FDA-Registered Medical Device Establishments (U.S.)
U.S. · 13,115 locations

There are 13,115 FDA-Registered Medical Device Establishments in the US as of October 2026. They are in 51 states and territories.

13,115 U.S. medical device sites with an active FDA registration, read on 26 October 2026 from FDA's device registration and listing files.

More about this list

5,251 are registered as manufacturers, 2,198 as contract manufacturers, 3,570 as specification developers, 2,766 as repackagers or relabelers and 153 as contract sterilizers. California has 2,419, Florida 1,091, New York 831 and Texas 812. Each row has the establishment types, the FDA product codes the site lists (10,273 sites list at least one) with device class and implant flags, 510(k) and PMA numbers, the owner/operator and its address, and FDA's official correspondent with a phone. Medical devices and PPE are under a Section 232 national security investigation (opened September 2025).

13,115Locations
51States
49Data Fields
October 26, 2026File built

Need just some of them? Ask in your own words.

TryOnly California, the state with the mostWithin 25 miles of Los Angeles, CA, the busiest areaOnly rows marked manufacturerEvery FDA-Registered Drug & Device Sites list combined, within 25 miles of Anaheim, CAEach one's nearest FDA-Registered Drug Establishments (U.S.), in California, with miles

●Where the rows are

Map of where the FDA-Registered Medical Device Establishments (U.S.) are
One dot for every ZIP code with at least one location. Ask above for any part of it: a state, a city, a distance.

≡Sample Data Preview

fda-registered-medical-device-manufacturer-list.csvscroll →UTF-8
nameaddresscitystatezipphoneowner operatorowner operator numberestablishment typesestablishment type countmanufacturerproduct codesproduct code countdevice classesany implantany life sustainingpremarket submissionscontact namecontact companyowner addressowner cityowner stateowner zipowner countryinitial importerregistration numberfda reg keyfei numberregistration yearsection232 sectorname as publishedsource filesource daterow iddirections urlnaics codenaics titlesic codesic titleupdated dategeo precisioncountycounty fipscounty noteaddress qualitycountrysource urllatitudelongitude
Atrion Medical Products, Inc.1426 CURT FRANCIS RD.ArabAL35016(256) 586-1580 ext 228Atrion Corp.9914015Contract Manufacturer; Manufacturer2YCAZ DXT FMI FQH HCG HNW KOE KTI LRC MAV PTM11class1:2 class2:14YNK020333 K032840 K041158 K043249 K060643 K080967 K090660 K953522 K962611 K972964Daniel SwantnerAtrion Medical Products, Inc.ONE ALLENTOWN PKWY.AllenTX75002USN10437292695210437292026medical devices and PPEATRION MEDICAL PRODUCTS, INC.https://www.accessdata.fda.gov/premarket/ftparea/registration.zip2026-10-2626952https://www.google.com/maps/dir/?api=1&destination=1426%20CURT%20FRANCIS%20RD.%2C%20Arab%2C%20AL%2C%2035016339112Surgical and Medical Instrument Manufacturing3841Surgical and Medical Instruments and Apparatus2026-10-26addressMarshall County01095ZIP 35016 spans 4 counties; assigned to the county holding 69% of its land areacompleteUShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=2695234.340320-86.519950
Medpharm Inc138 KAYEN CHANDO STREETDededoGU96929(671) 632-6000Medpharm Inc10094270registered establishment0N0NNJOSE MARIMLA138 KAYEN CHANDO STREETDededoGU96929USY300968644634433430096864462027medical devices and PPEMEDPHARM INChttps://www.accessdata.fda.gov/premarket/ftparea/registration.zip2026-10-26344334https://www.google.com/maps/dir/?api=1&destination=138%20KAYEN%20CHANDO%20STREET%2C%20Dededo%2C%20GU%2C%2096929339112Surgical and Medical Instrument Manufacturing3841Surgical and Medical Instruments and Apparatus2026-10-26completeUShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=344334
Beretta U.S.A Corp17601 Beretta DriveAccokeekMD20607(301) 283-2191 ext 1363Beretta USA Corporation10047353registered establishment0N0NNLISANDRA SMITH17601 Beretta DriveAccokeekMD20607USY100032167117390310003216712026medical devices and PPEBeretta U.S.A Corphttps://www.accessdata.fda.gov/premarket/ftparea/registration.zip2026-10-26173903https://www.google.com/maps/dir/?api=1&destination=17601%20Beretta%20Drive%2C%20Accokeek%2C%20MD%2C%2020607339112Surgical and Medical Instrument Manufacturing3841Surgical and Medical Instruments and Apparatus2026-10-26addressPrince George's County24033ZIP 20607 spans 2 counties; assigned to the county holding 96% of its land areacompleteUShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=17390338.647924-77.038384
Coda Resources Ltd75 Lower Main St Suite 200AberdeenNJ07747(718) 649-1666 ext 123Coda Resources Ltd10023200Complaint File Establishment1NEAX EFW EIX EJB ELA EMN JES JET LCN9class1:9NNCharnie Adler100 Matawan Road Suite 300MatawanNJ07747USY30052773547291630052773542026medical devices and PPECoda Resources Ltdhttps://www.accessdata.fda.gov/premarket/ftparea/registration.zip2026-10-2672916https://www.google.com/maps/dir/?api=1&destination=75%20Lower%20Main%20St%20Suite%20200%2C%20Aberdeen%2C%20NJ%2C%2007747339112Surgical and Medical Instrument Manufacturing3841Surgical and Medical Instruments and Apparatus2026-10-26addressMonmouth County34025ZIP 07747 spans 2 counties; assigned to the county holding 45% of its land areacompleteUShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=7291640.423927-74.216112
Norres Baggerman US, LLC528 Carwellyn RdAbbevilleSC29620(864) 366-8809Norres Baggerman US, LLC10042626Contract Manufacturer1YBYX1class1:1NNKaye Torgerson528 Carwellyn RdAbbevilleSC29620USN100059392714994810005939272026medical devices and PPENorres Baggerman US, LLChttps://www.accessdata.fda.gov/premarket/ftparea/registration.zip2026-10-26149948https://www.google.com/maps/dir/?api=1&destination=528%20Carwellyn%20Rd%2C%20Abbeville%2C%20SC%2C%2029620339112Surgical and Medical Instrument Manufacturing3841Surgical and Medical Instruments and Apparatus2026-10-26addressAbbeville County45001ZIP 29620 spans 2 counties; assigned to the county holding 96% of its land areacompleteUShttps://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=14994834.166989-82.397466
Five sample rows; the file you buy has all 49 columns.

