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.
Catalogue
Search and filter all 718 devicesShowing 1-50 of 718
Company details
- FDA FEI number
- 3001236105
- Address
- 7351-D LOCKPORT PL., LORTON, VA, 22079
FDA recalls
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.
2011
- 26 Jan 2011 Z-2153-2011 Unclassified (pre-2012) Terminated Medical device used in surgical procedure is defective and may break during use.
Frequently asked questions
How many devices does SURGICAL DESIGN, INC. have in the registry?
The registry currently lists 718 devices for SURGICAL DESIGN, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SURGICAL DESIGN, INC.'s devices?
Among its 50 most recently registered devices, SURGICAL DESIGN, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do SURGICAL DESIGN, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for SURGICAL DESIGN, INC.'s devices are Class I. Each device page shows its own class and authorisation.
Are there FDA recall records for SURGICAL DESIGN, INC.?
FDA recall records list 1 recall initiated by SURGICAL DESIGN, INC., the most recent initiated on 26 Jan 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from SURGICAL DESIGN, INC. in the registry?
The most recently registered devices listed for SURGICAL DESIGN, INC. include Surgical Design SD-DS-SS-10-BX, Surgical Design SD-DS-SS-11-BX, Surgical Design SD-DS-SS-12B-BX and Surgical Design SD-DS-SS-12-BX.