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Sign in to claim this brandSCANLAN INTERNATIONAL INC
United States·US-MF-000010251
Last updated May 25, 2026
What SCANLAN INTERNATIONAL INC makes
SCANLAN International Inc manufactures surgical instruments designed for neurosurgery and vascular procedures, including needle holders, forceps, clamps, scissors, and vascular appliers. Their portfolio includes micro-forceps, temporary clipping tools, and specialized cutting instruments like the Kerrison Punch, tailored for precision in delicate surgical applications.
The company’s devices are classified under Class I in the EU regulatory framework and are listed in the eudamed database. SCANLAN International Inc is based in 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 SCANLAN International Inc manufacture?
SCANLAN International Inc specializes in surgical instruments used primarily in neurosurgery and vascular procedures. Their product line includes needle holders, forceps, clamps, scissors, vascular appliers, and specialized tools like the Kerrison Punch. These instruments are designed for precision in delicate surgical applications, such as micro-forceps for fine tissue manipulation or temporary clipping tools for vascular control.
Where is SCANLAN International Inc based?
SCANLAN International Inc is headquartered in the United States. The company’s location in the US influences its regulatory compliance framework, though individual devices must meet specific authorization requirements in each market where they are sold.
Which regulatory registries list SCANLAN International Inc’s devices?
SCANLAN International Inc’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This listing is required for transparency and traceability under EU regulations, particularly for Class I devices, which are subject to mandatory registration in eudamed.
How are SCANLAN International Inc’s devices classified under EU regulations?
SCANLAN International Inc’s devices fall under Class I classification in the EU regulatory framework. This classification applies to low-risk surgical instruments like needle holders, forceps, and scissors, which generally require less stringent pre-market evaluation compared to higher-risk devices. However, compliance with essential requirements and regulatory obligations (such as labeling and traceability) remains mandatory.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- One, Scanlan Plaza, Saint Paul, United States
- Website
- www.scanlaninternational.com
- —
- —
- [email protected]
- Phone
- +1 651-298-0997
- PRRC Contact
- Waylon Vanderpoel
- EUDAMED SRN
- US-MF-000010251
- FDA FEI Number
- —
- DUNS Number
- 023055619
Catalogue (2865)
Page 42 of 58| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SCANLAN® John Ross Tunneler System | 9009-35 | FDA UDI | Class I | Active |
| SCANLAN® Super Cut™ | 7007-226SC | EUDAMEDFDA UDI | Class I | Active |
| SCANLAN® Needle Holders | 3003-450 | EUDAMEDFDA UDI | Class I | Active |
| Scanlan® | 7007-64 | EUDAMEDFDA UDI | Class I | Active |
| SCANLAN® Minimally Invasive Instrumentation | 9009-620 | EUDAMEDFDA UDI | Class II | Active |
| SCANLAN® Aorta Vein Punch | 1001-05A | FDA UDI | Class I | Active |
| SCANLAN® Needle Holders | 3003-540 | FDA UDI | Class I | Active |
| SCANLAN® Needle Holders | 3003-381 | EUDAMEDFDA UDI | Class I | Active |
