Company lists · Data refreshed September 2026

Top 25 Iso 13485 certified manufacturers based in the United States

Name: Iso 13485 certified manufacturers based in the United States
Creator: RevenueBase
License: https://creativecommons.org/licenses/by/4.0/

Compiled by the RevenueBase Data Team Data refreshed Sep 17, 2026 492 companies tracked

RevenueBase identified 492 iso 13485 certified manufacturers headquartered in 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 iso 13485 certified manufacturers headquartered in the United States, matched on what each company actually does as described in its own words. Ranked by team size, largest first. Every row shows the company's own description, its RevenueBase Smart Search rating, and when it was last checked. Data refreshed September 17, 2026.

Published by RevenueBase, a B2B data infrastructure company. This list was built with RevenueBase Smart Search, 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 HQ checked on every row RevenueBase Smart Search rating on every row Refreshed Sep 17, 2026 86% judged on-target in blind review

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 iso 13485 certified manufacturers based in the United States, ranked by team size, largest first. Data refreshed Sep 17, 2026. RevenueBase Smart Search rates how each company's information relates to iso 13485 certified manufacturers: strong evidence (its own description names it), partial (names part of it), indirect (matched on the rest of its profile rather than the description shown). Click a contact count to view that company's people.
#	Company	RevenueBase Smart Search	Headquarters	Employees	Contacts
1	Cirtec Medical	Partial evidence	Brooklyn Park, MN, United StatesHQ checked Sep 17, 2026	1,001-5,000	729 contacts →
	Partial evidence “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.” Source: RevenueBase Database · checked Sep 17, 2026
2	Ascential Medical & Life Sciences NOW Includes D&k Engineering	Indirect evidence	San Diego, CA, United StatesHQ checked Sep 17, 2026	501-1,000	405 contacts →
	Indirect evidence “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…” Source: RevenueBase Database · checked Sep 17, 2026
3	Cadence, INC	Indirect evidence	Staunton, VA, United StatesHQ checked Sep 17, 2026	501-1,000	359 contacts →
	Indirect evidence “Cadence is a vertically integrated, medical device contract manufacturing organization serving the medical device, diagnostics, and drug delivery markets, providing best-in-class…” Source: RevenueBase Database · checked Sep 17, 2026
4	Harmac Medical Products	Indirect evidence	Buffalo, NY, United StatesHQ checked Sep 17, 2026	1,001-5,000	308 contacts →
	Indirect evidence “Your Global Partner for Full-Service Contract Manufacturing of Single-Use Medical Devices.” Source: RevenueBase Database · checked Sep 17, 2026
5	Farm, A Flex Company	Indirect evidence	Hollis, NH, United StatesHQ checked Sep 17, 2026	n/a	239 contacts →
	Indirect evidence “Farm, a Flex company, advances healthcare and life science through innovation and deep industry knowledge.” Source: RevenueBase Database · checked Sep 17, 2026
6	Avante Health Solutions	Indirect evidence	Concord, NC, United StatesHQ checked Sep 17, 2026	501-1,000	230 contacts →
	Indirect evidence “Avante Health Solutions is moving healthcare forward by providing quality-and value-based medical equipment to healthcare facilities worldwide.” Source: RevenueBase Database · checked Sep 17, 2026
7	Seisa Medical	Partial evidence	El Paso, TX, United StatesHQ checked Sep 17, 2026	1,001-5,000	216 contacts →
	Partial evidence “Seisa Group is a premier full-service medical device manufacturer.” Source: RevenueBase Database · checked Sep 17, 2026
8	QMD	Indirect evidence	Cleveland, OH, United StatesHQ checked Sep 17, 2026	1,001-5,000	205 contacts →
	Indirect evidence “QMD™ provides a full range of products and services to help OEMs bring medical devices to market.” Source: RevenueBase Database · checked Sep 17, 2026
9	ADM Tronics Unlimited, INC	Indirect evidence	Northvale, NJ, United StatesHQ checked Sep 17, 2026	n/a	204 contacts →
	Indirect evidence “ADM Tronics ("ADMT") specializes in electronic medical device design, development and manufacturing for diagnostic and therapeutic medical technologies at its FDA-Registered…” Source: RevenueBase Database · checked Sep 17, 2026
10	Resolution Medical	Indirect evidence	Minneapolis, MN, United StatesHQ checked Sep 17, 2026	201-500	163 contacts →
	Indirect evidence “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…” Source: RevenueBase Database · checked Sep 17, 2026
