Company lists · Data refreshed September 2026

Top 25 Iso 13485 certified manufacturers based in the United States

RevenueBase identified 492 company matches for iso 13485 certified manufacturers associated with the United States as of September 2026 and tracks 8,523 professional contacts across them, including 2,995 with verified work emails. Irvine is the largest hub.

This list covers company matches for iso 13485 certified manufacturers associated with the United States, found by RevenueBase SmartSearch using the meaning of business descriptions in its company graph at Exact. Ranked by professionals tracked, largest first. Rows show recorded descriptions where available, Exact search membership and the snapshot date. Data refreshed September 17, 2026.

Published by RevenueBase, a B2B data infrastructure company. This list was built with RevenueBase SmartSearch, the natural-language company search RevenueBase customers use to build their own targeted lists and unlock verified emails and direct dials at the companies on them. How these lists are built and judged.

How to read this list RevenueBase SmartSearch · Exact Recorded Sep 17, 2026 How this list was built
492Companies
8,523Contacts tracked
2,995Verified emails
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The 25 largest iso 13485 certified manufacturers based in the United States

Ranked by team size
Top 25 of 492 company matches for iso 13485 certified manufacturers based in the United States, ordered by professional contacts tracked in RevenueBase, largest first. Recorded Sep 17, 2026. The RevenueBase SmartSearch column shows Exact match membership in this saved search. Click a contact count to view that company's people. Totals use company locations recorded by RevenueBase; the displayed preview is a smaller selection.
#CompanyRevenueBase SmartSearchHeadquartersEmployeesContacts
1Exact matchBrooklyn Park, MN, United StatesHQ recorded Sep 17, 20261,001-5,000729 contacts →

Exact match

“Whether you’re a startup or a leading Class II or medical device manufacturer, Cirtec is here to help bring life-enhancing therapies to market – quickly and cost-effectively.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
2Exact matchSan Diego, CA, United StatesHQ recorded Sep 17, 2026501-1,000405 contacts →

Exact match

“Ascential Medical & Life Sciences, now including Aspect, D&K Engineering, Kinematic, Korvis, Quantum 3, and NACS, is a turnkey development and manufacturing partner for highly…”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
3Exact matchStaunton, VA, United StatesHQ recorded Sep 17, 2026501-1,000359 contacts →

Exact match

“Cadence is a vertically integrated, medical device contract manufacturing organization serving the medical device, diagnostics, and drug delivery markets, providing best-in-class…”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
4Exact matchBuffalo, NY, United StatesHQ recorded Sep 17, 20261,001-5,000308 contacts →

Exact match

“Your Global Partner for Full-Service Contract Manufacturing of Single-Use Medical Devices.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
5Exact matchHollis, NH, United StatesHQ recorded Sep 17, 2026n/a239 contacts →

Exact match

“Farm, a Flex company, advances healthcare and life science through innovation and deep industry knowledge.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
6Exact matchConcord, NC, United StatesHQ recorded Sep 17, 2026501-1,000230 contacts →

Exact match

“Avante Health Solutions is moving healthcare forward by providing quality-and value-based medical equipment to healthcare facilities worldwide.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
7Exact matchEl Paso, TX, United StatesHQ recorded Sep 17, 20261,001-5,000216 contacts →

Exact match

“Seisa Group is a premier full-service medical device manufacturer.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
8Exact matchCleveland, OH, United StatesHQ recorded Sep 17, 20261,001-5,000205 contacts →

Exact match

“QMD™ provides a full range of products and services to help OEMs bring medical devices to market.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
9Exact matchNorthvale, NJ, United StatesHQ recorded Sep 17, 2026n/a204 contacts →

Exact match

“ADM Tronics ("ADMT") specializes in electronic medical device design, development and manufacturing for diagnostic and therapeutic medical technologies at its FDA-Registered…”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
10Exact matchMinneapolis, MN, United StatesHQ recorded Sep 17, 2026201-500163 contacts →

