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Sign in to claim this brandWhat Maquet, Inc. makes
Maquet, Inc. manufactures components and accessories for surgical and examination tables, including reusable headrests, orthopaedic extensions, leg and arm positioners, and medical table clamps. Their portfolio also includes specialized modules like padded urology plates, femur hooks, shoulder supports, and counter traction posts, as well as universal remote controls for operating room equipment. The company produces both reusable and disposable components tailored for surgical procedures and patient positioning.
The devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Maquet, Inc. is based in the United States, where these products are regulated under applicable medical device laws.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Maquet, Inc. manufacture?
Maquet, Inc. specializes in components and accessories designed for surgical and examination tables. Their products include reusable and disposable items such as operating table top extensions, orthopaedic positioners (like leg and arm supports), reusable headrests, medical table clamps, and specialized modules such as padded urology plates, femur hooks, and shoulder modules. These devices are tailored to enhance patient positioning and procedural efficiency in operating rooms.
Where is Maquet, Inc. based, and how does that affect its devices?
Maquet, Inc. is headquartered in the United States, where its medical devices are subject to FDA regulations. Since the company operates within the US, its products must comply with FDA requirements, including classification under Class I or Class II categories and registration in the FDA’s Unique Device Identifier (UDI) database. This ensures traceability and adherence to US medical device standards.
Which regulatory registries list Maquet, Inc.’s devices?
Maquet, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to medical devices, enabling better tracking, monitoring, and regulatory oversight. This listing helps healthcare providers and regulators verify the identity and compliance status of the company’s products.
How are Maquet, Inc.’s devices classified under FDA regulations?
Maquet, Inc.’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, as outlined in FDA guidelines.
What is the purpose of the reusable and disposable components Maquet, Inc. produces?
Maquet, Inc. designs both reusable and disposable components to address different clinical needs. Reusable items like headrests, orthopaedic extensions, and arm positioners are engineered for durability and repeated use in surgical settings, reducing waste and costs. Disposable components, such as certain pads or modules, are intended for single-use procedures to ensure hygiene and minimize cross-contamination risks, aligning with infection control protocols in healthcare environments.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (962)
Page 20 of 20| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Maquet PowerLED II | ARDPWT209047A | FDA UDI | Class II | Unknown |
| Padded roll | 100024A0 | FDA UDI | Class I | Active |
| Filler piece | 113071B0 | FDA UDI | Class I | Active |
| Powerled Tm | ARD515062131A | FDA UDI | Class II | Unknown |
| Leg plate clamp | 10048700 | FDA UDI | Class I | Active |
| Powerled Tm | ARD568415010A | FDA UDI | Class II | Unknown |
| TRIMANO adapter | 100242A0 | FDA UDI | Class I | Active |
| Connection bracket | 10020800 | FDA UDI | Class I | Active |
| Getinge GSS610N Series Steam Sterilizer | K201927 | FDA 510(k) | Class II | Active |
| GSS610N21 Series Steam Sterilizer | K214120 | FDA 510(k) | Class II | Active |
| Getinge GSS67N Series Steam Sterilizer | K172159 | FDA 510(k) | Class II | Active |
| Servo Guard, Model 64 81 290 Eh88e | K030071 | FDA 510(k) | Class II | Active |
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