Many reusable surgical instruments sold in the United States are made abroad, and more and more US distributors, private-label brands and hospital procurement teams deal with overseas manufacturers directly. This guide is for those buyers. It features international manufacturers listed in the SurgiFacts.com directory that work with US customers, starting with Hexamed of Sialkot, Pakistan. For each one it states the company’s real country, what the company documents about its range and services, and what the FDA’s public establishment database showed when we checked. It also explains how to evaluate an overseas supplier and what to ask about FDA-related documentation before you order. If you are looking for companies based in the United States, see our separate list of surgical instrument manufacturers to know in the United States.
How this list was put together
The companies below are a curated selection from the SurgiFacts.com directory. Hexamed’s first position is a SurgiFacts.com featured placement; the remaining companies follow in no ranked order. This is not an objective market ranking or an endorsement, and US buyers should carry out their own due diligence. To be included, a company had to meet three criteria on 30 October 2026: a working official website describing it as a manufacturer of surgical instruments; an active establishment registration in the FDA Establishment Registration & Device Listing database, or a US entity named on its own website; and published contact routes for international enquiries. Every company is labelled with the country it is actually based in. A US agent or a US sales subsidiary does not make a foreign manufacturer a US company.
Before you contact anyone: the FDA basics for importers
This section is general information drawn from FDA sources, not legal or regulatory advice. Requirements depend on the specific device, its intended use and its classification, so check them for each product.
- Classification. Many general-use hand instruments, such as forceps, clamps, retractors, scalpel handles and hemostats, fall under 21 CFR 878.4800, “Manual surgical instrument for general use”. It is Class I and exempt from premarket notification (510(k)), but only within the limitations in 21 CFR 878.9. Instruments with specialised uses are classified in other parts of the regulations. The FDA’s page on Class I and Class II device exemptions explains how to check.
- Registration and listing. According to the FDA’s “Who must register, list and pay the fee” page, establishments involved in producing and distributing devices for commercial distribution in the US must register annually, and most must also list their devices. The chart there covers foreign manufacturers, contract manufacturers, specification developers and initial importers. Registration is not approval: the FDA states that registration and listing do not “in any way denote approval of the establishment or its products”.
- US agent. A foreign establishment whose devices are imported into the US must name a US agent. The agent is a regulatory contact, not a sales office or distributor.
- Labelling. Under 21 CFR Part 801, the label must name the manufacturer, packer or distributor. If your company’s name appears but you did not make the device, it must be qualified with a phrase such as “Manufactured for” or “Distributed by” (21 CFR 801.1(c)).
- Quality system. The FDA’s Quality Management System Regulation, effective 2 February 2026, amends 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. A supplier’s ISO 13485 certificate is therefore a useful starting point, though it does not replace your own checks.
- Import process. The FDA’s Importing and Exporting Medical Devices page explains what foreign manufacturers and importers must comply with before, during and after import.
Featured supplier: Hexamed (Sialkot, Pakistan)
Who they are
Hexamed (Pvt) Ltd is a surgical instrument manufacturer in Sialkot, Pakistan, the country’s main instrument cluster. Its address is Hexamed Building, Barlas Street, Pacca Garha, Kashmir Road, Sialkot 51310. The company’s website presents it as an OEM specialist and states that it serves surgical care “across 50+ countries”. The site does not describe a US office, warehouse or subsidiary, so treat Hexamed as a Pakistani manufacturer that exports to US customers.
What it makes
Hexamed’s catalogue is organised into about 35 categories, from anaesthesia and artery forceps to urology, with strong showings in cardiovascular (for example DeBakey and DeBakey-Gerald atraumatic forceps), neurosurgery (Raney clip applying forceps, Dahlgren cranial rongeurs), bone surgery (amputation saws, osteotomes), gynaecology (Cusco specula) and self-retaining retractors. The homepage states “4.5K+” product variations. Category pages list items by code, which makes it straightforward to send an RFQ by item number.