{}What's in each row

FieldWhat it isRows filled
nameEstablishment name as registered with FDA (all-capitals names set in title case)100%
ownerOperatorOwner or operator firm FDA lists for the registration100%
ownerOperatorNumberFDA owner/operator number (groups a firm's sites)100%
establishmentTypesFDA establishment types: Manufacturer, Contract Manufacturer, Specification Developer, Repackager/Relabeler, Contract Sterilizer, Foreign Exporter and others100%
establishmentTypeCountHow many establishment types the site holds100%
manufacturerY when the site makes, contract-makes, sterilizes or repackages devices100%
productCodesFDA product codes the site lists, space-separated78%
productCodeCountHow many product codes the site lists100%
deviceClassesListed products by FDA device class (e.g. class2:14)78%
anyImplantY when a listed product code is an implant100%
anyLifeSustainingY when a listed product code is life-sustaining or life-supporting100%
premarketSubmissions510(k), PMA and De Novo numbers on the site's listings41%
addressStreet address of the site100%
cityCity100%
stateTwo-letter state code (U.S. lists); region as FDA writes it, Canadian provinces as two-letter codes (foreign lists)100%
zipZIP or postal code100%
countryCountry (U.S. lists: US)100%
contactNameContact person FDA publishes for the site (drugs: establishment contact; devices: official correspondent)100%
contactCompanyCompany of the official correspondent, where it differs14%
phoneOfficial correspondent's phone100%
ownerAddressOwner/operator street address80%
ownerCityOwner/operator city80%
ownerStateOwner/operator state or province80%
ownerZipOwner/operator ZIP or postal code80%
ownerCountryOwner/operator country code80%
initialImporterY when the site is registered as an initial importer100%
registrationNumberFDA registration number100%
fdaRegKeyFDA's record key for the registration100%
feiNumberFDA Establishment Identifier (FEI)100%
registrationYearYear the registration is current through100%
section232SectorSection 232 investigation the site falls under (pharmaceuticals; medical devices and PPE)100%
nameAsPublishedEstablishment name exactly as FDA writes it100%
sourceUrlFDA's public search page for the register (devices: the registration's own page)100%
sourceFileFDA bulk file the row was read from100%
sourceDateDate of the FDA file100%
rowIdRow id: the site's DUNS number (drugs) or FDA's registration record key (devices)100%
directionsUrlGoogle Maps directions link to the site100%
naicsCodeNAICS code (drugs 325412, devices 339112)100%
naicsTitleNAICS title100%
sicCodeSIC code (drugs 2834, devices 3841)100%
sicTitleSIC title100%
updatedDateDate the list was built100%
latitudeLatitude, geocoded from the address100%
longitudeLongitude, geocoded from the address100%
geo_precisionHow the map point was found: address, ZIP centre or city centre100%
countyCounty name100%
county_fipsFive-digit county FIPS code100%
county_noteSet when the ZIP code spans more than one county18%
address_qualitycomplete, no house number, po box, missing city or zip or missing100%

Rows filled is measured on every row of the delivered file.

