Merit Medical Systems, Inc.

Entity profile compiled from public source records

Public Record Profile Registrations: 15 510(k) filings: 0 Recalls: 3

Known Identifiers & Locations

FEI Numbers 1721504, 3000335778, 3002806476, 3002808761, 3002975287, 3003295907, 3006950086, 3010665433, 3011642792, 3012276280, 3012536737, 3015225571, 3015309643, 3021179744, 3033589330
Owner Operator Numbers 1721504
Locations Covered ALISO VIEJO, CA, US; Arden Hills, MN, US; Braiside Victoria, AU; Carlsbad, CA, US; Chester, VA, US; Earley Reading, GB; Galway, IE; Houston, TX, US; Maastricht Airport Limburg, NL; Markham Ontario, CA; Roissy Val-d'Oise, FR; SINGAPORE Central Singapore, SG; South Jordan, UT, US; Tijuana Baja California, MX; Tsim Sha Tsui, HK

Registered Establishments (15)

Registration # Establishment Name Location Establishment Type(s) Action
1125782 MERIT MEDICAL SYSTEMS, INC Chester, VA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
1721504 MERIT MEDICAL SYSTEMS, INC. South Jordan, UT, US Manufacture Medical Device View Details
2032338 Merit Medical Systems, Inc. ALISO VIEJO, CA, US Develop Specifications But Do Not Manufacture At This Facility View Details
3006950086 Merit Medical Nederland BV Maastricht Airport Limburg, NL Export Device to the United States But Perform No Other Operation on Device View Details
3010665433 Merit Medical Systems, Inc. Houston, TX, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3011642792 Merit Maquiladora Mexico, S. DE R.L. DE C.V. Tijuana Baja California, MX Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3012276280 KA Medical Arden Hills, MN, US Manufacture Medical Device View Details
3012536737 Merit Medical Canada Ltd. Markham Ontario, CA Export Device to the United States But Perform No Other Operation on Device View Details
3015225571 Merit Medical Asia Company Limited Tsim Sha Tsui, HK Export Device to the United States But Perform No Other Operation on Device View Details
3015309643 Merit Medical UK Limited Earley Reading, GB Export Device to the United States But Perform No Other Operation on Device View Details
3021179744 VIEW POINT MEDICAL, INC. Carlsbad, CA, US Manufacture Medical Device View Details
3033589330 Merit Medical Australia Pty Ltd. Braiside Victoria, AU Export Device to the United States But Perform No Other Operation on Device View Details
8020616 Merit Medical Singapore Pte. Ltd. SINGAPORE Central Singapore, SG Manufacture Medical Device View Details
9615728 BIOSPHERE MEDICAL, S.A. Roissy Val-d'Oise, FR Manufacture Medical Device View Details
9616662 MERIT MEDICAL IRELAND, LTD Galway, IE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (3)

Recall # Product Description Initiation Date Status Action
Z-0002-2017 Merit Inflation Syringe Kit. Catalog Number KOS-02857 Reason: Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information. 2016-08-25 Terminated View Details
Z-0026-2020 Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409 Reason: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free) 2018-10-26 Terminated View Details
Z-0027-2020 Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580 Reason: Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free) 2018-10-26 Terminated View Details

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