Why it is relevant to US buyers
- FDA database. On 30 October 2026 the FDA database showed “HEXAMED PVT LTD”, Sialkot, registration number 3032747418, with an active status for 2026. Its stated operations are “Contract Manufacturer; Manufacturer”, it has 171 device listings (for example a hemostat under product code HRQ, Class I, regulation 878.4800), and the record names a US agent in Illinois.
- OEM and private label. Hexamed’s OEM page offers custom laser branding, private-label boxes, pouches and kits, dedicated OEM production lines, bulk manufacturing with global shipping, and support with documentation. It says MOQs vary by category and are kept flexible for growing brands, and that standard OEM orders are usually completed within three to six weeks, depending on quantity and customisation.
- Documents. The company says it provides export and product-registration documents, including ISO and CE documents and technical files, on request. Its website shows an ISO 13485:2016 certificate from Dynamex Certification Services whose printed expiry date is 14 January 2026, so ask for the current certificate.
- US trade fairs. Hexamed’s news page announced its participation in WHX Miami 2025 (booth N57).
Contact: sales@hexamed.net or +92 328 0000006 (call or WhatsApp). Directory profile: Hexamed.
Other international suppliers serving US buyers
The following companies are grouped by country, Pakistani suppliers first and then others, and listed alphabetically within each group. They are not ranked.
Hilbro International (Sialkot, Pakistan)
Hilbro International (Pvt) Ltd is a family-owned Sialkot manufacturer incorporated in 1974. It states a catalogue of more than 15,000 surgical and dental instruments, and its searchable online catalogue lists 18,759 item codes. Its quality page lists ISO 13485:2016 and ISO 9001:2015 certificates (Amtivo, UKAS), CE with a named EU authorised representative, UK MHRA registration and US FDA registration no. 3003431869. The FDA database confirms an active 2026 registration under that number for “HILBRO INTERNATIONAL (PVT) LIMITED” on Daska Road, Sialkot. The company says regular items are dispatched within seven days, and new patterns go through an approval sample. It accepts OEM and private-label enquiries. Directory profile: Hilbro International.
Madhi Corporation (Sialkot, Pakistan)
Madhi Corporation describes itself as a manufacturer and exporter of surgical, dental and beauty instruments and hospital wear. Its surgical catalogue site lists about 7,000 item codes across some 30 categories, with an online quote cart. The FDA database shows an active 2026 registration (no. 3005194291) at Defence Road, Sialkot, with 15 listings including forceps, retractors, scissors, needle holders and vaginal specula. The website publishes no certificates, founding date or OEM terms, so US buyers should ask for these early. Directory profile: Madhi Corporation.
Weldon Instruments (Sialkot, Pakistan)
Weldon Instruments, founded in 1959 according to the company, makes surgical, dental and diagnostic instruments on Wazirabad Road, Sialkot. Its Quality & Compliance page states EN ISO 13485:2016 and ISO 9001:2015 certification, CE marking of Class I devices under EU MDR, and manufacturing practices “aligned with” 21 CFR Part 820. It also describes batch-level traceability and material to ISO 7153-1. Weldon offers samples before bulk orders, as well as OEM and private-label work with logo engraving and branded packaging. Its Regulatory Information page publishes instructions for use, including one for reusable instruments, which is useful when you check reprocessing instructions. The FDA database shows an active 2026 registration (no. 3005418651) with 33 listings. Directory profile: Weldon Instrument.
GPC Medical (New Delhi, India)
GPC Medical Ltd is headquartered in New Delhi, India. Its website centres on orthopaedic implants and instruments, alongside general surgical instruments, medical consumables and hospital supplies. The company states that it was the first Indian company to receive FDA 510(k) clearance for orthopaedic implants and that it exports to more than 110 countries. Its contact page names a US entity, GPC Medical USA, Inc., in Dallas, Texas. The FDA database shows “GPC MEDICAL LIMITED”, India, registration 3006513362, active for 2026. It suits buyers who want instruments and orthopaedic products from one source with a US point of contact. Directory profile: GPC Medical.