✓Where this data comes from

Each row names the public source it came from, so any record can be checked against where it was published.

October 26, 2026

Snapshot built

49 fields

Columns in the file

Fill measured

On every row of the delivered file

How we build and date every file: methodology.

Using ChatGPT, Claude or an API?

No setup needed. Ask ChatGPT or Claude your question about the FDA-Registered Medical Device Establishments (U.S.) and give it this page: it can open https://locationlists.com/find?dataset=fda-registered-medical-device-manufacturer-list with the filters you need and show you the count and price.

Using ChatGPT or Claude? Tell it to answer from locationlists.com/find — no account, no connector.

How assistants ask

No connector needed. Any AI assistant can answer from this site with a web link, no connector, no account: open https://locationlists.com/find with the question as query parameters.

If a question needs filtering, distance, combining lists or a price, open a /find link: either put the question itself in q=, or build the structured link. The answer does not need an API, a connector or an account.

Simplest, the question itself: https://locationlists.com/find?q=<the question in plain words>

Or set the parts yourself: https://locationlists.com/find?dataset=<slug>&state=<ST>&city=<city>&county=<county>&zip=<zip>&near=<place or zip>&radius=<miles>&where=<column>:<op>:<value>&total=<rows>

Leave out what the question does not need. Distance is radius, in straight-line miles; near can name several places separated by | to reach from any of them. To ask about several lists at once, use datasets with two or more names, or category with a kind of business. To compare two lists, add relate=nearest and the other list with b. in front of its parameters. To count by area, use areas=county (or zip, state, metro). To keep only places whose county, ZIP code, metro area or state meets a Census figure, add area_where (for example county:population>1000000); with areas, per=100000 gives counts per 100,000 residents.

Links an assistant can open, each showing how many rows match, a few preview rows and the price for just that part:

Optional: connect for repeat use or wallet payments:

Read https://locationlists.com/skill.md and follow the instructions to connect LocationLists. Then show me the FDA-Registered Medical Device Establishments (U.S.) list.

Your assistant will walk you through setup and show you the price before you pay.

For developers

Every step below has a no-connector equivalent: https://locationlists.com/find?dataset=fda-registered-medical-device-manufacturer-list with the same filters as query parameters.

  1. Connect your agent to https://locationlists.com/mcp (no key, no signup).
  2. Call count_locations with dataset: "fda-registered-medical-device-manufacturer-list" and any filter — it is free, and returns how many rows match and what they cost.
  3. Fetch the rows with query_locations: $0.76 per 100 rows from this dataset. Above 6,558 rows, buying the whole file is cheaper.

Paid in USDC over x402 — the agent gets an HTTP 402 with the exact price, signs, and retries. Money moves only after rows are delivered, so a failed or empty query costs nothing. Setup for Claude, Cursor and VS Code

?Frequently Asked Questions

How many FDA-Registered Medical Device Establishments are there in the US?

There are 13,115 FDA-Registered Medical Device Establishments in the US as of October 2026. They are in 51 states and territories.

Is every FDA-registered device site in the U.S. in the list?

It holds every U.S. registration FDA marks active in its device files on 26 October 2026. One row is one registration record. 2,839 active registrations list no establishment type, so they show 'registered establishment'.

Who can I reach with it?

FDA's official correspondent for each site: name and phone. 98% of phones are in U.S. ten-digit format. FDA's device files have no email for the correspondent.

What are product codes?

FDA's three-letter codes for each kind of device (e.g. FMI, hypodermic needle). We join each code to FDA's classification file for its device class and implant and life-sustaining flags. The productCodes column lists every code the site lists.

How current is the data?

Snapshot built on October 26, 2026. It is a one-time snapshot and is not rebuilt on a schedule.

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$49
13,115 locations
Buy the whole list — 13,115 rows · $49
Buy the whole list — 13,115 rows · $49