Merit Medical Systems, Inc.

FDA Device Registration & Listing · ALISO VIEJO, CA, US · Registration 2032338

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
2032338
FEI Number
3003295907
Entity Name
Merit Medical Systems, Inc.
City/State/Country
ALISO VIEJO, CA, US
Establishment Address
6 JOURNEY, SUITE 125, ALISO VIEJO, CA 92656, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
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
K181007
PMA Number
N/A

All Registered Proprietary Names

SAVI Applicator Kit SCOUT MD Console SCOUT MD Single-use Handpieces SCOUT MD Guides SCOUT MD Delivery System SCOUT Single-Use Handpiece, SCOUT Surgical Guides SCOUT Reflector and Delivery Systems SCOUT Surgical Console and SCOUT Check Console

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2018-11-28
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2024-11-04
NEU Marker, Radiographic, Implantable General, Plastic Surgery Class 2 878.4300 2018-11-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
1125782 MERIT MEDICAL SYSTEMS, INC Chester, VA, US
9615728 BIOSPHERE MEDICAL, S.A. Roissy Val-d'Oise, FR
3010665433 Merit Medical Systems, Inc. Houston, TX, US

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

Similar Registrations

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3016602874 Varian Medical Systems Haan GmbH Haan North Rhine-Westphalia, DE
9611894 NUCLETRON B.V. VEENENDAAL Utrecht, NL
2431392 MICK RADIO-NUCLEAR INSTRUMENTS, INC. MOUNT VERNON, NY, US
1721504 MERIT MEDICAL SYSTEMS, INC. South Jordan, UT, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032338. Last updated year: 2026. Please use registration number 2032338 when referencing this establishment in official correspondence.
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