11	Flexan, An Ingersoll Rand Business	Indirect evidence	Lincolnshire, IL, United StatesHQ checked Sep 17, 2026	501-1,000	153 contacts →
	Indirect evidence “Flexan is a global leader in custom medical device development and manufacturing solutions.” Source: RevenueBase Database · checked Sep 17, 2026
12	Tomz Corporation	Strong evidence	Berlin, CT, United StatesHQ checked Sep 17, 2026	201-500	124 contacts →
	Strong evidence “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…” Source: RevenueBase Database · checked Sep 17, 2026
13	Cogmedix	Strong evidence	West Boylston, MA, United StatesHQ checked Sep 17, 2026	51-200	113 contacts →
	Strong evidence “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…” Source: RevenueBase Database · checked Sep 17, 2026
14	Resonetics Previously Memry	Indirect evidence	Bethel, CT, United StatesHQ checked Sep 17, 2026	201-500	112 contacts →
	Indirect evidence “Memry was acquired by Resonetics in 2023.” Source: RevenueBase Database · checked Sep 17, 2026
15	Engineered Medical Systems, LLC	Indirect evidence	Bartlett, TN, United StatesHQ checked Sep 17, 2026	201-500	100 contacts →
	Indirect evidence “Engineered Medical Systems, LLC is a medical device manufacturing company based out of 3325 Appling Road, Bartlett, Tennessee, United States.” Source: RevenueBase Database · checked Sep 17, 2026
16	Pro-Dex, INC	Indirect evidence	Irvine, CA, United StatesHQ checked Sep 17, 2026	51-200	98 contacts →
	Indirect evidence “At Pro-Dex, we believe that the most impactful advancements in healthcare come from a commitment to excellence, integrity, and meaningful progress.” Source: RevenueBase Database · checked Sep 17, 2026
17	Vesta, A Lubrizol Company	Indirect evidence	Franklin, WI, United StatesHQ checked Sep 17, 2026	201-500	93 contacts →
	Indirect evidence “For almost four decades, Vesta has provided medical device manufacturing services for a vast range of medical applications.” Source: RevenueBase Database · checked Sep 17, 2026
18	PMC Smart Solutions	Indirect evidence	Cincinnati, OH, United StatesHQ checked Sep 17, 2026	51-200	91 contacts →
	Indirect evidence “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…” Source: RevenueBase Database · checked Sep 17, 2026
19	Dynamic Group	Partial evidence	Ramsey, MN, United StatesHQ checked Sep 17, 2026	51-200	83 contacts →
	Partial evidence “Dynamic Group, Inc.(DGI) is a leading contract manufacturer specializing in precision injection-molded plastic components and high-precision molds.” Source: RevenueBase Database · checked Sep 17, 2026
20	Engenious Design	Indirect evidence	Prairie Village, KS, United StatesHQ checked Sep 17, 2026	51-200	81 contacts →
	Indirect evidence “Our engineering team is a booster rocket for accelerating medical device design; we help clients launch products with certainty.” Source: RevenueBase Database · checked Sep 17, 2026
21	Robling Medical, LLC	Partial evidence	Youngsville, NC, United StatesHQ checked Sep 17, 2026	51-200	80 contacts →
	Partial evidence “Robling Medical, LLC is a full service contract manufacturer.” Source: RevenueBase Database · checked Sep 17, 2026
22	Pro-Tech Design & Manufacturing, INC	Strong evidence	Santa Fe Springs, CA, United StatesHQ checked Sep 17, 2026	201-500	69 contacts →
	Strong evidence “PRO-TECH Design and Manufacturing is a full service FDA and ISO Registered contract manufacturer and packager; primarily serving the medical industry.” Source: RevenueBase Database · checked Sep 17, 2026
23	Centerpiece	Indirect evidence	Solana Beach, CA, United StatesHQ checked Sep 17, 2026	51-200	69 contacts →
	Indirect evidence “To accelerate product innovation and product commercialization in the medical device industry by offering linked services – from product design through sterile product…” Source: RevenueBase Database · checked Sep 17, 2026
24	Regulatory Compliance Associates RCA	Indirect evidence	Pleasant Prairie, WI, United StatesHQ checked Sep 17, 2026	51-200	67 contacts →
	Indirect evidence “Regulatory Compliance Associates Inc.(RCA) is a team of experienced professionals from FDA-regulated industries including pharmaceutical, biologics and medical device.” Source: RevenueBase Database · checked Sep 17, 2026
25	Tensentric	Indirect evidence	Boulder, CO, United StatesHQ checked Sep 17, 2026	51-200	62 contacts →
	Indirect evidence “Tensentric has one focus: the design and manufacturing of medical devices and in vitro diagnostic systems.” Source: RevenueBase Database · checked Sep 17, 2026

