Vanguard Medical Concepts, Inc.
United StatesFDA applicant, unverified
- Devices
- 33
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Vanguard Medical Concepts, Inc. makes
The company manufactures reprocessed single-use medical devices, including biopsy forceps, femoral compression devices, diagnostic electrophysiology catheters, compression garments, disposable cutters and staplers, dilating tip and blunt trocars, external fixation devices, and pulse oximeter sensors.
These devices are regulated under FDA 510(k) clearance requirements, spanning Class I, Class II, and Unclassified (U) categories. The portfolio is listed in the FDA’s 510(k) registry, and the company is based in the United States.
Catalogue
Search and filter all 33 devicesFDA recalls
FDA recall records list 1 recall initiated by Vanguard Medical Concepts, Inc., initiated on 2006-03-17. 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.
2006
- 17 Mar 2006 Z-1212-06 Unclassified (pre-2012) Terminated Review of complaints and testing show that the distal tip of the trocars may separate while in use.
Frequently asked questions
How many devices does Vanguard Medical Concepts, Inc. have in the registry?
The registry currently lists 33 devices for Vanguard Medical Concepts, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vanguard Medical Concepts, Inc.'s devices?
Among its 33 most recently registered devices, Vanguard Medical Concepts, Inc. has devices listed in FDA 510(k) (33 devices).
What risk classes do Vanguard Medical Concepts, Inc.'s devices fall under?
Among its 33 most recently registered devices, the classes recorded for Vanguard Medical Concepts, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vanguard Medical Concepts, Inc.?
FDA recall records list 1 recall initiated by Vanguard Medical Concepts, Inc., the most recent initiated on 17 Mar 2006. 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 Vanguard Medical Concepts, Inc. in the registry?
The most recently registered devices listed for Vanguard Medical Concepts, Inc. include VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS, VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE, VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS and VANGUARD REPROCESSED COMPRESSION GARMENT.