| SCANLAN® Suction System Devices | 9009-990 | FDA UDI | Class II | Active |
| Scanlan® | 3003-282 | EUDAMEDFDA UDI | Class II | Active |
| Scanlan® | 4386-02 | EUDAMEDFDA UDI | Class II | Active |
| Scanlan® | 5005-35 | EUDAMEDFDA UDI | Class II | Active |
| Scanlan® | 4378-14SP3 | EUDAMEDFDA UDI | Class II | Active |
| SCANLAN® Suction System Devices | 9009-909 | EUDAMEDFDA UDI | Class II | Active |
| Scanlan® | 7007-97 | EUDAMEDFDA UDI | Class I | Active |
| Scanlan® | 4377-28 | EUDAMEDFDA UDI | Class II | Active |
| SCANLAN® Minimally-Invasive Instrumentation | 9009-286 | FDA UDI | Class II | Active |
| SCANLAN® Instrument | 8008-410-02 | FDA UDI | Class I | Active |
| Scanlan® | 4510-10 | EUDAMEDFDA UDI | Class II | Active |
| SCANLAN® Dilators | Q99-1.5 | FDA UDI | Class II | Active |
| SCANLAN® Retractor | 8008-47 | EUDAMEDFDA UDI | Class I | Active |
| Scanlan® | 7007-51-1 | EUDAMEDFDA UDI | Class I | Active |
| Scanlan® | 9909-693 | FDA UDI | Class II | Active |
| SCANLAN® Super Cut™ | 7007-217-1SC | EUDAMEDFDA UDI | Class I | Active |
| SCANLAN® Forceps | 4004-80 | EUDAMEDFDA UDI | Class I | Active |
| Scanlan® SURG-I-PAW® Instrument Covers | 1001-72B | FDA UDI | Class I | Active |
| SCANLAN® Titanium Forceps | 3003-01 | EUDAMEDFDA UDI | Class II | Active |
| Scanlan® | 7007-252-5SC2 | FDA UDI | Class I | Active |
| SCANLAN® Advantage™ Badie™ Suction Bipolar Forceps | 4004-406 | FDA UDI | Class II | Active |
| Scanlan® VASCU-STATT® II Plus s-use bulldog clamp w/firm press Gentle-Jaw™ | 1001-584 | FDA UDI | Class I | Active |
| SCANLAN® Aorta Vein Punch | 1001-07 | FDA UDI | Class I | Active |
| SCANLAN® Super Cut™ | 7007-224-1SC | EUDAMEDFDA UDI | Class I | Active |
| SCANLAN® Forceps/Haemostats | 4377-08 | EUDAMEDFDA UDI | Class I | Active |
| Scanlan® SURG-I-LOOP® silicone loops | 1001-81M | EUDAMEDFDA UDI | Class I | Active |
| Scanlan® | 2002-58 | FDA UDI | Class II | Active |
| SCANLAN® Clamps | 2002-188-3 | FDA UDI | Class II | Active |
| SCANLAN® Needle Holders | 3003-383 | EUDAMEDFDA UDI | Class I | Active |
| SCANLAN® Vascu-Statt Appliers | 9009-506M | EUDAMEDFDA UDI | Class II | Active |
| SCANLAN® Minimally-Invasive Instrumentation | 9909-226 | EUDAMEDFDA UDI | Class II | Active |
| SCANLAN® Neuro Instruments | 3003-841 | FDA UDI | Class I | Active |
| SCANLAN® Scanturian™ MIS Instrument | 9019-724-25SC | EUDAMEDFDA UDI | Class II | Active |
| Scanlan® | 9909-614 | EUDAMEDFDA UDI | Class II | Active |
| SCANLAN® Super Cut™ | 7007-218-2 | EUDAMEDFDA UDI | Class I | Active |
| Scanlan® | 7007-13 | EUDAMEDFDA UDI | Class I | Active |
| SCANLAN® Jacobson Micro Scissors | 7007-452 | FDA UDI | Class I | Active |
| Scanlan® | 7007-44F | EUDAMEDFDA UDI | Class I | Active |
| Scanlan® | 7007-48-5 | EUDAMEDFDA UDI | Class I | Active |
| SCANLAN® Rongeur | 8008-405 | EUDAMEDFDA UDI | Class I | Active |
| SCANLAN® Retractor | 1001-10-01 | FDA UDI | Class I | Active |
| Scanlan® | 3003-611 | EUDAMEDFDA UDI | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Scanlan International Inc. has one FDA recall record initiated on February 19, 2007, which is listed with a terminated status. The reason provided for the recall was that the product was incorrectly assembled by the manufacturer.
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 |
|---|---|---|---|---|
| Feb 19, 2007 | Z-0701-2007 | — | terminated | Incorrectly assembled by manufacturer |