Vygon Us, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- 510(k) 510(k)
Vygon Nutriline And Nutriline Twinflow Catheters Ref K052475
510(k) 510(k)Packaging Tray And Components Ref K040707
510(k) 510(k)
FDA recalls
2003
- 9 Sep 2003 Z-0160-04 Unclassified (pre-2012) Terminated mislabeled as sterile
Full distribution text
- 9 Sep 2003 Z-0161-04 Unclassified (pre-2012) Terminated mislabeled as sterile
Full distribution text
- 9 Sep 2003 Z-0160-04 Unclassified (pre-2012) Terminated mislabeled as sterile
Frequently asked questions
How many devices does Vygon Us, LLC have in the registry?
The registry currently lists 3 devices for Vygon Us, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vygon Us, LLC's devices?
Among its 3 most recently registered devices, Vygon Us, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Vygon Us, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Vygon Us, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vygon Us, LLC?
FDA recall records list 2 recalls initiated by Vygon Us, LLC, the most recent initiated on 2003-09-09. 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 Vygon Us, LLC in the registry?
The most recently registered devices listed for Vygon Us, LLC include MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS, VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS and PACKAGING TRAY AND COMPONENTS.