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FDA-registered medical device contract manufacturers in the US: new device listings, last 30 days

An FDA medical device contract manufacturer is a site that makes finished devices for another company and is registered with FDA in that role. This page shows US sites like that with a new device listing in the last 30 days of FDA data. Each row gives the site, the firm that owns the site, the city and state, and the devices, with a link to FDA.

FDA data through October 26, 2026.

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New contract manufacturer listings, last 30 days

Newest first. Open a site's FDA record from the FDA record column. FDA says the listing date "may be unreliable," so check the FDA record before you rely on a row.

New device listings at FDA-registered US contract manufacturers, last 30 days. Sep 27, 2026 to Oct 26, 2026.
ListedSiteCity, stateDevices listedClassOther FDA rolesFDA record
Oct 23, 2026HG MEDICAL USA, LLCHolland, MIHWC Screw, Fixation, BoneOrthopedicClass 23032588003
Oct 22, 2026Innovatus Imaging CorporationEnglewood, COITX Transducer, Ultrasonic, DiagnosticRadiologyClass 23009436116
Oct 21, 2026ACCUMEDIX, INC.Libertyville, ILHRX ArthroscopeOrthopedicClass 21424785
Oct 20, 2026S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICALSt Petersburg, FLHWX Tap, BoneOrthopedicClass 1specification developer, manufacturer2249418
Oct 19, 2026BIOSEALPlacentia, CADZN Instruments, Dental HandDentalClass 1manufacturer, relabeler2027062
Oct 19, 2026KARL STORZ ENDOVISION, INC.KARL STORZ SE & CO KGCharlton, MAGWG Endoscope, NeurologicalNeurologyClass 21221826
Oct 19, 2026MBM PACKAGING LABS, INCRogersville, TNFMP Protector, Skin PressureGeneral HospitalClass 13014553709
Oct 19, 2026Universal Plastics - LatrobeLatrobe, PAFMI Needle, Hypodermic, Single LumenGeneral HospitalClass 22530962
Oct 16, 2026Maestro Logistics, LLCMaestro LogisticsAustin, TXHTN Washer, Bolt NutOrthopedicHWC Screw, Fixation, BoneOrthopedicClass 23014129047
Oct 16, 2026NGInstruments, Inc dba Avalign Cutting InstrumentsNG Instruments, Inc dba Avalign Cutting InstrumentsWarsaw, INOLO Orthopedic Stereotaxic InstrumentNeurologyClass 21835251
Oct 15, 2026BIOPRO, INC.Port Huron, MIKWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedicLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedicLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedicMAX Intervertebral Fusion Device With Bone Graft, LumbarOrthopedicMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedicand 3 moreClass 21833506
Oct 15, 2026D & R PRODUCTS CO., INC.Hudson, MAHRX ArthroscopeOrthopedicClass 21222081
Oct 15, 2026LUMIQUICK DIAGNOSTICS, INC.Santa Clara, CAMIY Enzyme Linked Immunosorbent Assay, Coccidioides ImmitisMicrobiologyClass 23005984081
Oct 15, 2026Millstone Medical Outsourcing LLCOlive Branch, MSGFA Blade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic SurgeryHDD Table, Obstetrical, Ac-Powered (And Accessories)Obstetrics/GynecologyHRT Stripper, SurgicalOrthopedicHTP FileOrthopedicKDG Chisel (Osteotome)General, Plastic Surgeryand 29 moreClass 1 Class 23010097171
Oct 15, 2026PACIFIC INSTRUMENTS INC.Honolulu, HIOLO Orthopedic Stereotaxic InstrumentNeurologyClass 23005641619
Oct 15, 2026Tecomet Inc.TecometWilmington, MAJDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedicJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedicLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedicClass 21225675
Oct 14, 2026BARD SHANNON LIMITEDC. R. Bard, Inc.Humacao, PRFTL Mesh, Surgical, PolymericGeneral, Plastic SurgeryOOD Surgical FilmGeneral, Plastic SurgeryOWT Mesh, Surgical, Absorbable, Abdominal HerniaGeneral, Plastic SurgeryClass 23005636544
Oct 14, 2026FRUH PACKAGING INC.Exton, PAHRS Plate, Fixation, BoneOrthopedicHWC Screw, Fixation, BoneOrthopedicClass 23030714745
Oct 14, 2026Lincotek MedicalSurface Dynamics LLCBartlett, TNMAX Intervertebral Fusion Device With Bone Graft, LumbarOrthopedicClass 23008421730
Oct 13, 2026COOK MEDICAL LLCCOOK MEDICALBloomington, INEYB Catheter, Ureteral, Gastro-UrologyGastroenterology, UrologyKOD Catheter, UrologicalGastroenterology, UrologyClass 23005580113
Oct 12, 2026Aptyx - CharlotteAptyxCharlotte, NCQSK Hybrid Stent Graft, Thoracic Aortic Lesion TreatmentUnknownClass 33011324393
Oct 12, 2026Swiss-American CDMO,LLCCarrollton, TXFRO Dressing, Wound, DrugUnknownNUC Lubricant, PersonalObstetrics/GynecologyPEB Lubricant, Personal, Gamete, Fertilization, And Embryo CompatibleObstetrics/GynecologyClass 21649690
Oct 9, 2026ACERTARA ACOUSTIC LABORATORIES, LLCLongmont, COITX Transducer, Ultrasonic, DiagnosticRadiologyIYO System, Imaging, Pulsed Echo, UltrasonicRadiologyClass 23012665486
Oct 9, 2026Burbank Dental LaboratoryBurbank Dental LabBurbank, CANXC Aligner, SequentialDentalClass 23007233968
Oct 9, 2026STRYKER MANUFACTURING KALAMAZOOSTRYKER CORP.Portage, MILFL Instrument, Ultrasonic SurgicalUnknown3007997036
  • Oct 23, 2026Class 2
    HG MEDICAL USA, LLC

