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 | K034025 | NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC | 2004-03-26 |
| US | K994191 | SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T | 2000-02-08 |
| CA | 22864 | CARDIOSEAL | Class IV |
| CA | 64293 | NMT TRANSSEPTAL SHEATH SET | Class II |
| CA | 74215 | BIOSTAR SEPTAL REPAIR IMPLANT | Class IV |