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Sign in to claim this brandOsmed, Inc.
US
Last updated May 23, 2026
What Osmed, Inc. makes
Osmed, Inc. manufactures skin-port tissue expanders designed for reconstructive and aesthetic surgical applications. Their portfolio includes expanders shaped as orbital, hemisphere, and sphere configurations, as well as hemi socket variants, which are implanted to gradually stretch skin and tissue for subsequent surgical procedures.
The company’s devices are regulated under FDA classifications, with some authorised as Class II and others as Class III. These products are listed under the FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) programs, reflecting their compliance with US medical device regulations.
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 Osmed, Inc. manufacture?
Osmed, Inc. specializes in skin-port tissue expanders, which are used in reconstructive and aesthetic surgery. These devices come in various shapes, including orbital, hemisphere, sphere, and hemi socket configurations, allowing surgeons to gradually stretch skin and tissue for later surgical procedures like reconstruction or contouring.
Where is Osmed, Inc. based?
Osmed, Inc. is headquartered in the United States. The company’s focus on tissue expanders aligns with US regulatory frameworks, including FDA oversight.
Which regulatory registries or databases list Osmed’s devices?
Osmed’s devices are listed under the FDA’s Premarket Approval (PMA) program and the Unique Device Identification (UDI) system. These registries ensure traceability and compliance with US medical device regulations, particularly for Class II and Class III devices.
How are Osmed’s tissue expanders classified under FDA regulations?
Osmed’s tissue expanders fall into Class II and Class III categories under FDA regulations. Class II devices generally pose moderate risk and require special controls beyond general controls, while Class III devices are higher risk and typically require Premarket Approval (PMA) due to insufficient data from lesser stringent classifications.
Why do some of Osmed’s devices require Class III classification?
The Class III classification for certain Osmed devices is likely due to their higher risk profile, such as sustained implantation, potential complications (e.g., infection, rupture), or lack of a well-established history of safety and effectiveness. Under FDA guidelines, devices in this category—like some tissue expanders—require scientific evidence of safety and efficacy through a Premarket Approval (PMA) process to ensure patient safety before market authorization.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (21)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| osmed Orbital Expander | 4.0ml | FDA UDI | Class II | Active |
| osmed Hemisphere Expander | 0.9ml | FDA UDI | Class II | Active |
| osmed Hemisphere Expander | 0.4ml | FDA UDI | Class II | Active |
| osmed Orbital Expander | 1.0ml | FDA UDI | Class II | Active |
| osmed Hemi Socket Expander | 1.5ml | FDA UDI | Class II | Active |
| osmed Hemisphere Expander | 1.5ml | FDA UDI | Class II | Active |
| osmed Hemi Socket Expander | 2.0ml | FDA UDI | Class II | Active |
| osmed Sphere Expander | 1.0ml | FDA UDI | Class II | Active |
| osmed Hemi Socket Expander | 0.4ml | FDA UDI | Class II | Active |
| osmed Sphere Expander | 4.0ml | FDA UDI | Class II | Active |
| osmed Sphere Expander | 5.0ml | FDA UDI | Class II | Active |
| osmed Sphere Expander | 2.0ml | FDA UDI | Class II | Active |
| osmed Orbital Expander | 5.0ml | FDA UDI | Class II | Active |
| osmed Orbital Expander | 2.0ml | FDA UDI | Class II | Active |
| osmed Hemisphere Expander | 0.9ml parallel | FDA UDI | Class II | Active |
| osmed Hemi Socket Expander | 0.9ml parallel | FDA UDI | Class II | Active |
| osmed Hemi Socket Expander | 0.9ml | FDA UDI | Class II | Active |
| osmed Sphere Expander | 3.0ml | FDA UDI | Class II | Active |
| osmed Hemisphere Expander | 2.0ml | FDA UDI | Class II | Active |
| osmed Orbital Expander | 3.0ml | FDA UDI | Class II | Active |
| Drilac Cubes And Granules | P800012 | FDA PMA | Class III | Active |
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