Exact match

“Resolution Medical's Mission is to Provide Innovative Business Solutions to the Medical Device Industry with the Highest Quality and Reliability, Exceptional Customer Service, and…”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
11Exact matchLincolnshire, IL, United StatesHQ recorded Sep 17, 2026501-1,000153 contacts →

Exact match

“Flexan is a global leader in custom medical device development and manufacturing solutions.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
12Exact matchBerlin, CT, United StatesHQ recorded Sep 17, 2026201-500124 contacts →

Exact match

“ISO 13485:2016 Certified & FDA Registered TOMZ Corporation was founded in 1988 and is a leader in the manufacturing of precision components for major medical device, healthcare…”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
13Exact matchWest Boylston, MA, United StatesHQ recorded Sep 17, 202651-200113 contacts →

Exact match

“Cogmedix provides FDA and ISO 13485 compliant product development and commercialization services to a broad range of dental and medical device innovators with unsurpassed quality…”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
14Exact matchBethel, CT, United StatesHQ recorded Sep 17, 2026201-500112 contacts →

Exact match

“Memry was acquired by Resonetics in 2023.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
15Exact matchBartlett, TN, United StatesHQ recorded Sep 17, 2026201-500100 contacts →

Exact match

“Engineered Medical Systems, LLC is a medical device manufacturing company based out of 3325 Appling Road, Bartlett, Tennessee, United States.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
16Exact matchIrvine, CA, United StatesHQ recorded Sep 17, 202651-20098 contacts →

Exact match

“At Pro-Dex, we believe that the most impactful advancements in healthcare come from a commitment to excellence, integrity, and meaningful progress.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
17Exact matchFranklin, WI, United StatesHQ recorded Sep 17, 2026201-50093 contacts →

Exact match

“For almost four decades, Vesta has provided medical device manufacturing services for a vast range of medical applications.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
18Exact matchCincinnati, OH, United StatesHQ recorded Sep 17, 202651-20091 contacts →

Exact match

“PMC SMART Solutions draws upon more than 90 years of manufacturing know-how and innovation to give customers a comprehensive, scientific approach to manufacturing technology that…”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
19Exact matchRamsey, MN, United StatesHQ recorded Sep 17, 202651-20083 contacts →

Exact match

“Dynamic Group, Inc.(DGI) is a leading contract manufacturer specializing in precision injection-molded plastic components and high-precision molds.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
20Exact matchPrairie Village, KS, United StatesHQ recorded Sep 17, 202651-20081 contacts →

Exact match

“Our engineering team is a booster rocket for accelerating medical device design; we help clients launch products with certainty.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
21Exact matchYoungsville, NC, United StatesHQ recorded Sep 17, 202651-20080 contacts →

Exact match

“Robling Medical, LLC is a full service contract manufacturer.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
22Exact matchSanta Fe Springs, CA, United StatesHQ recorded Sep 17, 2026201-50069 contacts →

Exact match

“PRO-TECH Design and Manufacturing is a full service FDA and ISO Registered contract manufacturer and packager; primarily serving the medical industry.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
23Exact matchSolana Beach, CA, United StatesHQ recorded Sep 17, 202651-20069 contacts →

Exact match

“To accelerate product innovation and product commercialization in the medical device industry by offering linked services – from product design through sterile product…”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
24Exact matchPleasant Prairie, WI, United StatesHQ recorded Sep 17, 202651-20067 contacts →

Exact match

“Regulatory Compliance Associates Inc.(RCA) is a team of experienced professionals from FDA-regulated industries including pharmaceutical, biologics and medical device.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase
25Exact matchBoulder, CO, United StatesHQ recorded Sep 17, 202651-20062 contacts →

Exact match

“Tensentric has one focus: the design and manufacturing of medical devices and in vitro diagnostic systems.”

Recorded in the RevenueBase company graph · Sep 17, 2026 · View company records in RevenueBase

Showing 25 of 492 iso 13485 certified manufacturers based in the United States

See the full list, filter by size, metro and specialty, and access 2,995 tracked professional contacts with verified work emails. Direct dials are available where recorded.

