Surgical Design, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 3001236105

Devices: 718
Registrations: FDA
FDA recalls: 1

What Surgical Design, Inc. makes

Surgical Design, Inc. manufactures surgical clamps and ocular surgical devices, including the OCUSYSTEM ART ADVANTAGE (Model 995), a precision instrument for eye procedures, and the Circumcision Clamp for pediatric surgical applications. The company also produces the Model 700 Low Pressure Mattress, a surgical fixation device designed for wound stabilization.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

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Company details

FDA FEI number: 3001236105
Address: 7351-D LOCKPORT PL., LORTON, VA, 22079

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by SURGICAL DESIGN, INC., initiated on 2011-01-26. By recorded status: 1 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

2011
- 26 Jan 2011 Z-2153-2011 Unclassified (pre-2012) Terminated Medical device used in surgical procedure is defective and may break during use. Distribution: Class 2 Recall -- Nationwide Distribution. Submission number: K043533

This is an FDA establishment record. No EUDAMED registration is known for this company.