Technical category

FDA for medical devices

40 Companies in this category

Anyone placing medical devices on the market in the United States works not with the MDR but with the Food and Drug Administration — and its logic is different. Instead of conformity assessment by a notified body, the first question is the regulatory pathway: 510(k) for devices substantially equivalent to one already cleared, De Novo for novel devices of low to moderate risk, PMA for class III with clinical evidence.

On the quality side, the two worlds have recently converged. Since February 2026 the former Quality System Regulation has been replaced by the Quality Management System Regulation, which largely adopts ISO 13485. Anyone operating a certified system is therefore in a considerably better position than before — although the requirements are still not identical, for instance on labelling, complaint handling and reporting obligations.

On top of this come formalities that are easily underestimated: establishment registration and device listing, a US agent for foreign manufacturers, and UDI submission to the GUDID database. The providers listed here support different parts of this — from strategy through submission to local representation.

Companies in this category

12 of 40

Supplier

Rudischhauser Surgical Instruments Manufacturing GmbH

Tuttlingen, DE

Development and manufacture of surgical instruments and implants for the spine, traumatology and orthopaedics in Tuttlingen since 1954 — customer-specific, ISO 13485 certified and FDA registered.

MachiningCoatingTitanium

ISO 13485 · FDA

Manufacturer

KARL STORZ SE & Co. KG

Tuttlingen, DE

Welcome to the world of endoscopy - Discover the innovative medical solutions from KARL STORZ. | KARL STORZ | Germany

SterilisationTitanium

ISO 13485 · ISO 9001 · MDSAP

Supplierchecked 23.09.2026

Ilg Medizintechnik GmbH

Durchhausen, DE

Family-run OEM partner from Durchhausen near Tuttlingen, now in its third generation: surgical instruments to customer specification, CNC precision parts, contract milling as well as assemblies and assembly work — ISO 13485, manufacturing around the clock.

MachiningStainless Steel

ISO 13485 · FDA

Manufacturerchecked 09.10.2026

Anton Hipp GmbH

Fridingen an der Donau, DE

Surgical instruments, titanium implant systems and patient-specific implants — manufactured in Germany, certified to DIN ISO 13485 with Annex II for implants and single-use products, FDA registered.

MachiningTitanium

ISO 13485 · FDA

Manufacturerchecked 07.10.2026

PRO-MED Instrumente GmbH

Tuttlingen, DE

About us Since 1978 we have been serving the medical specialist trade all over the world. Our high-quality instruments for operative medicine are successfully used in more than 50 countries (and in space research). We regard it as …

ISO 13485 · FDA · EU 2017/745 (MDR)

Supplierchecked 10.09.2026

Glaser AG

Tuttlingen, DE

Contract manufacturer for microsurgery from Tuttlingen: development, approval and production of high-precision surgical instruments from prototype to large-scale production — certified to DIN EN ISO 13485:2016 and FDA.

MachiningLaser MarkingStainless Steel

ISO 13485 · FDA

Manufacturer

Balda Medical GmbH & Co. KG

Bad Oeynhausen, DE

Integrated solutions for pharma and biotech, from drug containment to delivery systems, analytical services, technologies and equipment. Explore our capabilities

ISO 13485 · ISO 9001 · FDA

Manufacturer

W + S Solutions GmbH

Tuttlingen-Nendingen, DE

SterilisationEngineeringStainless Steel

ISO 13485 · FDA

Manufacturer

Smiths Medical Deutschland GmbH

Grasbrunn, DE

We connect patients and nursing staff through safe, life-saving and life-enhancing medical devices and offer innovative, cost-effective solutions for patient care.

Titanium

FDA

Supplier

BBC Cellpack Technology Cellpack AG

Villmergen, CH

High-performance plastics and precision metal parts. BBC Cellpack Technology is a leading provider of semi-finished plastic products, machined finished parts and assemblies.

CoatingEngineeringPlastics

ISO 13485 · FDA

Manufacturer

ADMEDES GmbH

Pforzheim, DE

For more than 20 years ADMEDES has been a contract manufacturer of medical device components in Nitinol. For some years now not only in Pforzheim, but also in Livermore, California. Our approach: the perfect interplay of the latest …

CoatingLaser ProcessingTitanium

ISO 13485 · FDA

Supplier

Aptean Germany GmbH

Ettlingen, DE

As part of the Aptean group, oxaion gmbh has been among the technology leaders in complete business management software for over four decades and specialises in the requirements of medium-sized businesses in the DACH region. The focus is …

MachiningInspection Technology

ISO 13485 · ISO 9001 · FDA

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FDA for medical devices

Companies in this category

Rudischhauser Surgical Instruments Manufacturing GmbH

KARL STORZ SE & Co. KG

Ilg Medizintechnik GmbH

Anton Hipp GmbH

PRO-MED Instrumente GmbH

Glaser AG

Balda Medical GmbH & Co. KG

W + S Solutions GmbH

Smiths Medical Deutschland GmbH

BBC Cellpack Technology Cellpack AG

ADMEDES GmbH

Aptean Germany GmbH

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