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Iso 13485 certified manufacturers based in the United States at a glance

As of Sep 17, 2026
35.1%Verified-email coverage
17.3Average contacts per company
11-50Median size (employees)
2.4%Largest-city concentration · Irvine
Sep 17, 2026Page data refreshed

Companies by employee count

1-10
226
11-50
149
51-200
80
201-500
19
501-1,000
13
1,001-5,000
5

Email recency for this list is measured worldwide rather than for United States, so it is reported there. Company counts and contact totals on this page are exact for United States, over 492 companies.

How this list was built

The recorded descriptions help you assess these company matches. Check a company’s website for its current services and locations.

Source
The RevenueBase company graph: 60 million companies and 398.9 million professional contacts resolved from primary sources, queried with RevenueBase SmartSearch, the natural-language company search available to every RevenueBase user.
What qualifies
Company records associated with the United States whose business descriptions match “iso 13485 certified manufacturers” by meaning at the Exact setting. Descriptions are compiled in the RevenueBase company graph from public websites, profiles and company information where available; they are not guaranteed quotations from the company's website.
RevenueBase SmartSearch
Describe a niche company in your own words to find businesses by meaning. Exact, Similar, Related and Broad control the breadth of RevenueBase SmartSearch. This saved list uses Exact. Each row's Exact match badge shows inclusion in that search, not an individual score or a service-quality judgment.
Public preview
The public preview omits records without a verified work email. Where headquarters information is recorded, preview rows are also filtered to this page’s location. Dataset totals and geographic summaries describe the full matched records before these preview filters.
Match quality
RevenueBase's August 25, 2026 study assessed 4,198 description/company pairs across matching settings. The publisher reports 86% good or better at Exact. This evaluates the method across queries; it does not audit this individual list. Recorded company descriptions, where available, help you judge each match yourself. Read the full methodology: how the lists are built and what the study measures.
Ranking
Team size, largest first: companies are ordered by the number of professionals RevenueBase tracks at each one. Employee ranges shown are reported bands, for context.
Verification
Every displayed company carries at least one verified work email. RevenueBase tracks 2,995 professional contacts with verified work emails across the full matched dataset. Contacts re-verify on a rolling cadence, and each contact's own verification date is shown inside RevenueBase.
Refresh
This page's figures were pulled from the company graph on September 17, 2026. Lists refresh periodically as the graph is re-checked.
Record context
Company records and descriptions can change. Check the company's website for its current services and locations.

Frequently asked

What is RevenueBase SmartSearch?

RevenueBase SmartSearch finds niche companies by the meaning of their business descriptions in the RevenueBase company graph. Exact, Similar, Related and Broad control how closely companies must fit your description. This list uses Exact for “iso 13485 certified manufacturers”; each Exact match badge shows search membership, not an individual similarity or quality score.

How many iso 13485 certified manufacturers are there based in the United States?

RevenueBase identified 492 company matches for iso 13485 certified manufacturers associated with the United States as of September 2026, using the meaning of business descriptions at Exact. This is the recorded matched set in the RevenueBase company graph.

What is the largest company on this list?

Cirtec Medical tops the displayed preview by professional contacts tracked in RevenueBase. Recorded headquarters appear in the company rows.

Which city has the most iso 13485 certified manufacturers?

Irvine leads with 12 company records, followed by Salt Lake City (7) and San Diego (7).

How do I get contact information for these companies?

A free RevenueBase account lets you run this exact search and work limited free results with 500 credits to start. Upgrading provides access to the 2,995 professional contacts with verified work emails tracked across these 492 companies; direct dials are available where recorded.

How current is this list?

The list refreshes periodically as the company graph is re-checked. This page's figures were pulled on September 17, 2026.

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About this data

RevenueBase is a B2B data infrastructure company. Its company graph covers 60 million companies and 398.9 million professional contacts, with emails verified on a rolling cadence rather than scraped once and left to decay. These company lists are generated directly from that graph with RevenueBase SmartSearch, the same natural-language company search every RevenueBase user has: describe a market in plain words, get the companies that match, and add verified emails and direct dials for the people at them. It is the same data that powers RevenueBase's B2B data products, and a free account includes 500 credits to start. How these lists are built and judged.