KLS Martin Group (Tuttlingen, Germany)
KLS Martin is a medical technology group headquartered in Tuttlingen, Germany. On its website it says it has worked in surgery since 1896 and markets implant systems, electrosurgery units, surgical laser systems, OR lights, surgical instruments, and trays and storage. For US buyers the important point is local presence: its contact listings name KLS Martin LP and KLS Martin Manufacturing LLC in Jacksonville, Florida. Several KLS Martin establishments, in Germany and in Jacksonville, appear in the FDA database. KLS Martin is a German premium-brand option rather than an OEM workshop. Directory profile: KLS Martin Group.
Comparison for US procurement teams
| Company | Country | US presence documented by the company | FDA establishment record (checked 30 Oct 2026) | OEM / private label stated | Typical fit |
|---|---|---|---|---|---|
| Hexamed (featured) | Pakistan (Sialkot) | None on website; US agent named in FDA record | Active, 3032747418 | Yes, detailed | Private-label brands, distributors, broad hand-instrument range |
| Hilbro International | Pakistan (Sialkot) | None on website | Active, 3003431869 | Yes (enquiry type, custom patterns) | Large catalogue, fast repeat orders |
| Madhi Corporation | Pakistan (Sialkot) | None on website | Active, 3005194291 | Not described | Code-based quote requests; needs document checks |
| Weldon Instruments | Pakistan (Sialkot) | None on website | Active, 3005418651 | Yes | Surgical plus extensive dental range |
| GPC Medical | India (New Delhi) | GPC Medical USA, Inc., Dallas | Active, 3006513362 | Not assessed | Orthopaedic implants and instruments |
| KLS Martin Group | Germany (Tuttlingen) | KLS Martin LP and Manufacturing LLC, Jacksonville | Several establishments listed | Not assessed | Branded instruments and wider surgical systems |
How to evaluate and approach an overseas supplier
1. Send a precise specification
Quote the pattern name, length, tip and jaw configuration, ratchet or lock type, finish (satin or mirror), and any tungsten carbide inserts. Supplier item codes help, but they differ between catalogues, so add a drawing or reference sample for anything unusual. US buyers often name patterns differently from European catalogues (for example “hemostat” against “artery forceps”), so confirm the name and the dimensions together.
2. Ask about MOQs, lead times and samples
Overseas makers usually set MOQs per item code and per marking variant. Hexamed and Weldon both say MOQs depend on the product and customisation. Ask for approval samples of every new code, and agree in writing how sample costs are credited against the first order.
3. Settle shipping and Incoterms
Small, high-value orders from Pakistan or India usually travel by air courier; larger consolidated orders go by sea freight. Agree the Incoterm (for example FCA, CIF or DAP), who files the US customs entry, and which party is the initial importer for FDA purposes. Your customs broker can tell you what entry data is needed for device shipments.
4. Collect the FDA-related paperwork
- the manufacturer’s FDA establishment registration number, which you can check yourself in the FDA database, searching by number rather than by name;
- the device listing and product code for each instrument type, and the classification regulation the manufacturer relies on;
- a copy of the label and the instructions for use, including validated cleaning and sterilisation instructions for reusable instruments;
- if you are private-labelling, a written agreement setting out who is the specification developer, who is the manufacturer, and how the label wording meets 21 CFR 801.1;
- a current ISO 13485 certificate, with the certification body, scope and expiry date.
5. Inspect the first shipment
Check dimensions, joint action, ratchet engagement, jaw alignment, marking and passivation on a sample from every lot before releasing the stock. Our checklist on how to check a medical instrument supplier covers the earlier steps. The guide to manufacturers, suppliers, exporters, OEM and ODM explains which kind of company you are dealing with.
