Surgical Appliance Industries, Inc.
United Statesfrom the FDA registration address FDA establishment FEI 1511629
- Devices
- 2,453
- Registrations
- FDA
- FDA recalls
- 2
What Surgical Appliance Industries, Inc. makes
Surgical Appliance Industries, Inc. manufactures compression and pressure socks and stockings, including the Truform® and NuVein product lines.
The company's devices are classified as Class II and are listed in the FDA UDI registry. Surgical Appliance Industries, Inc. is based in the US.
Catalogue
Search and filter all 2,453 devicesShowing 1-50 of 2,453
Company details
- FDA FEI number
- 1511629
- Address
- 3960 ROSSLYN DR., CINCINNATI, OH, 45209
FDA recalls
FDA recall records list 2 recalls initiated by SURGICAL APPLIANCE INDUSTRIES, INC., initiated on 2011-10-07. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 7 Oct 2011 Z-0391-2012 Unclassified (pre-2012) Terminated During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s
Full distribution text
- 7 Oct 2011 Z-0392-2012 Unclassified (pre-2012) Terminated During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s
Full distribution text
- 7 Oct 2011 Z-0391-2012 Unclassified (pre-2012) Terminated During an audit with the FDA, it was discovered that a new compression testing device used for testing hosiery had been implemented and that the operators were not properly trained. Additionally, the acceptance criteria for the new device were not changed from the old testing device to reflect additional data (compression profile percentages). This resulted in the device history files containing s
Frequently asked questions
How many devices does SURGICAL APPLIANCE INDUSTRIES, INC. have in the registry?
The registry currently lists 2453 devices for SURGICAL APPLIANCE INDUSTRIES, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list SURGICAL APPLIANCE INDUSTRIES, INC.'s devices?
Among its 50 most recently registered devices, SURGICAL APPLIANCE INDUSTRIES, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do SURGICAL APPLIANCE INDUSTRIES, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for SURGICAL APPLIANCE INDUSTRIES, INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for SURGICAL APPLIANCE INDUSTRIES, INC.?
FDA recall records list 2 recalls initiated by SURGICAL APPLIANCE INDUSTRIES, INC., the most recent initiated on 7 Oct 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 APPLIANCE INDUSTRIES, INC. in the registry?
The most recently registered devices listed for SURGICAL APPLIANCE INDUSTRIES, INC. include Truform® 31773ND-L, Truform® 1926BL-S, Truform® 1926BL-L and Truform® 1926BL-M.