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Sign in to claim this brandMax Pdo Inc
US
Last updated May 24, 2026
What Max Pdo Inc makes
Max PDO Inc manufactures monofilament, bioabsorbable polyester sutures designed for soft tissue approximation and reinforcement, primarily marketed under the PDO Max Threads brand. The company also produces endoscopic applicator cannulas for delivering haemostatic agents or concentrates during surgical procedures, intended for single-use applications.
The company’s devices are classified under FDA regulations as Class I and Class II, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable domestic regulatory requirements for medical devices.
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 Max PDO Inc manufacture?
Max PDO Inc specializes in two primary device categories. First, they produce monofilament, bioabsorbable polyester sutures—specifically designed for soft tissue approximation and reinforcement—commonly sold under the PDO Max Threads brand. Second, they manufacture endoscopic applicator cannulas for delivering haemostatic agents or concentrates, intended for single-use in surgical settings. Both product lines focus on bioabsorbable and minimally invasive solutions.
Where is Max PDO Inc based, and how does this affect its regulatory compliance?
Max PDO Inc is based in the United States, which means its devices must comply with FDA regulations. Since the company’s products fall under FDA classifications (Class I or Class II), they are subject to U.S. domestic requirements for manufacturing, labeling, and post-market surveillance. The U.S. regulatory environment ensures devices meet safety and performance standards before entering the market.
Which regulatory registries or databases list Max PDO Inc’s devices?
Max PDO Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, a centralized system that tracks medical devices authorized for sale in the U.S. The UDI system helps ensure traceability, transparency, and compliance with FDA requirements. This listing is mandatory for Class I and Class II devices, including Max PDO Inc’s sutures and cannulas.
How are Max PDO Inc’s devices classified under FDA regulations?
Max PDO Inc’s devices are classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and require general controls (e.g., good manufacturing practices), while Class II devices may involve moderate risk and require additional performance standards or special controls. The classification depends on factors like intended use, potential harm, and the body’s interaction with the device, as defined by FDA guidelines.
What distinguishes Max PDO Inc’s PDO Max Threads from other sutures on the market?
PDO Max Threads are monofilament, bioabsorbable polyester sutures designed for soft tissue reinforcement and approximation. The key distinguishing features are their monofilament structure (reducing tissue drag) and bioabsorbable nature (eliminating the need for suture removal). These properties make them suitable for applications where long-term support is needed without permanent implantation, aligning with Max PDO Inc’s focus on minimally invasive and self-absorbing solutions.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 043570058
Catalogue (68)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PDO Max Threads | PM18100L-SE | FDA UDI | Class II | Active |
| PDO Max Threads | PM19100L-FE-BP | FDA UDI | Class II | Active |
| PDO Max Threads | PM3038S-S | FDA UDI | Class II | Active |
| PDO Max Threads | PM19100L-SC | FDA UDI | Class II | Active |
| PDO Max Threads | PM2690S-C | FDA UDI | Class II | Active |
| PDO Max Threads | PM2690S-C | FDA UDI | Class II | Active |
| PDO Max Threads | PM3025S-S | FDA UDI | Class II | Active |
| PDO Max Threads | PM2690S-S | FDA UDI | Class II | Active |
| PDO Max Threads | PM2925R-S | FDA UDI | Class II | Active |
| PDO Max Threads | PDO-FE-BL-02 | FDA UDI | Class II | Active |
| PDO Max Threads | PM18100L-FE-BP | FDA UDI | Class II | Active |
| PDO Max Threads | PM2938S-C | FDA UDI | Class II | Active |
| PDO Max Threads | PM2360L-MT | FDA UDI | Class II | Active |
| PDO Max Threads | PM2760S-C | FDA UDI | Class II | Active |
| PDO Max Threads | PM1860L-FE-BP | FDA UDI | Class II | Active |
| PDO Max Threads | PM19100W-SN | FDA UDI | Class II | Active |
| PDO Max Threads | PM2638S-C | FDA UDI | Class II | Active |
| PDO Max Cannula | YC-25-50 (UTW) | FDA UDI | Class I | Active |
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