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Medical device manufacturer

Merit Medical Systems, Inc.

Merit Medical Systems, Inc. holds 180 FDA 510(k) clearances across 49 product codes. Median elapsed review time is 90 days. openFDA lists 299 recall records naming the company. FDA publishes it under 8 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
180
Product codes
49
Median review
90 days
Recall records
299

How does FDA spell Merit Medical Systems, Inc.?

FDA publishes this company under 8 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
MERIT MEDICAL SYSTEMS, INCdevice/registrationlistingnormalised
MERIT MEDICAL SYSTEMS, INC.device/registrationlistingnormalised
Merit Medical Systemsdevice/510knormalised
Merit Medical Systems, Incdevice/recallnormalised
Merit Medical Systems, Inc.device/510knormalised
Merit Medical Systems, Inc.device/recallnormalised
Merit Medical Systems, Inc.device/registrationlistingnormalised
Merit Medical Systems, Inc.device/enforcementnormalised

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Merit Medical Systems, Inc. file in?

49 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
DQXWire, Guide, Catheter2288 days
DYBIntroducer, Catheter1986 days
FMFSyringe, Piston1073 days
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)955 days
DREDilator, Vessel, For Percutaneous Catheterization977 days
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass983 days
DQOCatheter, Intravascular, Diagnostic888 days
DXTInjector And Syringe, Angiographic790 days
KRACatheter, Continuous Flush7113 days
DQYCatheter, Percutaneous696 days
MAVSyringe, Balloon Inflation630 days
FGEStents, Drains And Dilators For The Biliary Ducts5116 days
MMXDevice, Percutaneous Retrieval530 days
QEYMechanical Thrombolysis Catheter529 days
DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter3155 days
DXCClamp, Vascular330 days
FPASet, Administration, Intravascular384 days
KNWInstrument, Biopsy3119 days
MSDCatheter, Hemodialysis, Implanted382 days
QEZAspiration Thrombectomy Catheter3118 days
ESWProsthesis, Esophageal250 days
JCTProsthesis, Tracheal, Expandable2137 days
KTIBronchoscope Accessory2105 days
LITCatheter, Angioplasty, Peripheral, Transluminal221 days
NAJAgents, Embolic, For Treatment Of Uterine Fibroids221 days

Showing the 25 they file in most, of 49.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Merit Medical Systems, Inc. had a recall?

openFDA lists 299 recall records naming this company across its whole history, of which 16 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

  • Z-2517-2026Class IIOpen, ClassifiedDQX

    Due to unsealed portions of pouches.

  • Z-2002-2026Class IIOpen, ClassifiedOEQ

    catheter may experience resistance when being advanced over the guidewire

  • Z-2003-2026Class IIOpen, ClassifiedOEQ

    catheter may experience resistance when being advanced over the guidewire

  • Z-2004-2026Class IIOpen, ClassifiedOEQ

    catheter may experience resistance when being advanced over the guidewire

  • Z-1575-2026Class IOpen, ClassifiedMSD

    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.

Showing the 5 most recently initiated of 299.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Merit Medical Systems, Inc. cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K262086PreludeSYNC™ Radial Compression DeviceDXC30
K254073StatSeal DiscFRO146
K251802STAR RF Ablation SystemGXI246
K252892SCOUT MD Surgical Guidance SystemNEU99
K250853Merit SyringeFMF228
K251265Resilience Fully Covered Esophageal Stent SystemESW90
K250909Prelude Wave Hydrophilic Sheath IntroducerDYB30
K242873Ventrax™ Delivery SystemDQY114
K242229Micro Ace Gold Advanced Micro Access SystemDRE169
K241521Prelude Small O.D. Introducer Guide WireDQX195

Source: openFDA device/510k · retrieved

Where is Merit Medical Systems, Inc. registered?

FDA lists 4 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

Watch what Merit Medical Systems, Inc. files next

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.