This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | 2026-06-29 |
| US | K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter | 2024-10-11 |
| US | K190478 | Reprocessed ViewFlex Xtra ICE Catheter | 2019-11-14 |
| CA | 98143 | REPROCESSED VESSEL SEALER/DIVIDER | Class II |
| CA | 99691 | REPROCESSED LAPAROSCOPIC ELECTRICAL INSTRUMENTS | Class II |
| CA | 99692 | REPROCESSED LAPAROSCOPIC ELECTRICAL INSTRUMENTS | Class II |