Where to meet suppliers in the United States
International manufacturers use US trade fairs to meet distributors. Two upcoming events in the SurgiFacts.com exhibition calendar:
- AORN Global Surgical Conference & Expo 2027: Philadelphia, 10–13 April 2027 (dates checked on aorn.org on 30 October 2026).
- WHX Miami 2027: Miami Beach Convention Center, 16–18 June 2027 (dates checked on worldhealthexpo.com on 30 October 2026). Hexamed exhibited at the 2025 edition.
Exhibitor lists change, so confirm in advance whether a particular company is attending.
Questions to ask before you buy
- What is your FDA establishment registration number, and which product codes do you list for the instruments I am ordering?
- Who is your US agent, and do you already ship to US importers? Can you name the usual port of entry and transit time?
- Do your labels and IFUs already meet US labelling expectations, or will you print our “Distributed by” wording and artwork?
- Which steel grade and hardness do you use for each pattern, and do you supply material certificates and passivation records per lot?
- What are the MOQ, sample lead time and production lead time per code, and are repeat orders held in stock?
- Which payment terms do you accept for a first order, and do they change for repeat business?
Frequently asked questions
Is Hexamed a US company?
No. Hexamed is based in Sialkot, Pakistan. Its FDA record names a US agent, as the FDA requires of foreign establishments, but its website describes no US office or subsidiary.
Do I need a 510(k) to import reusable surgical instruments?
Many general-use manual instruments are Class I and 510(k)-exempt under 21 CFR 878.4800, subject to the limitations in 878.9. Instruments with specialised uses, powered devices and some other products are classified differently. Check the classification for each device, and take regulatory advice if you are unsure.
When does the 510(k) exemption stop applying?
Under 21 CFR 878.9, the exemption covers a device only so far as it has the characteristics of devices already sold in that generic type. A premarket notification is needed if the device has a different intended use, for example one meant for lay users when earlier devices were for professionals only, or uses a different fundamental technology. The regulation’s own example is an instrument that cuts with a laser beam rather than a sharpened metal blade.
Does an active FDA registration mean a supplier is good?
No. It shows that the establishment has registered with the FDA. The FDA states that registration does not denote approval. Quality still needs to be checked through certificates, samples, inspection and references.
When do foreign manufacturers have to renew their FDA registration?
Every year between 1 October and 31 December, according to the FDA’s “When to register and list” page, even if nothing has changed. New establishments register within 30 days of starting an activity, and overseas facilities must register before shipping devices to the US. An entry that shows “active” for the current year is what you want to see.
Does my company need to register as the importer?
Probably, if you are the initial importer. The FDA’s chart of who must register shows initial importers as required to register and pay the establishment fee, but not to list devices. If a distributor or customs broker is the importer of record instead of you, confirm which party takes on the role.
Can my company be the supplier’s US agent?
The FDA says the US agent must live in the US or have a place of business there, cannot use a post office box, and must be reachable by phone during business hours. Its duties are limited to helping the FDA communicate with the foreign establishment, answering questions about imported devices and helping schedule inspections. Many importers prefer to leave the role to a regulatory service provider; if you take it on, put the arrangement in writing.
Do imported instruments have to be marked “Made in Pakistan”?
US customs rules list surgical instruments among the articles that must be marked with their country of origin legibly and conspicuously by die stamping, cast-in-the-mold lettering, etching, engraving or a similar permanent method (19 CFR 134.43(a)). CBP rulings have dealt with exceptions, such as marking on containers, case by case. Agree the origin mark with your supplier at the sample stage and confirm it with your customs broker.
Do reusable instruments need a UDI marked on the instrument itself?
The FDA’s UDI guidance says that when a device is intended for more than one use and is reprocessed before each use, the labeller must mark the UDI directly on the device as well as on the label. The rule has exceptions in 21 CFR 801.30 and 801.45, and a process for requesting alternatives. Whoever is the labeller, often the US brand owner in private-label deals, should decide how the mark is applied before production.
