09-27
2247091388918170K231468SCOUT MD Surgical Guidance SystemNEU2024-02-12
792181388918170K231468SCOUT MD Surgical Guidance SystemNEU2024-02-12
792181571817268K230636Maestro MicrocatheterKRA2023-03-30
792181437350721K230418Mighty Wire Guide WireDQX2023-10-28
792181930057323K223872Low Profile Companion SheathDYB2023-01-19
792182048761327K213845HeRO GraftDSY2022-08-15
792181835782116K213434Elation Pulmonary Balloon Dilation CatheterKTI2022-03-08
792181109772545K212882SCOUT BX Delivery SystemNEU2022-04-08
792181641674125K212696Aspira Pleural Drainage SystemDWM2023-03-03
792181815942949K212675Aspira Peritoneal Drainage SystemPNG2021-12-14
792181060185167K212199ASAP Aspiration Catheter, ASAPLP Aspiration CatheterQEZ2021-11-03
792181174118912K212152Prelude IDeal 9F Hydrophilic Sheath IntroducerDYB2022-01-07
792182045283295K211525SwiftNINJA Steerable MicrocatheterKRA2021-07-16
792182035533355K211405Prelude Guide SheathDYB2021-10-04
792181641400896K203724HeRO Graft, HeRO AdapterDSY2021-05-25
792181729048806K201595Merit Hydrophilic Guide WireDQX2020-10-14
792182067222822K201166Temno Elite Biopsy SystemKNW2020-08-28
792181149658667K193571Go2Wire Guide WireDQX2020-04-08
792182000952041K193507Merit ONE Snare SystemMMX2020-01-17
792181951561052K193082Fountain ValveTip Infusion CatheterKRA2020-08-07
792181753322922K193036C2 CryoBalloon EndoGripOCX2019-11-22
1670031293186696K191608Impress Angiographic CatheterDQO2019-07-16
792181293186696K191608Impress Angiographic CatheterDQO2019-07-16
792182019387955K191596Arcadia Balloon CatheterHRX2019-10-09
792181915083061K190175S-MAK XLDRE2019-04-10
792181238575322K182279Merit SyringeFMF2018-11-06
792181071255089K182216Merit SyringeFMF2018-11-06
792181999588746K181669ConvertX Biliary Stent SystemFGE2019-03-14
792181282987888K181200AEROmini Tracheobronchial Stent SystemJCT2018-09-21
2247091057030621K181007Cianna Medical SAVI Scout Reflector and SAVI Scout SystemNEU2018-08-02
792181057030621K181007Cianna Medical SAVI Scout Reflector and SAVI Scout SystemNEU2018-08-02
792181012652458K180723PreludeSYNC DISTAL Radial Compression SystemDXC2018-04-17
792181046757651K180450Corvocet Biopsy SystemKNW2018-03-12
792181343519939K173750Prelude IDeal Hydrophilic Sheath IntroducerDYB2018-02-15
792181730780946K173601Merit SyringeFMF2018-01-31
792181358717141K173548Merit Pursue MicrocatheterDQY2018-03-30
792181198224465K172637HeRO GraftDSY2017-11-30
1521221824741574K172117Prelude Pursuit Splittable Sheath IntroducerDYB2017-09-11
792181824741574K172117Prelude Pursuit Splittable Sheath IntroducerDYB2017-09-11
792181277128208K172081Maestro MicrocatheterKRA2017-08-04
792181010342649K171362Merit SyringeFMF2017-08-07
792181877293097K170933Merit Hydrophilic Guide WireDQX2017-06-22
792181887409229K170700Inqwire Diagnostic Guide WireDQX2017-04-06
792181482185045K170668HeartSpan Steerable Sheath IntroducerDYB2017-04-05
1521221482185045K170668HeartSpan Steerable Sheath IntroducerDYB2017-04-05
792181094850246K170532True Form Reshapable Guide WireDQX2017-07-21
792181551516661K170298Liberator Beacon Tip Locking StyletDRB2017-10-18
792182072895685K163597VacLok AT Vacuum SyringePUR2017-07-27
792181381905025K163575Inqwire Diagnostic Guide WireDQX2017-03-03
792181639290438K163084Merit Coronary Control SyringeDXT2017-06-15
792181894386063K162988PreludeSYNC Radial Compression DeviceDXC2017-01-25
792181868019912K162777Squirt Fluid Delivery SystemQEY2016-10-31
792181343217284K161921SwiftNINJA MicrocatheterKRA2016-11-04
792181086042338K161392Elation Pulmonary Balloon DilationKTI2016-09-01
792181328074689K161277ConvertX Nephroureteral Stent SystemFAD2016-11-22
792181876718580K160107DiamondTOUCH Inflation Device and Fluid Dispensing SyringeDXT2016-07-29
792181765702182K153502ClariVein ICKRA2016-01-06
792181815269655K153337Corvocet Biopsy SystemKNW2016-03-25
792181529956482K152783Merit 20 mL SyringeFMF2015-12-07
1521221905038004K152381Prelude SNAP Splittable Hydrophilic Sheath IntroducerDYB2015-10-30
792181905038004K152381Prelude SNAP Splittable Hydrophilic Sheath IntroducerDYB2015-10-30
1521221060103238K152310HeartLight Deflectable SheathDRA2016-02-24
792181060103238K152310HeartLight Deflectable SheathDRA2016-02-24
1521221108344441K1521165.5 F Worley Advanced LVI Lateral Vein IntroducerDYB2015-08-27
792181108344441K1521165.5 F Worley Advanced LVI Lateral Vein IntroducerDYB2015-08-27

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
DYB312025-04-25
DQX242026-01-31
DQO122024-05-22
DRE112025-01-15
FMF92025-11-04
KRA92023-03-30
JCT82018-09-21
DXT72017-06-15
MSD72016-04-04
FJS72012-05-21
NEU62025-12-19
DQY62025-01-15
FGE62019-03-14
NDN62015-04-09
KNW52020-08-28
MMX52020-01-17
DSY42022-08-15
DXC42018-04-17
QEY42016-10-31
FKX41983-01-26
ESW32025-07-23
QEZ32021-11-03
FCG32015-08-07
QBP32015-05-22
QSY32013-07-09
KNS32010-09-07
DRC32002-05-02
QJH22025-09-10
NAJ22023-12-21
DWM22023-03-03
KTI22022-03-08
PNG22021-12-14
DRA22016-02-24
JAQ22010-07-12
DTL22010-04-28
FPA22008-12-23
DRS21992-12-11
HET21983-05-06
GXI12026-02-13
GEH12024-07-24

PMA

PMN

Applications

GUDID

DuraMax®

2026-03-24

Merit Medical Systems, Inc.