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Sign in to claim this brandOlsen Medical
US
Last updated May 23, 2026
What Olsen Medical makes
Olsen Medical produces electrosurgical handpieces and electrodes for open-surgery procedures, including bipolar and monopolar reusable and single-use variants, as well as reusable and single-use electrical connection cables for medical devices.
The company’s products are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Olsen Medical operates from the United States.
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 Olsen Medical manufacture?
Olsen Medical specializes in electrosurgical handpieces and electrodes designed for open-surgery applications. Their portfolio includes bipolar and monopolar reusable and single-use handpieces/electrodes, as well as reusable and single-use electrical connection cables for medical devices. These products are primarily used in surgical settings to facilitate precise tissue manipulation and cutting.
Where is Olsen Medical based, and does this affect its regulatory standing?
Olsen Medical is headquartered in the United States. The company’s location influences its regulatory framework, as it operates under FDA guidelines. However, regulatory status depends on individual devices, not the company itself, and must be verified through official FDA listings or device-specific authorizations.
Which regulatory registries or databases list Olsen Medical’s devices?
Olsen Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry provides transparency on device identification, classification, and manufacturer details, allowing healthcare providers and regulators to verify specific product information independently.
How are Olsen Medical’s devices classified under FDA regulations?
Olsen Medical’s devices fall under FDA’s Class I and Class II categories. Class I generally includes low-risk devices requiring general controls, while Class II involves additional performance standards or special controls. Classification determines the regulatory pathway for authorization, with Class II often requiring pre-market notifications or submissions to ensure safety and effectiveness.
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
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Catalogue (1255)
Page 11 of 26| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Boston Scientific | M00561500 | FDA UDI | Class II | Active |
| Symmetry Olsen | 40-5105-28 | FDA UDI | Class II | Active |
| Symmetry Olsen | 44005 | FDA UDI | Class II | Active |
| Symmetry Surgical | e2401-50 | FDA UDI | Class I | Active |
| Symmetry Olsen | 68005 | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1445KI | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1384KI | FDA UDI | Class II | Active |
| Symmetry Olsen | 11600S | FDA UDI | Class II | Active |
| Symmetry Olsen | 80502 | FDA UDI | Class II | Active |
| Symmetry Olsen | 44000 | FDA UDI | Class II | Active |
| Symmetry Olsen | 68502 | FDA UDI | Class II | Active |
| Symmetry Olsen | 68200 | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1440K-28 | FDA UDI | Class II | Active |
| Symmetry Olsen | 08-0013IG | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1030K-28 | FDA UDI | Class II | Active |
| Symmetry Olsen | 11213 | FDA UDI | Class II | Active |
| Symmetry Olsen | 42409 | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1010KI | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1375K-28 | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1180K-28 | FDA UDI | Class II | Active |
| Symmetry Olsen | 66000 | FDA UDI | Class II | Active |
| Symmetry Olsen | 11903 | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1484 | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-0571IMT | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1520K | FDA UDI | Class II | Active |
| Symmetry Olsen | 10-0201I | FDA UDI | Class II | Active |
| Symmetry Olsen | 10-0431I | FDA UDI | Class II | Active |
| Symmetry Olsen | 80582 | FDA UDI | Class II | Active |
| Symmetry Olsen | 10-0211IMT | FDA UDI | Class II | Active |
| Symmetry Olsen | 12104 | FDA UDI | Class II | Active |
| Symmetry Olsen | 90067 | FDA UDI | Class II | Active |
| Symmetry Olsen | 97117BX | FDA UDI | Class II | Active |
| Symmetry Olsen | 66302 | FDA UDI | Class II | Active |
| Symmetry Olsen | 97115 | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1560K-28 | FDA UDI | Class II | Active |
| Symmetry Olsen | 90-7007 | FDA UDI | Class II | Active |
| Symmetry Olsen | 10-0371I | FDA UDI | Class II | Active |
| Boston Scientific | M00561450 | FDA UDI | Class II | Active |
| Symmetry Olsen | 96200 | FDA UDI | Class II | Active |
| Symmetry Olsen | 97114 | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1486K-28 | FDA UDI | Class II | Active |
| Symmetry Olsen | 20-1340I | FDA UDI | Class II | Active |
| Symmetry Olsen | 11205 | FDA UDI | Class II | Active |
| Symmetry Olsen | 75540 | FDA UDI | Class II | Active |
| Symmetry Olsen | 41301 | FDA UDI | Class II | Active |
| Symmetry Olsen | 12006 | FDA UDI | Class II | Active |
| Symmetry Surgical | e2401-52 | FDA UDI | Class I | Active |
| Symmetry Olsen | 20-1540KI-28 | FDA UDI | Class II | Active |
| Symmetry Olsen | 66206 | FDA UDI | Class II | Active |
| Symmetry Olsen | 80201 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Olsen Medical has six FDA recall records, all initiated between August 29, 2006, and May 11, 2018, with all records marked as terminated. The reasons cited include potential detachment of electrodes from electrosurgical devices, which could affect patient or user safety, and products that may compromise sterile pouch seals. No other recall reasons were documented.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 11, 2018 | Z-1942-2018 | — | terminated | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. |
| May 11, 2018 | Z-1941-2018 | — | terminated | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. |
| May 11, 2018 | Z-1943-2018 | — | terminated | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. |
| May 11, 2018 | Z-1945-2018 | — | terminated | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. |
| May 11, 2018 | Z-1944-2018 | — | terminated | Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. |
| Aug 29, 2006 | Z-0182-2007 | — | terminated | Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user. |