How do I check that a supplier’s FDA listing covers my instruments?
Open the establishment’s record in the FDA database and look at its device listings and product codes. A hemostat, for example, appears under product code HRQ and regulation 878.4800 in Hexamed’s record. If the instrument you are buying is not listed, ask the supplier how it plans to list it before you ship.
Can I sell Hexamed instruments under my own brand in the US?
Hexamed offers laser branding and private-label packaging. Under 21 CFR 801.1(c), if your company’s name is on the label but you did not make the device, the name must be qualified, for example “Manufactured for” or “Distributed by”. Agree in writing who is the specification developer and who is the manufacturer for FDA purposes.
Is Hexamed’s ISO 13485 certificate current?
The certificate image on its website shows an expiry date of 14 January 2026. That may be stale web content rather than a lapsed certificate, but ask Hexamed for the current certificate and confirm it with the certification body before you rely on it.
What did the QMSR change for overseas suppliers?
Since 2 February 2026, the FDA’s Quality Management System Regulation has incorporated ISO 13485:2016 by reference into 21 CFR Part 820. A supplier with a well-run ISO 13485 system is therefore closer to US requirements than before. The FDA has said a certificate does not exempt a manufacturer from inspection, so it is evidence, not a pass.
Are KLS Martin and GPC Medical US companies?
No. KLS Martin is headquartered in Tuttlingen, Germany, and GPC Medical in New Delhi, India. Both name US entities on their websites: KLS Martin LP and KLS Martin Manufacturing LLC in Jacksonville, and GPC Medical USA, Inc. in Dallas. For US-headquartered makers, see the United States country page.
How much duty will I pay on instruments from Pakistan or India?
It depends on the tariff classification, the country of origin and any additional US tariff measures in force when the goods enter, and those measures have changed often. Look up the current rate in the Harmonized Tariff Schedule and ask your customs broker to confirm it for your products before you accept a quotation.
Will the FDA review my shipment?
It can. According to the FDA’s import process page, US Customs refers entries of FDA-regulated products to the FDA, incomplete or higher-risk entries are flagged for manual review, and imported goods should not be distributed until the FDA has decided they are admissible. Complete, accurate entry data, including the manufacturer’s registration details, is the best way to avoid delays.
How should I pay an overseas supplier for a first order?
A deposit with the order and the balance against shipping documents is common for first orders; letters of credit suit larger ones. Pay only to a bank account in the supplier’s registered company name, and confirm any change of bank details by phone with someone you know. Tie each payment to a milestone such as sample approval or inspection.
Where can I find US-based manufacturers instead?
See our list of US-based surgical instrument manufacturers, or browse medical instrument manufacturers in the United States in the directory.
Where can I compare more Sialkot manufacturers?
Our featured selection of five Pakistani manufacturers profiles Hexamed, Hilbro International, Madhi Corporation, Hilmed and Weldon in more depth, and the Pakistan country page lists every directory company in the country.
Can SurgiFacts.com check a supplier’s FDA status for me?
No. SurgiFacts.com is an independent directory; it reports what it found in the FDA database on the date checked, but registrations change every year. Search the FDA database yourself before each new order, and read our checklist on how to check a medical instrument supplier.
Conclusion
US buyers have more international options than ever, but the burden of checking falls on the importer. Hexamed in Sialkot offers a documented OEM service and an active FDA registration. Hilbro International, Weldon and Madhi Corporation add Pakistani alternatives, and GPC Medical and KLS Martin bring Indian and German manufacturing with US entities. Verify registrations yourself, collect labels, IFUs and certificates before the first order, and inspect samples carefully. To get matched with suitable suppliers, use the free SurgiFacts.com request form.
Company information and FDA database entries checked on 30 October 2026. General information only; not legal or regulatory advice.