Orbus Medical Technologies
Country not established
- Devices
- 8
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Orbus Medical Technologies makes
Orbus Medical Technologies manufactures biliary endoprostheses, including self-expanding stent designs such as the LIFESTENT and R STENT series. These devices are intended for biliary drainage in patients with obstructive conditions, including malignant or benign strictures. Variations include standard, long-profile (LP), and SDS (short delivery system) configurations, as well as modifications for specific clinical needs.
The company’s biliary endoprostheses are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory clearance for commercial distribution in the US. The company is headquartered in the United States.
Catalogue
Lifestent LP Sds Biliary Endoprosthesis Ref K023248
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Lifestent Biliary Endoprosthesis Ref K023121
Regimes: 510(k) Registry: 510(k)Lifestent Sds Biliary Endoprosthesis Ref K033212
Regimes: 510(k) Registry: 510(k)Lifestent LP Sds Biliary Endoprosthesis Ref K041370
Regimes: 510(k) Registry: 510(k)R Stent Biliary Endoprosthesis Ref K010107
Regimes: 510(k) Registry: 510(k)Lifestent Sds And Xl Sds Biliary Endoprosthesis Ref K040550
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Orbus Medical Technologies, initiated on 2004-03-19. By recorded status: 1 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.
2004
- 19 Mar 2004 Z-1075-04 Unclassified (pre-2012) Terminated BALLOONS HAVE LONGER THAN EXPECTED DEFLATION TIMES.
Frequently asked questions
How many devices does Orbus Medical Technologies have in the registry?
The registry currently lists 8 devices for Orbus Medical Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orbus Medical Technologies's devices?
Among its 8 most recently registered devices, Orbus Medical Technologies has devices listed in FDA 510(k) (8 devices).
What risk classes do Orbus Medical Technologies's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Orbus Medical Technologies's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Orbus Medical Technologies?
FDA recall records list 1 recall initiated by Orbus Medical Technologies, the most recent initiated on 19 Mar 2004. 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 Orbus Medical Technologies in the registry?
The most recently registered devices listed for Orbus Medical Technologies include LIFESTENT LP SDS BILIARY ENDOPROSTHESIS, LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS, LIFESTENT BILIARY ENDOPROSTHESIS and LIFESTENT SDS BILIARY ENDOPROSTHESIS.