    HWC Screw, Fixation, BoneOrthopedic

    3032588003Holland, MI
  • Oct 22, 2026Class 2
    Innovatus Imaging Corporation

    ITX Transducer, Ultrasonic, DiagnosticRadiology

    3009436116Englewood, CO
  • Oct 21, 2026Class 2
    ACCUMEDIX, INC.

    HRX ArthroscopeOrthopedic

    1424785Libertyville, IL
  • Oct 20, 2026Class 1
    S.S. WHITE TECHNOLOGIES, INC. / DBA SHUKLA MEDICAL

    HWX Tap, BoneOrthopedic

    2249418St Petersburg, FLspecification developer, manufacturer
  • Oct 19, 2026Class 1
    BIOSEAL

    DZN Instruments, Dental HandDental

    2027062Placentia, CAmanufacturer, relabeler
  • Oct 19, 2026Class 2
    KARL STORZ ENDOVISION, INC.

    KARL STORZ SE & CO KG

    GWG Endoscope, NeurologicalNeurology

    1221826Charlton, MA
  • Oct 19, 2026Class 1
    MBM PACKAGING LABS, INC

    FMP Protector, Skin PressureGeneral Hospital

    3014553709Rogersville, TN
  • Oct 19, 2026Class 2
    Universal Plastics - Latrobe

    FMI Needle, Hypodermic, Single LumenGeneral Hospital

    2530962Latrobe, PA
  • Oct 16, 2026Class 2
    Maestro Logistics, LLC

    Maestro Logistics

    HTN Washer, Bolt NutOrthopedicHWC Screw, Fixation, BoneOrthopedic

    3014129047Austin, TX
  • Oct 16, 2026Class 2
    NGInstruments, Inc dba Avalign Cutting Instruments

    NG Instruments, Inc dba Avalign Cutting Instruments

    OLO Orthopedic Stereotaxic InstrumentNeurology

    1835251Warsaw, IN
  • Oct 15, 2026Class 2
    BIOPRO, INC.

    KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedicLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedicLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedicMAX Intervertebral Fusion Device With Bone Graft, LumbarOrthopedicMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedicand 3 more

    1833506Port Huron, MI
  • Oct 15, 2026Class 2
    D & R PRODUCTS CO., INC.

    HRX ArthroscopeOrthopedic

    1222081Hudson, MA
  • Oct 15, 2026Class 2
    LUMIQUICK DIAGNOSTICS, INC.

    MIY Enzyme Linked Immunosorbent Assay, Coccidioides ImmitisMicrobiology

    3005984081Santa Clara, CA
  • Oct 15, 2026Class 1 Class 2
    Millstone Medical Outsourcing LLC

    GFA Blade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic SurgeryHDD Table, Obstetrical, Ac-Powered (And Accessories)Obstetrics/GynecologyHRT Stripper, SurgicalOrthopedicHTP FileOrthopedicKDG Chisel (Osteotome)General, Plastic Surgeryand 29 more

    3010097171Olive Branch, MS
  • Oct 15, 2026Class 2
    PACIFIC INSTRUMENTS INC.

    OLO Orthopedic Stereotaxic InstrumentNeurology

    3005641619Honolulu, HI
  • Oct 15, 2026Class 2
    Tecomet Inc.

    Tecomet

    JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedicJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedicLPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic

    1225675Wilmington, MA
  • Oct 14, 2026Class 2
    BARD SHANNON LIMITED

    C. R. Bard, Inc.

    FTL Mesh, Surgical, PolymericGeneral, Plastic SurgeryOOD Surgical FilmGeneral, Plastic SurgeryOWT Mesh, Surgical, Absorbable, Abdominal HerniaGeneral, Plastic Surgery

    3005636544Humacao, PR
  • Oct 14, 2026Class 2
    FRUH PACKAGING INC.