RevenueBase Smart Search

RevenueBase Smart Search assesses information from a company’s LinkedIn profile, information supplied directly by the company, its website, and other publicly available sources. It uses that information to rate how closely the company relates to this list’s category: iso 13485 certified manufacturers. Every row carries its rating and the description the rating was read from, so each one can be checked rather than taken on trust.

Strong evidence: The company's own public description of its business names iso 13485 certified manufacturers.
Partial evidence: Its own public description names part of iso 13485 certified manufacturers, so it works in or next to the category without describing itself that way.
Indirect evidence: The description shown does not name iso 13485 certified manufacturers. The match rests on the rest of the company's public profile rather than the one sentence quoted here, so this is the rating to check first.

RevenueBase Smart Search is how these lists are built: RevenueBase's data engine and AI assemble the companies that match a category defined in a user's own words, so a list can be about what companies actually do rather than about whichever industry code they were filed under.

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

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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

201-500

501-1,000

1,001-5,000

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

Company categories are rarely black and white. RevenueBase reads each company's own description of its business to decide whether it belongs among iso 13485 certified manufacturers, so some rows will be adjacent to the category rather than pure plays. The description and RevenueBase Smart Search rating on every row are there so you can check each match yourself.

Source: The RevenueBase company graph: 60 million companies and 398.9 million professional contacts resolved from primary sources, queried with RevenueBase Smart Search, the natural-language company search available to every RevenueBase user.
What qualifies: Companies headquartered in the United States whose own description of what they do matches “iso 13485 certified manufacturers”. Matching reads each company's description, not its industry code or its name.
RevenueBase Smart Search: RevenueBase Smart Search is how this list is assembled and how each row is rated. RevenueBase's data engine and AI assess a company's LinkedIn profile, information supplied directly by the company, its website and other publicly available information, then relate it to a category defined in a user's own words. Each row is rated strong evidence (its own description names iso 13485 certified manufacturers), partial evidence (it names part of the category) or indirect evidence (the description shown names none of it and the match rests on the rest of the company's profile). The description supporting each rating is quoted on the row.
What we exclude: Companies whose own description does not clearly place them among iso 13485 certified manufacturers, and records with no verified work email. Companies headquartered outside United States are excluded even when they keep an office there.
Match quality: In blind human judging of this matching method, 86% of matched companies were on target. Expect roughly 1 in 7 rows to be adjacent to the category rather than a pure play. Every row shows the company's own description and its RevenueBase Smart Search rating so you can judge each match yourself. Read the full methodology: how the lists are built, how the judging worked, and what the figure means.
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 listed company carries at least one verified work email, 2,995 across the full list. 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.
Corrections: Wrong category, wrong headquarters, or a company that has closed? Use “Report an issue” on any row. Reports go to the RevenueBase Data Team and feed back into the company graph.

Frequently asked

What is RevenueBase Smart Search?

RevenueBase Smart Search is how RevenueBase decides which companies belong on this list and how strongly each one fits. Its data engine and AI assess a company's LinkedIn profile, information supplied directly by the company, its website and other publicly available information, then relate it to the category the list is about. Each row is rated strong evidence when the company's own description names iso 13485 certified manufacturers, partial evidence when it names part of the category, and indirect evidence when the description shown names none of it and the match rests on the rest of the company's profile.

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

RevenueBase identified 492 iso 13485 certified manufacturers headquartered in the United States as of September 2026, matched on each company's own description of what it does rather than its industry code.

What is the largest company on this list?

Cirtec Medical, headquartered in Brooklyn Park, tops this list with the largest team on record.

Which city has the most iso 13485 certified manufacturers?

Irvine leads with 12 headquartered companies, 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 the top results, verified emails and direct dials included. Upgrading unlocks all 2,995 verified decision-maker contacts tracked across these 492 companies.

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 Smart Search, 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.