Enquirer Consulting Group

A Buyer Map of US Device Companies in Three Areas

Prepared for Chad Troup | Cape MedTech | October 2026

As of Oct 10, 2026. Counts from public FDA device registration and clearance records

This page counts the US medical device companies in three areas. Cardiovascular takes in coronary and peripheral vascular devices, orthopedic takes in spine, and neurology takes in neurovascular devices and the stimulators used to treat pain. We picked those three ourselves. If your focus sits somewhere else, tell us and we will redo the page for that area. It counts companies, not people, and it says nothing about who you already know.

US device makers across the three areas

1,500

Companies registered with FDA that make or design at least one device in these areas.

Of those, the designer of record on a device

810

Companies listed as the specification developer for at least one device in these areas.

Companies with a new device cleared in the last year

310

US companies with a 510(k) clearance in these areas between Oct 2025 and Sep 2026.

Of those, exactly one clearance

240

One clearance across all three areas in the year, each company counted once.

Who makes devices in these areas

US companies with an active FDA registration that make, or design and specify, at least one device in that area.

A company that works in two areas counts once in each, and once in the last row. The designer of record is the specification developer FDA has on file for a device, so another plant may make it for them. Many of those companies also make devices themselves.
Area	Companies	Of those, designer of record
Cardiovascular, including coronary and peripheral vascular	590	320
Orthopedic, including spine	610	380
Neurology, including neurovascular and stimulators for pain	520	250
Any of the three	1,500	810

Who had a new device cleared in the last twelve months

510(k) clearances to US companies decided between Oct 1, 2025 and Sep 30, 2026, by the device's FDA classification panel.

310 different companies across the three areas. Special 510(k)s, which cover changes to a device already cleared, are left out. A few De Novo grants filed in the same database are in. Premarket approvals are not counted. The public database may miss the last few days of September.
Area	Clearances	Companies	Companies with one clearance in the area
Cardiovascular, including coronary and peripheral vascular	170	130	100
Orthopedic, including spine	220	130	86
Neurology, including neurovascular and stimulators for pain	90	70	61

Where the openings sit

Companies with one new clearance

240 companies had exactly one new device cleared across these areas in the last year. Many of them are smaller companies, where one clearance can be the device they now have to sell. Some are units of large groups. The people who usually own the launch are the founder or CEO and the head of sales or commercial.

Companies that are the designer of record

810 companies across the three areas are the specification developer for at least one device. The roles to reach are the CEO, the head of commercial and the head of business development.

Physician-facing roles

Inside the same companies, physician partnerships usually sit with medical affairs, a medical director or clinical affairs. These counts do not size that group.

Denominators, definitions and sources

Makers come from FDA's device establishment registration and listing files, dated Oct 5, 2026. We kept US sites with an active registration where the site is listed as the manufacturer or the specification developer of a device, then grouped sites into companies by their FDA owner and operator number.
An area is the FDA classification panel of the device, cardiovascular, orthopedic or neurology. For devices with no regulation panel on file, mostly those that go through premarket approval, we used the panel FDA lists for review. Coronary and peripheral vascular devices sit in cardiovascular, neurovascular devices and spinal cord and nerve stimulators in neurology, and spine devices in orthopedic. Some pain devices sit in other panels and are not counted.
New clearances come from the public 510(k) database, US applicants only, by the device's classification panel. Companies are matched on the applicant name on file, with legal suffixes such as Inc. and LLC set aside, so two units of one group can still count as two.
A registration is a compliance record, not a size measure. A company here can be very small or very large. Figures of 100 or more are rounded on purpose.

The named version of this page, the actual companies inside a row, is built one row at a time. Reply on the thread, or write to my colleague Paul Smaldone, your point of contact from here, at paul@enquirerai.com.

Enquirer Consulting Group | enquirerconsulting.com