    HRS Plate, Fixation, BoneOrthopedicHWC Screw, Fixation, BoneOrthopedic

    3030714745Exton, PA
  • Oct 14, 2026Class 2
    Lincotek Medical

    Surface Dynamics LLC

    MAX Intervertebral Fusion Device With Bone Graft, LumbarOrthopedic

    3008421730Bartlett, TN
  • Oct 13, 2026Class 2
    COOK MEDICAL LLC

    COOK MEDICAL

    EYB Catheter, Ureteral, Gastro-UrologyGastroenterology, UrologyKOD Catheter, UrologicalGastroenterology, Urology

    3005580113Bloomington, IN
  • Oct 12, 2026Class 3
    Aptyx - Charlotte

    Aptyx

    QSK Hybrid Stent Graft, Thoracic Aortic Lesion TreatmentUnknown

    3011324393Charlotte, NC
  • Oct 12, 2026Class 2
    Swiss-American CDMO,LLC

    FRO Dressing, Wound, DrugUnknownNUC Lubricant, PersonalObstetrics/GynecologyPEB Lubricant, Personal, Gamete, Fertilization, And Embryo CompatibleObstetrics/Gynecology

    1649690Carrollton, TX
  • Oct 9, 2026Class 2
    ACERTARA ACOUSTIC LABORATORIES, LLC

    ITX Transducer, Ultrasonic, DiagnosticRadiologyIYO System, Imaging, Pulsed Echo, UltrasonicRadiology

    3012665486Longmont, CO
  • Oct 9, 2026Class 2
    Burbank Dental Laboratory

    Burbank Dental Lab

    NXC Aligner, SequentialDental

    3007233968Burbank, CA
  • Oct 9, 2026
    STRYKER MANUFACTURING KALAMAZOO

    STRYKER CORP.

    LFL Instrument, Ultrasonic SurgicalUnknown

    3007997036Portage, MI

Source: FDA public records, from openFDA's device registration and listing data (api.fda.gov), last updated October 26, 2026. FDA notes that the listing date may be unreliable. Registration does not mean FDA approval. Each row links to FDA. Whimbrel shows US sites only and leaves out the names, phone numbers, emails and street addresses in FDA records.

What FDA registration tells you

What a contract manufacturer is in FDA records

When a site registers with FDA, the site picks one or more establishment types. One of them is "Manufacture Medical Device for Another Party (Contract Manufacturer)." FDA says a contract manufacturer "manufactures a finished device to another establishment's specifications." Contract packagers count too. An FDA-registered contract manufacturer can hold other roles at the same time, such as contract sterilizer or manufacturer.

Sources: FDA, Establishment Registration and Medical Device Listing Files for Download; FDA, Who Must Register, List and Pay the Fee.

Registration is not FDA approval

A federal rule, 21 CFR 807.39, says registration "does not in any way denote approval of the establishment or its products." Registration means the site told FDA what the site does and which devices the site makes. Source: eCFR, 21 CFR 807.39.

What a device listing shows

A device listing shows the product code, the device name FDA uses, the device class and the medical specialty. Some listings also show a 510(k) or PMA number. A listing does not name the company the site makes the device for.

How to search FDA's Registration and Listing database

  1. Open FDA's Establishment Registration & Device Listing search.
  2. In the Establishment Type box, pick "Contract Manufacture." (FDA's box cuts the name short.)
  3. Pick a state, or type a product code, to narrow the search.
  4. Press Search. Click a site name to open its record.

FDA caps how many sites one search shows, so add a state or a product code. FDA also posts download files with all registration and listing data, updated on FDA's own schedule.

Links: FDA Search Registration and Listing (rl.cfm); FDA Establishment Registration and Medical Device Listing Files for Download.

Questions you can ask Whimbrel

Get back the hours you spend researching medtech device companies. Ask in plain words, in ChatGPT or Claude:

Give me a rundown of [company website], including its FDA-registered sites.

Example

Varrowmede Surgical (Example) makes surgical staplers in the US. FDA shows one site registered as a manufacturer and one site registered as a contract sterilizer. Each site links to its FDA record.

Is Ostlehurst Medical (Example) registered as a specification developer only?

Example

Yes. FDA shows Ostlehurst Medical (Example) as a specification developer only, so another firm builds its devices. The record names the partner-run sites that FDA shows for those devices.

Find catheter companies in Minnesota hiring for design transfer.

Made-up example companies; the record types are real.

FAQ

Is FDA registration the same as FDA approval?
No. A federal rule, 21 CFR 807.39, says registration does not mean FDA approves the site or its devices. Registration means the site told FDA what the site does and which devices the site makes.
Where does this data come from?
From openFDA, FDA's public data service at api.fda.gov. The page uses openFDA's device registration and listing data, and each row links to FDA.
When does this page change?
The page changes when openFDA posts new registration and listing data, on FDA's own schedule. The line at the top of the page shows how far the FDA data goes.
Why only US sites?
Whimbrel covers US medical device companies and their suppliers, including contract manufacturers. So this page shows sites with a US address.
Can I see older listings?
This page shows the last 30 days only. To find any FDA contract manufacturer, including older ones, search FDA's Registration and Listing database by establishment type and state.
What does "may be unreliable" mean for the listing date?
openFDA's notes say the date a listing was created "may be unreliable." Treat the date as a guide, and open the FDA record before you rely on a row.

FDA-registered medical device contract manufacturers appear in FDA's Registration and Listing database under the establishment type "Manufacture Medical Device for Another Party (Contract Manufacturer)." Whimbrel's page shows US contract manufacturer sites with a new device listing in the last 30 days of FDA data, each linked to FDA. Registration is not FDA approval.

Pricing

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