# Orbus Medical Technologies

- Location (FDA's records): Fort Lauderdale, FL
- FDA decisions: 8 (2001–2004): 8 510(k) clearances
- Product codes: FGE (8)
- Predicates its devices cite: 7 (6 its own); citations of its devices by later devices: 14 (6 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Vas-Cath, Inc.: 1 (https://510kreport.com/company/vas-cath)

## Firms that cite its devices most
- Edwards Lifesciences, LLC: 6 (https://510kreport.com/company/edwards-lifesciences)
- Cook, Inc.: 2 (https://510kreport.com/company/cook)

## Its most-cited devices
- K023248: Lifestent LP SDS Biliary Endoprosthesis (2003), cited by 4
- K023308: Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary Endoprosthesis (2003), cited by 3
- K033212: Lifestent SDS Biliary Endoprosthesis (2003), cited by 2
- K041032: Modification to Lifestent SDS and XL SDS Biliary Endoprosthesis (2004), cited by 1
- K040550: Lifestent SDS and XL SDS Biliary Endoprosthesis (2004), cited by 1
- K041370: Lifestent LP SDS Biliary Endoprosthesis (2004), cited by 1

## Recent decisions
- K041370: Lifestent LP SDS Biliary Endoprosthesis (Jun 24, 2004)
- K041032: Modification to Lifestent SDS and XL SDS Biliary Endoprosthesis (May 10, 2004)
- K040550: Lifestent SDS and XL SDS Biliary Endoprosthesis (Mar 16, 2004)
- K033212: Lifestent SDS Biliary Endoprosthesis (Oct 30, 2003)
- K023308: Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary Endoprosthesis (Apr 14, 2003)
- K023121: Lifestent Biliary Endoprosthesis (Mar 10, 2003)
- K023248: Lifestent LP SDS Biliary Endoprosthesis (Feb 11, 2003)
- K010107: R Stent Biliary Endoprosthesis (Jul 31, 2001)

Source page: https://510kreport.com/company/orbus-medical-technologies